PODCAST - Steve Usdin: Tariffs, Price Controls & Inflation Reduction Act (IRA)

In this episode, host Duane Schulthess sits down with Steve Usdin, Senior Washington Editor at BioCentury Publications since 1993 and one of the most cited experts on FDA regulation, Medicare policy and the political forces driving biopharma innovation, to explore the major forces reshaping U.S. life sciences: looming Section 232 tariff probes, the unintended “small-molecule penalty” baked into the Inflation Reduction Act, deep NIH/FDA budget cuts, post-COVID science skepticism and China’s surge in clinical filings, and what these policy shifts mean for innovation, patient access and America’s competitive edge.

New Research Reveals the Devastating Impact of the Inflation Reduction Act’s “Pill Penalty” on Small Molecule Medicines

New research reveals the harmful impacts of the Inflation Reduction Act’s drug pricing provisions on biopharmaceutical investment, research and development and patients’ treatment options. Vital Transformation’s research found that aggregate small molecule investments by companies valued at less than $2 billion dropped by 68% since the Inflation Reduction Act was introduced. Further, the study also found a 74% drop in the median size of aggregate investments into indications specifically targeting the Medicare-aged population, with a significant decrease in investments in small molecules compared to large molecules after the IRA was introduced. The small molecule “pill penalty” has particularly exacerbated R&D funding of therapies with a high exposure to the Medicare-aged population.

The Inflation Reduction Act and Drug Development: Potential Early Signals of Impact on Post-Approval Clinical Trials

The Inflation Reduction Act’s (IRA) Drug Price Negotiation Program (DPNP) may reduce incentives for industry investments in post-approval clinical development. We aimed to explore the IRA’s impact on the initiation of industry-sponsored, post-approval clinical trials. Using Citeline’s Trialtrove database (7/2014–8/2024), we conducted an interrupted time series analysis (ITSA) to estimate the IRA’s impact on the initiation of industry-sponsored Phase I-III trials in previously approved drugs, excluding all vaccines and COVID-19 treatments. We conducted an additional ITSA to examine post-IRA changes in government-funded trials, hypothesized to be unaffected by the IRA and sensitivity analyses to explore potential exogenous confounding factors. Finally, we explored differences in the IRA’s impact on post-approval industry-sponsored clinical trial initiation in small versus large molecule drugs.

340B State-Specific Insights & Trends

IQVIA has released one-page fact sheets on "The Cost of 340B" for each U.S. state, showing how the cost of the program to employers can vary drastically. 340B is not free. The cost of 340B to employers can vary drastically across states. Explore the cost of the 340B Program across all 50 states. Understand how it affects employers, workers and government health plans. These one-page fact sheets break down the costs, highlight state-specific trends and provide valuable insights into the broader implications of 340B utilization nationwide.

NIH Cuts Threaten U.S. Life Sciences Dominance to China

The current debate over capping federal research overhead rates misses the forest for the trees. Federal investments in medical research have built a thriving U.S. biotech sector that employs 2.3 million people. Funding from the National Institutes of Health (NIH) provides the foundation for this success, supporting universities and research institutions that attract top scientists and foster innovation. The Trump Administration’s proposed cuts to NIH’s indirect cost reimbursement— dismissed by some as mere “overhead” — threaten to undermine American exceptionalism, ceding our leadership in life sciences, global health and biosecurity to China.

A Letter to Senate HELP Committee Chairman Bill Cassidy on Preserving and Modernizing the FDA

From U.S. Biomedical innovators, investors and Patient advocates 

We are U.S. biomedical innovators, the investors that support them, and patient advocates who depend on continued medical progress, as all Americans do. We rely on the U.S. Food and Drug Administration’s guidance and rigor to navigate policy and medical standards and to approve new medicines. Our ability to develop medicines, medical devices, vaccines and diagnostics to better the health of all Americans is predicated on a science-focused agency that can do its job effectively and efficiently. While we share a desire to strengthen and modernize the FDA, we are writing to share that we are deeply concerned about the current state of the agency and its future.

Bayh-Dole Coalition Supports President Trump’s Renewed Commitment to Scientific Progress and Innovation

The Bayh-Dole Coalition sent a letter to President Trump thanking him for tasking Michael Kratsios, Director of the Office of Science and Technology Policy, with revisiting the vision set forth in Dr. Vannevar Bush’s landmark 1945 report, Science: The Endless Frontier. “The President’s call to ‘blaze a trail to the next frontiers of science’ is timely and firmly rooted in Bush’s visionary foundation,” said Joseph P. Allen, Executive Director of the Bayh-Dole Coalition. “The Bayh-Dole Coalition stands ready to support this important endeavor in any way we can.” The letter offered the president important background on the central role that the Bayh-Dole Act of 1980 has played in translating federally funded research into real-world innovations.

Assembly Democrats to Host Hearings Examining Impact of PBMs on Drug Prices

New Jersey Assembly Democrats Craig Coughlin and Roy Freiman said that the committee will begin a series of hearings focused on pharmacy benefit managers (PBMs) and their impact on prescription drug prices for New Jersey residents. Pharmacy benefit managers are companies that work with health insurers, large employers, and other payers to manage their prescription drug benefits. In the 1960s, PBMs were created to help set reimbursement rates, process claims and pay pharmacies. Since then, their business model has become more complex, with PBMs adding other lines of business. These hearings come as concern increases about the impact PBMs have on the health care system. PBMs were originally established to control drug costs and improve efficiency, however, recent federal investigations suggest that some of these businesses may in actuality be contributing to higher prescription prices and reduced medication access.

Amneal Donates $1.5M This Parkinson’s Awareness Month

After Alzheimer’s, Parkinson’s is the second-most common neurodegenerative disorder in the United States, according to the National Institutes of Health. And this April, Amneal Pharmaceuticals Inc. is making a major contribution to support patients living with the disease. The Bridgewater-based global biopharmaceutical company announced donations totaling $1.5 million to multiple patient assistance foundations that offer help to individuals living with PD in recognition of Parkinson’s Awareness Month. Parkinson’s disease affects more than 10 million people worldwide, according to Amneal. And the Parkinson’s Foundation puts the number of people in the U.S. living with PD at 1 million. With nearly 90,000 new diagnoses in the U.S. each year, the group anticipates that total figure will hit 1.2 million by 2030.

