Other Countries Are Not Paying Their Fair Share of the Cost of Biopharmaceutical Innovation ― What Can the United States Do to Change That?

The U.S. has long been the global leader in biopharmaceutical innovation, investing in research and development that has led to breakthrough treatments and life-saving medications that have extended both the length and quality of life of patients around the world. Yet many developed countries pay only a fraction of what Americans do for these medical miracles ― effectively leaving the U.S. to shoulder the cost. This system of global freeriding is plainly inequitable and places a disproportionate burden on American patients and the American healthcare system. This is not a new or surprising issue ― it is well established that the U.S. generally pays significantly more for patented prescription medications than other developed nations. The question is why and what can be done about it?

PBMs, Policy Risk and Biopharma’s Future

In this Vital Health Podcast, host Duane Schulthess speaks with Jocelyn Ulrich, Vice President of Policy and Research at PhRMA, to discuss the far-reaching implications of current U.S. drug pricing and reimbursement policies. With a unique journey from opera stages to Senate testimony, Ulrich brings both strategic acumen and firsthand experience in navigating complex policy terrain. The conversation explores PBM consolidation, the fallout from the Inflation Reduction Act, vertical integration in biosimilars and looming tariff threats — all through the lens of innovation, patient access and economic resilience.

Beyond the Sloganeering — A Data-Driven Analysis of Recent 340B Growth

The 340B Drug Discount Program (340B program) obligates drug makers to sell their outpatient drugs to a wide range of providers at heavily discounted prices. The 340B program has tripled in size over the last decade, even as the vulnerable patient population it was ultimately created to serve has halved, and in 2024, it reached $148 billion as measured by the list price value of the products sold. The Health Resources and Services Administration (HRSA), the agency responsible for the program’s oversight, recently announced that the program grew by 24% over the course of just one year in 2023. A number of commercial insurers, managed care plans and employers have criticized the growth of the program. Prior studies have shown that 340B program growth increases costs to payers, including employers, because payers pay undiscounted reimbursements to 340B providers for the sharply discounted drugs that they receive from drug manufacturers. 

The Bayh-Dole Act’s Role in Stimulating University-Led Regional Economic Growth

Universities play a pivotal role in America’s technology economy, serving as a crucial source of research, inventions, patents, start-up technology companies, and regional economic and employment growth. In fact, the impact of academic technology transfer from U.S. universities has been so extensive that, from 1996 to 2020, it resulted in 554,000 inventions disclosed, 141,000 U.S. patents granted, and 18,000 start-ups formed. Moreover, academic technology transfer has bolstered U.S. gross domestic product (GDP) by up to $1 trillion, contributed to $1.9 trillion in gross U.S. industrial output, and supported 6.5 million jobs over that time. But it wasn’t always that way. That American universities have been transformed into engines of innovation and powerful catalysts of regional economic growth has been in no small part the result of seminal bipartisan legislation introduced in 1980 called the Patent and Trademark Law Amendments Act, better known as the “Bayh-Dole Act.”

Price-Setting Policies: A Threat to Innovation & Patient Access

As featured in ROI-NJ

Although proponents argue that government-imposed price controls on prescription drugs help reduce healthcare costs, such policies often have unintended consequences — undermining innovation and limiting patient access to new treatments. Government intervention in healthcare pricing can weaken the economic incentives that fuel medical research and development. Therefore, the stakes couldn’t be higher for New Jersey, where the life sciences sector employs thousands and contributes billions to the U.S. economy. Biopharmaceutical companies with a footprint in our State represent an innovation powerhouse, with over 5,400 life sciences establishments developing groundbreaking treatments that support patients worldwide. For the many families waiting for a cure, stalling innovation can mean ongoing stress, lower quality of life or a lack of any viable treatment option altogether. Furthermore, price controls can adversely affect patient access to treatments currently on the market, by increasing access barriers through the practices of health system middlemen and complicating the patient journey to care.  

Life Sciences Workforce Collaborative (LSWC) Officially Launches to Strengthen Talent Pipelines Across the U.S.

The Life Sciences Workforce Collaborative (LSWC) formally announced its debut at the 2025 BIO International Convention. Formerly known as the Coalition of State Bioscience Institutes (CSBI), the LSWC brings together more than 50 state and regional life sciences associations and workforce leaders to scale industry-led solutions to talent development across the U.S. As the life sciences industry navigates macroeconomic shifts, disruptive technologies and continued and projected (or anticipated) shortages in biomanufacturing and regulatory talent, the Life Sciences Workforce Collaborative now enters the field as a formal 501(c)(3) nonprofit. The LSWC thanks its Investor-level supporters: AZBio/AZ Advances, BioNJ, BioUtah, California Life Sciences, Colorado Bioscience Association / Institute, Georgia Life Sciences / Institute, MichBio, NewYorkBIO, Ohio Life Sciences, Oregon Bio, SCbio and SoCalBio.

2025 New Jersey Life Sciences Report

In New Jersey, life sciences businesses find comprehensive support to flourish and an ecosystem that fosters rapid growth. We are home to more scientists and engineers per square mile than anywhere in the country. Our premier universities and world-class training programs keep our workforce ahead in this ever-evolving industry, and we have the space for companies to grow at our top-tier R&D and manufacturing spaces, including repurposed legacy sites that are business-ready and cost-effective. Our robust infrastructure offers early stage and established companies operational flexibility and significant cost savings. In collaboration with BioNJ, the New Jersey Economic Development Authority and commercial real estate and investment management firm JLL, Choose New Jersey has developed a comprehensive report on New Jersey’s life sciences industry. Check it out here.

RegenLab USA’s New R&D and Manufacturing Facility Opens in Jersey City

Medical Device Innovator Plans to Hire 150 Additional Employees

RegenLab USA, a pioneering medical device company specializing in autologous regenerative medicine and tissue engineering, has chosen Jersey City, New Jersey, for its state-of-the-art R&D and manufacturing facility, further solidifying New Jersey’s reputation as a global leader in life sciences innovation. BioNJ was excited to be part of the celebration as the company celebrated the grand opening of the new research and manufacturing facility with a ribbon-cutting ceremony. “The presence of multiple academic institutions in New Jersey provides invaluable collaboration opportunities for in vitro and ex vivo studies that will accelerate our research,” said Antoine Turzi, Founder & President of RegenLab USA. “We chose New Jersey because of its unmatched access to scientific talent, a thriving innovation ecosystem and a strategic location near major metropolitan hubs.”

ProBio Celebrates Opening of Plasmid & Viral Vector Center of Excellence in Hopewell

ProBio hosted a ribbon cutting ceremony for the launch of its Plasmid & Viral Vector Center of Excellence in Hopewell ― a 128,000-square-foot GMP facility designed to accelerate high-quality plasmid and viral vector manufacturing to support the next generation of advanced therapies. The facility will serve as the hub for ProBio’s North American operations, enhancing the company’s capability to support the manufacturing of life-changing cell and gene therapies in North America. The Hopewell site will support more than 100 high paying jobs in myriad roles such as process development, GMP manufacturing, quality control, supply chain and engineering. Debbie Hart, President and CEO of BioNJ, was honored to take part in the ribbon-cutting ceremony, expressing heartfelt gratitude to ProBio for choosing New Jersey as the home for its vital and impactful work.

Ferring Debuts Gene Therapy Manufacturing Facility in Parsippany

BioNJ was on hand for Ferring Pharmaceutical's ribbon-cutting ceremony for its new 12,000-square-foot gene therapy manufacturing facility located within its U.S. headquarters in Parsippany. The new facility is producing ADSTILADRIN, the first and only FDA-approved gene therapy delivered directly to the bladder for high-risk, non–muscle-invasive bladder cancer (NMIBC). The treatment is given to patients when Bacillus Calmette-Guérin (BCG) is no longer effective. ADSTILADRIN is delivered via a catheter and is given every three months, unlike many gene therapies which are one-and-done treatments. Ferring’s vision for ADSTILADRIN production is for the company’s manufacturing facilities in Finland to develop the therapy’s drug substance (the active ingredient) globally, while the Parsippany location will be the primary site for the drug product (the finished dosage) globally.

NJBIZ Conversations: SpotitEarly CEO Shlomi Madar

Getting screened for cancer is daunting and scary. You know what would make it less daunting and scary? If dogs were involved. At SpotitEarly, a cancer diagnostic startup based in Englewood, dogs are very involved. SpotitEarly uses dogs to diagnose four common types of cancer: lung, breast, colorectal and prostate. When the system is operational, patients will provide a breath sample that the company’s dogs will smell. The animals’ behavior lets the testers know whether the cancer is present. According to SpotitEarly, “The Rainbow Study, a large-scale observational double blind clinical performance trial, measured the effectiveness and accuracy of SpotitEarly’s breath test in detecting the four most common types of cancer at various stages, using breath samples.” In the study, the dogs scored 93.9% on sensitivity and 94.3% on specificity for the four types. In this edition of NJBIZ Conversations, SpotitEarly CEO Shlomi Madar, fresh off an appearance at BioNJ‘s BioPartnering Conference in Jersey City, elaborates on the company’s technology and where it goes from here.

NJ Offers the Tools for Innovative & Economic Success

As featured in New Jersey Business Magazine

New Jersey is advancing as a national innovation leader through strategic initiatives led by organizations, such as the New Jersey Economic Development Authority (NJEDA), the Commission on Science, Innovation and Technology (CSIT), BioNJ and the Research & Development Council of New Jersey. These organizations collectively support startups, the life sciences and other technology sectors by providing funding and tax credit incentives, government advocacy, networking and partnering opportunities, workforce development initiatives and more. In a time marked by uncertainty, where disruption, change and an array of unknowns are seemingly the only constants, it is essential for an industry to have a guiding force that can unite the community, inspire collaboration and lead the charge in navigating challenges while shaping a dynamic future. This is the role that BioNJ plays within New Jersey’s life sciences ecosystem, offering the unwavering support and leadership needed to help propel the sector forward.

Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir)—the company’s injectable HIV-1 capsid inhibitor—as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the United States for people who need or want PrEP. Data show that ≥99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative. The first PrEP medication, which was also developed by Gilead, was approved in the U.S. in 2012. However, data from the Centers for Disease Control and Prevention (CDC) show that, in 2022 (the most recent year with available data), only about 1 in 3 (36%) people in the U.S. who met the CDC’s eligibility criteria for PrEP were prescribed a form of PrEP. 

