What They Are Saying: Voices Against Harmful Drug Pricing Policies

While some in Washington are proposing damaging drug pricing policies, including “Most Favored Nation,” China is gaining ground in clinical trials, drug approvals and breakthroughs. The unintended consequences of harmful drug pricing policies are substantial: stifled innovation in the biopharmaceutical sector; reduced access to life-saving treatments; and significant U.S. job losses across an industry that has long anchored American economic competitiveness. This policy debate comes at a particularly strategic moment. As China and other nations aggressively expand their biotechnology investments, America faces a choice: maintain its innovative advantage or adopt harmful policies that could cede this critical ground to international competitors.

Our Innovation Economy: Thanks to the Bayh-Dole Act

The Bayh-Dole Act of 1980 enables universities to retain intellectual property rights to discoveries made with federal funding, spurring an explosion of innovation in the life sciences. Innovation drives national and local economic growth, creating jobs and developing life-saving treatments. To maintain America’s technological leadership, the U.S. must continue supporting policies that invest in American universities and businesses. Proposed policies like ‘Most Favored Nation’ foreign reference pricing (MFN) threaten this progress and open the door for China to gain competitive advantage. New research from the Information Technology & Innovation Foundation (ITIF) underscores how Bayh-Dole and the innovation ecosystem support local economies, specifically in six states.

Ferring Japan Announces PMDA Acceptance of NDA Filing for Nadofaragene Firadenovec

Parsippany-based BioNJ Member Ferring Pharmaceuticals Co., Ltd. announced that the PMDA has accepted the NDA for nadofaragene firadenovec for review. This non-replicating gene therapy, administered intravesically, offers patients with NMIBC a bladder-sparing treatment option. Nadofaragene firadenovec’s quarterly dosing eliminates the burden of frequent treatments, while delivering a non-chemotherapy mechanism of action through interferon gene therapy. The NDA acceptance further highlights Ferring’s ongoing commitment to establish the new standard of care for high-risk BCG- unresponsive NMIBC. The NDA for nadofaragene firadenovec is based on results from a Phase 3 trial conducted in Japan. All treatment-related adverse events were limited to Grade 1 (84.2%) or Grade 2 (15.8%), with zero Grade 3, 4, or 5 adverse events reported – confirming the therapy’s favourable safety and tolerability profile.

Celldex Presents Data Demonstrating Barzolvolimab Improves Chronic Spontaneous Urticaria Independent of Baseline Immunoglobulin E levels in Phase 2 Study at EADV Congress 2025

Hampton-based BioNJ Member Celldex announced new data demonstrating rapid and strong efficacy regardless of baseline immunoglobulin E (IgE) levels in patients with chronic spontaneous urticaria (CSU), an immune-related condition driven by mast cell activation. Barzolvolimab specifically targets mast cells by binding the receptor tyrosine kinase KIT with high specificity and potently inhibiting its activity, which is required for mast cell function and survival. “These data reinforce that mast cells are important drivers of CSU and that barzolvolimab, with its novel mechanism of action, has significant potential to be a meaningful treatment for all patients with CSU, regardless of underlying disease endotype,” said Diane C. Young, MD, Senior Vice President and Chief Medical Officer of Celldex.

Pfizer Reaches Landmark Agreement with U.S. Government to Lower Drug Costs for American Patients

BioNJ Member Pfizer Inc., with a site in Parsippany, announced a historic agreement with the Trump Administration that will ensure U.S. patients pay lower prices for their prescription medicines while strengthening America’s role as the global leader in biopharmaceutical innovation. In response to the four points covered in the President’s July 31st letter, Pfizer has voluntarily agreed to implement measures designed to ensure Americans receive comparable drug prices to those available in other developed countries and pricing newly launched medicines at parity with other key developed markets. Pfizer will also participate in a direct purchasing platform, TrumpRx.gov, that will allow American patients to purchase medicines from Pfizer at a significant discount. The large majority of the company’s primary care treatments and some select specialty brands will be offered at savings that will range as high as 85% and on average 50%.

Pfizer to Acquire Metsera and its Next-Generation Obesity Portfolio

BioNJ Member Pfizer Inc., with a site in Parsippany, and Metsera, Inc. announced the companies have entered into a definitive agreement under which Pfizer will acquire Metsera, a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and cardiometabolic diseases. The acquisition brings deep expertise and a portfolio of differentiated oral and injectable incretin, non-incretin and combination therapy candidates with potential best-in-class efficacy and safety profiles. The Boards of Directors of both Metsera and Pfizer have unanimously approved the transaction. Metsera has a portfolio of promising therapeutic candidates and combinations with four programs in clinical development and several next-generation programs with IND-enabling studies ongoing, aimed at addressing key unmet needs via fewer injections while achieving improved efficacy and tolerability. 

Bristol Myers Squibb Announces Phase 3 EXCALIBER-RRMM Study Evaluating Iberdomide in Combination With Standard Therapies Demonstrated a Significant Improvement in Minimal Residual Disease Negativity Rates in Relapsed or Refractory Multiple Myeloma

Princeton-based BioNJ Member Bristol Myers Squibb announced that the Phase 3 EXCALIBER-RRMM study evaluating iberdomide, an investigational cereblon E3 ligase modulator (CELMoD™), combined with standard therapies (daratumumab + dexamethasone) in patients with relapsed or refractory multiple myeloma (RRMM) demonstrated a statistically significant improvement in minimal residual disease (MRD) negativity rates, compared with the control arm, in a planned interim analysis of the MRD endpoint. In accordance with the trial design and based on the recommendation from the Data Monitoring Committee, the trial will continue without changes to evaluate the other dual-primary endpoint of progression-free survival (PFS), and the key secondary endpoint of overall survival and safety. The safety profile of iberdomide in combination with daratumumab and dexamethasone in this study is generally consistent with previous studies.

Bristol Myers Squibb Builds on Eliquis® (apixaban) Direct-to-Patient Program, Announces New BMS Patient Connect Platform Offering Sotyktu® (deucravacitinib)

Princeton-based BioNJ Member Bristol Myers Squibb announced an expansion of its direct-to-patient offerings, providing eligible U.S. patients with steeply discounted prices for Eliquis® (apixaban) and Sotyktu® (deucravacitinib). Eligible cash-pay patients can now purchase these medicines directly from BMS and significantly lower their out-of-pocket costs. Beginning January 2026, Sotyktu, BMS’ medicine for moderate-to-severe plaque psoriasis, will be offered through the new BMS Patient Connect platform, which follows the launch of our Bristol Myers Squibb-Pfizer Alliance program for Eliquis® (apixaban) earlier this month. The platform will offer Sotyktu at more than 80% less than the current list price. “We are proud to now offer Sotyktu at a lower price via BMS Patient Connect, our new direct-to-patient platform designed to make our innovative medicines more accessible and affordable for patients living with serious conditions,” said Christopher Boerner, Ph.D., Board Chair and CEO, BMS.

Sanofi’s SAR446268 Earns U.S. Fast Track Designation for the Treatment of Non-Congenital Myotonic Dystrophy Type 1

Morristown-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration (FDA) has granted fast track designation to SAR446268, Sanofi's one-time AAV gene therapy for the treatment of non-congenital (juvenile and adult onset) DM1 myotonic dystrophy type 1 (DM1). This designation process aims to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. The FDA created this process to help deliver important new medicine to patients earlier and it covers a broad range of serious illnesses. SAR446268 employs a vectorized RNA interference (RNAi) approach to silence DMPK expression through a single administration. By reducing DMPK transcripts, the gene therapy aims to eliminate the abnormal and toxic RNA foci responsible for splicing defects in muscle tissue, thereby restoring normal splicing and improving muscular function.