Sanofi’s Foundation S and Sobi Extend Their Partnership With the World Federation of Hemophilia Humanitarian Aid Program

Sanofi, through its philanthropic organization Foundation S, and Sobi, together with the World Federation of Hemophilia (WFH) and WFH USA, announce the signing of a contract providing support to the WFH Humanitarian Aid Program in the form of medicine donations and financial assistance for up to 5 years. This is the second renewal of the collaboration, which has been in place for more than ten years and demonstrates the partners’ commitment to providing the necessary care and resources for people with hemophilia around the world.

The commitment includes the donation of up to 100 million international units (IU) of factor therapy per year that will be distributed by the WFH Humanitarian Aid Program worldwide to developing countries. This will enable the WFH to deliver aid to people with inherited bleeding disorders across the globe.

ROI Influencers: Women in Business 2025: Top 50 — No. 38 Debbie Hart

President and CEO of BioNJ, Debbie Hart, has been a key architect of New Jersey’s biotechnology and life sciences ecosystem for more than three decades. Since co-founding BioNJ in 1994, she has led the organization in representing nearly 400 research-based companies, advocating for medical innovation, investment, and patient access, and positioning the state as a global leader in biopharmaceutical development. Appointed by Gov. Murphy, Hart serves as Chair of the New Jersey Commission on Science, Innovation, and Technology (CSIT), where she drives initiatives to advance research, commercialization, and workforce development. She also co-chairs the Higher Education Strategic Plan’s Research, Innovation, and Talent Working Group, serves on the New Jersey Commission on Higher Education and Business Partnership and has played a pivotal role in shaping the state’s economic and technological landscape through her work with the New Jersey Economic Development Authority (NJEDA). Her relentless advocacy continues to strengthen New Jersey’s reputation as a hub for biotechnology, pharmaceutical innovation, and life sciences investment, ensuring the State remains at the forefront of global healthcare advancements.

BioNJ is proud of the numerous BioNJ Members featured on the ROI-NJ’s Influencers list. Please click here for the full list of recipients. 

BioNJ Brings 15th BioPartnering Conference Back to Jersey City

As Featured in NJBIZ

BioNJ will host its 15th Annual BioPartnering Conference May 13 at the Liberty Science Center in Jersey City. The annual event brings together leaders and stakeholders from life sciences, investment, academia and everything in between. NJBIZ has reported on past iterations of the event. The gathering offers an opportunity for emerging companies to present to potential investors. It also provides the chance for attendees to network and collaborate — all in the name of driving innovation forward. J.P. Morgan and Morgan Lewis serve as co-sponsors for the BioPartnering Conference. Additionally, CoreWeave joins this year as the newest addition to the group of Title Conference Partners. BioNJ President and CEO Debbie Hart said the conference is a premier opportunity to discover breakthrough innovations and connect with some of the most promising companies across life sciences, biotech, health care and digital health.

BioNJ Conference Will Draw as Many as 600 Companies

As Featured in ROI-NJ

About 600 companies will convene at the Liberty Science Center in Jersey City to participate in the 15th annual BioPartnering Conference on May 13 hosted by BioNJ, the life sciences trade association for New Jersey. The conference attracts emerging companies, investors and innovators from across the globe who will engage in panel discussions, pitches, spontaneous conversations and private meetings. What distinguishes the event is the variety of ways start-ups can connect with larger companies. Companies can meet with potential partners by scheduling one-to-one partnering meetings throughout the day; talk discreetly with business development professionals from big biopharma at the industry connections desks; or chat with company representatives at the Exhibit Hall. This year, more than 100 early stage companies will make pitches to investors or potential partners.

Tevogen CEO to Join Dialogue on Paths to Liquidity: Strategies for Adapting to a Volatile Market at BioNJ’s Fifteenth Annual Bio Partnering Conference with Experts from J.P. Morgan, RSM and Cantor Fitzgerald

Warren-based BioNJ Member Tevogen CEO Dr. Ryan Saadi, M.D., MPH, will participate in BioNJ’s Fifteenth Annual BioPartnering Conference. Dr. Saadi will be featured on the panel discussion titled Paths to Liquidity: Strategies for Adapting to a Volatile Market, moderated by David C Schwartz, Partner at Morgan Lewis. Along with Dr. Ryan Saadi, the panel will also include commentary from Matt Vamvakis, Managing Director, J.P. Morgan Private Bank, Amanda Laskey, Life Sciences Senior Analyst, RSM US and Kee Colon, Managing Director, Cantor Fitzgerald. “The conference’s action-packed agenda was thoughtfully designed to provide entrepreneurs with a dynamic environment geared toward growth and collaboration,” said BioNJ President and CEO Debbie Hart. “With that in mind, we’re thrilled to welcome Dr. Saadi and his fellow panelists to share their invaluable insights during 'Paths to Liquidity: Strategies for Adapting to a Volatile Market'. Attendees are certain to walk away with meaningful, actionable takeaways.”

BeiGene Receives Positive CHMP Opinion for TEVIMBRA® as a First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

Hopewell-based BioNJ Member BeOne Medicines Ltd. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of TEVIMBRA® (tislelizumab), in combination with etoposide and platinum chemotherapy, as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC). The extension of indication for ES-SCLC is based on results from RATIONALE-312 (NCT04005716), a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate the efficacy and safety of TEVIMBRA, in combination with platinum (investigator’s choice of cisplatin or carboplatin) plus etoposide, as first-line treatment in adult patients with ES-SCLC. The study met its primary endpoint, exhibiting a statistically significant and clinically meaningful improvement in overall survival (OS) with TEVIMBRA in combination with chemotherapy, compared with placebo plus chemotherapy in the intent-to-treat (ITT) population.