Insmed Announces Positive Topline Results from Phase 2b Study of Treprostinil Palmitil Inhalation Powder (TPIP) as Once-Daily Therapy in Patients With Pulmonary Arterial Hypertension

Bridgewater-based BioNJ Member Insmed Incorporated announced positive topline results from its randomized, double-blind, placebo-controlled Phase 2b study evaluating the efficacy and safety of treprostinil palmitil inhalation powder (TPIP), administered once daily in patients with pulmonary arterial hypertension (PAH, World Health Organization Group 1). The study met its primary endpoint and all secondary efficacy endpoints. For the primary endpoint, the placebo-adjusted reduction from baseline in pulmonary vascular resistance (PVR) was 35% with Least Squares (LS) mean ratio of 0.65 (95% CI: 0.54, 0.79; p<0.001). For the secondary efficacy endpoints, the placebo-adjusted improvement in six-minute walk distance (6MWD) was 35.5 meters (95% CI: 11.2, 60.7; p=0.003) and the placebo-adjusted reduction from baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) concentrations, a biomarker for cardiac stress, was 60% with LS mean ratio of 0.40 (95% CI: 0.27, 0.59; p<0.001).

Phathom Pharmaceuticals Announces Positive FDA Decision to Recognize 10 Years of Regulatory Exclusivity for VOQUEZNA® (vonoprazan) Tablets through May 3, 2032

Florham Park-Based BioNJ Member Phathom Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Phathom’s Citizen Petition filed on December 11, 2024 and communicated the Agency’s intention to correct the Orange Book to recognize the proper 10 years of New Chemical Entity exclusivity for VOQUEZNA® (vonoprazan) tablets, extending through May 3, 2032. Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB) that is currently marketed in the United States as VOQUEZNA® (vonoprazan) tablets for the relief of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and relief of associated heartburn, in addition to VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. 

TransCon® hGH Boosted Treatment Benefits of TransCon® CNP in Children With Achondroplasia at Week 26 Interim Analysis of the Phase 2 COACH Trial

BioNJ Member Ascendis Pharma, with a site in Princeton, announced Week 26 interim analysis results from its ongoing COACH Trial, the first clinical trial to evaluate combination treatment with once-weekly investigational TransCon CNP (navepegritide) and once-weekly TransCon hGH (lonapegsomatropin) in children with achondroplasia. Results demonstrated that TransCon hGH boosted treatment benefits of TransCon CNP, resulting in significant growth and proportionality improvements in children with achondroplasia after 26 weeks of combination treatment, with a safety and tolerability profile consistent with those observed for TransCon hGH and TransCon CNP monotherapies. TransCon CNP, which is under priority review as a monotherapy for children with achondroplasia by the U.S. Food & Drug Administration (FDA), is an investigational prodrug of C-type natriuretic peptide (CNP) administered once weekly, providing continuous exposure of active CNP to receptors on tissues throughout the body.

FDA Accepts TransCon® CNP NDA for Priority Review

BioNJ Member Ascendis Pharma, with a site in Princeton, announced that the U.S. Food & Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for TransCon CNP (navepegritide) for the treatment of children with achondroplasia and has set a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2025 to complete its review. The FDA also informed Ascendis that they are not currently planning to hold an advisory committee meeting to discuss this application. TransCon CNP is an investigational prodrug of C-type natriuretic peptide (CNP) administered once weekly and designed to treat people living with achondroplasia by providing continuous exposure of active CNP to receptors on tissues throughout the body, including growth plates and skeletal muscle.

U.S. FDA Approves Tablet Formulation of BeOne’s BRUKINSA® for All Approved Indications

Hopewell-based BioNJ Member BeOne Medicines Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of BRUKINSA® (zanubrutinib) for all five approved indications. BRUKINSA remains the leader in new chronic lymphocytic leukemia (CLL) patient starts across all lines of therapy in the U.S., and for the first time, has become the overall BTK inhibitor market share leader. BRUKINSA tablets have the same efficacy and safety as BRUKINSA capsules based on the results of two single-dose, open-label, randomized Phase 1 crossover studies of healthy adults designed to establish bioequivalence. BRUKINSA is the only BTK inhibitor to offer the flexibility of once or twice daily dosing, with the ability to tailor the schedule to patient needs.

BioAegis Therapeutics Receives FDA Fast Track Designation for Lead Product, Recombinant Human Gelsolin, for the Treatment of Acute Respiratory Distress Syndrome (ARDS)

North Brunswick-based BioNJ Member BioAegis Therapeutics announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate, recombinant human plasma gelsolin (rhu-pGSN) for the treatment of acute respiratory distress syndrome (ARDS). The company’s portfolio is built around gelsolin, a highly conserved and critical immune regulatory protein which rebalances dysfunctional inflammation without suppressing immune function. For BioAegis, this designation highlights the therapeutic promise of rhu-pGSN and provides a clear regulatory pathway to expedite its development as a treatment for ARDS. ARDS is a life-threatening condition marked by severe pulmonary inflammation and fluid accumulation in the lungs. Even with aggressive medical management, 40% of ARDS patients do not survive, and those who do may suffer from long-term complications, including impaired lung function and reduced quality of life.

BioAegis Therapeutics Announces U.S. Navy Contract to Support Phase 2 Study of Recombinant Human Gelsolin, for Inflammasome-Driven Decompression Sickness (DCS)

North Brunswick-based BioNJ Member BioAegis Therapeutics announces that it will conduct a Phase 2 study of rhu-pGSN for decompression sickness (DCS) under a contract awarded by the U.S. Navy’s Office of Naval Research to the University of Maryland School of Medicine (UMSOM). This work is the culmination of an extended collaboration with Dr. Stephen Thom, Professor of Emergency Medicine at UMSOM. The company’s portfolio is built around gelsolin, a highly conserved and critical immune regulatory protein which rebalances dysfunctional inflammation without suppressing immune function. The study, “Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers,” NCT06216366 is being conducted under a contract with the Office of Naval Research with the University of Maryland.

Celldex Presents Data Demonstrating Profound Long-Term Improvement in Angioedema in Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EAACI 2025

Hampton-based BioNJ Member Celldex announced data demonstrating that barzolvolimab profoundly improves angioedema at 52 weeks in the company’s Phase 2 clinical trial in chronic spontaneous urticaria (CSU). Angioedema, characterized by swelling of the deeper dermal layers of the skin and mucous membranes, is a painful, debilitating symptom of CSU that has significant impact on quality of life. It commonly affects the face (lips and eyelids), hands, feet, and genitalia but can also involve the tongue, uvula, soft palate and pharynx. The data presented further support these results by demonstrating improvements in AAS7 (weekly angioedema activity score) and additional measures of angioedema control over the 52 week treatment period. AAS7 measures the frequency and intensity of angioedema episodes, where higher scores indicate increased angioedema activity.

Celldex Presents Unprecedented 76 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EAACI Congress 2025

Hampton-based BioNJ Member Celldex announced new data demonstrating profound, sustained complete response and improved quality of life at 76 weeks, 7 months after the completion of dosing with barzolvolimab in chronic spontaneous urticaria (CSU), an immune-related condition driven by mast cell activation. Barzolvolimab specifically targets mast cells by binding the receptor tyrosine kinase KIT with high specificity and potently inhibiting its activity, which is required for mast cell function and survival. The company previously announced that this Phase 2 study of barzolvolimab in patients with moderate to severe CSU refractory to antihistamines, including patients with biologic-refractory disease, met its primary endpoint—a significant improvement in UAS7 compared to placebo at 12 weeks — across all dose groups tested.

Pfizer and Arvinas' Vepdegestrant Significantly Improves Progression-Free Survival for Patients With ESR1-Mutant, ER+/HER2- Advanced Breast Cancer

BioNJ Member Pfizer Inc., with a site in Peapack, and Arvinas, Inc. announced detailed results from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer (MBC) whose disease progressed following prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors and endocrine therapy. In the trial, vepdegestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) among patients with an estrogen receptor 1 (ESR1) mutation, reducing the risk of disease progression or death by 43% compared to fulvestrant [Hazard Ratio (HR)=0.57 (95% CI 0.42–0.77); 2-sided P<0.001]. The median PFS, as assessed by blinded independent central review (BICR), was 5.0 months with vepdegestrant versus 2.1 months with fulvestrant.

Pfizer’s BRAFTOVI® Combination Regimen Cuts the Risk of Death in Half for Patients With BRAF V600E-Mutant Metastatic Colorectal Cancer

BioNJ Member Pfizer Inc., with a site in Peapack, announced statistically significant and clinically meaningful survival results from the Phase 3 BREAKWATER trial evaluating BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. In a second interim analysis of overall survival (OS), a key secondary endpoint, the BRAFTOVI combination regimen reduced the risk of death by 51% compared to standard-of-care chemotherapy with or without bevacizumab (Hazard Ratio [HR] 0.49; 95% Confidence Interval [CI], 0.38, 0.63, p<0.0001). Median OS was 30.3 months (95% CI, 21.7, Not Estimated) with BRAFTOVIin combination with cetuximab and mFOLFOX6 compared to 15.1 months with chemotherapy with or without bevacizumab (95% CI, 13.7, 17.7).

Novartis Pluvicto™ Demonstrates Statistically Significant and Clinically Meaningful rPFS Benefit in Patients With PSMA-Positive Metastatic Hormone-Sensitive Prostate Cancer

East Hanover-based BioNJ Member Novartis announced topline results from a pre-specified interim analysis of the Phase III PSMAddition trial. The trial met its primary endpoint with a statistically significant and clinically meaningful benefit in radiographic progression-free survival (rPFS) with a positive trend in overall survival (OS) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC) treated with radioligand therapy (RLT), Pluvicto™ (lutetium (177Lu) vipivotide tetraxetan), in combination with standard of care (SoC) versus SoC alone. In PSMAddition, the SoC is a combination of androgen receptor pathway inhibitor (ARPI) therapy and androgen deprivation therapy (ADT). Almost all mHSPC patients ultimately progress to metastatic castration-resistant prostate cancer (mCRPC).

Novartis Fabhalta® Shows Statistically Significant and Clinically Meaningful Improvements in Hemoglobin in New Population of Patients With PNH

East Hanover-based BioNJ Member Novartis announced positive results from APPULSE-PNH, a Phase IIIB study evaluating the efficacy and safety of twice-daily oral monotherapy Fabhalta® (iptacopan) in adult patients with paroxysmal nocturnal hemoglobinuria (PNH) with Hb levels ≥10g/dL who switched from anti-C5 therapies (eculizumab or ravulizumab)1. After 24 weeks of treatment with Fabhalta, the Hb level improved on average by 2.01 g/dL (95% CI, 1.74, 2.29) with most patients achieving normal or near-normal levels. No patients required transfusion during the study, and the vast majority (92.7%) achieved Hb ≥12g/dL, reaching normal or near-normal levels1. Patients treated with Fabhalta also reported clinically meaningful improvements in fatigue (as measured by FACIT-Fatigue score) through Day 168, reaching absolute levels similar to those reported in the general population.

