EU-U.S. Trade Deal Could Add Up to $19 Billion in Pharma Industry Costs, Analysts Say

The European Union's trade deal with the United States could cost the pharmaceutical industry between $13 billion and $19 billion as branded medicines become subject to a tariff of 15%, analysts said. The added costs could raise prices for consumers unless pharmaceutical companies take action to mitigate the impact of the tariffs, one of the analysts said. Pharmaceuticals had historically been exempt from duties. Medicines are the largest European exports to the United States by value and the EU accounts for about 60% of all pharmaceutical imports to the U.S. European officials said that a bilateral trade deal for an across-the-board 15% tariff included pharmaceuticals, except for some generic drugs, which would be subject to no tariffs.

The Impact of Formulary Controls on Commercially Insured Patients in Five Chronic Therapeutic Areas

Formulary controls such as prior authorizations and step therapy are increasingly used by commercial payers, often delaying treatment and increasing prescription abandonment among patients. These restrictions disproportionately affect lower-income and medically complex patients, raising concerns about equitable access to care. While they may reduce short-term costs, the long-term impact includes higher medical expenses and poorer health outcomes, prompting calls for more transparent and patient-centered formulary strategies.

More Than $150M in Economic Impact and Mission Trip to Gulf Arab States

Choose New Jersey announced that it secured more than $150 million in economic impact in the second quarter of 2025, due to the relocation or expansion of 12 companies in the State. These investments — from countries around the world and spanning sectors such as life sciences, clean energy, technology, advanced manufacturing and food and beverage — are expected to have a $156 million economic impact and create 242 new jobs across the State. The quarter also brought the possibility of more investment down the road as Gov. Phil Murphy led 14 delegates on a week-long mission to the Kingdom of Saudi Arabia, the Kingdom of Bahrain and the United Arab Emirates, advancing partnerships in business, higher education, and government. Choose New Jersey launched the 2025 New Jersey Life Sciences Report in partnership with JLL, BioNJ, HINJ and NJEDA.

FDA Approves BRINSUPRI™ (brensocatib) as the First and Only Treatment for Non-Cystic Fibrosis Bronchiectasis, a Serious, Chronic Lung Disease

Bridgewater-based BioNJ Member Insmed Incorporated announced that the U.S. Food and Drug Administration (FDA) has approved first-in-class BRINSUPRI™ (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older. BRINSUPRI is the first and only FDA-approved treatment for NCFB, giving hundreds of thousands of patients and clinicians across the U.S. an option to manage this chronic and progressive disease that can lead to permanent lung damage and lung function decline. There are approximately 500,000 people in the U.S. diagnosed with NCFB, and it is estimated that millions more are living with this disease globally. Unlike other respiratory diseases that are characterized by airway narrowing, bronchiectasis causes airways to permanently widen, making it harder to clear mucus and bacteria, leading to persistent inflammation and infection.

EmphyCorp Announced a Phase III Clinical Trial With Its Rx N115 Nonsteroidal Nasal Spray With No Adverse Effects for Moderate and Severe COPD Patients is Planned for 2nd Quarter 2026

Flemington-based BioNJ Member EmphyCorp Inc. has successfully completed (24) Phase II/III Clinical Trials with no adverse events reported. Given the success of our Pivotal Randomized Double Blinded Placebo Controlled Phase III Clinical Trial in patients with Idiopathic Pulmonary Fibrosis (IPF) Coughing (73% reduction) and Improved Lung Function (Hypoxemia and Dyspnea), EmphyCorp announced a change to its Rx N115 Drug Pipeline to include a Randomized Double Blinded, Placebo Controlled Phase III Clinical Trial with its Rx N115 Nonsteroidal Nasal Spray for treating Moderate and Severe COPD Patients to begin in the 2nd Quarter 2026. EmphyCorp has already completed (6) Randomized Double Blinded, Placebo Controlled Phase I/II Studies in Moderate and Severe COPD patients that produced clinically and statistically significant improvement in all lung functions including FEV-1, FVC, FEV-1/FVC Ratios and a decrease in Hypoxemia, Dyspnea and a decrease in Oxygen Radicals.

Genmab Announces Phase 3 EPCORE® FL-1 Clinical Trial Met Dual Primary Endpoints in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma (FL)

Princeton-based BioNJ Member Genmab A/S announced positive results of the Phase 3 EPCORE® FL-1 trial evaluating subcutaneous epcoritamab, a bispecific antibody, in combination with rituximab and lenalidomide (R2) versus R2 alone for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The study met its dual primary endpoints of overall response rate (ORR, p-value < 0.0001) and progression-free survival (PFS, HR 0.21, p-value <0.0001), demonstrating statistically significant and clinically meaningful differences in both endpoints, reducing the risk of disease progression or death by 79%. Separately, on July 24, the U.S. Food and Drug Administration (FDA) accepted for priority review the supplemental Biologics License Application (sBLA) for epcoritamab plus R2 following at least one prior systemic therapy.