Sanofi Caps All its Insulins at $35 Per Month for Every American Patient

Morristown-based BioNJ Member Sanofi announced a major expansion of its patient affordability initiative, ensuring that no American with a valid prescription will have to pay more than $35 per month for a 30-day supply of any Sanofi insulin. The expansion of the company’s Insulins Valyou Savings Program removes previous insurance restrictions, making the $35 cap available to all patients across the U.S., regardless of their insurance status, including those with commercial insurance and those covered by Medicare. The new, universal pricing will take effect on Jan. 1, 2026. The initiative covers any combination, type, and quantity of Sanofi insulins for the fixed monthly price, a move the company says is designed to simplify access and eliminate financial barriers for the millions of Americans living with diabetes.

Sanofi’s Brivekimig Achieved Positive Results in Hidradenitis Suppurativa in Phase 2a Study

New data from Morristown-based BioNJ Member Sanofi’s HS-OBTAIN Phase 2a study (clinical study identifier: NCT05849922) show that treatment with brivekimig led to clinically meaningful improvements in the primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR50) in patients naïve to biologics with moderate-to-severe hidradenitis suppurativa (HS). Brivekimig was well tolerated, with no serious adverse events. HS is a chronic and debilitating inflammatory skin disease characterized by painful cutaneous nodules, abscesses and draining tunnels. Approximately 196,000 adults in the EU live with HS. The HS-OBTAIN phase 2a study is a randomized, double-blind, placebo-controlled, proof-of-concept study assessing the efficacy and safety of brivekimig in adults with moderate-to-severe HS. The primary analysis population included biologic-naïve HS patients who were randomized 2:1 to receive brivekimig 150 mg or placebo subcutaneously every two weeks.

Sanofi and Regeneron’s Dupixent to Treat Chronic Spontaneous Urticaria Advances in EU with Positive CHMP Opinion

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of BioNJ Members Sanofi and Regeneron’s Dupixent (dupilumab) in the EU for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents. This recommendation covers those aged 12 years and above with moderate to severe disease, with inadequate response to histamine-1 antihistamines (H1AH), and who are naive to anti-immunoglobulin E (IgE) therapy. A final decision is expected in the coming months. The positive CHMP opinion is supported by data from two studies in the LIBERTY-CUPID Phase 3 program (NCT04180488; Study A and Study C), both of which demonstrated Dupixent significantly reduced itch and hives at 24 weeks compared to placebo.

Genmab to Acquire Merus, Expanding Late-Stage Pipeline and Accelerating into a Wholly Owned Model

Princeton-based BioNJ Member Genmab A/S and Merus N.V. announced that they have entered into a transaction agreement pursuant to which Genmab intends to acquire all the shares of Merus, a clinical-stage biotechnology company with its late-stage breakthrough therapy asset petosemtamab, which is in Phase 3 development, for USD 97.00 per share in an all-cash transaction representing a transaction value of approximately USD 8.0 billion. The proposed acquisition of Merus is expected to meaningfully accelerate Genmab’s shift to a wholly owned model, expanding and diversifying the company’s revenue, driving sustained growth into the next decade and contributing to Genmab’s evolution into a biotechnology leader. The addition of petosemtamab, Merus’ lead asset, to Genmab’s promising late-stage pipeline is a compelling strategic fit with Genmab’s portfolio and aligns with Genmab’s expertise in antibody therapy development and commercialization in oncology.

Regeneron Announces Positive Phase 3 Trial in Adults With Ultra-Rare Genetic Disorder Fibrodysplasia Ossificans Progressiva (FOP), Demonstrating that Garetosmab Prevents Greater than 99% of Abnormal Bone Formation

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced the primary endpoint was met in the Phase 3 OPTIMA trial investigating garetosmab in adults with fibrodysplasia ossificans progressiva (FOP). At 56 weeks, both doses of garetosmab, 3 mg/kg and 10 mg/kg, were highly efficacious in reducing the number of new bone lesions (heterotopic ossification, or HO lesions) as compared to placebo, demonstrating a 94% and 90% reduction, respectively. Garetosmab is a monoclonal antibody that neutralizes the Activin A protein, which Regeneron scientists discovered to be a critical protein in the development of HO lesions in people with FOP. OPTIMA, a global, multi-center, randomized, double-blind, placebo-controlled trial, enrolled 63 people with FOP aged 18 years and older.

Results from Phase 2 COURAGE Trial Demonstrating Potential to Improve Quality of GLP-1 Receptor Agonist-Induced Weight Loss by Preserving Lean Mass, Presented at EASD

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced updated analyses from the ongoing Phase 2 COURAGE trial investigating novel combinations of semaglutide (GLP-1 receptor agonist) and trevogrumab (anti-GDF8/anti-myostatin) with or without garetosmab (anti-activin A) for the treatment of obesity. The complete 26-week results were consistent with interim data previously reported, demonstrating that the addition of trevogrumab with or without garetosmab could significantly reduce the loss of lean mass associated with semaglutide-induced weight loss; the results confirmed that 33% of weight loss induced by semaglutide was due to loss of lean mass, and that adding trevogrumab could prevent about half of this lean mass loss. COURAGE was designed to investigate the quality of weight loss in patients with obesity (BMI ³30 kg/m2).

LEQEMBI® (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in China

Nutley-based BioNJ Member Eisai Co., Ltd. and Biogen announced that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name in China: “乐意保®”, generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing by the National Medical Products Administration (NMPA) in China. In January 2024, LEQEMBI was approved for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) in China. After 18 months of a dosing regimen of 10 mg/kg once every two weeks during initiation phase, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks may be considered or the regimen of 10 mg/kg once every two weeks may be continued.

LEQEMBI® (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in Australia

Nutley-based BioNJ Member Eisai Co., Ltd. and Biogen announced that the Therapeutic Goods Administration (TGA) of Australia has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name, generic name: lecanemab) for mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (AD) (collectively referred to as early AD) in adults who are either ApoEε4 non-carriers or heterozygous carriers. In Australia, the number of people living with dementia was estimated to be approximately 425,000 in 2024, and is reported to increase to nearly 1,100,000 by 2065. AD is considered the most common cause of dementia, typically accounting for 60-70% of cases. AD is a progressive, relentless disease with amyloid beta (Aβ) and tau as hallmarks that is caused by a continuous underlying neurotoxic process that begins before amyloid plaque removal and continues afterward.

Anti-MTBR (microtubule binding region) Tau Antibody Etalanetug Granted FDA Fast Track Designation

Nutley-based BioNJ Member Eisai Co., Ltd. announced that etalanetug (development code: E2814), an investigational anti-MTBR (microtubule binding region) tau antibody, was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). Fast Track designation is an FDA program that is intended to facilitate and expedite development of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition, such as Alzheimer’s disease (AD), and provide opportunities for frequent interactions with the FDA. AD is a chronic, progressive, neurodegenerative disease characterized by formation of protein deposits known as plaques made of amyloid-beta aggregates and neurofibrillary tangles made of tau protein in the brains of people living with AD. The data show that amyloid-beta protofibrils and tau tangles play roles in the neurodegeneration process.

Pilavapadin Provides Meaningful Pain Reduction in Adults with Diabetic Peripheral Neuropathic Pain (DPNP) in Data Presented at the European Association for the Study of Diabetes (EASD) and NEUROdiab Annual Meetings

BioNJ Member Lexicon Pharmaceuticals, with a site in Bridgewater, announced the presentation of clinical data from the company’s Phase 2b PROGRESS study for its investigational, AAK1-inhibitor, pilavapadin, for the treatment of diabetic peripheral neuropathic pain (DPNP). “The data presented provide additional support for our understanding of pilavapadin’s profile, as well as its potential as a much-needed new therapy for DPNP,” said Suma Gopinathan, Lexicon’s Senior Vice President, Discovery. “Pilavapadin has potential to become the first non-opioid, oral medication approved for DPNP in over two decades. We look forward to Phase 3 trials for this potential new therapy.” The Phase 2b, dose-finding PROGRESS study evaluated once daily pilavapadin doses of 10 mg, 20 mg or 20 mg for seven days followed by 10 mg thereafter, in adults with DPNP.