Novartis Kisqali® Reduces Risk of Recurrence in Younger Patients With Early Breast Cancer in NATALEE Subgroup Analysis

East Hanover-based BioNJ Member Novartis announced data from a new subgroup analysis of the Phase III NATALEE trial evaluating the efficacy and safety of Kisqali® (ribociclib) plus endocrine therapy (ET, a non-steroidal aromatase inhibitor) in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) at high risk of recurrence across age and menopausal status. Results at median follow-up of 44.2 months show that patients receiving Kisqali continued to see consistent reductions in risk of recurrence across all efficacy measures, regardless of age and menopausal status. In this one-year post-treatment analysis, pre-menopausal and younger patients, who often present with more aggressive disease characteristics, experienced greater reductions in risk of recurrence and fewer treatment discontinuations due to adverse events (AEs) than post-menopausal patients.

AbbVie Announces New Data Demonstrating Atogepant (QULIPTA® / AQUIPTA®) Achieves Superiority Across All Endpoints in Phase 3 Head-to-Head Study Compared to Topiramate for Migraine Prevention

BioNJ Member AbbVie, with a site in Madison, announced positive topline results from its Phase 3 TEMPLE multicenter, randomized, double-blind, head-to-head study evaluating the tolerability, safety and efficacy of atogepant (QULIPTA® / AQUIPTA®, 60 mg once daily) compared to the highest tolerated dose of topiramate (50, 75 or 100 mg/day) in adult patients with a history of four or more migraine days per month. The study met the primary endpoint of treatment discontinuation due to adverse events (AEs), demonstrating that atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, had fewer discontinuations due to AEs than topiramate, an anticonvulsant medication also approved for migraine prevention. Over the 24-week double-blind treatment period, discontinuation due to AEs was significantly lower with atogepant (12.1%) compared to topiramate (29.6%), representing a relative risk of 0.41 (95% CI: 0.28, 0.59; p<0.0001).

U.S. FDA Approves Expanded Indication for AbbVie's MAVYRET® (Glecaprevir/Pibrentasvir) as First and Only Treatment for People With Acute Hepatitis C Virus

BioNJ Member AbbVie, with a site in Madison, announced that the U.S. Food and Drug Administration (FDA) approved a label expansion for MAVYRET® (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. It is now approved for the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. With this approval, MAVYRET is the first and only DAA therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate. HCV is a highly infectious blood-borne disease affecting the liver. People recently infected, or those with acute HCV, may not have symptoms. If left untreated, HCV could lead to liver-related complications, such as cirrhosis or liver cancer.

Quest to Develop Multi-Cancer Stratification Blood Test Based on MD Anderson Technology

Secaucus-based BioNJ Member Quest Diagnostics announced a collaboration with The University of Texas MD Anderson Cancer Center designed to improve the assessment of elevated risk of cancer in individuals who would benefit from medically appropriate cancer screenings. Under terms of the agreement, Quest will develop and validate a laboratory-developed blood test based on circulating protein biomarkers associated with high risk for one or more cancers, including colorectal, lung, breast, pancreatic, ovarian, liver, prostate, esophageal and stomach. Quest will base the test on a developmental license to technology and intellectual property associated with the Multi-Cancer Stratification Test (MCaST), a cohesive risk model developed by the laboratory of Dr. Samir Hanash at MD Anderson.

TPR1 Leads USDA’s National Citrus Greening Compound Evaluation — Advances to Phase 2 Grove Trials

Cliffside Park-based Pop Test Oncology LLC operating as Palisades Therapeutics is proud to announce a major milestone in the fight against citrus greening (Huanglongbing, HLB). After a year-long, rigorous USDA screening of over 200 candidate compounds, TPR1, our proprietary compound, has emerged as the leading molecule in efficacy against the causative agent of citrus greening disease. Based on these outstanding results, TPR1 is now advancing to Phase 2 testing across citrus groves, with replicated field trials to validate its performance under commercial conditions. This achievement builds on the success from our collaboration with the United States Department Of Agriculture (USDA), the Citrus Research and Development Foundation (CRDF) and Bayer Crop Science. The research collaboration has enabled the rapid evaluation and deployment of innovative solutions to address the devastating impact of HLB on the citrus industry.

EULAR: Rilzabrutinib Data in IgG4-Related Disease Show Reduction in Flares and Key Disease Markers; Earns Fast Track Designation in the U.S.

New data from Morristown-based BioNJ Member Sanofi’s Phase 2 study showed that treatment with rilzabrutinib led to a considerable reduction in disease flares and other key disease markers, as well as glucocorticoid (GC) sparing, in patients with active IgG4-related disease (IgG4-RD). The Phase 2 study (clinical study identifier: NCT04520451) was an open-label, proof-of-concept, 52-week study in adult patients with a diagnosis of IgG4-RD according to ACR/EULAR 2019 criteria and an IgG4-RD responder index (RI) of ≥2 at screening, with active disease in ≥1 organ system, excluding lymph nodes. Most patients received rilzabrutinib 400mg twice daily plus a GC taper over four weeks, followed by rilzabrutinib alone for the remainder of the 52-week period.

Rilzabrutinib Granted Orphan Drug Designation in the U.S. for Sickle Cell Disease

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Morristown-based BioNJ Member Sanofi’s rilzabrutinib, a novel, advanced, oral, reversible Bruton's tyrosine kinase (BTK) inhibitor that works via multi-immune modulation, to target a reduction in vaso-occlusive crises, which may occur via inflammation, in sickle cell disease. The FDA grants orphan drug designation to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the U.S. In addition to sickle cell disease, rilzabrutinib has received orphan drug designation for immune thrombocytopenia (ITP) in the U.S., the EU and Japan, for warm autoimmune hemolytic anemia (wAIHA) in the U.S. and the EU, and for IgG4-related disease (IgG4-RD) in the U.S.

Beyfortus Public Health Advantage Bolstered by First Real-World Comparison of Infant vs. Maternal RSV Immunization Programs

An immunization program implemented in Spain using Beyfortus cut infant hospitalizations due to RSV by 69.0% during the 2024-2025 RSV season compared to the 2022-2023 season, according to data presented by Morristown-based BioNJ Member Sanofi. The real-world analysis also showed that a program in the UK using only the RSVpreF maternal vaccine reduced infant RSV hospitalizations in infants by 26.7% over those same RSV seasons. Sanofi’s observational, retrospective REACH study is the first multi-country public health impact analysis of infant RSV prevention programs. In addition, durability data from the HARMONIE Phase 3b clinical study demonstrates Beyfortus reduced RSV hospitalizations in infants by 82.7% (95% CI: 67.8 to 91.5; p<0.0001) through six months (180 days) compared to no intervention, exceeding the typical length of the five-month RSV season.

Sanofi to Acquire Blueprint Medicines, Expanding Portfolio in Rare Immunological Disease and Adding Early Stage Pipeline in Immunology

Morristown-based BioNJ Member Sanofi and Blueprint Medicines Corporation, a rare immunological disease, and other KIT-driven diseases, have entered into an agreement under which Sanofi will acquire Blueprint. The acquisition includes a rare immunology disease medicine, Ayvakit/Ayvakyt (avapritinib), approved in the U.S. and the EU, and a promising advanced and early stage immunology pipeline. Furthermore, Blueprint’s established presence among allergists, dermatologists, and immunologists is expected to enhance Sanofi’s growing immunology pipeline. Ayvakit/Ayvakyt is the only approved medicine for advanced and indolent systemic mastocytosis (ASM & ISM), a rare immunology disease, which is characterized by the accumulation and activation of aberrant mast cells in bone marrow, skin, the gastrointestinal tract and other organs.

New Sarclisa Data Support Subcutaneous Administration With On-Body Injector

Morristown-based BioNJ Member Sanofi present new data from two clinical studies of the investigational use of Sarclisa administered subcutaneously (SC) via an on-body injector (OBI) (also referred to as an on-body delivery system) in relapsed or refractory multiple myeloma (R/R MM) support the potential use of this innovative delivery method to advance patient care, while upholding Sarclisa’s efficacy and safety profile. Recent studies and surveys suggest the use of an OBI may be associated with greater convenience, flexibility, and patient satisfaction compared to IV or manual SC administration methods. In addition, an OBI may also streamline the administration process for providers, potentially reducing the physical burden on nurses and enabling them to possibly move freely through the use of a hands-free device while monitoring the patient during injection.

Dupixent Demonstrated Superiority Over Xolair (omalizumab) in Chronic Rhinosinusitis With Nasal Polyps in Patients With Coexisting Asthma in First-Ever Presented Phase 4 Head-to-Head Respiratory Study

BioNJ Members Sanofi and Regeneron Pharmaceuticals, Inc. presented positive results from the EVEREST phase 4 study of adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma. In the study, Dupixent (dupilumab) outperformed Xolair (omalizumab) on all primary and secondary efficacy endpoints of CRSwNP, and in all asthma-related endpoints. The data are from the first-ever presented head-to-head respiratory study with biologic medicines. In the EVEREST study, 360 adults with severe, uncontrolled CRSwNP and coexisting asthma were randomized to receive Dupixent 300 mg (n=181) every two weeks or a weight- and immunoglobulin E (IgE) level-based dosing regimen of omalizumab (n=179) every two or four weeks. Both Dupixent and omalizumab were added to background mometasone furoate nasal spray (MFNS).

Dupixent Demonstrated Superiority Over Xolair (omalizumab) in Chronic Rhinosinusitis With Nasal Polyps in Patients With Coexisting Asthma in First-Ever Presented Phase 4 Head-to-Head Respiratory Study

BioNJ Members Sanofi and Regeneron Pharmaceuticals, Inc. presented positive results from the EVEREST phase 4 study of adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma. In the study, Dupixent (dupilumab) outperformed Xolair (omalizumab) on all primary and secondary efficacy endpoints of CRSwNP, and in all asthma-related endpoints. The data are from the first-ever presented head-to-head respiratory study with biologic medicines. In the EVEREST study, 360 adults with severe, uncontrolled CRSwNP and coexisting asthma were randomized to receive Dupixent 300 mg (n=181) every two weeks or a weight- and immunoglobulin E (IgE) level-based dosing regimen of omalizumab (n=179) every two or four weeks. Both Dupixent and omalizumab were added to background mometasone furoate nasal spray (MFNS).

Dupixent Data Reinforce Use in Atopic Dermatitis Patients With Skin of Color

Morristown-based BioNJ Member Sanofi announced results from the DISCOVER Phase 4, single-arm, open-label study assessing Dupixent (dupilumab) in adults and adolescents with moderate-to-severe atopic dermatitis with skin of color. These are the first clinical study results for Dupixent in a large population of patients with darker skin tones. The results, along with the Dupixent Phase 3 studies, demonstrated patients taking Dupixent experienced improvements in signs and symptoms of atopic dermatitis from baseline across many skin tones. In the study, 120 patients with atopic dermatitis and skin of color (82% Black, 11% Asian, 2% American Indian/Alaska Native, 5% Arab, Central American, or other) were treated with Dupixent every two weeks using a weight-based dosing regimen.