Positive Outcome in 75% of CTCL Patients Treated With HyBryte™ for 18 Weeks

Princeton-based BioNJ Member Soligenix, Inc. announced interim results from the ongoing open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ (synthetic hypericin) treatment for up to 54 weeks in patients with early stage cutaneous T-cell lymphoma (CTCL). Following 18 weeks of treatment, 75% of patients achieved "Treatment Success," reinforcing HyBryte™ as a potentially safe and fast-acting therapy for this chronic and underserved cancer. The IIS is sponsored by Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania who was a leading enroller in the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study and is the Principal Investigator for the confirmatory Phase 3 FLASH2 study for the treatment of early stage CTCL. 

Helsinn Group Submits a New Formulation of AKYNZEO® to the European Medicines Agency (EMA)

Iselin-based Helsinn Group announced the submission of a new formulation for AKYNZEO® to the European Medicines Agency (EMA). AKYNZEO® is indicated for the prevention of acute and delayed nausea and vomiting associated with both highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy. Once approved, this new innovative formulation may offer benefits to cancer patients in addition to the already approved formulations. The new AKYNZEO® formulation is expected to be launched in H1 2026. AKYNZEO® is the first and only 5-HT3 and NK1 receptor antagonist fixed dose combination approved in adults for the prevention of acute and delayed nausea and vomiting associated with highly and moderately emetogenic chemotherapy.

Novartis Receives FDA Accelerated Approval for Vanrafia® (atrasentan), the First and Only Selective Endothelin A Receptor Antagonist for Proteinuria Reduction in Primary IgA Nephropathy (IgAN)

East Hanover-based BioNJ Member Novartis announced the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia® (atrasentan), a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. This is generally defined as a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g. Vanrafia is a once-daily, non-steroidal, oral treatment that can be added onto supportive care, including a renin-angiotensin system (RAS) inhibitor with or without a sodium-glucose co-transporter-2 (SGLT2) inhibitor. Vanrafia was granted accelerated approval based on a prespecified interim analysis of the Phase III ALIGN study measuring the reduction of proteinuria at 36 weeks compared to placebo. It has not been established whether Vanrafia slows kidney function decline in patients with IgAN. 

Novartis $23 Billion Expansion Investment Includes Millburn Site

BioNJ Member Novartis said it plans to invest $23 billion over five years in construction and expansion of 10 U.S. facilities, including one in Millburn. The company said the planned increase would create 1,000 new jobs at Novartis and about 4,000 U.S. jobs overall. The company plans to expand on its current manufacturing, research and technology presence across the U.S. with 10 facilities, including seven new ones. The company said production capacity will cover active pharmaceutical ingredients (API) and biologics drug substances, as well as secondary production and packaging. Of the 10 facilities planned for construction or expansion over the next five years, one project is slated for Millburn. The Essex County town is home to a radioligand therapy (RLT) manufacturing facility. 

ACIP Votes to Expand Recommendation for Pfizer’s RSV Vaccine ABRYSVO® to Include Adults Aged 50 to 59 at Increased Risk of Disease

BioNJ Member Pfizer Inc., with a site in Peapack, announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease (LRTD). This includes ABRYSVO® (Respiratory Syncytial Virus Vaccine), which in October 2024, the U.S. Food and Drug Administration approved for the prevention of RSV-associated LRTD in adults aged 18 to 59 at increased risk of severe disease. According to the CDC, between 15,000 - 20,000 RSV-associated hospitalizations occur annually in U.S. adults aged 50 - 59 years. The risk of hospitalization is highest among those adults with one or more underlying medical conditions such as obesity, cardiovascular disease, diabetes, chronic obstructive pulmonary disorder (COPD), asthma and other chronic or immunocompromising conditions.

Lilly's Oral GLP-1, Orforglipron, Demonstrated Statistically Significant Efficacy Results and a Safety Profile Consistent With Injectable GLP-1 Medicines in Successful Phase 3 Trial

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced positive topline Phase 3 results from ACHIEVE-1, evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Orforglipron is the first oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist, taken without food and water restrictions, to successfully complete a Phase 3 trial. If approved, the company is confident in its ability to launch orforglipron worldwide without supply constraints. This would further Lilly's mission to reduce chronic diseases like type 2 diabetes, which is expected to impact an estimated 760 million adults by 2050. In the first Phase 3 trial of the ACHIEVE program, orforglipron met the primary endpoint of superior A1C reduction compared to placebo at 40 weeks, lowering A1C by an average of 1.3% to 1.6% from a baseline of 8.0%, using the efficacy estimand.

Dupixent Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria

Bridgewater-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment. The U.S. approval is based on data from two phase 3 clinical studies, Study A (n=136) and Study C (n=148), which included biologic-naïve patients aged 12 years and older who were symptomatic despite the use of antihistamines and assessed Dupixent as an add-on therapy to standard-of-care antihistamines, compared to antihistamines alone. Both studies met their primary and key secondary endpoints with Dupixent demonstrating reductions in itch severity and urticaria activity (a composite of itch and hives) compared to placebo at 24 weeks.

Sanofi’s Respiratory Pipeline Advances With New Data in Asthma and Plans for New Clinical Studies in COPD

Bridgewater-based BioNJ Member Sanofi shared new progress from its mid- to late-stage respiratory pipeline, including preliminary Phase 2 results for amlitelimab in adults with moderate-to-severe asthma. Preliminary results from the TIDE-Asthma Phase 2 study (clinical study identifier: NCT05421598) show that the primary endpoint of annualized exacerbation rate at week 48 was not met at the highest dose level, leading to nominal significance at the medium dose. However, the study demonstrates amlitelimab's compelling efficacy in heterogeneous inflammatory asthma, potentially representing a breakthrough for this underserved patient population if observed in later studies. Treatment with amlitelimab led to nominally significant and clinically meaningful reductions in asthma exacerbations at the medium dose tested and a numerically greater reduction in exacerbations at the high dose at week 60. The study also demonstrated nominally significant and clinically meaningful improvement in secondary endpoints of lung function and asthma control.