BioAegis Therapeutics Awarded Second FDA Fast Track Designation for Recombinant Human Gelsolin to Treat Inflammasome-Driven Decompression Sickness (DCS)

North Brusnwick-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 decompression sickness (DCS). The company is currently conducting a Phase 2 study of rhu-pGSN for decompression sickness 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.

BioAegis’ portfolio is built around plasma gelsolin, a highly conserved and critical immune regulatory protein which rebalances dysfunctional inflammation without suppressing immune function.

Novo Nordisk A/S: Wegovy® Approved in the U.S. for the Treatment of MASH

Plainsboro-based BioNJ Member Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved an additional indication for Wegovy® (semaglutide 2.4 mg) based on a supplemental New Drug Application (sNDA) for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), in combination with a reduced calorie diet and increased physical activity. The accelerated approval is based on part 1 of the ESSENCE trial, in which Wegovy® demonstrated a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis compared to placebo.

FDA Approves Expanded Indication for AJOVY® (fremanezumab-vfrm), the First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine

Parsippany-based BioNJ Member Teva Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved AJOVY for the preventive treatment of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. With this approval, AJOVY becomes the first and only calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of episodic migraine in pediatric patients and migraine in adults, marking a meaningful advancement in expanding preventive treatment options for those living with migraine. Preventative treatment can help reduce the frequency of migraine attacks, helping children and adolescents to better manage the condition day-to-day. AJOVY is administered once a month and available for in-office or at home use, offering a treatment option that is intended to support adherence and reduce treatment burden for families.

Izalontamab Brengitecan (EGFRxHER3 ADC) Granted Breakthrough Therapy Designation by U.S. FDA for Patients With Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Princeton-based BioNJ Member Bristol Myers Squibb and SystImmune Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to izalontamab brengitecan (iza-bren) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy. Iza-bren is a potential first-in-class bispecific antibody-drug conjugate (ADC) which targets both epidermal growth factor receptor and human epidermal growth factor receptor 3 (EGFRxHER3) with a topoisomerase 1 inhibitor payload. Iza-bren is being developed by Biokin in China and jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement in territories outside of China.

Bristol Myers Squibb’s Application for Breyanzi (lisocabtagene maraleucel) Accepted for Priority Review by U.S. Food and Drug Administration (FDA) in Fifth Cancer Type for Relapsed or Refractory Marginal Zone Lymphoma (MZL)

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Breyanzi^® (lisocabtagene maraleucel; liso-cel) as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 5, 2025. The application is based on results from the primary analysis of the MZL cohort in TRANSCEND FL, an open-label, multicenter, Phase 2, single-arm study. The development progress of Breyanzi reflects BMS’ continued efforts to collaborate across the healthcare ecosystem, with the ultimate goal of reaching more patients and democratizing access to cell therapy.

Sanofi’s Rilzabrutinib Earns Orphan Designation in the EU for IgG4-Related Disease

Morristown-based BioNJ Member Sanofi announced the European Medicines Agency has granted orphan designation to rilzabrutinib, a reversible covalent Bruton’s tyrosine kinase (BTK) inhibitor, for IgG4-related disease (IgG4-RD). EMA grants orphan designation to investigational therapies addressing rare, life-threatening or debilitating medical diseases or conditions that affect no more than 5 in 10,000 persons in the EU. Rilzabrutinib for the treatment of IgG4-related disease was evaluated in a Phase 2 study (clinical study identifier: NCT04520451). In IgG4-RD patients, treatment with rilzabrutinib for 52 weeks led to reduction in disease flare, other disease markers, and glucocorticoid sparing. The safety profile of rilzabrutinib in the study was consistent with previous studies, with no new safety signals observed. Rilzabrutinib is currently under regulatory review in the US, the EU, and China for its potential use in ITP. 

Novartis Announces Both Ianalumab Phase III Clinical Trials Met Primary Endpoint in Patients With Sjögren's Disease

East Hanover-based BioNJ Member Novartis announced positive top-line results from its Phase III trials evaluating ianalumab (VAY736) in adults with active Sjögren's disease. Both trials met the primary endpoint of demonstrating statistically significant improvements in disease activity. These results support the potential for ianalumab, a drug with a dual mechanism of action, B-cell depletion and BAFF-R inhibition, to become the first targeted treatment for patients with Sjögren's disease, a chronic, disabling autoimmune disease. The NEPTUNUS pivotal trials achieved the primary endpoint of improving disease activity measured by a reduction in EULAR Sjögren's syndrome disease activity index (ESSDAI), a multi-dimensional disease activity measurement compared to placebo. Ianalumab was well tolerated and demonstrated a favorable safety profile in Sjögren's disease.

Novartis Ianalumab Phase III Trial Meets Primary Endpoint in ITP, Demonstrating Statistically Significant Improvement in Time to Treatment Failure

East Hanover-based BioNJ Member Novartis announced positive top-line results from VAYHIT2, a Phase III trial evaluating ianalumab plus eltrombopag in patients with primary immune thrombocytopenia (ITP) previously treated with corticosteroids. Ianalumab plus eltrombopag, compared to placebo plus eltrombopag, significantly prolonged the time to treatment failure (TTF), the primary endpoint that assesses how long patients maintain safe platelet levels during and after the treatment period. Ianalumab is being investigated in other B cell-driven autoimmune diseases, including ongoing Phase III trials in first-line ITP and in second and later lines of warm autoimmune hemolytic anemia, with readouts expected in 2026. In VAYHIT2, patients treated with ianalumab plus eltrombopag experienced a significantly higher rate of sustained improvements in platelet count at six months, the key secondary endpoint of the study.

