NJ Council of County Colleges Launches Future Ready New Jersey Coalition

The New Jersey Council of County Colleges is proud to announce the 28 inaugural organizational members of the Future Ready New Jersey Coalition to Expand Economic Mobility and Broad-Based Prosperity, including BioNJ, New Jersey's life sciences trade association. In this time of rapid and complex technological, economic, demographic and social changes — where access to good jobs requires postsecondary education and where employers face challenges finding workers with the right skills and knowledge — these organizations are committing to working together in search of innovative solutions. To drive collective progress, the Future Ready New Jersey Coalition is calling for the state to adopt a new, ambitious educational attainment goal: for 75 percent of New Jersey adults in the labor market to have postsecondary degrees or credentials of value by 2040, meaning they lead to jobs with wages that exceed the average earnings of a high school graduate by at least 15 percent.

Outcomes Matter Innovations Partners With Regional Cancer Care Associates

Outcomes Matter Innovations (OMI), LLC in Jersey City has announced a new partnership with Regional Cancer Care Associates (RCCA), the largest by-volume provider of cancer services in New Jersey and a leader in providing all forms of innovative cancer care, including an NCI-designated consortium cancer center and community sites throughout the State. The new partnership aims to help improve outcomes and make care more affordable by implementing an Oncology Value-Based Care (VBC) program, enhancing and broadening the one at OMI, allowing it to provide even stronger support for oncologists and their patients. OMI’s VBC programs focus on treating specific qualifying conditions while helping payers track performance in real time.

Heavy on Price, Light on Access: ICER’s Launch Price and Access Report Misses the Mark

The Institute for Clinical and Economic Review (ICER) released its inaugural Launch Price and Access Report (LPAR). The LPAR paints an incomplete view of the value of medicines to patients and society, and risks misinterpretation of the misleading “overspending” analysis. It also highlights potential insurance concerns that hinder patient access to new medicines.

VT's Grumpies Talk MFN

In this episode of the Vital Health Podcast, host Duane Schulthess sits down with two Vital Transformation colleagues to explore key trends in drug pricing and macroeconomic policy. They unpack the Trump administration’s “Most Favored Nation” approach as applied to Medicaid, contrast it with past Medicare proposals, and discuss modeled employment, tax, and GDP impacts. The conversation explores why effects would differ by company and therapy area, the EU’s move toward streamlined compulsory licensing, the knock-on risks for premiums and investment, the fragility of the generics market, and how global competition ― including China’s growing clinical footprint ― could reshape innovation incentives.

Patient Engagement in Managed Care Pharmacy: Putting Policy into Practice

Plans offering essential health benefits must appoint at least one patient representative to their pharmacy and therapeutics (P&T) committees by the start of 2026. After July 10, 2026, every state Medicaid program must establish standalone Beneficiary Advisory Councils and ensure that 20% of Medicaid Advisory Committee members are Beneficiary Advisory Council members. These requirements dovetail with the Center for Medicare & Medicaid (CMS) expansion of Patient Listening Sessions under the Medicare Drug Price Negotiation. Although these requirements are new from CMS, the managed care community is not starting from scratch to engage patients. Method­ology for engaging patients and collecting patient experience data exists, and there is real-world experience from payers that highlights how patients can be successfully integrated into decision-making.

Kyowa Kirin and Kura Oncology Announce FDA Approval of KOMZIFTITM (ziftomenib), the First and Only Once-Daily Targeted Therapy for Adults With Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia

BioNJ Member Kyowa Kirin, with a site in Princeton, and Kura Oncology, Inc announced the U.S. Food and Drug Administration (FDA) has granted full approval of KOMZIFTITM (ziftomenib) for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. KOMZIFTI is the first and only once-daily, oral menin inhibitor approved for R/R NPM1mutated (NPM1-m) AML, a devastating blood cancer with limited treatment options. Approval is supported by the pivotal KOMET-001 trial (NCT04067336), which evaluated KOMZIFTI’s safety and efficacy in 112 R/R NPM1-m AML patients. The rate of complete remission (CR) plus CR with partial hematologic recovery (CRh) was 21.4% (95% CI: 14.2, 30.2).

Kyowa Kirin and Orchard Therapeutics Announce OTL-200 Granted Orphan Regenerative Medicine Product Designation for Early Onset MLD in Japan

BioNJ Member Kyowa Kirin, with a site in Princeton, and Orchard Therapeutics announced that Japan's Ministry of Health, Labor and Welfare (MHLW) has granted Orphan Regenerative Medicine Product Designation to OTL-200, also known as atidarsagene autotemcel, an investigational ex vivo autologous hematopoietic stem cell (HSC) gene therapy for the treatment of pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ), and early symptomatic early juvenile (ESEJ) — collectively referred to as early onset — metachromatic leukodystrophy (MLD). MLD is an ultra-rare, rapidly progressive, irreversible and ultimately fatal neurometabolic disease that affects approximately one in 100,000 live births based on existing literature. It is caused by an error in the gene responsible for encoding the enzyme arylsulfatase A (ARSA) leading to neurological damage and developmental regression.

Phathom Pharmaceuticals Announces First Patient Dosed in Phase 2 Study of VOQUEZNA® (vonoprazan) in Eosinophilic Esophagitis (EoE)

Florham Park-based BioNJ Member Phathom Pharmaceuticals, Inc. announced the first patient has been dosed in its Phase 2 pHalcon-EoE-201 clinical trial evaluating VOQUEZNA® (vonoprazan) tablets as an investigational treatment for eosinophilic esophagitis (EoE) in adults. Phathom’s Phase 2 EoE study is a two-part, randomized, double-blind, placebo-controlled study. The first part will enroll 80 adults with endoscopic-confirmed EoE and dysphagia, or trouble swallowing, to be randomized evenly to receive VOQUEZNA 20 mg or placebo, once daily for 12 weeks. Patients who complete the initial 12-week treatment period will be eligible to enter Part 2, a 12-week extension phase, where all subjects will receive VOQUEZNA 20 mg for the remainder of the study. Topline primary and secondary results are anticipated to be available in 2027.