Regeneron Expands Clinical-Stage Obesity Portfolio with Strategic In-Licensing of Novel Dual GLP-1/GIP Receptor Agonist

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced a strategic in-licensing agreement with Hansoh Pharmaceuticals Group Company Limited to acquire exclusive clinical development and commercial rights outside of the Chinese Mainland, Hong Kong and Macau for a dual GLP-1/GIP receptor agonist currently in Phase 3 testing. This novel therapeutic candidate (HS-20094) – studied in over 1,000 patients and administered as a weekly subcutaneous injection ― has demonstrated promising efficacy and safety clinical data, suggesting a potentially similar profile to the only FDA-approved GLP-1/GIP receptor agonist. A Phase 3 trial in obesity in China and Phase 2b study in diabetes are ongoing. Under the terms of the agreement, Regeneron will make an upfront payment to Hansoh of $80 million, with potential additional payments of up to $1.93 billion for achievement of development, regulatory and sales milestones.

Interim from Ongoing Phase 2 COURAGE Trial Confirm Potential to Improve the Quality of Semaglutide (GLP-1 receptor agonist)-induced Weight Loss by Preserving Lean Mass

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced interim results from the ongoing Phase 2 COURAGE trial investigating novel combinations of semaglutide (GLP-1 receptor agonist) and trevogrumab (anti-GDF8/anti-myostatin) with or without garetosmab (anti-activin A) for the treatment of obesity. The trial demonstrated that approximately 35% of semaglutide-induced weight loss was due to loss of lean mass, and further demonstrated that combining semaglutide with trevogrumab with or without garetosmab helped preserve lean mass while increasing loss of fat mass. The interim analysis was conducted when 50% of patients reached week 26 in the trial. The combination of semaglutide with trevogrumab was generally well-tolerated; the triplet combination of semaglutide with both antibodies had a substantially higher rate of discontinuations due to tolerability issues and other adverse events, consistent with the safety profile previously seen with garetosmab alone.

Libtayo® (cemiplimab) Phase 3 Data in the Adjuvant Treatment of Post-Surgical High-Risk Cutaneous Squamous Cell Carcinoma (CSCC) Have Potential to Be Practice-Changing

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced detailed analyses from the Phase 3 C-POST trial, which evaluated PD-1 inhibitor Libtayo® (cemiplimab) in patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery. The results published in the New England Journal of Medicine (NEJM), include additional data for the primary endpoint of disease-free survival (DFS) and the first presentation of key secondary endpoint outcomes. Results from the C-POST trial shared earlier this year established Libtayo as the first immunotherapy to show a statistically significant and clinically meaningful benefit in high-risk CSCC in the adjuvant setting.

Kyowa Kirin and Kura Oncology Report Positive Updated Combination Data for Ziftomenib in Newly Diagnosed AML at 2025 European Hematology Association Congress

BioNJ Members Kyowa Kirin Co., Ltd., with a site in Princeton, and Kura Oncology, Inc. provided positive updated clinical data from KOMET-007, a Phase 1a/1b trial of ziftomenib, a highly selective oral investigational menin inhibitor, in combination with standards of care in patients with newly diagnosed NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). In the ongoing study, ziftomenib dosed once daily at 600 mg in combination with 7+3 continued to demonstrate robust and evolving clinical activity in patients with newly diagnosed AML. Among 71 response-evaluable patients, 92% (65/71) achieved a composite complete remission (CRc) (93% for NPM1-m, 89% for KMT2A-r patients) and 80% (57/71) achieved a complete remission (CR) (84% for NPM1-m, 74% for KMT2A-r patients) at the time of data cutoff.

Kyowa Kirin and Kura Oncology Announce FDA Acceptance and Priority Review of New Drug Application for Ziftomenib in Adults With Relapsed or Refractory NPM1-Mutant AML

BioNJ Members Kyowa Kirin Co., Ltd., with a site in Princeton, and Kura Oncology, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted Kura’s New Drug Application (NDA) seeking full approval for ziftomenib as a treatment for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation. The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2025. The NDA is based on results from the Phase 2 KOMET-001 registrational trial in R/R NPM1-mutant (NPM1-m) AML (NCT #04067336). The KOMET-001 trial achieved its primary endpoint of complete remission (CR) plus CR with partial hematological recovery (CRh) and the primary endpoint was statistically significant. Ziftomenib was well‑tolerated with limited myelosuppression and 3% ziftomenib-related discontinuations.

Kyowa Kirin and Kura Oncology Report Positive Pivotal Ziftomenib Monotherapy Data at 2025 ASCO Annual Meeting

BioNJ Members Kyowa Kirin Co., Ltd., with a site in Princeton, and Kura Oncology, Inc. announced the presentation of positive pivotal results from the KOMET-001 Phase 2 registration-directed trial of ziftomenib, a once-daily, oral investigational menin inhibitor, in patients with relapsed/refractory (R/R) NPM1-mutant (NPM1-m) acute myeloid leukemia (AML). The KOMET-001 Phase 2 population included 92 adult patients with R/R NPM1-m AML. The median age was 69 (range: 33 to 84). Patients were heavily pretreated, with 33% having received three or more prior lines of therapy (median prior lines: 2) and 59% having been previously treated with venetoclax. A complete remission (CR) plus CR with partial hematological recovery (CRh) rate of 23% (21/92) was observed among patients with R/R NPM1-m AML in the Phase 2 portion of the KOMET-001 trial.

Bristol Myers Squibb Presents First Data from the Marginal Zone Lymphoma Cohort of the Transcend FL Trial Demonstrating Deep and Durable Responses With Breyanzi (lisocabtagene maraleucel)

Princeton-based BioNJ Member Bristol Myers Squibb announced the first disclosure of the primary analysis results of the marginal zone lymphoma (MZL) cohort of TRANSCEND FL, an open-label, global, multicenter, Phase 2, single-arm study evaluating Breyanzi (lisocabtagene maraleucel; liso-cel) in patients with relapsed or refractory disease. The MZL cohort of TRANSCEND FL enrolled adults with relapsed or refractory disease treated with liso-cel in the third-line plus setting. Patients received treatment with liso-cel at a target dose of 100 x 106 CAR-positive viable T cells. In efficacy-evaluable patients with relapsed or refractory MZL treated with liso-cel (n=66), liso-cel demonstrated clinically meaningful benefit, with high rates of durable responses. The overall response rate (ORR) was 95.5% (95% CI: 87.3-99.1; one-sided p<0.0001), with 62.1% of patients achieving a complete response (CR) (95% CI: 49.3-73.8; one-sided p<0.0001) by independent review committee per CT.

Bristol Myers Squibb Presents Data Across Targeted Protein Degradation Research Including CELMoD™ Agents and BCL6 Ligand-Directed Degrader at EHA 2025

Princeton-based BioNJ Member Bristol Myers Squibb announced new data from its targeted protein degradation platform. The data feature updated clinical findings on the company’s investigational oral CELMoD™ agents mezigdomide and iberdomide in multiple myeloma, and golcadomide in non-Hodgkin lymphoma, as well as the first results evaluating the company’s first-in-class, oral BCL6 ligand-directed degrader (LDD) (BMS-986458) in non-Hodgkin lymphoma. The latest data presented for the three lead CELMoD agents and BCL6 LDD underscore the potential impact that these therapies may have in addressing significant unmet medical needs in hematologic malignancies. These agents are part of continuing research across targeted protein degradation at Bristol Myers Squibb, which also encompasses additional CELMoD agents, LDDs and degrader antibody conjugates (DACs) across blood cancers and solid tumors, as well as non-malignant hematologic disorders.

Bristol Myers Squibb Presents Late-Breaking Data from Pivotal Phase 3 POETYK PsA-1 Trial Demonstrating Superiority of Sotyktu (deucravacitinib) Compared With Placebo in Adults With Psoriatic Arthritis

Princeton-based BioNJ Member Bristol Myers Squibb announced positive data from the pivotal Phase 3 POETYK PsA-1 trial (IM011-054) evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA) who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD). The trial met its primary endpoint, with a significantly greater proportion of patients treated with Sotyktu achieving ACR20 response (at least a 20 percent improvement in signs and symptoms of disease) compared with placebo at Week 16 (54.2% versus 34.1%, respectively; p<0.0001). The safety profile of Sotyktu through 16 weeks of treatment was consistent with what has been reported throughout the clinical trial programs for Sotyktu, including the Phase 3 POETYK PsA-2 trial and the Phase 3 moderate-to-severe plaque psoriasis (PsO) clinical trials.

Bristol Myers Squibb and BioNTech Announce Global Strategic Partnership to Co-Develop and Co-Commercialize Next-generation Bispecific Antibody Candidate BNT327 Broadly for Multiple Solid Tumor Types

Princeton-based BioNJ Member Bristol Myers Squibb and BioNTech SE announced that the companies have entered into an agreement for the global co-development and co-commercialization of BioNTech’s investigational bispecific antibody BNT327 across numerous solid tumor types. Under the agreement, BioNTech and BMS will work jointly to broaden and accelerate the development of this clinical candidate. BioNTech’s BNT327, a next-generation bispecific antibody candidate targeting PD-L1 and VEGF-A, is currently being evaluated in multiple ongoing trials with more than 1,000 patients treated to date, including global Phase 3 trials with registrational potential evaluating BNT327 as first-line treatment in extensive-stage small-cell lung cancer (“ES-SCLC”) and non-small cell lung cancer.

Otsuka Sibeprenlimab Phase 3 Data Show a Statistically Significant and Clinically Meaningful Proteinuria Reduction for the Treatment of Immunoglobulin A Nephropathy (IgAN)

Princeton-based BioNJ Member Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. presented results from a pre-specified interim analysis of the Phase 3 VISIONARY study (NCT05248646) evaluating sibeprenlimab, for the treatment of immunoglobulin A nephropathy (IgAN) in adults. Patients treated with sibeprenlimab achieved a 51.2% (P<0.0001) reduction in proteinuria (as measured by 24-hour uPCR [urine protein-to-creatinine ratio]) at nine months of treatment when compared to placebo. The study, the largest Phase 3 IgAN trial conducted to date, also showed the safety profile of sibeprenlimab was favorable and consistent with previously reported data. Specifically, 76.3% of patients treated with sibeprenlimab experienced any Treatment Emergent Adverse Event (TEAE) versus 84.5% in the placebo group. 

Otsuka Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)

Princeton-based BioNJ Member Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. announce the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sibeprenlimab, an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with immunoglobulin A nephropathy (IgAN). APRIL plays a key role in the pathogenesis of IgAN as explained by the 4-hit process, in which pathogenic galactose-deficient IgA (Gd-IgA1) is produced, leading to the synthesis of autoantibodies against Gd-IgA1, immune complex formation, and deposition in the glomerular mesangium. Sibeprenlimab is a single-dose prefilled syringe for subcutaneous injection every four weeks intended for self-administration, providing patients the convenience of at-home delivery.