Novartis Twice-Yearly Leqvio® (inclisiran) Receives FDA Approval for New Indication Enabling First-Line Use

East Hanover-based BioNJ Member Novartis announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Leqvio® (inclisiran), enabling its use as monotherapy along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. The FDA proactively requested the label update based on the robust LDL-C lowering data for PCSK9-targeting therapies. With its twice-yearly, health care provider-administered dosing, Leqvio is uniquely positioned to help support patient adherence and long-term LDL-C management, including goal attainment. This is a critical unmet need, as up to 80% of ASCVD patients in the US struggle to reach the LDL-C guideline-recommended target of <70 mg/dL. The updated label removes the requirement for Leqvio to be used on top of or in combination with statin therapy.

Lilly's Oral GLP-1, Orforglipron, Delivers Weight Loss of Up to an Average of 27.3 lbs in First of Two Pivotal Phase 3 Trials in Adults With Obesity

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced positive topline results from the Phase 3 ATTAIN-1 trial, evaluating orforglipron, an investigational oral glucagon-like peptide-1 (GLP-1) receptor agonist, in 3,127 adults with obesity, or overweight with a weight-related medical problem and without diabetes. At 72 weeks, all three doses of orforglipron, met the primary endpoint and all key secondary endpoints compared to placebo, delivering clinically meaningful weight loss as an adjunct to a healthy diet and physical activity. For the primary endpoint, orforglipron 36 mg, taken once per day without food and water restrictions, lowered weight by an average of 12.4% (27.3 lbs) compared to 0.9% (2.2 lbs) with placebo using the efficacy estimand. In the ATTAIN-1 trial, orforglipron met the primary endpoint of superior body weight reduction compared to placebo.

PADCEV™ Plus KEYTRUDA™ Significantly Improves Survival for Certain Patients With Bladder Cancer When Given Before and After Surgery

BioNJ Member Pfizer Inc., with a site in Parsippany, and Astellas Pharma Inc. announced positive topline results from the Phase 3 EV-303 clinical trial (also known as KEYNOTE-905). The EV-303 study is evaluating PADCEV™ (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with KEYTRUDA™ (pembrolizumab), a PD-1 inhibitor, as neoadjuvant and adjuvant treatment (before and after surgery) versus surgery alone, the current standard of care, in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy. At the first interim efficacy analysis, the trial demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS), the study’s primary endpoint, and overall survival (OS), a key secondary endpoint, with neoadjuvant and adjuvant PADCEV plus KEYTRUDA versus surgery alone.

Eisai Launches In-House Developed Anti-Insomnia Drug DAYVIGO® (Lemborexant) in China

Nutley-based BioNJ Member Eisai Co., Ltd. announced that the in-house discovered and developed orexin receptor antagonist DAYVIGO® has launched in China for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Eisai received approval for DAYVIGO in China on May 27, 2025. This marks the first orexin receptor antagonist to be launched in China. DAYVIGO is a dual orexin receptor antagonist that inhibits orexin neurotransmission regulating sleep-wake rhythm by binding competitively to the two subtypes of orexin receptors (OX1R and OX2R). Unlike conventional treatments such as benzodiazepines that act directly on sleepiness, DAYVIGO acts on the orexin neurotransmitter system, which regulates wakefulness. DAYVIGO is believed to facilitate sleep onset and sleep maintenance, and wake by regulating sleep-wake rhythm by suppressing hyperactive wakefulness.

Palisades Therapeutics Announces Groundbreaking Clinical Results for Its PT150 Drug, the Exemplar of Its Platform

Cliffside Park-based Pop Test Oncology LLC, operating as Palisades Therapeutics, announced the publication of landmark Phase I pharmacokinetic study results for PT150 in the Journal of Addiction Medicine. This groundbreaking study, funded by the Department of Defense, demonstrates that PT150, the company's lead selective glucocorticoid receptor antagonist, can be safely administered in alcoholic patients who have substantial alcohol exposure without clinically significant drug interactions—a crucial regulatory milestone that validates the compound's therapeutic potential across multiple indications such as AUD (alcohol use disorder) and post-traumatic stress disorder (PTSD) in patients with co-morbid AUD. PT150 crosses the blood brain barrier and thus has an ideal profile for these clinical settings.

CorMedix Buys Melinta Therapeutics for $300M

CorMedix purchased BioNJ Member Melinta Therapeutics, a biopharmaceutical business based in Parsippany, for $300 million. Melinta is a commercial-stage company providing therapies for acute and life-threatening illnesses, and CorMedix is a biopharmaceutical firm focused on developing and commercializing therapeutic products for life-threatening diseases and conditions. The deal strengthens and diversifies the commercial product portfolio for CorMedix. “This acquisition represents a milestone achievement for Melinta and validates our position as a recognized leader in acute care,” said Christine Ann Miller, CEO of Melinta Therapeutics. “I’m incredibly proud of our accomplishments. Through our talented team’s dedication, we have undergone an extraordinary transformation to build a highly sought-after commercialization platform with sustainable growth and profitability.”