Tolebrutinib Phase 3 Data Published in NEJM Demonstrate Benefit on Disability Progression in Multiple Sclerosis

Bridgewater-based BioNJ Member Sanofi announced The New England Journal of Medicine (NEJM) published positive results from the HERCULES Phase 3 study demonstrating that tolebrutinib delayed disability progression in people with non-relapsing secondary progressive multiple sclerosis (nrSPMS), where there are currently no treatment options approved. These findings further support the differentiated mechanism of oral, brain-penetrant tolebrutinib, targeting disability progression independent of relapse activity. The HERCULES data demonstrated that tolebrutinib delayed the time to onset of 6-month confirmed disability progression (CDP) by 31% compared to placebo (hazard ratio [HR] 0.69; 95% confidence interval [CI] 0.55-0.88; p=0.003). Additionally, results from the GEMINI 1 and 2 Phase 3 studies, evaluating tolebrutinib in people with relapsing multiple sclerosis (RMS) were also published in NEJM.

Leqembi® (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer’s Disease to be Authorized in the European Union

Nutley-based BioNJ Member Eisai Co., Ltd. and Biogen Inc. announced that the European Commission has granted the amyloid-beta (Aβ) monoclonal antibody Leqembi® (lecanemab) Marketing Authorization (MA) in the European Union (EU). This makes the medicine the first therapy that targets an underlying cause of Alzheimer’s disease (AD) to be granted a MA in the EU. Lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to AD (early AD) who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes with confirmed amyloid pathology. The lecanemab MA applies to all 27 EU Member States as well as Iceland, Liechtenstein and Norway. Lecanemab is the only approved Aβ monoclonal antibody that preferentially binds and clears toxic protofibrils (soluble Aβ aggregates), in addition to targeting and reducing Aβ plaques (insoluble Aβ aggregates).

Boehringer Ingelheim and Cue Biopharma Partner to Develop Next-Generation Treatment for Autoimmune and Inflammatory Diseases

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, and Cue Biopharma, Inc. announced a strategic research collaboration and license agreement to develop and commercialize Cue Biopharma’s CUE-501 product candidate, a differentiated B cell depletion therapy for autoimmune diseases. Cue Biopharma is a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the potential treatment of autoimmune and inflammatory diseases. Cue Biopharma’s preclinical candidate molecule binds to a B cell specific membrane protein and in parallel selectively engages virus-specific memory killer T cells. This enables it to selectively deplete B cells and dampen autoimmune and inflammatory processes, potentially offering improved benefit and safety versus other therapeutic approaches targeting B cells. 

Johnson & Johnson Unveils Highly Anticipated and Potential Practice-Changing Data in Bladder Cancer Treatment at AUA

Raritan-based BioNJ Member Johnson & Johnson announced new data from its leading oncology pipeline. Among the highlights are the 12-month duration of response (DOR) data from the Phase 2b Cohort 2 SunRISe-1 study, evaluating TAR-200—an intravesical gemcitabine releasing system—for patients with Bacillus Calmette-Guérin (BCG)—unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS) with or without papillary disease. “TAR-200 provides a new approach, with clinical data showing an impressive complete response rate, meaning the cancer was undetectable following treatment. The highly anticipated 12-month duration of response findings from our Cohort 2, SunRISe-1 study further support the potential for patients to remain cancer-free for a clinically meaningful period,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine.

Icotrokinra Results Show 75% of Adolescents With Plaque Psoriasis Achieved Completely Clear Skin and Demonstrate Favorable Safety Profile in a Once Daily Pill

New Brunswick-based BioNJ Member Johnson & Johnson announced new icotrokinra (JNJ-2113) data from a subgroup analysis of ICONIC-LEADa, the first ever Phase 3 registrational study in moderate-to-severe plaque psoriasis (PsO) to assess efficacy and safety of a systemic therapy in adolescents and adults simultaneously. These data show adolescents treated with once daily icotrokinra achieved higher rates of clear or almost clear skin at Week 16 compared to patients receiving placebo with no new safety signals identified. Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor and is being studied in adults and adolescents 12 years of age and older with moderate-to-severe plaque PsO.

TREMFYA® (guselkumab) is the First and Only IL-23 Inhibitor to Significantly Reduce Both the Signs and Symptoms and the Progression of Structural Damage in Adults Living With Active Psoriatic Arthritis

New Brunswick-based BioNJ Member Johnson & Johnson announced that the TREMFYA® (guselkumab) Phase 3b APEX study achieved both its primary endpoint (ACR20a) of reducing signs and symptoms and its major secondary endpoint of reducing progression of structural damage as measured by radiographic progression at 24 weeks, in adults living with active psoriatic arthritis (PsA), compared to placebo. TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved to treat PsA that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including active psoriatic arthritis.

Johnson & Johnson Highlights New Data that Showcase the Strength of Nipocalimab, Demonstrating Long-Term Sustained Disease Control in Adults Living With Generalized Myasthenia Gravis (gMG)

New Brunswick-based BioNJ Member Johnson & Johnson announced results from additional analyses of the Phase 3 Vivacity-MG3 double-blind study and the ongoing open-label extension (OLE), evaluating the long-term efficacy and safety of investigational nipocalimab in a broad population of antibody-positive (anti-AChR+, anti-MuSK+, anti-LRP4+) adults with generalized myasthenia gravis (gMG). Patients treated with nipocalimab plus standard of care (SOC) maintained improvements in their MG-ADL and QMG scores over 84 weeks with sustained reductions in total immunoglobulin G (IgG). Nipocalimab demonstrated a mean change in MG-ADL of -5.64 (p<0.001) from the double-blind baseline after 60 weeks in the OLE for study participants receiving nipocalimab and SOC, and -6.01 (p<0.001) mean change for study participants who transitioned from placebo and SOC to nipocalimab and SOC.

Teva Announces FDA Filing Acceptance for AJOVY® (fremanezumab) in Pediatric Episodic Migraine Prevention

Parsippany-based BioNJ Member Teva Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for AJOVY® (fremanezumab-vfrm) to expand the indication to include the prevention of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. If approved, AJOVY would be the only calcitonin gene-related peptide (CGRP) antagonist for migraine prevention in adults and episodic migraine prevention in pediatric patients, helping to address the high unmet need for effective treatments for those living with migraine. The application was based on positive results from the Phase 3 SPACE trial, which evaluated the efficacy and safety of AJOVY for the prevention of episodic migraine in pediatric patients.