Phathom Pharmaceuticals Announces Publication of Data from Phase 3 pHalcon-NERD-301 Study Showing VOQUEZNA® (vonoprazan) Improved Nocturnal GERD Symptoms in Patients With Non-Erosive Reflux Disease

Florham Park-based BioNJ Member Phathom Pharmaceuticals, Inc. announced that results of additional analyses from its pivotal Phase 3 pHalcon-NERD-301 trial evaluating VOQUEZNA® (vonoprazan) tablets in patients with Non-Erosive Reflux Disease (NERD) have been published in the American Journal of Gastroenterology. The article, titled “Vonoprazan Improves Nocturnal Gastroesophageal Reflux Symptoms in Non-Erosive Reflux Disease”, underscores the significant burden of nighttime GERD symptoms and the potential role of VOQUEZNA in addressing this aspect of the disease. Nighttime GERD symptoms are highly prevalent, affecting up to an estimated 80% of patients with GERD, and can be associated with impaired sleep, reduced work productivity, and increased risk of esophageal and respiratory complications.

Celldex Presents Additional Positive Data Demonstrating Barzolvolimab’s Ability to Drive Rapid, Profound and Durable Complete Urticaria Control in Phase 2 Chronic Spontaneous Urticaria (CSU) Study

Hampton-based BioNJ Member Celldex announced new data on exploratory endpoints (UCT7) further demonstrating barzolvolimab’s ability to improve urticaria control from the company’s recently completed Phase 2 study in chronic spontaneous urticaria (CSU). The Phase 2 study met its primary endpoint — a significant improvement in UAS7 compared to placebo at 12 weeks — across all dose groups tested. Barzolvolimab also demonstrated rapid, profound complete response rates (UAS7=0; no itch/no hives) in up to 51% of patients at 12 weeks, which continued to deepen over 52 weeks of active therapy to up to 71% of patients. Seven months after completion of dosing, patients continued to experience profound clinical benefit, with up to 41% of patients reporting a complete response at 76 weeks and 48% of patients reporting that their disease no longer impacted their quality of life.

Celldex Announces Initial Positive Results from Phase 1 Trial of CDX-622 Demonstrating Favorable Safety and PK Profile and Sustained Mast Cell Inhibition

Hampton-based BioNJ Member Celldex announced positive data from the ongoing Phase 1 study of CDX-622, a novel bispecific antibody that targets two non-redundant, complementary pathways implicated in inflammation and fibrosis — mast cell depletion via stem cell factor (SCF) starvation and neutralization of the alarmin thymic stromal lymphopoietin (TSLP). CDX-622 was well tolerated, exhibited a good pharmacokinetic profile and induced rapid and sustained reductions in serum tryptase, indicative of mast cell inhibition and depletion. The Phase 1 trial is a randomized, double-blind, placebo-controlled, dose escalation study designed to assess the safety, pharmacokinetics, pharmacodynamics and immunogenicity of single ascending doses (Part 1) and multiple ascending doses (Part 2) of CDX-622 in healthy participants.

Tevogen Reports Major Clinical Milestone: Expands HLA Coverage of its Investigational Precision T Cell Therapy for Acute and Long COVID

Warren-based BioNJ Member Tevogen Bio Holdings announced a clinical milestone in the evolution of its proprietary ExacTcell™ platform: completion of T cell target identification for an additional five human leukocyte antigen (HLA) restrictions. This advancement significantly broadens the accessibility of Tevogen’s investigational precision T cell therapies by extending therapeutic reach beyond the single HLA-A*02:01 restriction used in the company’s initial proof-of-concept (POC) clinical trial, the results of which were published in Blood Advances. That study demonstrated the safety and feasibility of Tevogen’s third-party cytotoxic T lymphocyte (CTL) therapy, TVGN 489, in high-risk patients with COVID-19. HLA type varies widely among individuals and population groups. HLA-A*02:01 was selected for the proof-of-concept trial because it is one of the most common HLA types in the United States, present in approximately 25% of the population.

AUSTEDO® (deutetrabenazine) tablets and AUSTEDO XR® (deutetrabenazine) Extended-Release Tablets Demonstrate Positive Real-World Impact, with Patients Reporting Improvement in Involuntary Movements and Activities of Daily Living

Parsippany-based BioNJ Member Teva Pharmaceuticals announced the presentation of new data from the ongoing, real-world IMPACT-TD Registry. The findings demonstrate that treatment with AUSTEDO (deutetrabenazine) tablets or AUSTEDO XR (deutetrabenazine) extended-release tablets for tardive dyskinesia (TD) led to reductions in the severity of involuntary movements and improvements in patient-reported quality of life. The interim analysis of the IMPACT-TD Registry, a Phase 4 study, evaluated 27 adults with TD treated with AUSTEDO or AUSTEDO XR after a three-month period using IMPACT-TD PRO, a 30-question scale measuring patient-reported impact across 5 key areas. The study included patients with common comorbid psychiatric disorders, such as bipolar disorder (41%), anxiety disorder (37%), depression (26%), and schizophrenia (19%), reflecting a diverse, real-world patient population.

Otsuka Announces First Participants Enrolled in Phase 3 Clinical Trial Evaluating Investigational Compound Quabodepistat for Drug-resistant Pulmonary Tuberculosis

Princeton-based BioNJ Member Otsuka Pharmaceutical Co. Ltd. announced that the first patients have been successfully enrolled and dosed in its Phase 3 clinical trial evaluating quabodepistat, an investigational compound for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB). TB, and particularly its resistant forms, remains a major global health challenge. According to the World Health Organization, 10 million people fall ill with tuberculosis each year, most of whom live in low- to middle-income countries. Despite being preventable and curable, 1.25 million people die from the disease annually. The Phase 3 trial named QUANTUM-TB (Quabodepistat Accelerating New Treatments for Multidrug- Resistant Tuberculosis), is a randomized study designed to evaluate efficacy, safety, and tolerability of quabodepistat-containing regimens in adults and adolescents aged 14 and above.