U.S. FDA Approves TREMFYA® (guselkumab) for the Treatment of Pediatric Plaque Psoriasis and Active Psoriatic Arthritis, Marking a First and Only Approval for an IL-23 Inhibitor

New Brunswick-based BioNJ Member Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA^® (guselkumab) for the treatment of children six years and older who also weigh at least 40 kg with moderate to severe plaque psoriasis (PsO), who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA). This milestone makes TREMFYA^® the first and only IL-23 inhibitor approved for these pediatric indications and builds on the initial FDA approvals in adults living with moderate to severe plaque PsO in 2017 and active PsA in 2020. These approvals for TREMFYA^® offer important new treatment options for the roughly 20,000 children under 10 diagnosed with plaque PsO annually and the approximately 14,000 children impacted by PsA.

TREMFYA® (guselkumab) Achieves U.S. Approval for Subcutaneous Induction in Adults With Ulcerative Colitis, Now the First and Only IL-23 Inhibitor With a Fully Subcutaneous Regimen

New Brunswick-based BioNJ Member Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) induction regimen of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). With this approval, TREMFYA® is the first and only IL-23 inhibitor to offer both SC and intravenous (IV) induction options for the treatment of UC and Crohn’s disease (CD), which combined affect approximately three million Americans.¹ TREMFYA® is the first and only approved fully-human, dual-acting monoclonal antibody 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 UC.

Johnson & Johnson Receives Positive CHMP Opinion of Nipocalimab to Treat a Broad Population of Antibody-Positive Patients Living With Generalised Myasthenia Gravis (gMG)

New Brunswick-based BioNJ Member Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of nipocalimab, a fully human FcRn-blocking monoclonal antibody, as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG). The recommendation is for nipocalimab in a broad population of people living with gMG including adults and adolescent patients 12 years of age and older who are anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody positive. gMG is a chronic, incurable autoantibody disease that affects approximately 56,000 to 123,000 people across Europe. Patients often experience debilitating symptoms such as muscle weakness, difficulty chewing, swallowing, speaking, and breathing that severely disrupt their ability to carry out even the most basic daily activities, such as going for a walk.

TECVAYLI® and DARZALEX FASPRO®-Based Induction Treatment Demonstrates Promising Rates and Depths of Response in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma

New Brunswick-based BioNJ Member Johnson & Johnson announced that an investigational immune-based induction regimen with TECVAYLI® (teclistamab-cqyv) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) demonstrated meaningful clinical efficacy in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM). Forty-nine patients were treated across three treatment cohorts, with a steroid-sparing approach, including regimens of TECVAYLI® with DARZALEX FASPRO® and lenalidomide, with and without bortezomib. Overall response (≥partial response) was achieved by 100% of patients in all treatment arms following induction therapy. Of 46 MRD-evaluable patients with available samples after Cycle 3 and/or Cycle 6, 100% achieved MRD negativity by next-generation flow at 10 sensitivity threshold. By next-generation sequencing, all were MRD-negative at 10 after Cycle 6. Overall, 85.7% (42/49) of patients achieved a complete response or better (≥CR) and were MRD-negative at Cycle 6 (≤10).

Johnson & Johnson’s Investigational Seltorexant Shows Numerically Higher Response in Patients With Depression With Insomnia Symptoms, With Fewer Side Effects Compared to Quetiapine XR

Titusville-based BioNJ Member Johnson & Johnson announced results from the Phase 3 MDD3005 26-week clinical trial evaluating the efficacy and safety of seltorexant compared to quetiapine extended release (XR) as an adjunctive treatment in adult and elderly patients with major depressive disorder (MDD) with insomnia symptoms. Seltorexant is an investigational, first-in-class selective antagonist of the human orexin-2 receptor being studied for the adjunctive treatment of MDD with insomnia symptoms. The Phase 3 randomized, double-blind, parallel-group study showed a numerically greater response rate at 26 weeks with seltorexant than quetiapine XR (57.4 percent versus 53.4 percent), a commonly prescribed adjunctive therapy for MDD patients experiencing insomnia symptoms, though this difference did not reach statistical significance for the primary endpoint. Seltorexant and quetiapine XR showed large and clinically meaningful improvements in depressive symptoms (-23.0 and -22.7, respectively).

Johnson & Johnson Announces Launch of its Shockwave Javelin Peripheral Intravascular Lithotripsy Catheter in Europe to Transform Treatment of Difficult-to-Cross Calcified Lesions

New Brunswick-based BioNJ Member Johnson & Johnson announced the European launch of its Shockwave Javelin Peripheral IVL Catheter, a novel intravascular lithotripsy (IVL) platform designed to modify calcium in extremely narrowed vessels to expand treatments in patients suffering from peripheral artery disease (PAD). The first-of-its-kind Forward IVL platform includes a catheter with a single lithotripsy emitter placed directly behind the tip of the device and has a similar safety and effectiveness profile to legacy Shockwave IVL catheters, bolstering the company’s market-leading IVL portfolio. PAD is the narrowing or blockage of the vessels that carry blood to the legs that reduce blood flow, resulting in debilitating symptoms, ulceration and an increased risk of amputation. People suffering from PAD have an impaired quality of life and increased risk of heart attack or stroke.

Merck Receives Two Positive EU CHMP Opinions for KEYTRUDA® (pembrolizumab), for Subcutaneous (SC) Administration and for New Indication for Earlier-Stage Head and Neck Cancer

Rahway-based BioNJ Member Merck & Co. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted two positive opinions for KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy. One recommends approval of a new subcutaneous (SC) route of administration and a new pharmaceutical form (solution for injection) for KEYTRUDA® (pembrolizumab), which if approved would be marketed in the European Union (EU) as KEYTRUDA SC™. The other positive opinion recommends approval of a new indication in locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The CHMP recommendations will now be reviewed by the European Commission (EC) for marketing authorization in the EU, Iceland, Liechtenstein and Norway, and final decisions are expected in the fourth quarter of 2025. The first CHMP opinion recommends approval of KEYTRUDA SC as a subcutaneous, or under the skin, injection administered by a health care provider.

FDA Approves Merck’s KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Injection for Subcutaneous Use in Adults Across Most Solid Tumor Indications for KEYTRUDA® (pembrolizumab)

Rahway-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for KEYTRUDA® (pembrolizumab). Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc. KEYTRUDA QLEX must be administered by a health care provider (HCP). The pivotal trial comparing subcutaneous KEYTRUDA QLEX to IV KEYTRUDA administered every six weeks, each with chemotherapy, was conducted in patients with treatment-naïve metastatic non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 genomic tumor aberrations. This trial demonstrated comparable pharmacokinetic exposure levels to pembrolizumab [assessed as Cycle 1 AUC0-6 weeks (area under the curve from 0 to 6 weeks) and Cycle 3 (i.e. Steady State) Ctrough].

Merck Receives Positive EU CHMP Opinion for ENFLONSIA™ (clesrovimab) for the Prevention of Respiratory Syncytial Virus (RSV) in Infants During Their First RSV Season

Rahway-based BioNJ Member Merck & Co. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of ENFLONSIA™ (clesrovimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants during their first RSV season. The CHMP recommendation will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU), Iceland, Liechtenstein and Norway, and a final decision is expected before the end of the year. ENFLONSIA is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a typical RSV season, with the same dose regardless of infant weight.

Raludotatug Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients With CDH6 Expressing Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Previously Treated with Bevacizumab

Raludotatug deruxtecan (R-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with bevacizumab. Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6 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.