Eisai to Launch “Pariet® S,” the First Proton Pump Inhibitor RX-to-OTC in Japan

Nutley-based BioNJ Member Eisai Co., Ltd. announced the launch of “Pariet® S” (pharmaceutical requiring guidance), which is highly effective in alleviating severe heartburn and stomach pain caused by gastric acid reflux, at pharmacies and drugstores throughout Japan. "Pariet S" is the first proton pump inhibitor (PPI ) to receive manufacturing and marketing approval as an over the counter (OTC) medicine in Japan. Rabeprazole sodium, in an amount equivalent to that used in the prescription product , works directly on the proton pumps that produce stomach acid, effectively alleviating severe heartburn caused by gastric acid reflux and stomach pain due to excessive acid secretion. The medicine comes in small, easy-to-swallow tablets, with a once-daily dosage providing 24-hour relief.

Novo Nordisk to Advance Subcutaneous and Oral Amycretin for Weight Management into Phase 3 Clinical Development

Plainsboro-based BioNJ Member Novo Nordisk announced that it will advance subcutaneous and oral amycretin into phase 3 development in weight management based on completed clinical studies. The decision to advance subcutaneous and oral amycretin into Phase 3 is based on feedback received from regulatory authorities following end-of-phase 2 interactions for subcutaneous and oral amycretin in weight management. Novo Nordisk is now planning to initiate a Phase 3 development program with amycretin for adults with overweight or obesity during the first quarter of 2026. Amycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide an efficacious and convenient treatment for adults with overweight or obesity and for adults with type 2 diabetes.

GSK’s RSV Vaccine, Arexvy, Accepted for Regulatory Review by the European Medicines Agency to Expand Use in Adults 18 Years and Older

Warren-based BioNJ Member GSK plc announced that the European Medicines Agency (EMA) has accepted the company’s regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to include adults from 18 years of age. Arexvy was the first RSV vaccine approved in the European Economic Area for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, and for those aged 50-59 years who are at increased risk for RSV disease. RSV is a common contagious virus affecting the lungs and breathing passages and impacts an estimated 64 million people of all ages globally every year. RSV can exacerbate certain medical conditions, and lead to severe illness resulting in hospitalization and even death.

GSK Licenses Shigella Vaccine Candidate to Bharat Biotech for Continued Development

Warren-based BioNJ Member GSK plc announced that it has licensed its Shigella vaccine candidate, altSonflex1-2-3, to Bharat Biotech International Limited (BBIL). The agreement paves the way for the ongoing development and potential distribution of the vaccine in low-and-middle--income countries where Shigella, the leading bacterial cause of diarrhoea, poses a significant health threat to children under five. The Phase 1 clinical trial, and interim statistical analysis conducted to date from Phase 2 trials, has demonstrated promising results and confirmed the achievement of pre-set immunogenicity success criteria. The Shigella vaccine candidate uses innovative GMMA technology (Generalized Modules for Membrane Antigens), a novel platform discovered and developed by scientists in GSK’s Global Health team that uses tiny particles naturally released from bacteria ― called outer membranes vesicles (OMVs) ― to deliver antigens that trigger the immune system.

Linerixibat New Drug Application (NDA) Accepted for Review by the U.S. FDA for Cholestatic Pruritus in Patients With Primary Biliary Cholangitis (PBC)

Warren-based BioNJ Member GSK plc announced the U.S. Food and Drug Administration (FDA) has accepted for review the NDA for linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter (IBAT), for the treatment of cholestatic pruritus in patients with PBC, a rare autoimmune liver disease. The Prescription Drug User Fee Act (PDUFA) goal date is 24 March 2026. The application is based on positive data from the GLISTEN Phase III trial, presented in May at the European Association for the Study of the Liver (EASL) Congress. GLISTEN met both primary and key secondary endpoints demonstrating a rapid, significant and sustained improvement in cholestatic pruritus and itch-related sleep interference versus placebo. The safety profile of linerixibat was consistent with previous studies and the mechanism of IBAT inhibition.

Teva and Fosun Pharma Enter into a Strategic Partnership to Develop Novel Anti-PD1-IL2 Therapy (TEV-56278) in Immuno-Oncology

Parsippany-based BioNJ Member Teva Pharmaceuticals and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that the companies, through their respective subsidiaries, have entered a strategic partnership for the development of investigational TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy. Teva’s internally developed ATTENUKINE technology provides a new mechanism of action, potentially offering high efficacy and low toxicity in a broad array of oncology indications. Under the terms of the agreement, which aims to accelerate clinical data generation, Fosun Pharma is granted an exclusive license to develop, manufacture and commercialize TEV-56278 in Chinese mainland, Hong Kong Special Administrative Region (SAR), Macau SAR and Taiwan region and select Southeast Asian countries.

Lilly to Acquire Verve Therapeutics to Advance One-Time Treatments for People With High Cardiovascular Risk

BioNJ Member Eli Lilly and Company, with a site in Branchburg, and Verve Therapeutics, Inc. announced a definitive agreement for Lilly to acquire Verve. Verve is developing a pipeline of gene editing medicines designed to address the drivers of atherosclerotic cardiovascular disease (ASCVD) through treatments that may only need to be given once in a lifetime. Verve's lead program (VERVE-102) is a potential first-in-class in vivo gene editing medicine targeting PCSK9, a gene linked to cholesterol levels and cardiovascular health. The treatment may be applicable for people who have heterozygous familial hypercholesterolemia (HeFH), a subset of ASCVD that affects 1 in 250 people in the general population, as well as certain patients with premature coronary artery disease (CAD). VERVE-102 is being evaluated in a Phase 1b clinical trial study and has been granted Fast Track designation by the U.S. Food and Drug Administration.

Lilly to Offer All Approved Doses of Zepbound (tirzepatide) Single-Dose Vials Through LillyDirect Self Pay Pharmacy Solutions

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that the highest approved doses of Zepbound (tirzepatide)—12.5 mg and 15 mg—will soon be available in single-dose vials for $499 per month through LillyDirect's Self Pay Pharmacy Solutions and the Zepbound Self Pay Journey Program.1 Health care providers can begin prescribing the 12.5 mg and 15 mg vials on July 7, and shipments to patients will begin in early August. With the addition of these doses, every strength of Zepbound vial will be available for $499/month or less ($349 for the 2.5 mg starter dose) to any eligible adult with obesity and a valid prescription, regardless of insurance.

Lilly Presents First Clinical Data for Its Investigational, Next-Generation FRα Targeting ADC in Platinum-Resistant Ovarian Cancer at the 2025 ASCO Annual Meeting

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced new Phase 1 data showing that its folate receptor alpha (FRα) antibody-drug conjugate (ADC) (LY4170156) demonstrated an encouraging safety profile and anti-tumor activity across dose and FRα expression levels in women with heavily pre-treated platinum-resistant ovarian cancer, including patients previously treated with mirvetuximab soravtansine. A preliminary overall objective response rate (ORR) of 55% was observed at the potential recommended Phase 2 dose of 4 mg/kg. Lilly's FRα targeting ADC is composed of an Fc-silent, FRα specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker. As of the March 9, 2025 data cutoff, the study enrolled 95 participants with high-grade serous ovarian cancer across four dose levels (2 - 6 mg/kg).  

Sandoz launches first and only interchangeable denosumab biosimilars in US, providing new affordable treatment options for over 10 million patients[1]

Princeton-based BioNJ Member Sandoz announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are available to patients in the U.S. starting today. WYOST® and Jubbonti® are the first and only interchangeable FDA-approved denosumab biosimilars and are approved to treat all indications of the reference medicines XGEVA® (denosumab) and Prolia® (denosumab), respectively. This launch builds on Sandoz established leadership in biosimilars and oncology, dating back to the introduction of the first biosimilar in the U.S .in 2015. WYOST® and Jubbonti® are key biosimilar value drivers that are integral to the Sandoz growth strategy, representing a significant step forward in advancing the company’s ambition to be the biosimilar leader in the U.S. WYOST® and Jubbonti® have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines.

Merck Animal Health Receives EU CVMP Positive Opinion for NUMELVI™ (atinvicitinib) Tablets for Dogs

Rahway-based BioNJ Member Merck Animal Health announced that the European Medicines Agency’s Committee for Veterinary Medicinal Products issued a positive opinion for NUMELVI™ (atinvicitinib) Tablets for Dogs. NUMELVI, a once-daily, first-line treatment, will be the only second-generation Janus kinase (JAK) inhibitor indicated for the treatment of pruritus associated with allergic dermatitis including atopic dermatitis and treatment of clinical manifestations of atopic dermatitis, in dogs upon full approval by the European Commission. NUMELVI inhibits the function of JAK1-dependent cytokines involved in itch and inflammation in allergic and atopic dermatitis and is at least 10-fold more selective for JAK1 compared to the other JAK family members (JAK2, JAK3 and TYK2). JAK1 selectivity minimizes interference with cytokines involved in hematopoiesis and immune functions dependent on the other JAKs, resulting in a compelling safety profile with proven efficacy in dogs and puppies.

U.S. FDA Approves Merck’s ENFLONSIA™ (clesrovimab-cfor) for Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants Born During or Entering Their First RSV Season

Rahway-based BioNJ Member Merck & Co. announced the U.S. Food and Drug Administration (FDA) has approved ENFLONSIA™ (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season. ENFLONSIA is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a typical RSV season, with the same 105 mg dose regardless of weight. A typical RSV season usually spans autumn to spring of the next year. The approval is based on results from the pivotal Phase 2b/3 CLEVER trial (MK-1654-004) evaluating a single dose of ENFLONSIA administered to preterm and full-term infants (birth to 1 year of age).

IDeate-Prostate01 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Patients With Pretreated Metastatic Castration-Resistant Prostate Cancer

Rahway-based BioNJ Member Merck & Co. announced the first patient has been dosed in the IDeate-Prostate01 Phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC) with disease progression during or after treatment with an androgen receptor pathway inhibitor. Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Basking Ridge-based Daiichi Sankyo Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck. While localized prostate cancer has a five-year survival rate of more than 90%, survival decreases to 31% in the advanced or metastatic stage. 

Merck Initiates Phase 3 Study Evaluating Dengue Vaccine Candidate

Rahway-based BioNJ Member Merck & Co. announced the initiation of the MOBILIZE-1 Phase 3 clinical trial evaluating the safety, immunogenicity and efficacy of a single dose of V181, an investigational quadrivalent vaccine, for the prevention of dengue disease caused by any of the four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4), regardless of prior dengue exposure. Recruitment for the trial has begun, and the first participants are now enrolling in Singapore. “The initiation of the MOBILIZE-1 study, the first Phase 3 trial in our clinical development program, marks a key milestone in our work to help address this widespread mosquito-borne disease,” said Dr. Paula Annunziato, Senior Vice President, Infectious Diseases and Vaccines, Global Clinical Development, Merck Research Laboratories.