Bristol Myers Squibb Presents Encouraging Data from Phase 1 Breakfree-1 Study of CD19 NEX-T™ CAR T Cell Therapy in Three Chronic Autoimmune Diseases at ACR Convergence 2025

Princeton-based BioNJ Member Bristol Myers Squibb announced updated data and first disclosure of results in chronic, refractory autoimmune diseases from the Phase 1 Breakfree-1 study of its investigational, autologous CD19-targeted NEX-T™ CAR T cell therapy BMS-986353. The preliminary Phase 1 safety and efficacy results presented are consistent with the potential for immune reset, as part of a treatment process that includes a one-time infusion of CD19 NEX-T, showing robust CAR T cell expansion, complete B cell depletion and re-emergence of a naive B cell phenotype across all three cohorts. At the time of analysis, 94% of evaluable patients remained off chronic immunosuppressive therapy. All cohorts presented demonstrate an acceptable safety profile, with the majority of adverse events occurring shortly after infusion and resolving quickly with standard management protocols, as is expected with CAR T cell therapies.

Bristol Myers Squibb Presents Two Late-Breaking Presentations Demonstrating Sotyktu (deucravacitinib) Efficacy in Psoriatic Arthritis and Systemic Lupus Erythematosus

Princeton-based BioNJ Member Bristol Myers Squibb announced Week 52 data from the pivotal Phase 3 POETYK PsA-1 trial further confirming the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis who were not previously treated with a biologic disease-modifying antirheumatic drug. The company also announced new findings from an integrated analysis of the Phase 2 PAISLEY-SLE and PAISLEY long-term extension studies supporting the safety and efficacy with up to four years of Sotyktu treatment for moderate-to-severe systemic lupus erythematosus. “The POETYK PsA-1 Week 52 data and PAISLEY LTE findings reinforce our confidence in Sotyktu for rheumatic conditions and underscore our commitment to addressing unmet needs and the pursuit of bold science that may elevate new standards of care in Immunology,” said Dennis Grasela, Vice President and Senior Global Program Lead, Immunology and Cardiovascular, Bristol Myers Squibb. 

Sanofi and Regeneron’s Dupixent Pivotal Study Met All Primary and Secondary Endpoints, Reducing Signs and Symptoms of Allergic Fungal Rhinosinusitis; sBLA Accepted for FDA Priority Review

BioNJ Members Sanofi and Regeneron announced positive results from the pivotal LIBERTY-AFRS-AIMS Phase 3 study (NCT04684524) evaluating the investigational use of Dupixent (dupilumab) in adults and children aged 6 years and older with allergic fungal rhinosinusitis (AFRS) demonstrated significant improvements in signs and symptoms of disease across all primary and secondary endpoints, including reductions in sinus opacification, nasal congestion, and nasal polyps compared to placebo. Recently, the US Food and Drug Administration (FDA) accepted for priority review the supplemental biologics license application (sBLA) for Dupixent in adults and children aged 6 years and older with AFRS. Priority review is granted by the FDA to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.

Dupixent® (dupilumab) Wins Prestigious 2025 Prix Galien USA Best Biotechnology Product Award

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced that Dupixent® (dupilumab) has been recognized as the “Best Biotechnology Product” of 2025 by the Galien Foundation, which acknowledges extraordinary scientific innovations that improve the human condition. The Prix Galien USA is the second “Best Biotechnology Product” award for Regeneron following the 2022 recognition of Inmazeb® (atoltivimab, maftivimab, and odesivimab-ebgn). Dupixent was conceived under a unifying scientific hypothesis that predicted many allergic and atopic diseases are driven by excess interleukin-4 (IL-4) and interleukin-13 (IL-13). Dupixent Phase 3 trials in eight different atopic and allergic diseases have since demonstrated significant clinical benefits in support of this hypothesis.

Gilead Sciences Wins Prestigious 2025 Prix Galien USA Award for Best Pharmaceutical Product With Yeztugo® (Lenacapavir)

BioNJ Member Gilead Sciences, with a site in Parsippany, announced it has been awarded the prestigious 2025 Prix Galien USA Award for Best Pharmaceutical Product for Yeztugo® (lenacapavir), the company’s twice-yearly injectable HIV-1 capsid inhibitor that provides adults and adolescents (≥35kg) at risk of HIV-1 acquisition with a new, highly effective option for pre-exposure prophylaxis (PrEP) for the prevention of HIV. The award, which recognizes outstanding pharmaceutical products for their contributions to improving human health, is a testament to Gilead’s long-standing commitment to HIV innovation. HIV continues to pose a formidable global health challenge, with 1.3 million new infections occurring each year—highlighting the critical need for innovative approaches in HIV prevention.

Lilly's Omvoh (mirikizumab-mrkz) Approved by U.S. FDA as a Single-injection Maintenance Regimen in Adults With Ulcerative Colitis

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that the U.S. Food and Drug Administration (FDA) approved a single-injection, once-monthly maintenance regimen (200 mg/2 mL) of Omvoh (mirikizumab-mrkz) for subcutaneous use in adults with moderately to severely active ulcerative colitis (UC). The Omvoh single-injection, citrate-free maintenance dose will be available in the U.S. via prefilled pen or prefilled syringe in early 2026. The U.S. approval follows the recent European Union authorization of Omvoh for single-injection maintenance dosing for UC. The single-injection approval is based on results from a Phase 1 study comparing one 200 mg/2 mL subcutaneous injection to two 100 mg/1 mL injections in participants. The study confirmed that Omvoh single-injection is bioequivalent to the previously approved two-injection regimen.

Lilly's EBGLYSS (lebrikizumab-lbkz) Delivered Durable Disease Control When Administered Once Every Eight Weeks in Patients With Moderate-To-Severe Atopic Dermatitis

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that new results show that EBGLYSS (lebrikizumab-lbkz) sustained similar levels of skin clearance when administered as a single injection of 250 mg once every eight weeks (Q8W) compared with once every four weeks (Q4W), supporting a potential additional, less frequent maintenance dosing option for more individualized treatment of patients with moderate-to-severe atopic dermatitis. EBGLYSS is an interleukin-13 (IL-13) inhibitor that selectively blocks IL-13 signaling with high binding affinity. The cytokine IL-13 is a primary cytokine in atopic dermatitis, driving the type-2 inflammatory cycle in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection.