Made Scientific and New Jersey Delegates Celebrate Grand Opening of Flagship Cell Therapy Manufacturing Facility

BioNJ Member Made Scientific held a ribbon-cutting ceremony to commemorate the grand opening of its new 60,000 sq. ft. GMP manufacturing facility and headquarters in Princeton, New Jersey. The event marked a major milestone for the company and the region, underscoring New Jersey's role in the growing national landscape of advanced biomanufacturing and cell and gene therapy innovation. The opening marks the completion of a $12 million initial investment in facility upgrades, equipment, and business system digitization, strengthening Made Scientific's position in the rapidly growing cell therapy sector and commitment to building long-term manufacturing capacity to support the next generation of cell therapies globally. A second phase of expansion has already been announced, and the company is expected to grow its workforce with more than 100 additional skilled professionals, strengthening the company's regional presence and industry influence.

Boehringer Ingelheim and Palatin Technologies to Develop Potential First-in-Class Melanocortin Receptor Targeted Treatment for Patients With Retinal Diseases

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, and Princeton-based Palatin Technologies, Inc., announced a global research collaboration and licensing agreement aiming to develop an innovative therapy for retinal diseases. The collaboration strengthens Boehringer’s innovative and diversified pipeline in retinal conditions and its underlying commitment to vision preservation and protection. Diabetic retinopathy, including diabetic macular edema (DME), affects one in three people with diabetes and is the leading cause of blindness in working-age people. Studies suggest that patients with DME face 30-50% higher healthcare costs than those with diabetes alone,2 underscoring the need for new approaches that mitigate the necessity of long-term, intensive care that often requires frequent monitoring and specialized procedures. 

Gepotidacin Accepted for Priority Review by the U.S. FDA for the Oral Treatment of Uncomplicated Urogenital Gonorrhoea

Warren-based BioNJ Member GSK plc announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental New Drug Application for gepotidacin as an oral option for the treatment of uncomplicated urogenital gonorrhoea in patients 12 years of age and older (weighing ≥45 kg). The US FDA has assigned a Prescription Drug User Fee Act action date of 11 December 2025. In March 2025, gepotidacin was approved by the U.S. FDA under the licensing name Blujepa as oral treatment for female adult and paediatric patients 12 years of age and older (weighing ≥40 kg) with uncomplicated urinary tract infection (uUTI). There is currently no vaccine licensed in the U.S. for the prevention of gonorrhoea infection and the standard of care is injectable treatment which may not be suitable or available for all patients.

GSK and Hengrui Pharma Enter Agreements to Develop up to 12 Innovative Medicines Across Respiratory, Immunology & Inflammation and Oncology

Warren-based GSK plc announced it has entered into agreements with Hengrui Pharma to develop up to 12 innovative medicines, adding significant new growth opportunities to the company beyond 2031. The programmes were selected to complement GSK’s extensive Respiratory, Immunology & Inflammation and Oncology pipeline, and assessed for their potential best- or first-in class profiles. The agreements include an exclusive worldwide license (excluding mainland China, Hong Kong, Macau and Taiwan) for a potential best-in-class, PDE3/4 inhibitor (HRS-9821) in clinical development for the treatment of chronic obstructive pulmonary disease as an add-on maintenance treatment, irrespective of background therapy. The addition of HRS-9821 supports GSK’s ambition to treat patients across the widest spectrum of COPD by including those who face continued dyspnoea (shortness of breath) or who are unlikely to receive inhaled corticosteroids or biologics, based on their disease profile. 

AbbVie Announces Positive Topline Results from Second Phase 3 UP-AA Trial Evaluating Upadacitinib (RINVOQ®) for Alopecia Areata

BioNJ Member AbbVie, with a site in Madison, announced positive topline results from the second of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) in adult and adolescent patients with severe alopecia areata (AA) with a mean baseline SALT score of 84.0 (approximately 16% scalp hair coverage).In Study 1, both doses of upadacitinib achieved the primary endpoint, with 45.2% and 55.0% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reaching 80% or more scalp hair coverage (SALT score ≤ 20) at week 24, compared to 1.5% of patients receiving placebo (p<0.001). These results are consistent with the topline results previously announced from the first parallel replicate study (Study 2) of the Phase 3 UP-AA clinical program.

Ifinatamab Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients With Pretreated Extensive-Stage Small Cell Lung Cancer

Ifinatamab deruxtecan (I-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. 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 and being jointly developed by Daiichi Sankyo and Rahway-based BioNJ Member Merck & Co. The FDA BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The medicine is required to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over currently available medicines.

Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia

Chatham-based Tonix Pharmaceuticals Holding Corp. announced that the U.S. Food and Drug Administration (FDA) approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Tonmya is a first-in-class, non-opioid, once-daily bedtime analgesic with a unique sublingual (under the tongue) formulation that is designed for rapid absorption into the bloodstream. Tonmya is the first new FDA-approved therapy for the treatment of fibromyalgia in over 15 years. The approval incorporated efficacy from two double-blind, randomized, placebo-controlled, Phase 3 clinical trials of nearly 1,000 patients in total that evaluated Tonmya as a bedtime treatment for fibromyalgia. Across both Phase 3 trials, Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks, the primary endpoint.

UroGen Announces 24-Month Duration of Response of 72.2% from the Pivotal Phase 3 ENVISION Trial of ZUSDURI, the First and Only FDA-Approved Medicine for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Princeton-based UroGen Pharma Ltd. announced the 24-month DOR of 72.2% (95% CI 64.1%, 78.8%) by Kaplan-Meier estimate in patients who achieved CR at three months from the Phase 3 ENVISION trial of ZUSDURI™ (mitomycin) for intravesical solution, a treatment for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The median follow-up time after a three-month CR in this analysis was 23.7 months. The median DOR has not been reached. The existing standard of care for LG-IR-NMIBC is a surgical procedure typically conducted under general anesthesia called transurethral resection of bladder tumor (TURBT). Repeated TURBT procedures can impact patients’ physical health and quality of life and can even be associated with an increased risk in mortality.

TRYVIO™ (aprocitentan) Now Included in ACC/AHA Clinical Practice Guidelines for the Treatment of Hypertension

Idorsia Ltd, with a site in Cherry Hill, announces that its novel dual endothelin receptor antagonist (ERA), TRYVIO™ (aprocitentan), has been included in the new comprehensive clinical practice guidelines for the management of systemic hypertension, published by the American College of Cardiology (ACC) and the American Heart Association (AHA) Joint Committee. The updated recommendations now list TRYVIO as a therapy that may be added for adults with difficult-to-control hypertension, including resistant hypertension. TRYVIO is the first systemic hypertension treatment to target a new pathway in over 30 years and the only new medicine to be included in the updated guidelines. Despite progress in improving patient outcomes, hypertension remains a major global health issue, and the number one modifiable risk factor of early morbidity/mortality, affecting an estimated 50% of adults in the US, with 50% of those patients not well controlled despite being on medication.

Fosun Pharma's Small Molecule Innovative Drug XH-S004 Achieves Overseas Licensing for a Potential Total of US$645 Million

Princeton-based Fosun Pharma announced it has signed a License Agreement with Expedition Therapeutics Inc. to grant Expedition the rights to develop, manufacture, and commercialize XH-S004, an orally administered dipeptidyl peptidase 1 (DPP-1) inhibitor independently developed by Fosun Pharma, in all regions globally except Chinese Mainland, Hong Kong SAR and Macau SAR. Fosun Pharma will retain the rights to develop, manufacture, and commercialize XH-S004 in Chinese Mainland, Hong Kong SAR and Macau SAR. XH-S004 is a small molecule orally administered DPP-1 inhibitor independently developed by Fosun Pharma. It reduces inflammatory responses and blocks the infection cycle and airway structural damage by inhibiting DPP-1 and the neutrophil serine proteases activated by it.

ProBio Launches cGMP AAV Manufacturing to Accelerate Gene Therapy

ProBio, a Hopewell-based contract development and manufacturing organization (CDMO) specializing in gene and cell therapy, officially launched its cGMP Adeno-Associated Virus (AAV) manufacturing services at its state-of-the-art 128,000 sq. ft. facility. This expansion directly addresses the growing industry demand for high-quality viral vector production, reinforcing ProBio’s dedication to advancing life-changing gene therapies. The Hopewell facility is designed as a comprehensive, single-site solution for AAV manufacturing. It offers fully integrated services that adhere to global regulatory standards, including GMP plasmid DNA production, AAV vector manufacturing and final drug product formulation with aseptic fill/finish. This approach is a key differentiator, as it simplifies complex logistics, reduces handoffs between multiple vendors and accelerates the entire drug development timeline.

CoreWeave Buys Building it is Occupying at NEST for $322 million

In a move that perhaps further solidifies its commitment to New Jersey, BioNJ Member CoreWeave bought the 280,000-square-foot building it has been leasing at the Northeast Science and Technology Center in Kenilworth for $322 million. The transaction follows CoreWeave’s October 2024 lease of the building within the campus, where it announced plans to invest $1.2 billion to develop its first New Jersey data center. That commitment served as a catalyst for the company’s broader acquisition strategy and further solidifies its expansion plans across the region. CoreWeave is a leading cloud provider specializing in AI infrastructure. Formerly owned by Merck, the campus was acquired in 2023 by Onyx Equities and Machine Investment Group with plans to reposition the property into a mixed-use life sciences and innovation hub.