Teva and Samsung Bioepis Announce Biosimilar EPYSQLI® (eculizumab-aagh) Injection Now Available in the United States

Parsippany-based BioNJ Member Teva Pharmaceuticals and Samsung Bioepis Co., Ltd. announced the availability of EPYSQLI® (eculizumab-aagh) in the U.S. EPYSQLI is a biosimilar to Soliris® (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive. The monoclonal antibody and anti-C5 complement inhibitor eculizumab is a well-established standard of care to treat PNH and aHUS, rare diseases with an estimated U.S. prevalence of approximately 50,000 and 5,000 respectively. 

AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Adults With Giant Cell Arteritis

BioNJ Member AbbVie, with a site in Madison, announced that the European Commission (EC) granted marketing authorization to RINVOQ® (upadacitinib; 15 mg, once daily) for the treatment of giant cell arteritis (GCA) in adult patients. RINVOQ is the first and only oral JAK inhibitor approved in the EU, as well as Iceland, Liechtenstein and Norway, for the treatment of adult patients with GCA. GCA is an autoimmune disease that causes inflammation of the temporal and other cranial arteries, the aorta, and other large and medium arteries. GCA generally impacts patients older than 50 years, most commonly between the ages of 70 and 80 years. The EC approval is supported by data from the Phase 3 SELECT-GCA trial. In this trial, primary and key secondary endpoints were achieved with RINVOQ 15 mg and a 26-week steroid taper regimen compared to placebo in combination with a 52-week steroid taper regimen.

Kyowa Kirin and Kura Oncology Announce Submission of New Drug Application for Ziftomenib to FDA

BioNJ Members Kyowa Kirin Co., Ltd., with a site in Princeton, Kura Oncology, Inc. announced Kura submitted a New Drug Application (NDA) for ziftomenib, a highly selective, once-daily, oral, investigational menin inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucelophosmin1 (NPM1) mutation to the U.S. Food and Drug Administration (FDA) on March 31, 2025. Ziftomenib has received Breakthrough Therapy, Fast Track, and Orphan Drug Designations. The FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review; Kura expects to receive notification from the FDA on this preliminary evaluation in the second quarter of 2025. Priority Review was requested, which, if granted, would provide a target FDA review period of six months after NDA acceptance.

EYLEA HD® (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority Review for Both the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing in Approved Indications

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for EYLEA HD® (aflibercept) Injection 8 mg. The sBLA seeks approval for EYLEA HD for both the treatment of macular edema following retinal vein occlusion (RVO), and for broadening the dosing schedule to include every 4-week (monthly) dosing across approved indications. The sBLA is supported by data from across the EYLEA HD clinical program, including the Phase 3 QUASAR trial investigating EYLEA HD in RVO. As previously presented, QUASAR met its primary endpoint at 36 weeks, with EYLEA HD patients dosed every 8 weeks (after either 3 or 5 monthly doses), achieving non-inferior visual acuity gains compared to those receiving EYLEA® (aflibercept) Injection 2 mg dosed every 4 weeks. 

First Positive Phase III Results Presented at Japanese Ophthalmological Society Meeting Demonstrated that Vabysmo Sufficiently Improved Vision in Japanese Patients With Angioid Streaks

BioNJ Member Chugai Pharmaceutical, with a site in Berkeley Heights, announced that results from the Phase III clinical trial (NIHONBASHI study) of anti-VEGF/anti-Ang-2 bispecific antibody Vabysmo® Intravitreal Injection 120 mg/mL [generic name: faricimab (genetical recombination)] (Hereafter Vabysmo), for angioid streaks associated with neovascularization. “Based on the study results, Vabysmo is expected to become the first drug for angioid streaks, for which there are currently no approved drugs in Japan. The regulatory approval review is currently underway under priority review. Chugai will make every effort to obtain approval in Japan so that we can deliver this drug to patients who are eagerly awaiting treatment as soon as possible,” said Chugai’s President and CEO, Dr. Osamu Okuda.

Blenrep (belantamab mafodotin) Combinations Approved by UK MHRA in Relapsed/refractory Multiple Myeloma

Warren-based BioNJ Member GSK plc announced the authorization of Blenrep by the Medicines and Healthcare products Regulatory Agency (MHRA). In the UK, Blenrep is approved for the treatment of adults with multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide. This UK regulatory authorization marks the first in the world for Blenrep in this treatment setting. Superior efficacy results from the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma support MHRA authorization of Blenrep combinations. These include statistically significant and clinically meaningful progression-free survival (PFS) results for Blenrep combinations versus standards of care in both trials and overall survival (OS) in DREAMM-7.

Arexvy Recommended for Adults Aged 50-59 at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease by U.S. Advisory Committee on Immunization Practices

Warren-based BioNJ Member GSK plc is pleased that the Advisory Committee on Immunization Practices (ACIP) voted in favor of recommending the use of RSV vaccines including GSK’s Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) in adults aged 50-59 who are at increased risk for severe RSV disease. This includes people with conditions like COPD, asthma, diabetes, heart disease and those in residential care. This expands on ACIP’s previous vote in June 2024 to recommend RSV vaccines for adults aged 60-74 who are at increased risk and all adults aged 75 and older. A systematic review of studies in the US shows that RSV is estimated to cause 42,000 hospitalizations each year in adults aged 50-64 years old.

GSK’s 5-in-1 Meningococcal Vaccine Penmenvy Receives Positive Recommendation from U.S. Advisory Committee on Immunization Practices

Warren-based BioNJ Member GSK plc announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to recommend use of Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) as part of the adolescent meningococcal vaccination schedule. Recommendations made by the ACIP are reviewed and, if adopted, are published as official CDC recommendations. ACIP voted to recommend that persons over 10 years old receive a single dose of Penmenvy as an alternative to separate administration of meningococcal serogroups A, C, W and Y (MenACWY) and meningococcal serogroup B (MenB) vaccinations when both vaccines would be given on the same clinic visit, typically at age 16. 