Lilly's Baricitinib Delivered Near-Complete Scalp Hair Regrowth at One Year for Adolescents With Severe Alopecia Areata in Phase 3 BRAVE-AA-PEDS Trial

BioNJ Member, Eli Lilly and Company, with a site in Branchburg, and Incyte announced new results that showed once-daily, oral baricitinib 4 mg helped the majority of adolescent patients (ages 12 to <18) with severe alopecia areata (AA) achieve successful hair regrowth on the scalp, eyebrows and eyelashes at one year. At the start of the study, patients had an average of 89% scalp hair loss, with 63.8% of them having very severe AA at baseline (Severity of Alopecia Tool [SALT] score 95-100). In addition, 65% had minimal or no eyebrow hair (clinician-reported outcome [ClinRO] score of 2 or 3) and 57% had minimal or no eyelash hair (ClinRO score of 2 or 3).

Lilly to Acquire Adverum Biotechnologies

BioNJ Member, Eli Lilly and Company, with a site in Branchburg, and Adverum Biotechnologies, Inc. a clinical-stage company pioneering the use of intravitreal gene therapy with the aim of preserving sight for life in highly prevalent ocular diseases, announced a definitive agreement for Lilly to acquire Adverum Biotechnologies including its lead product candidate, Ixo-vec. Adverum is developing a pipeline of intravitreal single-administration gene therapies with the aspiration of developing functional cures to restore vision and prevent blindness. Its lead product candidate, Ixo-vec, is an intravitreal gene therapy being developed for the treatment of wet age-related macular degeneration (wAMD). Ixo-vec is designed as a single one-time treatment to deliver continuous and stable intraocular aflibercept levels, thereby reducing the significant patient burden associated with current chronic anti-VEGF therapies, while also potentially leading to improved vision outcomes.

Lilly's Omvoh (mirikizumab-mrkz) Demonstrated Early and Sustained Improvement in Bowel Urgency Outcomes for Patients With Ulcerative Colitis

New data from BioNJ Member, Eli Lilly and Company, with a site in Branchburg, announced new results that showed Omvoh-treated patients with moderately to severely active ulcerative colitis (UC) and bowel urgency experienced early improvements in bowel urgency severity, frequency and stool deferral time by Week 12. These outcomes continued to improve through 28 weeks. The Phase 3b single-arm, open-label LUCENT-URGE study was specifically designed to assess bowel urgency and is the first in inflammatory bowel disease to include the novel endpoints of bowel urgency frequency and stool deferral time to more fully capture the patient experience. Clinical, endoscopic and histologic improvements were consistent with previously disclosed LUCENT Phase 3 trial data.

Lilly's Selective Amylin Agonist, Eloralintide, Demonstrated Meaningful Weight Loss and Favorable Tolerability in a Phase 2 Study of Adults With Obesity or Overweight

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced positive results from a Phase 2 trial evaluating the safety and efficacy of eloralintide, an investigational once-weekly, selective amylin receptor agonist, in 263 adults with obesity or overweight with at least one obesity-related comorbidity and without type 2 diabetes. At 48 weeks, all treatment arms of eloralintide met the primary endpoint, demonstrating superior mean weight reductions from 9.5% to 20.1% compared to 0.4% with placebo using the efficacy estimand. Results from the trial were published in The Lancet. In the trial, all doses of eloralintide delivered clinically meaningful improvements compared to placebo for the secondary endpoints of reductions in body weight and body mass index.

FDA Approval of CAPLYTA® (lumateperone) has the Potential to Reset Treatment Expectations, Offering Hope for Remission in Adults With Major Depressive Disorder

Titusville-based BioNJ Member Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) approved CAPLYTA® (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. The approval – the first under J&J leadership following its acquisition of Intra-Cellular Therapies, Inc. – provides patients with a safe and effective new treatment option that can enable a path to remission. CAPLYTA® makes it easy to start and stay on treatment without the need for titration. Weight gain and other metabolic side effects that typically lead to discontinuation of care were similar to placebo. This approval marks the fourth indication for CAPLYTA®, the first and only FDA-approved treatment for bipolar I and II depression in adults, as an adjunctive and monotherapy; also approved for the treatment of schizophrenia in adults.

DARZALEX FASPRO® is the First and Only Treatment Approved by the U.S. FDA for Patients With High-Risk Smoldering Multiple Myeloma

New Brunswick-based BioNJ Member Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). DARZALEX FASPRO® is the first and only approved treatment for HR-SMM, enabling earlier intervention before the disease progresses to active multiple myeloma. FDA approval is based on findings from the AQUILA study (NCT03301220), which evaluated the efficacy and safety of DARZALEX FASPRO® compared to active monitoring (or “Watch and Wait”) in the largest Phase 3 trial in patients with HR-SMM. The AQUILA study demonstrated a significant improvement in the primary endpoint of progression-free survival, with DARZALEX FASPRO® reducing the risk of disease progression to active multiple myeloma or death by 51 percent compared to active monitoring, according to the International Myeloma Working Group (IMWG) diagnostic criteria for multiple myeloma.

New Study Reveals Substantial Unmet Need in Psoriasis, Shows Strong Patient and Provider Preference for Highly Effective Oral Treatments With Favorable Safety Profile

New Brunswick-based BioNJ Member Johnson & Johnson announced findings from the U.S. dataset from the global ENCOMPASS study evaluating patient and healthcare provider (HCP) perspectives on barriers and unmet needs in psoriasis care. The results reveal significant unmet needs and a strong preference for oral treatment options that achieve treatment goals with high efficacy and favorable safety. The ENCOMPASS study is comprised of a cross-sectional survey of 400 adults, 200 adolescents living with psoriasis, and 200 dermatology providers and aims to inform patient-centered treatment strategies in the U.S. The findings help to characterize the clinical profile of patients, quantify disease burden, evaluate treatment preferences and goals, and assess the impact of psoriasis on patient quality of life (QoL) using the Dermatology Life Quality Index (DLQI/cDLQI).