Tevogen Expecting to Get Additional $1 Million in Grant Funding for AI Drug Discovery Initiative

BioNJ Member Tevogen, the quickly growing Warren-based life sciences company aimed at delivering clinically impactful, economically accessible therapies by leveraging cutting-edge science and technology, said that it expects to receive $1 million in grant funding to advance Tevogen.AI, its artificial intelligence–powered drug discovery and development program. The funding would be provided under the previously announced grant agreement with KRHP LLC, under which Tevogen received $2 million in January 2025 and may receive up to an additional $8 million, for an aggregate of $10 million in non-dilutive funding. “Tevogen.AI, our AI initiative, stands at the intersection of innovation and equity,” Tevogen CEO Ryan Saadi said. “This grant is an endorsement of its potential role in accelerating drug development, bringing down costs, speeding up timelines and expanding access to precision cell therapies for those who need them most.”

Princeton Joins New $20M NSF-Funded AI Institute for Materials Discovery

Princeton University has been selected as one of five higher education partners in a new National Science Foundation Artificial Intelligence Materials Institute (NSF AI-MI). This $20 million federal investment, which is part of a larger $100 million NSF initiative, is set to open this fall at Cornell University. Its mission is to use AI to dramatically accelerate the discovery of new materials critical for advancements in energy, sustainability, and quantum technologies.

The institute will leverage AI to overcome existing limitations in materials research by creating a coalition of scientists, materials researchers and data scientists. In partnership with Intel, the group includes scholars from Princeton, Cornell, the City College of the City University of New York and Boston University.

LinusBio and Coralis Partner to Reduce Autism Diagnosis Waitlists

North Brunswick-based LinusBio and Coralis Health have announced a partnership to provide end-to-end diagnostic services for autism spectrum disorder (ASD). This collaboration combines LinusBio’s ClearStrand-ASD™ biomarker test with Coralis Health’s specialized care platform, creating a seamless pathway from early screening to diagnosis and intervention. The partnership addresses a critical gap in autism diagnosis and care by connecting families who receive ClearStrand-ASD results indicating potential autism risk directly to Coralis Health’s network of specialized clinicians and diagnostic services, dramatically reducing the typical years-long diagnostic journey to just 90 days. Once ClearStrand results are available, LinusBio directly refers qualifying families to Coralis Health, with virtual diagnostic teams reaching out within five calendar days to schedule intake appointments and complete comprehensive evaluations within 90 days.

CentralReach Acquires AI.Measures and SpectrumAi to Lead Outcomes-Based Care in Autism and IDD

CentralReach, a software provider for autism and intellectual and developmental disabilities (IDD) care with an office in Holmdel, announced it acquired of two companies, AI.Measures and SpectrumAi. This strategic move is designed to expand CentralReach’s platform to enable and accelerate the adoption of outcomes-based care (OBC) in the autism and IDD fields. Outcomes-based care is a model that prioritizes measurable clinical progress and quality-of-life improvements over the volume of services delivered. These acquisitions will allow CentralReach to expand its current position as a platform for fee-for-service providers to also support those operating an outcomes-based model. The new additions bring critical capabilities to CentralReach’s platform.

Princeton and Simons Foundation Study Identifies Four Subtypes of Autism

In a significant step towards understanding the complexities of autism, researchers from Princeton University and the Simons Foundation have identified four clinically and biologically distinct subtypes of the condition. Funded by the Simons Foundation and published in Nature Genetics, the study used a computational model to analyze data from over 5,000 children in the SPARK autism cohort study. Instead of looking for single genetic links, the researchers took a “person-centered” approach, considering over 230 traits per individual to find clinically relevant groupings. “Understanding the genetics of autism is essential for revealing the biological mechanisms that contribute to the condition, enabling earlier and more accurate diagnosis, and guiding personalized care,” senior study author Olga Troyanskaya, said.

Ten N.J. Schools Make Princeton Review’s ‘Best Colleges’ List

The Princeton Review’s list of the top colleges in the country does not include a ranking. The organization simply selects 391 universities that it feels stand above the crowd. New Jersey had 10 entrees in the Princeton Review’s 2026 Rankings of the 391 Best Colleges, including Drew, Monmouth, NJIT, Princeton, Rider, Rowan, Rutgers-New Brunswick, Seton Hall, Stevens and TCNJ. NJIT was ranked No. 27 for value and No. 10 for job placement among public schools. Princeton was ranked No. 1 for value and No. 5 for job placement among private schools. Stevens was ranked No. 12 for job placement among private schools

Premier Polytechnic and Princeton Review Best College Since 1992

The Princeton Review continues to recognize New Jersey Institute of Technology as one of the best universities in the U.S. NJIT is featured in this year’s edition of the educational services company’s guide, The Best 391 Colleges. Just 15% of all four-year colleges and universities made the guide, which NJIT has been in since its inception in 1992. The selections are listed alphabetically. The Princeton Review also recognizes NJIT in a string of national ”best” lists, including Top 50 Best Value Colleges (Public Schools), Top 20 Best Career Placement (Public Schools), Top 50 Game Design: Undergraduate, Top 50 Entrepreneurship: Undergraduate and Green Colleges. More specifically, NJIT ranks No. 27 in best value, No. 10 in best career placement, No. 36 in game design and No. 44 in entrepreneurship — all underscoring the university’s standing as a premier public polytechnic institution.