Bristol Myers Squibb Announces Topline Results from Phase 3 ARISE Trial Evaluating Cobenfy (xanomeline and trospium chloride) as an Adjunctive Treatment to Atypical Antipsychotics in Adults With Schizophrenia

Princeton-based BioNJ Member Bristol Myers Squibb announced topline results from the Phase 3 ARISE trial evaluating the efficacy and safety of Cobenfy (xanomeline and trospium chloride) as an adjunctive treatment to atypical antipsychotics in adults with inadequately controlled symptoms of schizophrenia. In the Phase 3 trial, adjunctive Cobenfy treatment demonstrated a 2.0-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo with an atypical antipsychotic at Week 6, which did not reach the threshold for statistical significance for the primary endpoint (P = 0.11). Preliminary analyses suggest that Cobenfy as an adjunctive treatment to an atypical antipsychotic was associated with improvements in symptoms of schizophrenia compared to placebo plus an atypical antipsychotic for certain patients. In a post-hoc subgroup analysis there was a notable difference in response between subjects treated with risperidone as a background therapy compared with the remaining subjects treated with other background antipsychotics (non-risperidone).

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) Plus Yervoy® (ipilimumab) as a Treatment for Patients With Previously Untreated Microsatellite Instability-High or Mismatch Repair Deficient Unresectable or Metastatic Colorectal Cancer

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). This approval is based on the CheckMate-8HW trial, which is the largest Phase 3 trial (n=839) of immunotherapy in patients with MSI-H/dMMR mCRC, evaluating Opdivo plus Yervoy (n=354) vs. Opdivo monotherapy (n=353) in the all-lines setting and Opdivo plus Yervoy (n=202) vs. investigator’s choice chemotherapy (n=101) (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) in the first-line setting.1 Opdivo plus Yervoy met the dual primary endpoints of progression free survival (PFS) when compared to Opdivo monotherapy across all lines of therapy and when compared to chemotherapy in the first-line setting, as assessed by Blinded Independent Central Review (BICR).

Trodelvy® Plus Keytruda® Demonstrates a Statistically Significant and Clinically Meaningful Improvement in Progression Free Survival in Patients With Previously Untreated PD-L1+ Metastatic Triple-Negative Breast Cancer

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced positive topline results from the Phase 3 ASCENT-04/KEYNOTE-D19 study, demonstrating that Trodelvy® (sacituzumab govitecan-hziy) plus Keytruda® (pembrolizumab) significantly improved progression-free survival (PFS) compared to Keytruda and chemotherapy in patients with inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1 (CPS ≥ 10). The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in PFS. The safety profile of Trodelvy plus Keytruda in the ASCENT-04 study was consistent with the known safety profile of each agent. No new safety signals were identified with the combination.

U.S. Food and Drug Administration Updates CAMZYOS® (mavacamten) Label to Reduce Echocardiography Monitoring Requirements and Contraindications

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has updated the U.S. Prescribing Information for CAMZYOS® (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules), simplifying treatment for patients and physicians by reducing the required echo monitoring for eligible patients in the maintenance phase and expanding patient eligibility by reducing contraindications. CAMZYOS is the first and only FDA-approved cardiac myosin inhibitor for the treatment of adults with symptomatic New York Heart Association (NYHA) Class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. FDA-approved updates include reduced frequency of required echo monitoring from once every 12 weeks to every 6 months for patients with left ventricular ejection fraction (LVEF) ≥55% and a Valsalva left ventricular outflow tract (LVOT) gradient <30 mmHg (or Valsalva LVOT ≥30 mmHg without up-titration) who have reached the maintenance phase (at Week 12 or later).

Evotec Announces Significant Progress in Strategic Protein Degradation Collaboration With Bristol Myers Squibb

Princeton-based Evotec SE announced further significant progress of the company’s strategic research collaboration with Bristol Myers Squibb relating to building a high value molecular glue-based pipeline for unmet medical needs. Performance-based and program-based achievements trigger payments of in total US$ 75 m to Evotec.Initiated in 2018, the collaboration combines Evotec’s high-performance multi-omics screening as well as AI-supported data analytics and drug design capabilities with Bristol Myers Squibb’s industry-leading library of cereblon E3 ligase modulators (“CELMoDs™”). The collaboration, expanded in 2022, continues to deliver on its goal to identify novel molecular glue degraders for high-value targets in the field of oncology and beyond. The performance-based and program-based achievements further strengthen Evotec’s joint program pipeline.

FDA Grants Orphan Drug Designation to NS-229 for the Treatment of Eosinophilic Granulomatosis With Polyangiitis

Paramus-based NS Pharma, Inc. announced that the U.S Food & Drug Administration (FDA) has granted Orphan Drug Designation to NS-229, which is being developed for the treatment of the rare disease eosinophilic granulomatosis with polyangiitis (EGPA). NS-229 is being investigated as a selective Janus kinase 1 (JAK1) inhibitor to help regulate immune cell function and prevent the immune system from causing tissue damage. FDA Orphan Drug Designation status is granted for treatments of rare diseases affecting fewer than 200,000 people in the U.S. This designation provides NS Pharma with a seven-year market exclusivity period, in support of the company’s continued development and evaluation of this therapy. EGPA is a rare autoimmune disease causing inflammation in the small-to-medium-sized blood vessels which can cause tissue and organ damage to the lungs, sinuses, peripheral nerves, skin and kidneys. 

Hikma Acquires Novugen’s FDA-Approved ANDA for Trametinib

Berkeley Heights-based Hikma Pharmaceuticals PLC announces it has acquired the FDA-approved Abbreviated New Drug Application (ANDA) for trametinib tablets from Novugen. Hikma also announces it has entered into a commercial agreement with Novugen where Hikma will be responsible for all US sales and marketing of this product, which Novugen will manufacture and supply to Hikma. Trametinib is an orally administered kinase inhibitor medication used to treat certain cancers. When launched, Hikma will have 180 days of U.S. generic market sales exclusivity for this product. “Hikma’s Generics business is accelerating its efforts to expand its pipeline by developing and acquiring important medicines in growing therapeutic areas most needed by US patients and healthcare providers,” said Dr. Hafrun Fridriksdottir, president of Hikma Generics.