TREMFYA® (guselkumab), the First and Only IL-23 Inhibitor With a Fully Subcutaneous Treatment Regimen, Demonstrates Durable Remission in Crohn’s Disease at Two Years

New Brunswick-based BioNJ Member Johnson & Johnson announced new 96-week data from the long-term extensions (LTE) of the Phase 3 GRAVITI, GALAXI 2 and GALAXI 3 studies, which show the durability of TREMFYA® (guselkumab) in adults with moderately to severely active Crohn’s disease (CD) at two years. TREMFYA® is the first and only approved, 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. Findings are based on in vitro studies.

Icotrokinra Maintains Standout Combination of Therapeutic Benefit and a Favorable Safety Profile in Once-Daily Pill Through 28 Weeks in Ulcerative Colitis

New Brunswick-based BioNJ Member Johnson & Johnson announced Week 28 results from the Phase 2b ANTHEM-UC study of icotrokinra, a first-in-class investigational targeted oral peptide that precisely blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC). These results underscore the potential of icotrokinra to deliver a combination of therapeutic benefit and a favorable safety profile with once-daily oral dosing. At Week 28, icotrokinra demonstrated sustained and clinically meaningful results, with all doses (100 mg, 200 mg and 400 mg) showing higher rates of clinical response, clinical remission, endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI) at Week 28 compared to placebo.

Icotrokinra Long-Term Results Affirm Promise of Targeted Oral Peptide With High Rates of Durable Skin Clearance and Favorable Safety Profile in Difficult-to-Treat Scalp and Genital Psoriasis

New Brunswick-based BioNJ Member Johnson & Johnson announced new long-term 52-week data from the Phase 3 ICONIC-TOTAL study evaluating icotrokinra, a first-in-class investigational targeted oral peptide that precisely blocks the IL-23 receptor, in adults and pediatric patients 12 years of age and older (adolescents) with plaque psoriasis (PsO) affecting high-impact sites. The ICONIC-TOTAL study simultaneously evaluated adults and adolescents with at least moderate scalp, genital and/or hand/foot plaque psoriasis with ≥1% Body Surface Area (BSA) affected. Through Week 52, icotrokinra demonstrated high and durable rates of site-specific psoriasis clearance affecting all these high-impact and difficult-to-treat areas of the body. In the smaller subset of patients with hand/foot psoriasis, treatment with icotrokinra showed a numerically higher rate of skin clearance at Week 16, which increased through Week 52 with patients achieving a hand and/or foot Physician’s Global Assessment (hf-PGA) score of 0/1 increasing from 42% to 62%.

Johnson & Johnson Announces First Head-to-Head Study Comparing IMAAVY™ with an Alternative FcRn Blocker in Generalized Myasthenia Gravis (Gmg) at AANEM Annual Meeting

New Brunswick-based BioNJ Member Johnson & Johnson announced plans to initiate the first head-to-head study comparing FcRn blockers for patients with generalized myasthenia gravis (gMG), which aims to affirm IMAAVY™ (nipocalimab-aahu) as the FcRn blocker of choice for appropriate gMG patients. EPIC is a Phase 3b, randomized, open-label study designed to compare FcRn blockers in adults with gMG. The study will evaluate whether treatment with IMAAVY™ provides superior disease control versus efgartigimod in adults with gMG who have never received an FcRn blocker. It also includes a treatment-switch arm to assess efficacy and safety of IMAAVY™ in participants switching from efgartigimod to IMAAVY™. The study’s key primary and secondary endpoints are change from baseline in total immunoglobulin G (IgG) levels and sustained disease control measured by MG-ADL and QMGb scores 8-12 weeks post-initiation of treatment, respectively.

Johnson & Johnson Submits Application to U.S. FDA for STELARA® (Ustekinumab) in the Treatment of Pediatric Ulcerative Colitis

New Brunswick-based BioNJ Member Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand approval of STELARA® (ustekinumab) for the treatment of children two years and older with moderately to severely active ulcerative colitis (UC). Ulcerative colitis affects approximately one million people in the U.S., with an increasing rate in the pediatric population, who often experience more severe symptoms than adults. This submission is supported by data from the Phase 3 UNIFI Jr clinical trial, a multicenter interventional study to evaluate the efficacy, safety and pharmacokinetics of STELARA® for the treatment of pediatric UC through Week 52.

“LEQEMBI®” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in the United Kingdom

Nutley-based BioNJ Member Eisai Co., Ltd. and BioNJ Member Biogen Inc. announced that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. In August 2024, LEQEMBI was approved for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers in the United Kingdom. With this latest approval for IV maintenance dosing, after 18 months of a dosing regimen of 10 mg/kg once every two weeks patients may be transitioned to the maintenance dosing regimen of 10 mg/kg once every four weeks, or the regimen of 10 mg/kg once every two weeks may be continued.

Health Canada Grants Authorization for “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease

Nutley-based BioNJ Member Eisai Co., Ltd. and BioNJ Member Biogen Inc. announced that Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (lecanemab) for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer’s disease (early AD) who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes and who have confirmed amyloid pathology. LEQEMBI is the first treatment for early AD that targets an underlying cause of the disease, to be authorized in Canada. LEQEMBI selectively binds to soluble Aβ aggregates (protofibrils**), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques, thereby reducing both Aβ protofibrils and Aβ plaques in the brain.

Merck and Eisai Announce WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Met Primary Endpoint of Progression-Free Survival (PFS) in Certain Previously Treated Patients with Advanced Renal Cell Carcinoma

Rahway-based BioNJ Member Merck & Co. and Nutley-based BioNJ Member Eisai announced that the Phase 3 LITESPARK-011 trial evaluating the dual oral regimen of WELIREG® (belzutifan), Merck’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, plus LENVIMA® (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, met one of its primary endpoints of progression-free survival (PFS) for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with anti-PD-1/L1 therapy. At a pre-specified interim analysis, WELIREG plus LENVIMA demonstrated a statistically significant and clinically meaningful improvement in PFS compared to cabozantinib in these patients. The combination also showed a statistically significant improvement in the trial’s key secondary endpoint of objective response rate (ORR) compared to cabozantinib.