New Long-term Safety Data from the Completed Phase 3 SOLARIS Trial Support the Potential of Olanzapine LAI (TEV-'749) as the First Long-Acting Olanzapine Treatment Option for Schizophrenia With No PDSS Observed

Parsippany-based BioNJ Member Teva Pharmaceuticals announced the presentation of 10 posters from its innovative schizophrenia medicines portfolio, including long-term safety data from the completed SOLARIS Phase 3 trial showing no incidence of post-injection delirium/sedation syndrome (PDSS) in study participants taking olanzapine LAI (TEV-'749), a once-monthly, long-acting injectable (LAI) subcutaneous formulation of olanzapine. New data evaluating UZEDY®, an extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults, found that it was associated with a shorter length of hospitalization compared to a once-monthly intramuscular injection of Invega Sustenna®. “With these long-term safety results from SOLARIS, olanzapine LAI (TEV-'749) has the potential to address a critical treatment gap by introducing a new era of long-acting olanzapine treatment,” said Dr. Eric Hughes, Executive Vice President, Global R&D and CMO at Teva.

Lilly's Kisunla (donanemab) Receives Marketing Authorization by European Commission for the Treatment of Early Symptomatic Alzheimer's Disease

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that the European Commission (EC) has granted marketing authorization for Kisunla (donanemab) for the treatment of early symptomatic Alzheimer's disease (AD), in adults with mild cognitive impairment as well as those with mild dementia stages of AD with confirmed amyloid pathology who are apolipoprotein E (ApoE4) heterozygotes or non-carriers. Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques.^1,2 The excessive buildup of amyloid plaques in the brain may lead to memory and thinking issues associated with Alzheimer's disease. Kisunla can help the body remove the excessive buildup of amyloid plaques and slow the decline that may diminish people's ability to: remember new information, important dates and appointments; plan and organize; make meals; use household appliances; manage finances; and be left alone.

U.S. FDA Approves Inluriyo (imlunestrant) for Adults With ER+, HER2-, ESR1-Mutated Advanced or Metastatic Breast Cancer

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that the U.S. Food and Drug Administration (FDA) has approved Inluriyo (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer (MBC) whose disease progressed after at least one line of endocrine therapy (ET). In the Phase 3 EMBER-3 trial, Inluriyo reduced the risk of progression or death by 38% versus ET. Among patients with ESR1-mutated MBC, Inluriyo significantly improved progression-free survival (PFS) versus fulvestrant or exemestane, with a median PFS of 5.5 months vs 3.8 months (HR=0.62 [95% CI: 0.46-0.82]); p-value=0.0008. Inluriyo is a treatment for ER+, HER2–, ESR1-mutated MBC.

Lilly's Mounjaro (tirzepatide), a GIP/GLP-1 Dual Receptor Agonist, Reduced A1C by an Average of 2.2% in a Phase 3 Trial of Children and Adolescents With Type 2 Diabetes

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced detailed results from SURPASS-PEDS, the first Phase 3 trial to evaluate the safety and efficacy of Mounjaro (tirzepatide), a GIP/GLP-1 dual receptor agonist, in children and adolescents (ages 10 to less than 18) with type 2 diabetes inadequately controlled with metformin, basal insulin or both. At 30 weeks, Mounjaro met the primary and all key secondary endpoints, achieving superior improvements in A1C and body mass index (BMI) compared to placebo. The trial met the primary endpoint of superior A1C reduction with Mounjaro (pooled doses) compared to placebo at 30 weeks, lowering A1C by an average of 2.2% from an average baseline of 8.05% using the efficacy estimand.

Lilly's Oral GLP-1, Orforglipron, Superior to Oral Semaglutide in Head-to-Head Trial

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced positive topline results from ACHIEVE-3, an open-label randomized Phase 3 clinical trial evaluating the safety and efficacy of orforglipron compared to oral semaglutide, administered according to approved label instructions, in 1,698 adults with type 2 diabetes inadequately controlled with metformin. The 52-week trial compared orforglipron (12 mg and 36 mg) to oral semaglutide (7 mg and 14 mg) across four active treatment arms to assess glycemic control and weight loss. At 52 weeks, orforglipron met the primary and all key secondary endpoints across each dose comparison vs. oral semaglutide, delivering greater improvements in A1C and weight. In the ACHIEVE-3 trial, orforglipron met the primary endpoint and showed superiority vs. oral semaglutide.

Lilly's Oral GLP-1, Orforglipron, Demonstrated Meaningful Weight Loss and Cardiometabolic Improvements in Complete ATTAIN-1 Results Published in The New England Journal of Medicine

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced detailed results from the Phase 3 ATTAIN-1 trial, evaluating the safety and efficacy of orforglipron, an investigational oral glucagon-like peptide-1 (GLP-1) receptor agonist, in adults with obesity, or overweight with a weight-related medical problem and without diabetes. At 72 weeks, all three doses (6 mg, 12 mg and 36 mg) of orforglipron met the primary endpoint of superior body weight reduction compared to placebo. In addition, all three doses delivered clinically meaningful results compared to placebo across the key secondary endpoints of body weight reduction (≥10%, ≥15% and ≥20%), and waist circumference reduction. In the ATTAIN-1 trial, orforglipron met the primary endpoint of superior body weight reduction compared to placebo, with participants taking the highest dose losing an average of 27.3 lbs (12.4%) at 72 weeks using the efficacy estimand.

Novo Nordisk A/S: Ozempic® Reduces the Risk of Heart Attack, Stroke and Death by 23% Compared to Dulaglutide in the First Head-to-Head Real-World Study

Plainsboro-based BioNJ Member Novo Nordisk announced results from the REACH real-world study, which demonstrated that compared to dulaglutide, Ozempic® (once-weekly injectable semaglutide) was associated with a reduced risk of major adverse cardiovascular events such as a heart attack or stroke by 23%. The data span nearly 60,000 US Medicare patients (aged ≥66 years) living with type 2 diabetes, atherosclerotic cardiovascular disease (ASCVD) ― a condition where fatty deposits build up in blood vessels, reducing blood flow and increasing the risk of heart attacks, strokes and related problems – and multiple health conditions. Beyond these essential benefits, once-weekly semaglutide was also associated with a 25% risk reduction of heart attack, stroke, hospitalisation for unstable angina or heart failure, and death from any cause (five-point MACE).

EU Approval Makes Novo Nordisk’s Oral Semaglutide the First and Only Oral GLP-1 RA to Reduce Cardiovascular Death, Heart Attack and stroke

Plainsboro-based BioNJ Member Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved an update to the Rybelsus® (oral semaglutide) label to reflect the cardiovascular benefits seen in the SOUL trial. SOUL was a phase 3b trial carried out to evaluate the effect of Rybelsus® on cardiovascular outcomes in people with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). Rybelsus® is now the first and only oral glucagon-like peptide 1 receptor agonist (GLP-1 RA) – mimicking a natural hormone in your body that helps regulate blood sugar, appetite, and digestion – available in the EU for type 2 diabetes with a proven cardiovascular benefit. In the U.S., a decision is expected later this year for a label extension for the cardiovascular indication for Rybelsus®.

Novo Nordisk’s Oral Semaglutide 25 mg (Wegovy® in a pill*) Delivered 16.6% Weight Loss in People With Obesity in a Newly Published Study

Plainsboro-based BioNJ Member Novo Nordisk published the results from the OASIS 4 phase 3 trial that studied the efficacy and safety of the investigational once-daily oral semaglutide 25 mg (Wegovy® in a pill*), marking a significant milestone in the company’s ambition to advance obesity care. In the 64-week trial, oral semaglutide 25 mg, alongside lifestyle modifications, was compared to placebo in 307 adults with obesity or overweight with one or more weight-related comorbidities, without diabetes. Results showed that if all participants adhered to treatment, average weight loss of 16.6% was achieved by people taking oral semaglutide 25 mg compared to 2.7% for placebo at 64 weeks, with over a third (34.4%) experiencing a weight loss of 20% or more, versus 2.9% for placebo.