Sonnet’s SON-1010 Demonstrates a Strong Safety Profile in Combination With Atezolizumab for Treatment of Platinum-Resistant Ovarian Cancer, Including a Partial Response at the Highest Dose

Princeton-based Sonnet BioTherapeutics Holdings, Inc. announced positive safety results of SON-1010 (IL12-FHAB) at the highest dose combined with atezolizumab in the Phase 1b/2a clinical trial in adult patients with advanced solid tumors or platinum-resistant ovarian cancer (PROC) (the SB221 study). Based on positive feedback from a formal evaluation by the Safety Review Committee (SRC) for the SB221 study, the study can now advance to the expansion phase, which will study the preliminary effect of the combination at the MTD, before proceeding to a Phase 2a randomized comparison with the standard of care in patients with PROC. The SB221 study was designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of increasing doses of SON-1010 administered with atezolizumab.

Sun Pharma Introduces a Novel Class of Drug, Fexuclue®(Fexuprazan) in India for Treatment of Erosive Esophagitis

Princeton-based Sun Pharmaceutical Industries Limited announced that it has launched Fexuprazan tablets 40 mg in India under the brand name “FEXUCLUE®”. FEXUCLUE®, a novel potassium competitive acid blocker (PCAB), is approved as a new treatment for adults with Erosive Esophagitis of all grades. Sun Pharma has obtained rights from Daewoong Pharmaceutical Co Ltd, Korea, a biopharmaceutical company, to manufacture and commercialise FEXUCLUE®(Fexuprazan) in India. As per agreement terms, Daewoong will be entitled to upfront and milestone payments, including royalties. Fexuprazan was evaluated in a double-blind, double-dummy, comparative Phase 3 study in adult Indian population. The primary efficacy measure was healing of Erosive Esophagitis which was confirmed endoscopically. The study met its primary endpoint.

ENHERTU® Plus Pertuzumab Demonstrated Highly Statistically Significant and Clinically Meaningful Improvement in Progression Free Survival Versus THP as First-Line Therapy for Patients With HER2 Positive Metastatic Breast Cancer

Basking Ridge-based Daiichi Sankyo announced positive topline results from a planned interim analysis of the DESTINY-Breast09 Phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) in combination with 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 for patients with HER2 positive metastatic breast cancer. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC). The PFS improvement was seen across all pre-specified patient subgroups with ENHERTU in combination with pertuzumab. The key secondary endpoint of overall survival (OS) was not mature at the time of this planned interim analysis; however, interim OS data showed an early trend favoring the ENHERTU combination compared to THP.  

ENHERTU® Approved in the EU as First HER2 Directed Therapy for Patients With HR Positive, HER2 Low or HER2 Ultralow Metastatic Breast Cancer Following at Least One Endocrine Therapy

Basking Ridge-based Daiichi Sankyo and AstraZeneca’s ENHERTU® (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from the DESTINYBreast06 Phase 3 trial.

DATROWAY® Approved in the EU for Patients With Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

Basking Ridge-based Daiichi Sankyo’s DATROWAY® (datopotamab deruxtecan) has been approved in the European Union (EU) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).  The approval by the European Commission follows the positive opinion of the Committee for Medical Products for Human Use of the European Medicines Agency and is based on results from the TROPIONBreast01 Phase 3 trial.  

FDA Grants ISTURISA® (osilodrostat) Expanded Indication for the Treatment of Endogenous Hypercortisolemia in Patients With Cushing’s Syndrome

Bridgewater-based Recordati announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ISTURISA® (osilodrostat) for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative. This is an expansion of the previous indication for the treatment of patients with Cushing’s disease which is a sub-type of Cushing’s syndrome. The ISTURISA® indication expansion was supported by the ISTURISA® extensive clinical development program which includes over 350 patients. ISTURISA is a prescription medicine used to treat elevated levels of cortisol in the blood (endogenous hypercortisolemia) in adults with Cushing’s syndrome: who cannot have surgery, or who have had surgery which did not cure their Cushing’s syndrome.

Cellares, UW-Madison Med School Launch Strategic Collaboration

BioNJ Member Cellares and the University of Wisconsin School of Medicine and Public Health announced a collaboration. The partnership is aimed at facilitating the manufacturing of the medical school’s internally developed CAR-T investigational therapy. Cellares, a cell therapy manufacturer, operates an Integrated Development and Manufacturing Organization (IDMO) Smart Factory in Bridgewater – equipped with its Cell Shuttle platform. The company supports early phase biotechnology and academic cell therapy developers. Cellares’ automated manufactured platform enables scaling production in an efficient manner with up to 50% lower batch prices compared with conventional Contract Development and Manufacturing Organizations (CDMO). The collaboration will automate the manufacturing of a CRISP-edited GD2 CAR-T investigational therapy for solid tumors, developed by the university.

CoreWeave Announces First Customers for NVIDIA Rack-Scale Systems

BioNJ Member CoreWeave, which provides cloud software to power AI, said Cohere, IBM and Mistral AI were the first customers to gain access to NVIDIA GB200 NVL72 rack-scale systems and CoreWeave’s portfolio of cloud services. The combination of these services is intended to advance AI model development and deployment. AI innovators now have access to advanced networking and NVIDIA Grace Blackwell Superchips purpose-built for reasoning and agentic AI. “CoreWeave is built to move faster – and time and again, we’ve proven it by being first to operationalize the most advanced systems at scale,” said Michael Intrator, co-founder and CEO of CoreWeave. “By delivering the most advanced compute resources at scale, CoreWeave empowers enterprise and AI lab customers to innovate faster and deploy AI solutions that were once out of reach.”

Kenvue Transforming Digital Operations With Microsoft Help

Summit-based Kenvue Inc. has announced a five-year collaboration with Microsoft which aims to transform digital operations through advanced Artificial Intelligence (AI) technologies. These technologies include machine-enabled collaboration, predictive analytics, smart agents, digital twins, and generative AI. By advancing predictive and AI-assisted capabilities, Kenvue aims to set new standards for innovation across commercial, operations, and technology practices ultimately delivering enhanced consumer experiences, increased productivity, and sustained growth. Over the next five years, Kenvue will scale its use of Microsoft Azure to capitalize on its wide range of services including data analytics and AI. The integration of Azure services is expected to enhance predictive capabilities and human-machine collaboration.