Merck Announces KEYTRUDA® (pembrolizumab) Plus WELIREG® (belzutifan) Met Primary Endpoint of Disease-Free Survival (DFS) in Certain Patients With Clear Cell Renal Cell Carcinoma (RCC) Following Nephrectomy

Rahway-based BioNJ Member Merck & Co. announced positive topline results from the Phase 3 LITESPARK-022 trial in patients with clear cell renal cell carcinoma (RCC) following nephrectomy. In this study, KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with WELIREG® (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, given in the adjuvant setting, demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS), the study’s primary endpoint, compared to KEYTRUDA in combination with placebo. The trial will continue to evaluate overall survival (OS), a key secondary endpoint. The safety profiles of KEYTRUDA plus WELIREG in this trial were overall consistent with those observed in previously reported studies for the individual therapies.

European Commission Approves KEYTRUDA® (pembrolizumab) as Part of a Treatment Regimen for Adults With Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC) Expressing PD-L1 (CPS ≥1)

Rahway-based BioNJ Member Merck & Co. announced that the European Commission (EC) has approved KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for the treatment of resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1. This approval marks the first and only anti-PD-1 treatment option for certain patients with resectable LA-HNSCC in the European Union (EU) and the third approval for KEYTRUDA in HNSCC in the EU. The EC approval is based on results from the pivotal Phase 3 KEYNOTE-689 trial.

FDA Grants Priority Review for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each in Combination With Padcev® (enfortumab vedotin-ejfv), for Certain Patients With Muscle-Invasive Bladder Cancer

Rahway-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has granted priority review for two supplemental Biologics License Applications (sBLA) for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev® (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action, date of April 7, 2026, marking the first concurrent review of both KEYTRUDA and KEYTRUDA QLEX for the same novel indication. The sBLAs are based on data from the Phase 3 KEYNOTE-905 trial (also known as EV-303), which was conducted in collaboration with BioNJ Member Pfizer and Astellas.

U.S. FDA Approves Updated Indication for WINREVAIR™ (sotatercept-csrk) in Adults With Pulmonary Arterial Hypertension (PAH, WHO Group 1 Pulmonary Hypertension) Based on Phase 3 ZENITH Study

Rahway-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved an update to the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR™ (sotatercept-csrk) for injection, 45mg, 60mg. WINREVAIR, an activin signaling inhibitor, is now FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death. WINREVAIR was initially approved based on the pivotal STELLAR study in March 2024. This approval expanded the indication of WINREVAIR to include components of the clinical worsening events: hospitalization for PAH, lung transplantation and death.

Merck’s Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Significantly Reduced LDL-C in Phase 3 CORALreef Lipids Trial

Rahway-based BioNJ Member Merck & Co. announced the first presentation of results from the pivotal Phase 3 CORALreef Lipids trial demonstrating that treatment with enlicitide decanoate, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, resulted in a statistically significant and clinically meaningful reduction in low-density lipoprotein cholesterol (LDL-C) of 55.8% (primary analysis; 95% CI: -60.9, -50.7; p<0.001) and of 59.7% in a post-hoc reanalysis (95% CI: -62.3, -57.1; p<0.001) compared to placebo at week 24. In CORALreef Lipids, adults with or at-risk for atherosclerotic cardiovascular disease (ASCVD) on background lipid-lowering therapies or a documented statin intolerance who received once-daily oral enlicitide had statistically significant and clinically meaningful reductions in LDL-C at week 24 (primary endpoint) and statistically significant and sustained reductions in LDL-C through one year (week 52).

Merck’s Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Significantly Reduced LDL-C in Adults With Heterozygous Familial Hypercholesterolemia (HeFH) in Phase 3 CORALreef HeFH Trial

Rahway-based BioNJ Member Merck & Co. announced the first presentation of results from the pivotal Phase 3 CORALreef HeFH trial demonstrating that treatment with enlicitide decanoate, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, resulted in a statistically significant and clinically meaningful reduction in low-density lipoprotein cholesterol (LDL-C) of 59.4% compared to placebo at week 24 (95% CI: -65.6, -53.2; p<0.001) in adults with heterozygous familial hypercholesterolemia (HeFH). The effect size and safety profile was comparable to that observed in the pivotal Phase 3 CORALreef Lipids study. In CORALreef HeFH, enlicitide demonstrated statistically significant and clinically meaningful reductions in LDL-C at week 24 (primary endpoint) and statistically significant reductions in secondary endpoints. 

Merck Enters into Research and Development Funding Agreement With Blackstone Life Sciences for Sacituzumab Tirumotecan (sac-TMT)

Rahway-based BioNJ Member Merck announced that the company has entered into an agreement to receive funds managed by Blackstone Life Sciences for the development of sacituzumab tirumotecan (sac-TMT), an investigational antibody-drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), a protein found on the surface of various cancer cells. Merck is currently evaluating sac-TMT in 15 global Phase 3 clinical trials spanning six tumor types, including breast, endometrial and lung cancers. Sac-TMT is being developed as part of an exclusive license and collaboration agreement with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., a holding subsidiary of Sichuan Kelun Pharmaceutical Co, Ltd, which is unchanged by this agreement with Blackstone.

GSK’s B7-H3-Targeted Antibody-Drug Conjugate, GSK’227, Receives Orphan Drug Designation in the EU

Warren-based BioNJ Member GSK plc announced that GSK5764227 (GSK’227), its B7-H3-targeted antibody-drug conjugate (ADC), has received Orphan Drug Designation (ODD) from the European Medicines Agency (EMA) for the treatment of pulmonary neuroendocrine carcinoma (NEC), a category of cancer that includes small-cell lung cancer (SCLC). The ODD was supported by preliminary clinical data showing durable responses in patients with extensive stage SCLC (ES-SCLC) who were treated with GSK’227 in the phase I ARTEMIS-001 clinical trial. This ODD recognizes the potential of GSK’227 to address a significant unmet need for ES-SCLC, an aggressive type of NEC with poor outcomes and limited treatment options. An estimated 250,000 patients globally are diagnosed with SCLC each year and it is responsible for approximately 200,000 deaths annually.