Novo Nordisk Presents Phase 3 Data for Next-Generation Amylin Cagrilintide, Leading to Advancement into Dedicated Clinical Program

Plainsboro-based BioNJ Member Novo Nordisk presented data from a sub-analysis of the Phase 3 REDEFINE 1 trial. This sub-analysis evaluated the efficacy and safety of once-weekly cagrilintide 2.4 mg monotherapy, plus lifestyle intervention, for adults with obesity or overweight and a weight‑related comorbidity without diabetes. Cagrilintide is a long-acting amylin analogue that mimics the naturally occurring hormone amylin and works differently than currently approved GLP-1-based treatments for weight loss. These findings represent the first and only Phase 3 clinical trial data with an investigational long-acting amylin analogue monotherapy for the management of obesity. In REDEFINE 1, cagrilintide provided clinically meaningful weight loss, with an average body weight reduction of 11.8% compared to 2.3% with placebo after 68 weeks, if all participants adhered to treatment. 

Soligenix Announces Pricing of $7.5 Million Public Offering

Princeton-based BioNJ Member Soligenix announced the pricing of its "reasonable best efforts" public offering with existing and certain healthcare focused institutional investors for the purchase and sale of 5,555,560 shares of common stock of the company (or common stock equivalents in lieu thereof) and warrants to purchase up to 5,555,560 shares of common stock at a combined purchase price of $1.35 per share and accompanying warrant (the "Offering"). The warrants will have an exercise price of $1.35 per share, will be exercisable immediately and will expire five years from the issuance date. The company intends to use the net proceeds of this Offering to fund research and development and commercialization activities, working capital and general corporate purposes.

Outlook Therapeutics Provides Update on Type A Meeting With FDA

Iselin-based BioNJ Member Outlook Therapeutics, Inc. announced that it has completed the Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. Based on the discussion with the FDA, Outlook Therapeutics expects to resubmit its BLA before the end of calendar year 2025, after reviewing the agency’s feedback and meeting minutes. ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD.

AbbVie Submits Biologics License Application (BLA) to U.S. FDA for Pivekimab Sunirine (PVEK) - An Investigational Antibody-Drug Conjugate (ADC) to Treat Rare Cancer With Limited Treatment Options

BioNJ Member AbbVie, with a site in Madison, announced submission of a new Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of investigational Pivekimab sunirine (PVEK) for treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). The submission is based on data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of PVEK in BPDCN. BPDCN is a rare and aggressive blood cancer that has features of both leukemia and lymphoma. Patients typically present with skin lesions and the disease often spreads to the bone marrow, central nervous system and the lymph nodes. First-line treatments are typically intensive chemotherapy and often followed by stem cell transplant. The need for additional and innovative treatment is high for both newly diagnosed patients and for those whose prior treatments have resulted in relapsed or refractory disease.

AbbVie Submits New Drug Application to U.S. FDA for Tavapadon for the Treatment of Parkinson's Disease

BioNJ Member AbbVie, with a site in Madison, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist that was studied as a once daily oral treatment for Parkinson's disease. The submission is based on results from the TEMPO clinical development program that evaluated the efficacy, safety and tolerability of tavapadon across a broad Parkinson's disease population. This includes two Phase 3 trials (TEMPO-1 and TEMPO-2) in early Parkinson's disease, and one Phase 3 trial (TEMPO-3) with tavapadon as adjunctive to levodopa in patients experiencing motor fluctuations. TEMPO-1 and TEMPO-2 demonstrated that patients experienced a statistically significant improvement from baseline in the Movement Disorder Society ― Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26.

Made Scientific Announces Strategic Collaboration With Basilard BioTech

BioNJ Member Made Scientific, a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO), and Basilard BioTech, announced a strategic collaboration to accelerate the development and translation of Basilard BioTech’s nanomechanical gene delivery platform, Celletto. Celletto addresses long-standing limitations of both viral vectors and conventional non-viral methods. By creating a controlled, transient disruption to the cell membrane using nanoneedles to directly transport nucleic acids (or any construct) into the nucleus of any cell type each time, Celletto enables exceptionally high transfection efficiency while preserving cell viability and function. Under the agreement, Basilard BioTech will leverage Made Scientific’s Center of Excellence for Process and Analytical Development and its state-of-the-art GMP manufacturing facility in Princeton to validate and scale the Celletto platform across T cell, iPSC processes and other cell substrates in the future.

Real World Data from LOTUS Study Evaluating Long-Term Efficacy and Tolerability Outcomes of DAYBUE® (trofinetide) in Patients With Rett Syndrome Published in Developmental Medicine and Child Neurology

BioNJ Member Acadia Pharmaceuticals Inc., with a site in Princeton, announced that the journal Developmental Medicine and Child Neurology published interim results from the caregiver-reported observational online, open-label, ongoing LOTUS study evaluating effectiveness and tolerability outcomes in patients with Rett syndrome who are prescribed DAYBUE® (trofinetide) under routine clinical care in the U.S. Findings included reported improvements in symptoms of Rett syndrome, with early insights into managing gastrointestinal (GI) symptoms in the real world among patients receiving up to 12 months of treatment with DAYBUE. “These findings from LOTUS help deepen our understanding of the potential outcomes associated with long-term treatment of DAYBUE in the real-world setting,” said Ponni Subbiah, M.D., M.P.H., Senior Vice President, Global Head of Medical Affairs and Chief Medical Officer.

Novartis Receives FDA Approval for Rhapsido® (remibrutinib), the Only Oral, Targeted BTKi Treatment for Chronic Spontaneous Urticaria (CSU)

East Hanover-based BioNJ Member Novartis announced that Rhapsido® (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Rhapsido is a pill taken twice daily and does not require injections or lab monitoring. It is the first FDA-approved Bruton's tyrosine kinase inhibitor (BTKi) for CSU. Rhapsido helps to inhibit the release of histamine and other proinflammatory mediators by targeting BTK, offering a unique approach to CSU treatment. CSU is a mast cell-driven condition thought to be caused by immune dysregulation. In people with CSU, the immune system can become activated through allergic (IgE) or autoimmune (IgG) pathways.

New Novartis Data Further Support Benefits of Kesimpta® in Relapsing MS Following Switch from Oral Disease Modifying Therapies

East Hanover-based BioNJ Member Novartis announced new data from two Kesimpta® (ofatumumab) studies in relapsing multiple sclerosis (RMS). Data from the ARTIOS Phase IIIb, open-label, single-arm, prospective study showed that patients who switched to Kesimpta after breakthrough disease on fingolimod or fumarate-based therapies had a substantial reduction in disease activity, as shown by a low annualized relapse rate (ARR, 0.06 over 96 weeks). The data also showed an almost complete suppression of MRI activity and over 9 out of 10 participants achieving no evidence of disease activity (NEDA-3). No new safety concerns were observed following the switch to Kesimpta, irrespective of the last prior disease modifying treatment (DMT). The separate ALITHIOS open-label extension study includes recently diagnosed (≤3 years) treatment-naïve (RDTN) people with RMS receiving first-line continuous Kesimpta. The study showed more than 90% achieved NEDA-3 at seven years. 

Novartis Assembles 2nd Molecular Glue Deal With Monte Rosa, This One Worth Up to $5.7B

East Hanover-based BioNJ Member Novartis has stuck on a second deal to its partnership with molecular glue degrader biotech Monte Rosa Therapeutics that includes a $120 million upfront payment. At the center of the latest deal is the exclusive license to an undisclosed discovery target, to which Monte Rosa will apply its molecular glue product engine, dubbed QuEEN. Novartis also secures an option to license another two programs from among the Boston biotech’s preclinical immunology portfolio. If all of the programs work out, Monte Rosa could be in line for up to $5.7 billion across upfront, milestone and option fee payments, along with tiered royalties on global net sales. The deal comes almost a year after Novartis handed $150 million to Monte Rosa for a clinical-stage molecular glue degrader also developed with the QuEEN platform.