Merck Announces Positive Topline Results from the First Two Phase 3 CORALreef Trials Evaluating Enlicitide Decanoate for the Treatment of Adults With Hyperlipidemia

Rahway-based BioNJ Member Merck & Co. announced positive topline results from the first two of three Phase 3 clinical trials evaluating the safety and efficacy of enlicitide decanoate, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hyperlipidemia on lipid-lowering therapies, including at least a statin. The CORALreef HeFH and CORALreef AddOn trials successfully met their primary and all key secondary endpoints, demonstrating statistically significant and clinically meaningful greater reductions in low-density lipoprotein cholesterol (LDL-C) for enlicitide compared to placebo (CORALreef HeFH) and compared to other oral non-statin therapies (CORALreef AddOn).

Merck’s Investigational Zilovertamab Vedotin at 1.75 mg/kg Dose Plus Standard of Care Showed Promising Antitumor Activity, Including Complete Response Rate, in Patients With Relapsed/Refractory DLBCL in Phase 2 Portion of waveLINE-003 Trial

Rahway-based BioNJ Member Merck & Co. announced results from the dose confirmation portion of the Phase 2/3 waveLINE-003 study evaluating zilovertamab vedotin in combination with standard of care rituximab and gemcitabine-oxaliplatin (R-GemOx) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Zilovertamab vedotin is an investigational, potential first-in-class antibody drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1). At a pre-planned analysis, zilovertamab vedotin 1.75 mg/kg in combination with R-GemOx achieved a 56.3% objective response rate (ORR) in patients with relapsed or refractory DLBCL (n=16), with eight complete responses (CR) and one partial response (PR).

Merck Announces MK-1084, an Investigational KRAS G12C Inhibitor, Shows Antitumor Activity in Phase 1 Trial of Patients With Advanced Colorectal Cancer and Non-Small Cell Lung Cancer Whose Tumors Harbor KRAS G12C Mutations

Rahway-based BioNJ Member Merck & Co. announced safety and efficacy results from the open-label Phase 1 KANDLELIT-001 study, a clinical trial evaluating MK-1084, an investigational next-generation KRAS G12C inhibitor, alone and in combination with other therapies in certain patients with KRAS G12C-mutant solid tumors, including advanced colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). In patients with advanced KRAS G12C-mutated CRC and NSCLC, a manageable safety profile and antitumor activity were observed with MK-1084 either as a monotherapy or in the combinations. In CRC, the study assessed MK-1084 as monotherapy, as well as in combination with cetuximab with or without chemotherapy (oxaliplatin and leucovorin plus 5-fluorouracil [mFOLFOX6]). For efficacy, the study evaluated overall response rate (ORR).

FDA Approves KEYTRUDA® (pembrolizumab) for PD-L1+ Resectable Locally Advanced Head & Neck Squamous Cell Carcinoma as Neoadjuvant Treatment, Continued as Adjuvant Treatment Combined With Radiotherapy With or Without Cisplatin Then as a Single Agent

Rahway-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. The approval is based on data from the pivotal Phase 3 KEYNOTE-689 trial.

KEYTRUDA® (pembrolizumab) Plus Trodelvy® (sacituzumab govitecan-hziy) Reduced Risk of Disease Progression or Death by 35% Versus KEYTRUDA Plus Chemotherapy in First-Line PD-L1+ Metastatic Triple-Negative Breast Cancer (TNBC)

Rahway-based BioNJ Member Merck & Co. announced that KEYTRUDA® (pembrolizumab) plus Trodelvy® (sacituzumab govitecan-hziy) reduced the risk of disease progression or death by 35% (HR=0.65, p<0.001) versus KEYTRUDA plus chemotherapy for the first-line treatment of patients with PD-L1+ (Combined Positive Score [CPS] ≥10) inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (TNBC), as determined by an FDA-approved test. KEYTRUDA, when given in combination with Gilead’s TROP2 antibody-drug conjugate (ADC) Trodelvy, resulted in a median progression-free survival (PFS) of 11.2 months versus 7.8 months when KEYTRUDA was given in combination with chemotherapy. The safety profile of KEYTRUDA plus Trodelvy in this study was consistent with the known safety profile of each agent. No new safety signals were identified with the combination.

Johnson & Johnson Seeks U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Crohn’s Disease

New Brunswick-based BioNJ Member Johnson & Johnson announced new results from the Phase 2 RedirecTT-1 study evaluating the investigational combination of TALVEY® (talquetamab-tgvs), the first U.S. Food and Drug Administration (FDA)-approved GPRC5D-directed bispecific antibody, and TECVAYLI® (teclistamab-cqyv), the first FDA-approved BCMA-directed bispecific antibody. The results show a high overall response rate (ORR) with durability in patients with triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM) who have true extramedullary disease (EMD). EMD is defined as soft tissue/organ-associated plasmacytomas with no contact to bony structures as per International Myeloma Working Group (IMWG) criteria. RedirecTT-1 is the largest study dedicated to patients with EMD to date. EMD represents an aggressive form of multiple myeloma and occurs when myeloma cells spread and form tumors (plasmacytomas) elsewhere in the body.

Investigational Combination of First-in-class Bispecifics TALVEY® and TECVAYLI® Shows Deep and Durable Responses in Heavily Pretreated Multiple Myeloma Patients With Extramedullary Disease

New Brunswick-based BioNJ Member Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand approval of STELARA^® (ustekinumab) for the treatment of children two years and older with moderately to severely active Crohn’s disease (CD). STELARA is currently approved for the treatment of adults living with moderately to severely active CD and ulcerative colitis, in addition to the treatment of adults and children six years and older with active psoriatic arthritis and moderate to severe plaque psoriasis. The sBLA is supported by data from the Phase 3 UNITI-Jr clinical study, a multicenter, open-label study to evaluate the efficacy, safety, and pharmacokinetics of STELARA for the treatment of pediatric CD through 52 weeks.

Johnson & Johnson’s Dual-Targeting CAR T-Cell Therapy Shows Encouraging First Results in Large B-cell Lymphoma

New Brunswick-based BioNJ Member Johnson & Johnson announced the first clinical data from an ongoing Phase 1b study for JNJ-90014496 (JNJ-4496), an investigational dual-targeting anti-CD19/CD20 bispecific autologous chimeric antigen receptor (CAR) T-cell therapy, being studied in patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) who have not been previously treated with CAR T-cell therapy. Findings demonstrate the potential of JNJ-4496 in the treatment of patients with R/R LBCL, including R/R diffuse large B-cell lymphoma (DLBCL) – the most common type of aggressive lymphoma, a blood cancer that originates in the lymphatic system. JNJ-4496, formerly known as C-CAR039, is a dual-targeting CAR T designed to bind to both CD19 and CD20 antigens — two cell surface proteins commonly expressed on malignant B-cells.

New Results for Johnson & Johnson’s Bleximenib Demonstrate Promising Antileukemic Activity in Combination With Venetoclax and Azacitidine for Acute Myeloid Leukemia

New Brunswick-based BioNJ Member Johnson & Johnson announced new Phase 1b data showing encouraging antileukemic activity and a promising safety profile for bleximenib (JNJ-75276617) in combination with venetoclax and azacitidine (VEN + AZA) for the treatment of acute myeloid leukemia (AML) harboring KMT2A gene rearrangements (KMT2Ar) or NPM1 gene mutations (NPM1m). The study evaluated patients with newly diagnosed, intensive chemo-ineligible AML and relapsed or refractory AML. Even though AML is the most common type of acute leukemia in adults, it has the lowest survival rate and is associated with poor patient outcomes, despite treatment advances to date ― especially for patients with KMT2Ar and NPM1m.

Single Infusion of CARVYKTI® (ciltacabtagene autoleucel) Delivered Lasting Treatment-free Remissions for at Least Five Years in Patients With Relapsed or Refractory Multiple Myeloma

New Brunswick-based BioNJ Member Johnson & Johnson announced new long-term follow-up data from the Phase 1b/2 CARTITUDE-1 study demonstrating 33 percent (n=32) of patients in the study (n=97) with relapsed or refractory multiple myeloma (RRMM) treated with CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) achieved progression-free survival (PFS) of five years or more with a single infusion and no maintenance or subsequent anti-myeloma therapy. These data underscore Johnson & Johnson’s dedication to advancing transformative therapies that aim to reshape the treatment landscape for patients with multiple myeloma. In a subset of 12 patients who underwent serial evaluations at a single site, all were minimal residual disease (MRD) negative and imaging negative throughout five years of post-treatment follow-up.

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-Based Regimen Shows 95 Percent Progression-free Survival at Four Years in Transplant-Eligible, Newly Diagnosed Patients With Multiple Myeloma Who Achieved Sustained MRD Negativity

New Brunswick-based BioNJ Member Johnson & Johnson announced data from two studies highlighting that a DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen demonstrated deep and sustained minimal residual disease (MRD) negativity rates, and improved long-term progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status. New analysis from the Phase 3 PERSEUS study shows the addition of DARZALEX FASPRO® to bortezomib, lenalidomide and dexamethasone (D-VRd), followed by an investigational maintenance regimen of DARZALEX FASPRO® with lenalidomide (D-R), led to improved and deepened rates of overall and sustained MRD negativity (10-5, defined as no cancer cells detected within 100,000 bone marrow cells) for at least 24 months, compared to VRd induction and consolidation with R maintenance.

Johnson & Johnson Unveils First-in-Human Results for Pasritamig, Showing Early Anti-Tumor Activity in Prostate Cancer

New Brunswick-based BioNJ Member Johnson & Johnson announced new data from a Phase 1 study evaluating pasritamig (JNJ-78278343), a first-in-class bispecific antibody that activates T-cells to harness the body’s immune system against prostate cancer cells, showing promise in patients with advanced disease who have progressed after multiple lines of therapy. These first data on pasritamig, from the first-in-human study, demonstrate that pasritamig appears well-tolerated and exhibits a promising antitumor activity in patients with metastatic castration-resistant prostate cancer (mCRPC), highlighting the potential of KLK2 as a novel target for T-cell engagement in advanced disease. Pasritamig is a novel T-cell engager designed to bind both CD3 on T-cells and KLK2 — a prostate-specific antigen with minimal expression outside of the prostate.

Johnson & Johnson Leads With First PARP Inhibitor Combo to Improve Efficacy in Patients With HRR-Altered mCSPC

New Brunswick-based BioNJ Member Johnson & Johnson first results from the Phase 3, randomized, double-blind, placebo-controlled AMPLITUDE study evaluating the combination of niraparib and abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) genetic alterations including BRCA. The results show a clinically meaningful and statistically significant improvement in both radiographic progression-free survival (rPFS) and time to symptomatic progression (TSP), with an early trend toward improved overall survival (OS)—highlighting the potential of the combination in this patient population to delay both cancer progression and the worsening of symptoms. This marks the first Phase 3 data to show clinical improvement with a PARP-based combination in mCSPC.