GSK Acquires Exclusive Rights from Syndivia for Antibody-Drug Conjugate (ADC) in Prostate Cancer

Warren-based BioNJ Member GSK plc and Syndivia announced an agreement granting GSK exclusive worldwide rights to develop and commercialize a preclinical ADC for mCRPC. Approximately 1.4 million men worldwide are diagnosed with prostate cancer each year and approximately 10-20% develop advanced disease, castration resistance with metastases, within five years. For patients whose cancer has advanced to mCRPC, targeted treatment options are limited, and standard of care options may be difficult to access in community practice settings, and can be poorly tolerated with modest efficacy outcomes. Survival rates for these patients are low, with a 5-year survival rate of approximately 30% and a median survival of approximately two years.

GSK and Empirico Enter License Agreement for Clinical-Stage, First-in-class Oligonucleotide Candidate to Treat Respiratory Diseases

Warren-based BioNJ Member GSK plc and Empirico Inc. announced that they have entered into a worldwide exclusive license agreement for EMP-012, a highly selective first- and potentially best-in-class siRNA, a type of oligonucleotide. EMP-012 addresses a novel therapeutic target and is currently in a Phase I trial for the treatment of chronic obstructive pulmonary disease (COPD), with the potential for expansion into other inflammatory respiratory diseases. Medical need in COPD remains high despite ongoing innovation. By 2050, COPD prevalence is expected to increase to about 600 million people and become the leading cause of all hospital admissions, costing healthcare systems approximately $4 trillion. 

Novartis to Buy Avidity for $12 Billion

East Hanover-based BioNJ Member Novartis said it will buy Avidity for $12 billion. The deal is expected to close in the first half of 2026, after Avidity spins out parts of its business, including its early stage precision cardiology programs, the company said in a statement. The proposed acquisition will bring Avidity’s late-stage neuroscience programs into Novartis and provide Novartis access to a differentiated RNA-targeting delivery platform. These programs are expected to advance the company’s neuroscience strategy and complement the current pipeline with potential first-in-class therapeutic candidates that address the genetic drivers of muscle-damaging conditions. The acquisition raises the expected 2024-2029 sales CAGR for Novartis from +5% to +6% CAGR, representing a significant opportunity to deliver substantial shareholder returns over time.

Novartis Ianalumab First Drug to Reduce Disease Activity and Patient Burden in Sjögren’s Disease Phase III Trials

East Hanover-based BioNJ Member Novartis presented new ianalumab data in Sjögren’s disease, the second most prevalent rheumatic autoimmune disease. Ianalumab 300 mg monthly delivered a clinically meaningful benefit in the global NEPTUNUS-1 and NEPTUNUS-2 Phase III trials, showing both improvement in disease activity and reductions in patient burden. Compared to placebo, ianalumab achieved a numerically greater reduction in disease activity by Week 16 with improvements sustained through Week 52 as measured by the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI). Ianalumab is a fully human monoclonal antibody with a novel dual mechanism of action that depletes B-cells and also inhibits their activation and survival via BAFF-R blockade. B-cell dysfunction plays a significant role in Sjögren’s disease by causing an autoimmune response that leads to inflammation and tissue damage.

Novo Nordisk’s Wegovy® (semaglutide 2.4 mg) Was Associated With Liver Health-Related Benefits Not Solely Based on Weight Loss in Adult Patients With MASH With Liver Scarring, According to a New Post Hoc Analysis

Plainsboro-based BioNJ Member Novo Nordisk presented data evaluating the effects of semaglutide 2.4 mg in people with metabolic dysfunction-associated steatohepatitis (MASH) and moderate-to-advanced liver scarring (fibrosis). Results from a post hoc analysis of the ESSENCE Phase 3 trial showed semaglutide 2.4 mg was associated with reduction in liver injury (steatohepatitis) in adults with MASH even at low levels of weight loss. This post hoc analysis of the ESSENCE trial evaluated the first 800 randomized patients at 72 weeks. Histological and non-invasive testing (NIT)–related treatment responses were evaluated according to specific weight loss thresholds (≤2%, ≤5%, ≤7%, >7%). Steatohepatitis-related NITs improved in all groups receiving semaglutide 2.4 mg, with the greatest treatment effect observed for alanine aminotransaminase (ALT) in patients with weight loss of ≤7%.

Sandoz Signs Global License Agreement to Commercialize Breast Cancer Biosimilar Pertuzumab

Princeton-based BioNJ Member Sandoz announced the signing of a global license agreement to commercialize a proposed biosimilar of oncology medicine pertuzumab. The agreement with EirGenix Inc. is milestone-based for a total consideration of up to USD 152 million, including an upfront payment and further potential incentives dependent upon market performance. The reference medicine market is worth an estimated USD 4.1 billion in global sales, and pertuzumab will join the deep Sandoz pipeline with the strategic objective to capitalize on a projected ~USD 300 billion biosimilar market opportunity over the next 10 years. Under the terms of the agreement, Sandoz has exclusive worldwide commercial rights to a biosimilar of pertuzumab, excluding certain countries in Asia, while EirGenix Inc. will be responsible for development, manufacturing and supply.

Evotec Announces Progress in Preclinical Neuroscience Partnership With Bristol Myers Squibb

Princeton-based Evotec announced that the company has received a payment of US$ 25M from Princeton-based BioNJ Member Bristol Myers Squibb for scientific progress achieved within their strategic neuroscience partnership. The payment will advance further research and the partners’ joint pipeline of programs aimed at tackling neurogenerative diseases. Launched in 2016, the collaboration focuses on discovering and developing disease-modifying treatments for neurodegenerative diseases, where current treatment options remain limited. Since then, the companies have built a strong pipeline of innovative programs, including EVT8683, in-licensed by Bristol Myers Squibb in 2021 as BMS-986419, that has completed Phase 1 clinical trials. The partnership was extended in 2023 for an additional eight years, reflecting the shared commitment to bringing transformative treatments into the clinic.