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

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

Amneal Receives FDA Approval of Treatment for Narcoleptic Sufferers

Piscataway-based Amneal Pharmaceuticals Inc. said that the Food and Drug Administration approved of Amneal’s sodium oxybate oral solution treatment. Amneal had previously been distributing an authorized generic of sodium oxybate oral solution in limited quantities. Sodium oxybate oral solution is a central nervous system depressant used for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years old and older with narcolepsy.Narcolepsy is characterized by excessive daytime sleepiness, sudden sleep attacks, and cataplexy, a sudden loss of muscle control often triggered by emotions. Sodium oxybate is considered a standard of care therapy in narcolepsy because of its ability to consolidate nighttime sleep and significantly reduce cataplexy episodes.

ENHERTU® Plus Pertuzumab Granted Priority Review in the U.S. as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer

Basking Ridge-based Daiichi Sankyo and AstraZeneca’s supplemental Biologics License Application (sBLA) for ENHERTU® (famtrastuzumab deruxtecan-nxki) in combination with pertuzumab has been accepted and granted Priority Review in the U.S. for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer. The U.S. Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA for ENHERTU plus pertuzumab based on data from the DESTINY-Breast09 phase 3 trial in July 2025.

Bylvay® (odevixibat) Approved in Japan for Rare Liver Disease PFIC

Ipsen, with a site in Basking Ridge, announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval for Bylvay® (odevixibat) for the treatment of pruritus associated with progressive familial intrahepatic cholestasis (PFIC). PFIC is a group of rare genetic disorders in which bile acid accumulates in the liver, leading to progressive liver damage and potentially liver failure. The condition severely impacts quality of life through debilitating symptoms such as severe itching (pruritus), caused by the bile accumulation in the liver and bloodstream, which can cause skin mutilation, sleep disruption, irritability, and impaired cognitive and social development. Bylvay is a potent, once-daily, oral, ileal bile acid transport inhibitor (IBATi) that reduces reabsorption of bile acid back to the liver.

Ipsen’s LANTIC Phase II in Aesthetics Delivers a First-in-Class, Differentiated Long-Acting Clinical Profile for IPN10200, Enabling the Initiation of Phase III

Ipsen, with a site in Basking Ridge, announced the first aesthetic data (n=183) for glabellar lines with internally developed IPN10200, following Stage 1 of the multi-stage, ongoing Phase II LANTIC trial. Patients treated with IPN10200 showed a statistically significant improvement in response at Week 4 vs placebo (primary endpoint). A longer duration of effect was also observed with a substantial majority of patients experiencing a clinically significant response at Week 24 compared with placebo and Dysport, defined as a score of “none” or “mild”. IPN10200 continued to show a greater response in line severity vs Dysport at Week 36. In this trial Dysport was shown to perform consistently with its profile.

Biocon Opens First U.S. Manufacturing Facility in New Jersey

An India-headquartered global biopharmaceutical company is making a big bet on the Garden State. Biocon Ltd. focuses on enhancing affordable access to complex therapies for chronic conditions, such as diabetes, cancer and autoimmune diseases. Earlier this month, the company opened its first U.S. manufacturing facility in Cranbury. In 2023, Biocon acquired the Oral Solid Dosage (OSD) facility from Eywa Pharma Inc. Since, it’s invested more than $30 million to modernize and expand the site, which now has the capacity to produce up to 2 billion tablets annually. We are incredibly grateful that Biocon has decided to open its first U.S. manufacturing facility in the Garden State,” Gov. Murphy said. “This state-of-the-art facility marks a significant moment in Biocon’s global expansion and reinforces New Jersey’s reputation as the medicine chest to the world.”

Character Biosciences Named a ‘Fierce 15’ Biotech Company in 2025

Jersey City-based Character Biosciences, a precision medicine company transforming drug development for polygenic diseases, announced that Fierce Biotech has named it as one of 2025’s “Fierce 15” biotechnology companies. The annual special report features the most innovative and promising private biotechnology companies in the industry. Character Biosciences was recognized for its pioneering approach to precision ophthalmology, bringing human genetics, longitudinal clinical data, and computational biology to drug discovery and development to some of the most urgent unmet needs in eye disease. By combining deep scientific insight with a relentless focus on patients, Character is building a pipeline with the potential to transform how diseases like dry AMD and glaucoma are treated. Character’s first two programs, CTX203, a first-in-class lipid regulator, and CTX114, a novel complement inhibitor, are entering Phase 1 studies, and the company has an ongoing drug discovery collaboration with Bausch + Lomb.

Celltrion Pays $330M for Eli Lilly Plant to Avoid Tariffs, Boost Output

Celltrion Inc. has its U.S. base in Jersey City, but will expand its in-state presence following the acquisition of an Eli Lilly & Co. plant in Somerset County. The Korean-based global biopharmaceutical company announced signing a Sept. 20 agreement to acquire the approximately 37-acre site. The biosimilar maker pegged purchase price at $328 million for 33 Imclone Drive in Branchburg. The move comes in response to U.S. tariffs rolled out by the Trump administration. It also follows other initiatives from the company to “proactively address tariff-related risks.”

Celltrion noted moving two years’ worth of inventory to the U.S. and expanding contracts with local contract manufacturing organizations to preempt the levies. After an estimated 12–18 month validation period, the biophama says it will manufacture and supply products directly from Somerset County.

Morristown’s Alvogen Pharma to be Acquired by Lotus Pharmaceutical

Alvogen Pharma, a Morristown pharmaceutical company, will be sold and become a controlled subsidiary of Lotus Pharmaceutical, the company announced. Alvogen and Lotus have a continued history of collaboration, and this agreement will give Lotus access to a U.S. platform including a dedicated salesforce, in-house manufacturing at Alvogen’s Norwich, New York facility, and a complementary R&D pipeline. Alvogen CEO Lisa Graver spoke on the future of both companies. “This acquisition represents a culmination of Alvogen’s operational excellence and targeted portfolio aimed at sustainable growth,” she said. “Joining Lotus positions Alvogen for its next stage of expansion into multiple segments.” “With Lotus’ global partnerships and APAC distribution, we expect to extend the reach of our specialized generics and brands while maintaining our commitment to quality and reliable supply from our Norwich facility.”

SpotitEarly and Hackensack Meridian Health Partner to Advance Cancer Detection With Cancer-Sniffing Canines

SpotitEarly, an early cancer detection startup using trained dogs and AI to identify cancer-odor signatures in breath samples, announced Sept. 30 a research collaboration with the Hennessy Institute for Cancer Prevention and Applied Molecular Medicine. The Hennessy Institute is part of the Hackensack Meridian John Theurer Cancer Center ― part of the National Cancer Institute-designated Lombardi Comprehensive Cancer Center at Georgetown University ― and Hackensack University Medical Center. This partnership with New Jersey’s largest and most comprehensive health network is a foundational collaboration for SpotitEarly, which entered the market in May 2025. The clinical research expertise of the Hennessy Institute and Hackensack Meridian Health will be critical in validating SpotitEarly’s technology.

Cellares Expands Cell Q Platform With New Tech Partners

BioNJ Member Cellares, cell therapy manufacturer, which operates a Smart Factory in Bridgewater, announced multiple strategic technology partners to advance its Cell Q. Cellares has been growing and expanding rapidly ― announcing a slew of key milestones and partnerships over the last few years. In 2024, the company launched the Cell Q. The first fully automated platform for cell therapy quality control, it is purpose-built to match the throughput of the Cell Shuttle. The collaborations will develop specialized hardware, software and reagents designed to integrate seamlessly into the Cell Q platform. Cellares notes that a single Cell Q system can support automated QC release testing of up to 6,000 cell therapy batches per year.