Jersey Shore Debuts N.J.’s first TAMP Cancer Therapy

Hackensack Meridian Jersey Shore University Medical Center has become the first hospital in New Jersey to offer a new, targeted treatment for pancreatic cancer using RenovoRx’s Trans-Arterial Micro-Perfusion (TAMP™) therapy platform. The RenovoCath, an FDA-cleared catheter device, enables this localized delivery method. It is already in use for applications such as vessel occlusion, arteriography, and chemotherapy infusion. One of the first patients, 51-year-old Christopher Goodwin of Brigantine, said the therapy has given him new hope. “After multiple rounds of chemo and radiation, I was told I had no other options,” Goodwin said. “But this therapy lets me continue treatment close to home, and I’m grateful for that.” 

NJEDA Board Approves New $30M Loan Program

The New Jersey Economic Development Authority (NJEDA) Board approved a new loan program designed to support the evolving needs of New Jersey businesses. The $30 million pilot program, known as the New Jersey Loan Expansion and Network Development (NJ LEND) program, will offer loans up to $5 million, more than double the amount offered through the Authority’s already existing loan products. NJ LEND is modeled after the NJEDA’s Premier Lender and Direct Loan programs, but offers higher lending limits for financing to small businesses with no more than 750 employees. The new program will offer fixed asset loans of up to $5 million for the purchase or refinance of owner occupied commercial real estate or new equipment. The program will also offer working capital loans of up to $1 million. For more information and to apply, email businessbanking@njeda.gov.

Phathom Pharmaceuticals Appoints Ted Schroeder to its Board of Directors

Florham Park-based BioNJ Member Phathom Pharmaceuticals, Inc. announced the appointment of Ted Schroeder to its Board of Directors. Mr. Schroeder brings more than three decades of experience leading innovative biopharmaceutical companies and has a strong track record of building and scaling commercial organizations, bringing new therapies to market, and successfully guiding companies through key business milestones and strategic transactions. Mr. Schroeder served as CEO of Nabriva Therapeutics from 2018 to 2023 and as a director until March 2025, following Nabriva’s acquisition of Zavante Therapeutics, where he was co-founder, President, and CEO. Prior to that, he co-founded Cadence Pharmaceuticals and served as President and CEO until its $1.4 billion acquisition by Mallinckrodt Pharmaceuticals in 2014. 

Organon Appoints Ramona A. Sequeira to the Company’s Board of Directors

Jersey City-Based BioNJ Member Organon announced the appointment of Ramona A. Sequeira, President of the Global Portfolio Division at Takeda Pharmaceutical Company, to Organon’s Board of Directors, effective July 1, 2025. Ms. Sequeira will serve on the Board’s Talent Committee. In connection with Ms. Sequeira’s appointment, the size of Organon’s Board will be expanded to 12 directors. Ms. Sequeira brings more than 30 years of pharmaceutical industry expertise, with 20 years at Eli Lilly and Company and 10 years at Takeda. She is a proven commercial leader with a steadfast commitment to building strategies around the needs of patients and a track record of strong execution across global markets including the USA, Europe and Emerging Markets.

Raghu Rao, Interim Chief Executive Officer and Dr. Richard Kenney, Chief Medical Officer, of Sonnet Discuss the Recently Announced Safety Data Related to SON-1010

Windsor-based Sonnet BioTherapeutics’ lead program, SON-1010, an IL-12- FHAB, is in development for the treatment of solid tumors and being evaluated in an ongoing Phase 1 study. Through a Material Supply Agreement with Roche, Sonnet is evaluating SON-1010 in combination with atezolizumab (Tecentriq®) for the treatment of Platinum-Resistant Ovarian Cancer (PROC). The Company is also evaluating its second program, SON-1210, an IL-12-FHAB-IL-15 for solid tumors, and entered into a collaboration with the Sarcoma Oncology Center to commence an investigator-initiated and funded Phase 1/2a study for the treatment of Pancreatic Cancer. In this interview, Sonnet’s Raghu Rao, Interim CEO and Dr. Richard Kenney, Chief Medical Officer, discuss recent safety data related to SON-1010.

Sustainability: Empowers Us to Build a More Equitable and Thriving Future for Everyone.

At BioNJ Member Legend Biotech, we recognize that sustainability is crucial for ensuring the long-term health and success of our organization. It allows us to operate responsibly, reduce our environmental footprint, and contribute positively to society. Last year, we reached an important milestone by publishing our inaugural sustainability report. This report not only laid the foundation for our sustainability strategy but also serves as a roadmap for how we do business, underscoring our commitment to our patients, employees, and our company as a whole. In our 2024 report, we made significant strides in advancing our Environmental, Social and Governance (ESG) initiatives.

New Jersey Discovery Showcase 25

April 29, 2025 | Hosted by New Brunswick Development Corporation (DEVCO

Register today for the Inaugural NJ Discovery Showcase hosted by New Brunswick Development Corporation (DEVCO) on April 29th at the New Brunswick Performing Arts Center (NBPAC). This fast-paced, full-day event is dedicated to celebrating science through research and discovery showcases from pioneering entities across New Jersey. Unlike traditional demo or pitch days, the HELIX NJ Discovery Showcase is a unique opportunity to explore groundbreaking scientific advancements and foster collaboration within our vibrant community.

The Jersey City Summit

May 15, 2025 | Hosted by Roundtable & Advisory

Jersey City continues to evolve as one of the most dynamic urban centers in the region, and this transformation is once again set to take center stage at The Jersey City Summit for Real Estate Investment, Placemaking & Innovation 2025. Celebrating a special 10th anniversary, this event will take place on Thursday, May 15, 2025, with owners and venue partner, The 601W Companies. The Summit will be at Harborside – taking over the entire 4th Floor overlooking the Manhattan skyline. Harborside is well into a generational transformation with plans well underway to make it the epicenter of the Hudson waterfront and one of the region’s leading live-learn-work-play neighborhoods.

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.