Rutgers Health Chancellor Brian Strom Named ‘Educator of the Year’ for Transforming Medical Education

The Research & Development Council of New Jersey has named Dr. Brian Strom, chancellor of Rutgers Biomedical and Health Sciences (now Rutgers Health), the recipient of its prestigious “Educator of the Year” award. The council cited his “transformative impact on medical education in New Jersey,” recognizing his efforts to unify and strengthen the state’s medical and health professional schools. According to the R&D Council, Dr. Strom’s leadership has been instrumental in positioning New Jersey as a national leader in health sciences education. He was the “chief architect” of Rutgers Health, a premier academic health-care center that was established after the integration of the former University of Medicine and Dentistry of New Jersey into Rutgers University in 2013.

HMH Researcher Receives $27M NIH Grant to Study Environment Impacts on Children With Disabilities

A Hackensack Meridian Health physician-scientist has been awarded a major National Institutes of Health (NIH) grant to continue her research into how environmental factors affect children with a variety of disabilities, as part of a massive ongoing nationwide study. The five-year, $27 million grant to Judy Aschner, M.D. and team is part of the Environmental Influences on Child Health Outcomes (ECHO) program, a massive national cohort started in 2016 and renewed in 2023. The new funding for a pregnancy cohort of women recruited from HUMC and Northwestern University in Chicago, continues the long-standing ECHO research of Dr. Aschner, member of the Center for Discovery and Innovation (CDI). The grant, entitled “Enriching ECHO Cohorts with High-risk Pregnancies and Children with Health Challenges (Enriching ECHO)” will advance ECHO research by focusing on the impact of the environment on outcomes for children with a variety of sensory, motor and neurodevelopmental challenges.

HMH’s Hennessy Institute is Pioneering Ways to Identify — and Treat — Precancerous Activity

Imagine treating cancer before it starts. That’s the goal. And it’s more than a dream. It’s becoming a reality at the Hennessy Institute for Cancer Prevention and Applied Molecular Medicine, which is finding ways to test and detect cancerous activity at its earliest stages — even before it starts. And, more importantly, before it returns. The facility, located at the Hackensack Meridian Health & Wellness Center in Clifton — thanks to a generous donation from the Mike & Patti Hennessy Foundation, provides next-level care for cancer, according to Dr. Andre Goy, the director of the facility. Dr. Goy said the pioneering technology being utilized has the potential to move the field of oncology. “We now have technology, using genomics, where we can do a liquid biopsy from a blood line to detect traces of cancer,” he said.

Seton Hall Receives $10M Estate Gift to Support STEM Scholarships

Seton Hall University has received a $10 million gift from the estate of the late Frank Rubino ’64 to establish the Frank Rubino Endowed Scholarship, providing financial support to students pursuing degrees in traditional STEM fields. “This gift comes at a pivotal moment, as the job market increasingly demands professionals in STEM fields. “By 2032, it is estimated that there will be more than 11.8 million new jobs in STEM,” said Jonathan Farina, dean of Seton Hall’s College of Arts and Sciences. “Gifts like Frank Rubino’s ensure that we are preparing graduates to take advantage of these economic opportunities and to serve society in healthcare, security, technology and innovation. By correlating Italian studies with STEM, this gift also reinforces Seton Hall’s commitment to educating well-rounded students who excel in both technical disciplines and the arts, humanities and sciences.

Murphy Signs Bill Strengthening Manufacturing in New Jersey

Gov. Phil Murphy signed a bill creating a $500 million tax credit program that provides incentives for manufacturing investment and job creation. The Next New Jersey Manufacturing Program, administered by the New Jersey Economic Development Authority (NJEDA), provides tax credits up to $150 million per project for manufacturers and clean energy producers and reserves $100 million for clean energy businesses in the program’s first two years. The program provides tax credits to qualifying businesses that invest at least $10 million into New Jersey-based facilities and create at least 20 full-time jobs. The law shifts up to $500 million in previously allocated credits from the Aspire and Emerge programs to fund the new manufacturing initiative, with $100 million set aside during the first two years specifically for clean energy manufacturing.

SBA Announces Regional Innovation Cluster Funding to Support Domestic Manufacturing

The U.S. Small Business Administration (SBA) announced the availability of new Regional Innovation Cluster (RIC) funding of up to $7.5 million to support domestic manufacturers. The new funding will empower small businesses with the resources and technical assistance to start building and strengthening the nation’s supply chains. “Our new RIC funding and ongoing outreach serves small businesses with practical tools to reshore jobs and critical industries,” said SBA Administrator Kelly Loeffler, “reducing our reliance on foreign suppliers and protecting American strength and security. Not only will small businesses rebuild our industrial base – they will solidify America as the global leader in advanced manufacturing and innovation for the long term.” The new funding will support the formation of up to 20 RICs to assist small businesses with rebuilding America’s manufacturing dominance.