Sanofi Commits an Additional $625 Million to Sanofi Ventures to Accelerate Investment in Biotech and Digital Health Innovation

Sanofi Ventures has announced an additional $625 million multi-year capital commitment from Sanofi, increasing its total assets under management to over $1.4 billion. This new commitment to the evergreen venture fund builds on more than a decade of investing in innovative biotech and digital health companies that align with Sanofi’s long-term growth ambitions. Sanofi Ventures is the corporate venture capital arm of BioNJ Member Sanofi, investing in top-tier biotech and artificial intelligence/digital health companies that focus on helping patients and transforming the practice of medicine. Since its inception in 2012, the fund has deployed over $800 million across more than 70 innovative companies in biotech and digital health.

CoreWeave Inks $14.2B AI Cloud Deal With Meta

Livingston-headquartered CoreWeave continued its flurry of major deals. The latest secures a $14.2 billion long-term AI cloud infrastructure agreement with Meta. This pact comes on the heels of a $6.5 billion expansion of CoreWeave‘s contract with OpenAI – as companies and organizations ratchet up efforts and investment to build out their AI computing infrastructure. CoreWeave offers access to leading chips from Nvidia needed for advanced AI models. Under this agreement, Meta will have access to Nvidia’s latest GB300 systems. The deal with Meta, first reported by Bloomberg, runs through December 2031, with an option to extend through 2032 for additional cloud computing capacity. “The agreement underscores that behind every AI breakthrough are the partnerships that make it possible,” a CoreWeave spokesperson said.

CoreWeave Expands OpenAI Contract to $22.4 Billion Total Value

CoreWeave, the Livingston-based AI Hyperscaler, has significantly strengthened its partnership with OpenAI through an expanded agreement worth up to $6.5 billion. This latest deal brings the total contract value between the two companies to a massive $22.4 billion, cementing CoreWeave’s status as a critical infrastructure provider for the world’s most demanding artificial intelligence workloads. The expanded contract will see CoreWeave continue to power the training of OpenAI’s most advanced next-generation models. This builds upon an initial agreement announced in March 2025, valued up to $11.9 billion, and a subsequent expansion in May 2025 worth up to $4 billion. The new agreement is the latest in a series of milestones underscoring CoreWeave’s central position in the rapidly evolving AI landscape. 

Raritan Valley Community College Unveils Expanded Workforce Training Center to Address Regional Labor Demands

Raritan Valley Community College (RVCC) celebrated the official opening of its expanded Workforce Training Center, a project that increases the facility by 50% and is designed to meet the growing talent needs of local and regional employers. The $9.8 million expansion, supported by the State of New Jersey, Somerset County, and Hunterdon County, allows RVCC to offer hands-on training and experiential learning in high-demand fields such as Biomanufacturing, Electric Vehicle (EV) Technology, Mechatronics and Robotics, and Welding. “The expanded Workforce Training Center transforms our campus, enabling RVCC to provide students and the community with cutting-edge facilities and programs,” RVCC President Michael McDonough said. He emphasized that the expansion is a testament to the college’s innovative public-private partnerships, which ensure programs align with emerging workforce demands.

Murphy, Choose NJ Announce 7 New Jersey-India Higher Education Partnerships

Choose New Jersey, as part of its Governor-led mission to India, announced the signing of seven memoranda of understanding (MOUs) between colleges and universities in New Jersey and India. The agreements are intended to advance higher education collaboration and innovation between the U.S. state and world’s most populous nation. India is one of New Jersey’s top trade partners, with two-way trade in goods totaling $11.3 billion annually, highlighting the strong economic ties supporting these educational collaborations. “These agreements reflect New Jersey’s leadership in fostering global academic and research partnerships,” said Gov. Phil Murphy. “By connecting our top universities with leading institutions in India, we are laying the groundwork for breakthroughs in medicine, technology, and science while creating new opportunities for students and researchers on both sides of the globe.” These agreements expand educational collaboration, research exchange and innovation opportunities.

MOUs Signed to Advance Cardiovascular Research Between New Jersey and India

As part of its Governor-led mission to India, Choose New Jersey today announced the signing of two Memoranda of Understanding (MOUs) between Rutgers University and Govind Ballabh Pant Institute of Postgraduate Medical Education and Research in New Delhi (GIPMER), one of India’s leading medical institutions, and Montclair State University and the Association of Indian Universities (AIU), the world’s largest higher education network representing more than 1,100 universities across India. The agreements establish partnerships for cardiovascular research and medical innovation with Rutgers and GIPMER, and for exploring academic, cultural and research collaborations through Montclair State and the AIU. Gov. Phil Murphy shared, “The collaboration between Rutgers, Montclair State University, and these leading Indian research institutions will strengthen ties between world-class institutions with the potential to save lives and advance medical knowledge worldwide.”

NJDOL Announces $8M in Grants to Support Apprenticeship and Pre-Apprenticeship Programs

The New Jersey Department of Labor and Workforce Development (NJDOL) Office of Apprenticeship has announced a total of $8 million in available funding through the Growing Apprenticeship in Nontraditional Sectors (GAINS) and Pre-Apprenticeship in Career Education (PACE) grant programs to foster the creation and expansion of apprenticeship and pre-apprenticeship programs throughout the state. Over the past eight years, the state has invested more than $100 million through grant programs to create and develop work-based learning, pre-apprenticeship, and apprenticeship programs. This has supported the creation of 918 new Registered Apprenticeship programs in New Jersey– a 150% increase – and enabled 25,608 new apprentices to be onboarded since 2018.

N.J. Places Six Schools in Top 100 of U.S. News Rankings

Princeton University is once again No. 1 in the U.S. News and World Report college rankings, earning the top spot for a fifteenth consecutive year. New Jersey has plenty of other reasons to celebrate, too. The State placed six universities in the top 100 of the national rankings, including Princeton (No. 1); Rutgers-New Brunswick (tied for No. 42); Rutgers-Newark (tied for No. 75); Stevens (tied for No. 80); NJIT (tied for No. 80); and Rutgers-Camden (tied for No. 97). The State placed four other schools in the top 200. Montclair State, Seton Hall and Stockon all tied for No. 158. Rowan tied for No. 169. Kean University came in at No. 318.

Rutgers’ O’Brown Receives HHMI Support for Blood-Brain Barrier Research

Scientist Natasha O’Brown, a professor in Rutgers’ Department of Cell Biology and Neuroscience in the School of Arts and Sciences, is the first faculty member to receive Howard Hughes Medical Institute (HHMI) support in more than a decade. Her research explores the blood-brain barrier, a network of cells that regulates what can enter the brain — a complex process that promotes healthy brain function but also creates obstacles for medical treatment. Dr. O’Brown’s work in this emerging area of life science was recognized earlier this year when she was named a Freeman Hrabowski Scholar by the HHMI — an honor that provides up to 10 years of support for early career faculty who show the potential to become leaders in their fields.

Newsweek Names NJ Hospitals Among World’s Best for Tech, Specialties

Two of the World’s Best Smart Hospitals for 2026 are based right here in New Jersey, according to the latest ranking from Newsweek. The publication, along with data firm Statista, recognized the top 350 medical institutions across 30 countries “that are transforming health care through technology and innovation,” Newsweek said. The publication noted the top hospitals are employing technology such as artificial intelligence, automation, robotics and digital health tools to improve outcomes, streamline workflows and support disease prevention. New Jersey’s hospitals include Morristown Medical Center at No. 238 and Hackensack University Medical Center at No. 275.