Early Results from Johnson & Johnson’s Trispecific Antibody Show Promising Response in Heavily Pretreated Multiple Myeloma Patients

New Brunswick-based BioNJ Member Johnson & Johnson initial Phase 1 results of JNJ-79635322 (JNJ-5322), a novel investigational trispecific antibody (TsAb) in patients with relapsed or refractory multiple myeloma. Among the 36 patients who received the recommended phase 2 dose (RP2D), the overall response rate (ORR) was 86.1 percent. In the 27 patients who were naive to BCMA and GPRC5D directed therapies, the ORR was 100 percent at the RP2D. JNJ-5322 has a novel and distinct structure that builds upon the experience with two approved first-in-class bispecific antibodies: teclistamab and talquetamab. Unlike these bispecific antibodies, JNJ-5322 is a single molecule that simultaneously binds to three distinct targets (BCMA and GPRC5D on multiple myeloma cells, as well as CD3 on T-cells).

Amneal Receives U.S. FDA Approval for Prednisolone Acetate Ophthalmic Suspension

Bridgewater Amneal Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approval of prednisolone acetate ophthalmic suspension, 1% sterile which references Pred Forte®. Pred Forte and its design are trademarks of Allergan, Inc., an AbbVie company. Launch of this product is planned for the third quarter of 2025. Prednisolone acetate ophthalmic suspension, USP 1% is a sterile, topical anti-inflammatory agent for ophthalmic use and is indicated for treating steroid-responsive ocular inflammation. “Our Affordable Medicines portfolio continues to grow with a strong and diverse pipeline that supports broader access to high-quality treatments across the U.S. healthcare system,” said Andy Boyer, Executive Vice President and Chief Commercial Officer, Affordable Medicines. “The approval of prednisolone acetate ophthalmic suspension — a complex product to develop and manufacture—highlights the depth of our R&D capabilities and the strength of our manufacturing and supply operations.”

DESTINY-Endometrial01 Phase 3 Trial of ENHERTU® Initiated as First-Line Therapy in Patients With HER2 Expressing Primary Advanced or Recurrent Endometrial Cancer

The first patient has been dosed in the DESTINYEndometrial01 Phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) in combination with rilvegostomig or pembrolizumab versus platinum-based chemotherapy (carboplatin and paclitaxel) in combination with pembrolizumab as a first-line therapy in patients with HER2 expressing (IHC 3+/ 2+), mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer. DESTINYEndometrial01 will be conducted in collaboration with The GOG Foundation, Inc. (GOG-F) and the European Network of Gynecological Oncological Trial (ENGOT). ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Basking Ridge-basedDaiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

ENHERTU® Plus Pertuzumab Reduced the Risk of Disease Progression or Death by 44% Versus THP as First-Line Therapy in Patients With HER2 Positive Metastatic Breast Cancer in DESTINYBreast09 Phase 3 Trial

Positive results from the DESTINY-Breast09 Phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) plus pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment in patients with HER2 positive metastatic breast cancer. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Basking Ridge-based Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. In a pre-specified interim analysis, ENHERTU plus pertuzumab reduced the risk of disease progression or death by 44% versus THP (hazard ratio [HR]: 0.56; 95% confidence interval [CI]: 0.44-0.71; p<0.00001).

Bayer’s Sevabertinib Gets Priority Review for Treatment of Non-Small Cell Lung Cancer

Bayer announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) and granted priority review designation for the investigational compound sevabertinib (BAY 2927088), an oral, small molecule, tyrosine kinase inhibitor (TKI), for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptors 2 (HER2) (ERBB2) mutations and who have received a prior systemic therapy. The NDA for sevabertinib is based on positive results from the ongoing Phase I/II SOHO-01 trial. Results from patients with advanced NSCLC harboring a HER2-activating mutation, who experienced disease progression after at least one systemic therapies for advanced disease and were naïve to HER2-targeted therapy.

U.S. FDA Approves UroGen’s ZUSDURI™ (mitomycin) for Intravesical Solution as the First and Only Medication for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)

Princeton-based UroGen Pharma Ltd. announced the U.S. Food and Drug Administration (FDA) approved ZUSDURI, the first and only FDA-approved medication for adults with recurrent LG-IR-NMIBC. ZUSDURI consists of mitomycin and sterile hydrogel, using UroGen’s proprietary sustained release RTGel® technology. ZUSDURI has been designed for potent tumor ablation. This landmark approval is based on the positive results from the Phase 3 ENVISION trial that demonstrated ZUSDURI delivers 78% complete response (CR) for patients at 3 months, and of those patients 79% remained event-free 12 months later. “The approval of ZUSDURI represents a significant step forward for our company and for the treatment of recurrent LG-IR-NMIBC," said Liz Barrett, President and CEO of UroGen. "For the first time, the estimated 59,000 U.S. patients facing recurrent LG-IR-NMIBC each year have access to an FDA-approved medicine. This historic achievement is a bold leap forward in our mission to redefine uro-oncology and bring innovation to patients who need it most.”

Tevogen Bio Doubles Warren HQ Footprint for AI expansion

Tevogen Bio continues to grow its presence here in the Garden State. BioNJ Member Tevogen is a Warren-based company that was founded as a biotech focusing on developing immunotherapies, which continues to evolve into a multifaceted operation. Tevogen Bio CEO Dr. Ryan Saadi said, “This expansion will provide the infrastructure needed to support two of our evolving initiatives, Tevogen.AI and Generics & Biosimilars. From advancing domestic pharmaceutical manufacturing to harnessing the power of AI in drug discovery, these programs reflect our commitment to building a more resilient and accessible health care system.” Expanded space will centralize cross-functional teams, including executive leadership, regulatory affairs, corporate strategy and research and development. HQ will also house Tevogen.AI as well as the Generic & Biosimilars initiative.

Tevogen Bio Details its AI Initiative; Proprietary AI-Powered Immunotherapy With Microsoft and Databricks Partnerships

Warren-based BioNJ Member Tevogen Bio Holdings recently outlined its artificial intelligence initiative, Tevogen.AI™ which aims to integrate advanced machine learning and predictive modeling into Tevogen’s proprietary ExacTcell™ technology to significantly enhance its target identification and pre-clinical processes. Tevogen.AI currently has two proprietary technologies, each with patents pending, and an internal valuation of these assets is forthcoming. The company plans to expand its AI initiative with applications that extend well beyond Tevogen Bio. In preparation for this anticipated growth, Tevogen is expanding its headquarters to include dedicated facilities for Tevogen.AI’s team of data scientists and engineers. Tevogen CEO, Dr. Ryan Saadi, said. “Tevogen.AI’s vision extends beyond transforming how therapies are developed; it is expected to make a meaningful impact across multiple sectors of health care.”

Novo Signs $812 Million Weight-Loss Drug License Deal With US Biotech Deep Apple

Plainsboro-based BioNJ Member Novo Nordisk is partnering with biotech company Deep Apple Therapeutics in a deal worth up to $812 million to develop drugs for cardiometabolic diseases, including obesity. Deep Apple discovers drug candidates using its AI-based platform that screens virtual libraries of billions of compounds to cut drug discovery time, the company said. Under the deal, Novo will receive exclusive global rights to develop and commercialize so-called non-incretin oral therapies, which belong to a different class of medicines than its popular weight-loss and diabetes drugs Wegovy and Ozempic. Novo has been trying to strengthen its foothold in the potential $150 billion weight-loss drug market through the development of next-generation treatments as well as acquisitions and partnerships.

Johnson & Johnson Launches the ETHICON™ 4000 Stapler for Elevated Surgical Experience and the Most Secure Staple Line Yet

New Brunswick-based BioNJ Member Johnson & Johnson Medtech announced the U.S. launch of the ETHICON™ 4000 Stapler, an advanced surgical stapler designed to manage tissue complexities and deliver exceptional staple line integrity to minimize risk factors for surgical leaks and bleeding complications across specialties.With proprietary 3D Staple Technology, a redesigned end effector, and streamlined reload options for consistency from the first staple to the last to reduce potential leak pathways, the ETHICON™ 4000 and ETHICON™ 3D Reloads are approved for use in open and laparoscopic surgery today. The new advanced stapling technology and reloads are also planned for future use exclusively on the OTTAVA™ Robotic Surgical System.

Johnson & Johnson Launches KINCISE™ 2 System, the Only Automated Surgical Impactor Approved for Knee and Hip Revision Procedures

New Brunswick-based BioNJ Member Johnson & Johnson MedTech announced the launch of the KINCISE 2™ Surgical Automated System, a next-generation automated power tool engineered to improve surgical efficiency, provide control and aims to reduce physical burden on surgeons compared to manual impaction across both primary and revision hip, and revision knee replacement procedures. Orthopaedic surgeons today face growing complexity in the operating room (OR), from longer procedures and increasing case volumes to the physical demands of surgery itself. Many procedures require repetitive, high-force tasks such as repeated mallet strikes, which have been linked to overuse injuries. 97% of surgeons report musculoskeletal pain related to their work, commonly in the lower back, hands and neck. The KINCISE™ 2 System was developed to address these challenges head on, aiming to improve surgical efficiency⁵ and lessen the physical burden experienced by surgeons.

Liat Krawczyk Named Inaugural Executive Director of the NJ AI Hub

Liat Krawczyk, a former senior adviser on the CHIPS for America strategy team at the U.S. Department of Commerce, has been named the inaugural Executive Director of the NJ AI Hub, which brings together academia, government and industry to foster innovation in artificial intelligence in New Jersey. “Liat Krawczyk brings to the NJ AI Hub a powerful combination of strategic vision, an ability to launch new initiatives, and demonstrated expertise in building multi-sector partnerships,” said Princeton University Vice President and Secretary Hilary A. Parker, to whom Krawczyk will report. “I am confident that, under her leadership, the Hub will simultaneously help to advance some of the University’s highest strategic priorities and fulfill a shared vision that will have a transformative impact on our region.”

NJ HAX Plasma Forge, 11th Strategic Innovation Center in state, is created

The State announced later that it has created NJ HAX Plasma Forge – a partnership between the N.J. Economic Development Authority, venture capital firm SOSV and the Princeton Plasma Physics lab aimed at bolstering plasma-focused startup creation and acceleration, BINJE has learned. NJ HAX Plasma Forge will aim to leverage the world-class research conducted by PPPL and SOSV’s robust investment experience to promote industry collaboration and commercialize groundbreaking technologies in an emerging economic sector. To be located in the Princeton area, NJ HAX Plasma Forge, will be the State’s 11th Strategic Innovation Center – one of the legacy initiatives of Gov. Phil Murphy. The HAX Plasma Forge will include up to 10,000 square feet of lab and co-working space close to PPPL’s facility in the Princeton area, with equipment, staff and infrastructure suitable for low-temperature plasma research, which is essential to semiconductor manufacturing processes, and fusion supply chain development.