Osteogene to Receive uUp to $1M in Matching Funding from NJEDA to Boost Rollout of Therapy

Osteogene Tech Corp., a commercial-stage bone regenerative business, said that it was selected as one of the early-stage technology companies to receive up to $1 million in matching funding from the New Jersey Economic Development Authority’s Angel Match Program. The funds will be used to help accelerate the commercialization of the company’s InRoad technology, an FDA-cleared, engineered bioceramic bone graft that leads to natural bone regeneration and restoration promoting blood absorption and circulation. Osteogene will receive an initial $400,000 investment to help support its commercialization and scale-up efforts. Over the coming months, Osteogene and the NJEDA plan to collaborate on an additional $600,000 in matching funds — bringing the total potential investment to $1 million. The funding will support supply and demand, distribution to dental practices, and further research to discover applications for their patented technology in bone regeneration.

Mental Health Association in New Jersey Receives $112,500 Grant from KPMG U.S. Foundation

The Mental Health Association in New Jersey (MHANJ) received a three-year, $112,500 grant from the KPMG U.S. Foundation. The funding will support MHANJ’s mission to help people overcome mental illness and substance use disorders through advocacy, education, training and services. “KPMG’s generous support will help us expand our advocacy and educational efforts. By engaging with people on a grassroots level across the State, we educate them about how to identify and begin to address mental health issues in the early stages to prevent more serious outcomes. It also helps to break the stigma of mental illness and substance use conditions that often keep people from seeking the help that they need,” said Carolyn Beauchamp, MHANJ’s President and CEO.

Legend Biotech Appoints Former AstraZeneca Exec as Chief Financial Officer

BioNJ Member Legend Biotech Corporation, based in Somerset, said it appointed Carlos Santos as its new Chief Financial Officer. Mr. Santos will assume the role from Jessie Yeung, who has served as the interim CFO since January 2025. In his new position, Santos will be responsible for overseeing Legend Biotech’s financial operations, with a focus on strengthening the company’s balance sheet and achieving profitability in 2026. He brings extensive experience from the pharmaceutical and technology sectors, having held leadership positions across the globe. Prior to joining Legend Biotech, Mr. Santos served as the CFO for U.S. Oncology at AstraZeneca, where he spent a decade in various financial and leadership roles. He also held CFO positions at Alcon, a division of Novartis, and financial leadership roles at Intel Corporation.

Bristol Myers Squibb Names Pennell SVP, Worldwide Head of Medical Affairs, Hematology and Oncology

Princeton-based BioNJ Member Bristol Myers Squibb said it appointed Dr. Nathan Pennell as Senior Vice President, Worldwide Head of Medical Affairs, Hematology and Oncology.

Dr. Pennell, a board-certified medical oncologist with nearly 25 years of experience, will lead the BMS oncology medical affairs program, overseeing scientific strategy and execution, competitive intelligence, medically informed regulatory insights and medical input for business development. Before joining Bristol Myers Squibb, he served as head of thoracic oncology and clinical research at the Cleveland Clinic Taussig Cancer Center. Dr. Pennell is recognized as a leading expert in oncology, known for his expertise in thoracic cancers and a strong track record of advancing clinical trials with novel therapies.

Milestone Scientific Appoints Hines as CEO

Milestone Scientific Inc., a leading developer of computerized drug delivery instruments that provide painless and precise injections based in Roseland, announced the appointment of Eric C. Hines as Chief Executive Officer. Mr. Hines brings more than 25 years of leadership experience in scaling sales-driven enterprise software companies, serving customers across a range of industries, including health care. Most recently, he served as President of North America at Ex Libris, a division of Clarivate, where he led operations across the U.S., Canada and Latin America, and increased annual revenue from approximately $50 million to over $100 million. Additionally, he launched multiple new product lines; managed marketing, sales and service organizations; and drove new customer expansion.

Sandoz Launches Renewable Energy Partnership to Cover Nearly 90% of Electricity Demand for European Operations

BioNJ Member Sandoz signed a 10-year virtual Power Purchase Agreement (PPA) with Elawan Energy, a global player in the renewable energy sector, for new-build solar projects. This new partnership contributes to Sandoz’s ongoing efforts to decarbonize electricity use globally, complementing similar Power Purchase Agreements for production operations across multiple sites. In a broader context, Sandoz announced in 2024 the formal submission of a Commitment Letter to the Science Based Targets Initiative (SBTi), confirming the company’s intent to set science-based carbon emission reduction targets.

Manufacturing Alliance of South Jersey Quarterly Meeting

Tuesday, August 27, 2025 | Virtual | Hosted by Manufacturing Alliance of South Jersey

This event is your opportunity to connect with local fellow manufacturers, learn about industry partnerships, different grant opportunities and gain valuable insights to drive your manufacturing business forward. Don't miss out on this chance to be a part of a thriving community dedicated to advancing the manufacturing sector in South Jersey.

2025 FemaleFounded Conference

November 15, 2025 | Hosted by Princeton University

This year’s conference celebrates the powerful intersection of innovation, entrepreneurship, and wellbeing—spotlighting female-founded companies that are redefining the future of healthcare. From cutting-edge wearables and digital health platforms to groundbreaking solutions in mental health and wellness, we’re showcasing a dynamic range of ventures improving lives across the health spectrum. While many of these companies focus on women’s health, the innovations represented span all areas of healthcare and wellbeing, driven by founders who are breaking barriers and building a healthier future for all.

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.