State Labor Department Announces $1.5M Available to Spur Scientific Research and Innovation

The New Jersey Department of Labor and Workforce Development (NJDOL) has announced the availability of $1.5 million in grant funding through the Innovation and Research Fellowship Program (IRFP), which supports technological and scientific research by encouraging Ph.D. graduates and doctoral candidates to continue research in collaboration with the state’s science and technology companies. Grants will be awarded to qualified employers to fund research fellowships lasting up to two years, with funds primarily intended to support the fellow’s salary. To be eligible, the employer and the fellow candidate must submit a joint application. The fellowship grant would provide a salary up to $85,000 in the first year. In the second year, the grant will provide a salary up to $95,000, and participating companies would be required to contribute at least $25,000 toward the fellow’s salary. Applications must be submitted by 3 p.m., Oct. 28. 

NJEDA to Open Applications for Next NJ Manufacturing Program

The New Jersey Economic Development Authority (NJEDA) opened applications for the Next New Jersey Manufacturing Program. The program will encourage growth in New Jersey’s manufacturing sector by offering long-term benefits to manufacturing companies. Last month, Governor Phil Murphy signed A5687/ S4407 into law, establishing the $500 million tax credit program. The Next NJ Manufacturing Program is a tax credit initiative designed to spur significant investment, create new jobs, and solidify the state’s manufacturing industry. Under the program, manufacturers can receive a tax credit award of up to $150 million, based on an applicant’s proposed new jobs and capital investment. Eligible applicants include businesses in manufacturing industries, such as advanced manufacturing, non-retail food and beverage, defense, clean energy and life sciences. Application for the program can be found here: NJEDA Programs · Custom Portal.

Soligenix Announces Appointment of Former White House Economic Adviser Tomas J. Philipson, Ph.D. as Strategic Advisor

Princeton-based BioNJ Member Soligenix, Inc. announced the appointment of Tomas J. Philipson, Ph.D. as a Strategic Advisor. Dr. Philipson is considered an expert in United States (U.S.) economic policy, particularly health care policy, and frequently appears on major media outlets. He currently serves as Managing Partner of the venture capital firm MEDA Ventures; serves on several corporate boards; and has co-founded several companies, including Precision Health Economics LLC, with an exit in 2015 (currently owned by Blackstone). His government service includes a full-time position as vice chairman and acting chairman of President Trump's White House Council of Economic Advisers from 2017 to 2020. He previously served as a senior economic adviser to the head of the U.S. Food and Drug Administration (FDA) and a senior economic advisor to the head of the Centers for Medicare and Medicaid Services (CMS).

Luke Miels Appointed CEO Designate for GSK

Warren-based BioNJ Member GSK plc announces that Luke Miels is appointed CEO Designate, GSK. He will assume full responsibilities as CEO and join the Board on 1st January 2026. Mr. Miels joined GSK in 2017 and is currently Chief Commercial Officer, with world-wide responsibility for medicines and vaccines. He has been instrumental in building GSK’s specialty medicines portfolio, notably in oncology and respiratory. Mr. Miels is a highly respected, experienced global biopharma leader, having worked at senior levels in the US, Europe and Asia, at AstraZeneca, Roche and Sanofi-Aventis, prior to joining GSK. This experience, and significant contribution to GSK, mean he is exceptionally well-qualified to lead the company, and to deliver the patient and shareholder value inherent in the company’s future ambitions.

Milestone Scientific Appoints Sayed to Board of Directors

Livingston-based Milestone Scientific Inc., a developer of computerized drug delivery instruments that provide painless and precise injections, announced the appointment of Dr. Dawood Sayed, a nationally recognized leader in interventional pain medicine, to its board of directors, effective immediately. Dr. Sayed is a professor of anesthesiology and pain medicine at the University of Kansas Medical Center and serves as division chief of pain medicine, director of interventional spine services, and director of the center for neuromodulation. He brings over a decade of leadership in pioneering minimally invasive pain therapies, neuromodulation and health system innovation. Dr. Sayed also serves as vice chairman and co-founder of the American Society of Pain and Neuroscience, where he works with stakeholders, including commercial payers, regulators, and medical device manufacturers to advance access to innovative pain relief technologies.

Integra LifeSciences Adds Turner to Leadership Team as Chief Medical Officer

Integra LifeSciences Holdings Corp. appointed Dr. Raymond Turner as Corporate Vice President and Chief Medical Officer. Dr. Turner will lead worldwide medical affairs and clinical development activities including clinical research, clinical trial operations, evidence generation, medical safety and communications. In addition to his role with Integra, he will continue his clinical practice, providing patients with neurosurgical care. “Dr. Turner’s extensive medical and clinical experience and expertise will be a significant asset to Integra as we strengthen our focus on building robust clinical evidence,” said Mojdeh Poul, president and chief executive officer, Integra LifeSciences. “His proven leadership and passion for advancing safety and quality will help us continue to deliver innovative solutions and transform patient care.”

Safeguarding Medicare: Proactive Care Could Unlock $500B in Annual Program Savings

Strategic investments in disease prevention, early detection and other proactive measures could save the U.S. health care system up to $2.2 trillion a year by 2040—more than $7,000 per person—according to new research from Deloitte’s actuarial and health care teams. These investments could also help save Medicare more than $500 billion a year on medical and prescription drug claims, strengthen the program’s long-term financial outlook, and expand the number of years beneficiaries live in good health. Deloitte analysis suggests that lowering Medicare spending in this way could delay potential insolvency and ease the need for benefit reductions or tax increases to maintain the program as it currently exists.

Role of Royalties in Funding Biopharma Innovation

Whitepaper by BioNJ Member Deloitte

The biopharma industry continues to evolve rapidly. Novel treatments and new modalities are quickly emerging, while rising R&D costs and infrastructure investments are increasing capital demands. In response to growing capital needs, biopharma companies are diversifying their funding approaches, with royalty funding gaining prominence as a non-dilutive capital source that preserves operational control at an attractive cost of capital and avoids the challenges of debt alternatives, among other benefits. From November 2024 to January 2025, Deloitte engaged with over 110 biopharma leaders, primarily CFOs and CEOs (including a select number of bankers), through a digital survey and interviews, to assess views on royalty funding and its role relative to other options.

RVCC Honored as Top U.S. Community College for Sustainability Achievements

Raritan Valley Community College has been recognized as the top community college in the United States for sustainability efforts in the 2025 Sustainable Campus Index. A publication from the Association for the Advancement of Sustainability in Higher Education (AASHE), the 2025 Sustainable Campus Index recognizes top-performing sustainable colleges and universities overall, and in 13 specific impact areas, as measured through the Sustainability Tracking, Assessment & Rating System (STARS). With more than 1,200 participants in 56 countries, AASHE’s STARS program is the most widely recognized framework in the world for publicly reporting comprehensive information related to a college or university’s sustainability performance. This is the 11th year in a row that RVCC has been recognized nationally for its sustainability efforts, earning a gold ranking in 2025 as an Overall Top Performer among Associate & Short-Cycle Institutions and had the highest score of any U.S. community college.  

Data & Drinks - Biotech Startups: Insights and Lessons Learned

October 15, 2025 | Hosted by Princeton BioLabs

​Please join us for Collaborative Drug Discovery's (CDD) Data & Drinks on October 15, 2025 at Princeton Innovation Center BioLabs while we enjoy an evening of drinks, hors d'oeuvres, and an exciting discussion on timely topics by our esteemed panelists.  

2025 Female Founded 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.

Community Colleges, NJBIA to Report Out on Career Pathways Projects

The State’s community colleges and NJBIA have scheduled a series of online presentations that will update the public on the progress of various Pathways to Career Opportunities initiatives related to rapidly growing industries where highly skilled workers are in-demand. Leaders in business, industry, labor unions, workforce development boards, county vocational-technical schools, colleges and universities and community-based organizations are urged to participate in these collaborative meetings to gain insights into work that’s shaping the future of the workforce in these five sectors: Manufacturing & Supply Chain Management; Technology & Innovation; Health Services; Infrastructure & Energy; and Emerging Industries.  

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.