Princeton Plasma Physics Laboratory Launches New Device to Research Magnetic Reconnection

At Princeton University, the Princeton Plasma Physics Laboratory (PPPL) celebrated the start of operations for the Facility for Laboratory Reconnection Experiments (FLARE) with a private ribbon-cutting event. Featuring a device that is 12 feet long, 9 feet in diameter and weighing more than 10 tons, FLARE represents the next generation of research into fundamental plasma physics. FLARE allows researchers to study magnetic reconnection, a phenomenon that occurs when magnetic field lines snap apart and join again, releasing enormous amounts of energy. “FLARE is a new research platform with capabilities that scientists have not had access to before,” said Hantao Ji, a Professor of astrophysical sciences at Princeton, a distinguished research fellow at PPPL and FLARE’s principal investigator. “It’s a new way of doing research that goes beyond what is currently available.”

Strategically Innovating in NJ

While New Jersey has a renowned life sciences sector and is internationally recognized as the “Medicine Chest of the World” due to the biopharmaceutical companies dotting the landscape here, it has enormous opportunities for growth in this and other innovative realms including, but not limited to: science; aerospace; high technology and information technology; tech startups; and artificial intelligence. The State’s Strategic Innovation Centers (SICs) aim to bolster the entire innovation equation while simultaneously strengthening the economy. With funding of $145 million stemming from both state budget allocations as well as the New Jersey Economic Development Recovery Act (ERA), SICs are designated facilities – either already operational or planned for construction – that support various iterations of entrepreneurship, innovation and research and development (R&D).

Rowan Announces Strategic Leadership Changes to Support Growth, Innovation

Rowan University announced a major leadership reorganization that it believes will support growth and innovation at the South Jersey university. Effective July 1, Tony Lowman, now Provost and Senior Vice President for Academic Affairs, will be promoted to the newly created role of Chancellor. Vojislava “Voki” Pophristic, now Dean of the College of Science & Mathematics, will be promoted to Provost and Executive Vice Chancellor for Academic Affairs. President Ali Houshmand’s decision to reorganize the university’s management came after consulting with the board of trustees. The administration is aiming to better serve the state and region by increasing enrollment to 38,000 in the next decade, a goal that requires a redistribution of responsibilities across the institution.

CSIT Taking applications for 4th Round of Clean Tech Seed Grant program

The New Jersey Commission on Science, Innovation and Technology opened applications for Round 4 of its Clean Tech Seed Grant pilot program. The program is designed to help accelerate development and innovation of clean technologies by furthering research and development within the Garden State’s clean technology start-up community. CSIT developed the program in coordination with the New Jersey Board of Public Utilities and New Jersey Economic Development Authority. Applications will be accepted until 5 p.m. July 11. (For more information and an application, click here.) Round 4 will provide grants of up to $75,000 for research & development activities to very early stage, New Jersey-based companies developing or testing clean technologies intended to avoid emissions of, or recapture, greenhouse gases and/or criteria pollutants. Click here for a full list of eligibility requirements.

Rowan Venture Fund Names Partner to Lead Next Phase of Innovation

Rowan Innovation Venture Fund (RIVF) announced the appointment of Garden State Venture Partners (GSVP) as its new management team. The GSVP leadership team is comprised of three Rowan alumni, including Michael Connallon, Jr., who brings 24 years of experience in global financial services, including leadership roles at JPMorgan Chase, where he advised highly sophisticated institutional investors, following years at Goldman Sachs and Deutsche Bank. Shawn Hill has two decades of venture capital and private equity management positions, including Partner at Moderne Ventures, Venture Partner at Polymath Ventures, and management positions at Constellation Software, one of Canada’s largest private equity firms. Connallon and Hill join Ernie Holtzheimer, a distinguished corporate and securities attorney and partner at Eckert Seamans Cherin & Mellott, LLC, who has managed RIVF since 2020.

EY Entrepreneur of Year Awards Show True Impact of Innovation

The annual EY Entrepreneur of the Year Awards for New Jersey always has been a moment to laud the innovative efforts of individuals and companies that are transforming the business ecosystem in the state. The 40th version of the event certainly was the latest example of that. Will Lewis, the CEO of BioNJ Member Insmed and former BioNJ Chair, took it one step further. After he was selected as one of the State’s eight winners, Lewis offered a heartfelt acknowledgement to the other 27 finalists — saying he was moved by their efforts to have an impact that goes beyond the business world. “It’s a wonderful thing to be able to be in the presence of entrepreneurs, because they’re always driven by their original vision — they have this idea that they want to pursue, and they’re going to run through whatever wall is necessary in order to accomplish it,” he said.

CoreWeave Appoints Rogers to Strategic Leadership Role

Livingston-based BioNJ Member CoreWeave announced the appointment of Ernie Rogers as Chief Architect of Strategic Financing. Mr. Rogers brings decades of expertise in financial strategy and operational leadership. He most recently served as Magnetar‘s Chief Operating Officer, where he led the firm’s operations and finances, including managing a diverse array of both back-office and select front-office teams. His leadership helped foster innovation and efficiency across Magnetar’s platform. “Ernie has been an invaluable partner since the beginning of CoreWeave, and we’re thrilled to welcome him to the team,” said Michael Intrator, Co-Founder and Chief Executive Officer at CoreWeave. “His deep understanding of our business makes him uniquely qualified to help drive our next phase of growth.”

Bristol Myers Squibb Names Shibutani as EVP, Chief Strategy Officer

Bristol Myers Squibb (BMS) appointed Chris Shibutani as Executive Vice President, Chief Strategy Officer. Dr. Shibutani’s role is a new position on the BMS leadership team. He will lead the development and advancement of the company’s long-term strategic plan, collaborating across the enterprise to drive innovation and growth. Dr. Shibutani brings more than 25 years of experience in the financial services industry covering global pharmaceutical, biotechnology and medical device industries. Prior to BMS, he served as managing director in the global investment research division at Goldman Sachs. Previous roles include senior analyst positions at Hambrecht & Quist, Cowen, UBS and J.P. Morgan. Before his career in finance, Dr. Shibutani was a physician trained in anesthesiology and critical care medicine. That experience brings a frontline clinical perspective to his strategic vision.

Celldex Therapeutics Announces Election of Denice Torres to its Board of Directors

Hampton-based BioNJ Member Celldex Therapeutics, Inc. announced that Denice M. Torres has been elected to the company’s Board of Directors. Ms. Torres currently serves as Chief Executive Officer of The Ignited Company, a consulting firm she founded in 2017. From 2009 to 2017, she served in various senior leadership roles at Johnson & Johnson. From 2015 to 2017, she was Chief Strategy and Transformation Officer for J&J’s global medical device business, a $25 billion business with more than 50,000 employees. From 2011 to 2015, she was President of J&J McNeil Consumer Healthcare, where she led the recovery of OTC brands, including the iconic Tylenol portfolio, by transforming business operations, manufacturing, quality systems and commercialization approaches, and creating high levels of employee engagement across all functions of the business.

Johnson & Johnson Elects Daniel Pinto, President, JPMorganChase to its Board of Directors

New Brunswick-based BioNJ Member Johnson & Johnson announced that Daniel Pinto, President, JPMorganChase, has been elected to its Board of Directors. Mr. Pinto is a prominent business leader with more than three decades of financial expertise helming critical leadership roles within JPMorganChase, one of the world’s preeminent global financial services firms, where he currently serves as President and as a member of the company’s Operating Committee. “We are thrilled to have Daniel join Johnson & Johnson’s Board of Directors,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “Daniel’s unique perspective and wealth of experience will be a tremendous asset to Johnson & Johnson as we continue to invest in and advance the next generation of healthcare innovation for patients.”

Hepion Names New Interim CEO, Shifts to Diagnostic Innovation

BioNJ Member Hepion Pharmaceuticals Inc. is undergoing a CEO transition as Dr. Kaouthar Lbiati steps into the interim role, the Edison-based biopharmaceutical company announced. Dr. Lbiati succeeds John Brancaccio, who also served in an interim Chief Executive Officer capacity as well as the company’s Executive Chairman. Hepion announced that Mr. Brancaccio is retiring. 

The leadership shift follows a few years of major changeups at the firm. The company previously focused on treatments for chronic liver diseases. Now it is shifting to developing and commercializing diagnostic tests for celiac disease, respiratory multiplex (COVID/Influenza A/B and RSV), helicobacter pylori (H. pylori) and hepatocellular carcinoma. To that end, Hepion entered into a patent and associated assets acquisition agreement with Panetta Partners Ltd. for its primary liver disease treatment candidate, Rencofilstat.  

Idorsia Announces the Appointment of Srishti Gupta, MD as CEO to Ensure the Long-Term Success of Idorsia

Idorsia Ltd, with a site in Cherry Hill, announced the appointment of Dr. Srishti Gupta as Chief Executive Officer of Idorsia, effective July 1, 2025. Dr. Gupta is uniquely placed to take the leadership of the company having served on the Board of Directors since 2021, gaining a deep understanding of the company, the people, the business and Idorsia’s outstanding product and development portfolio. Srishti is a physician and seasoned leader in global health and biopharmaceutical innovation, with more than 20 years of experience advancing science-driven solutions across medicine, strategy and healthcare systems. She has led high-impact teams and advised companies across therapeutic areas on portfolio development, business strategy and patient access. Dr. Gupta spent 18 years at McKinsey & Company as a senior leader in the pharmaceutical and global health practices.

Regeneron Pharmaceuticals 2024 Responsibility Report

For over 30 years, Regeneron has been committed to turning science into life-saving medicines. This mission continues to drive innovation, trust, and resilience. The 2024 report highlights the critical role of Regeneron’s people and inclusive, science-led culture. The Board remains focused on nurturing talent and inspiring future innovators through programs like the Regeneron Science Talent Search. With oversight from the Corporate Governance and Compliance Committee, Regeneron remains dedicated to advancing science to improve lives.

Doing Business in Eurasia

Throughout Spring 2025 - Fall 2026 | Hosted by Mid-Atlantic - Eurasia Business Council

Mid-Atlantic - Eurasia Business Council is pleased to invite you to its Doing Business in Eurasia seminar series that will be taking place throughout Spring 2025 - Fall 2026. The upcoming seminars organized by the Mid-Atlantic - Eurasia Business Council will be held in Philadelphia, PA; Harrisburg, PA; Wilmington, DE; Pittsburgh, PA; New York, NY; Allentown, PA; Baltimore, MD; and Princeton, NJ. The Doing Business in Eurasia seminar series addresses emerging business opportunities for foreign companies and discusses the legal and regulatory environment in Eurasian countries, including Central Asia, Eastern Europe and European Union.

Students 2 Science STEM Volunteer Opportunities

Inspire the next generation of STEM leaders – Volunteer at Students 2 Science (S2S), a recognized leader in providing rigorous, hands-on STEM experiences for students in 5th-12th grades. S2S is currently recruiting volunteers for its in-lab ISAAC program, which offers rigorous, hands-on STEM experiences for middle and high school students in state-of-the-art laboratories in East Hanover and Newark, NJ. For more information, click here. To register to volunteer with S2S or if you have any questions, please email info@students2science.org or call (973) 947-4880 ext. 545.