DESTINY-Lung06 Phase 3 Trial of ENHERTU® Initiated as First-Line Therapy in Patients With HER2 Overexpressing Metastatic NonSquamous Non-Small Cell Lung Cancer

Daiichi Sankyo, with a site in Basking Ridge, announced that the first patient has been dosed in the DESTINYLung06 Phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) plus pembrolizumab versus pembrolizumab, platinum-based chemotherapy and pemetrexed as a first-line treatment in patients with unresectable, locally advanced or metastatic HER2 overexpressing and PD-L1 TPS <50% non-squamous non-small cell lung cancer. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. One of the current recommended first-line treatments for patients with HER2 overexpressing metastatic non-squamous NSCLC is pembrolizumab plus platinum-based chemotherapy and pemetrexed. Improved outcomes for immunotherapy-based treatments correlate with higher PD-L1 levels, underscoring the need for more targeted treatment options for patients with PD-L1 TPS <50%.

LEO Pharma Announces NICE Recommendation of Reimbursement in England and Wales

Madison-based LEO Pharma announced that the National Institute for Health and Care Excellence (NICE) has issued Technology Appraisal Guidance (TAG) recommending the reimbursement of Anzupgo® (delgocitinib) cream for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. Anzupgo® is now the first approved topical pan-Janus kinase (JAK) inhibitor treatment for this indication in England and Wales.CHE is a fluctuating inflammatory skin disease, characterized by persistent itch, pain, redness and irritation on the hands and wrists. The disease is diagnosed when these symptoms last more than three months, or when they return two or more times within a year. 

Hovione Finishes $100M Investment Cycle for 200K SF Manufacturing Site

East Windsor-based Hovione announced the completion of an initial multimillion-dollar investment cycle to expand its manufacturing site in East Windsor. Upon completion, this campus will cover over 200,000 square feet, integrating the latest technologies within sustainably designed facilities. The initiative advances Hovione’s long-term strategy to grow its U.S. operations and enhance its integrated drug substance, drug product intermediate and drug product capabilities. The initial expansion phase includes a 31,000-square-foot building that will house two size-3 spray dryers (PSD-3) designed to produce amorphous solid dispersions (ASDs) for the company’s customers who have an interest in having a supply node in North America. This investment more than doubles Hovione’s spray-drying capacity in the United States, expanding capabilities for ASD development and commercial manufacturing.

Murphy Joins Lupin to Inaugurate New Corporate Offices in Bridgewater

Global pharmaceutical leader Lupin Limited commemorated the inauguration of its new corporate offices at 100 Somerset Corporate Blvd in Bridgewater marking a significant expansion of its presence in the State. New Jersey Gov. Phil Murphy and Somerset County Commissioner Deputy Director Melonie Marano attended the ribbon-cutting ceremony alongside Lupin executives, including CEO Vinita Gupta and President, U.S. Generics, Spiro Gavaris. The new office space, spanning approximately 18,000 square feet, will accommodate various corporate functions, including commercial, HR, finance, legal, marketing, business development and R&D. Lupin first established its footprint in the State in 2016 with a manufacturing facility in Somerset. Lupin’s New Jersey-based workforce currently exceeds 300 employees, with plans for continued growth.

Celularity Enters Strategic Partnership with DefEYE to Advance Regenerative Therapies in Eye Care

Florham Park-based Celularity announced a strategic partnership with DefEYE, a newly established ophthalmic product and technology company. Under the terms of the agreement, Celularity has executed an exclusive license and pricing arrangement with DefEYE, following Celularity’s in-kind investment in DefEYE’s $12 million Series Seed Preferred Equity funding round. DefEYE was founded to expand on the commercial foundation of Verséa Ophthalmics. Proceeds from the Series Seed Preferred round will fund the launch and scale of a portfolio of decellularized biologic solutions for ophthalmology, including: Biovance and Biovance 3L Ocular – single and tri-layer Decellularized Amniotic Basement Membrane products; Interfyl – a flowable human connective tissue matrix derived from the chorionic plate; and Collaborative R&D initiatives for future commercial innovations.

Microsoft to Bring Breakthrough Discovery Platform to NJ AI Hub

In a major boost for the New Jersey Artificial Intelligence Hub, founding partner Microsoft announced that it will deploy its new Discovery platform — an advanced Agentic AI and cloud technology designed to accelerate scientific research and problem-solving — at the West Windsor-based facility. Microsoft officials say the Discovery platform will expand access to AI’s computational power for academia, government, start-ups and industry in two key ways: leveraging high-performance computing and AI to rapidly analyze massive datasets, simulate experiments and uncover new materials or solutions far faster than traditional methods; ostering dynamic collaboration by pairing specialized AI agents with human experts, enabling continuous, iterative breakthroughs across disciplines. NJ AI Hub Executive Director Liat Krawczyk said the Discovery platform aligns with a key mission of the Hub: To bring the power of artificial intelligence to New Jersey for the benefit of the region and the economy.

Lilly Partners With NVIDIA to Build the Industry's Most Powerful AI Supercomputer, Supercharging Medicine Discovery and Delivery for Patients

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced it is building the most powerful supercomputer owned and operated by a pharmaceutical company, in collaboration with NVIDIA. The supercomputer will power an "AI factory," a specialized computing infrastructure that manages the entire AI lifecycle from data ingestion and training to fine-tuning and high-volume inference. The supercomputer is the world's first NVIDIA DGX SuperPOD with DGX B300 systems. It is powered by more than 1,000 B300 GPUs on a unified networking fabric, which means communication across GPUs, storage and related systems runs on just one high-speed network. The new supercomputer and AI factory enable rapid learning and iteration. Scientists will be able to train AI models on millions of experiments to test potential medicines, dramatically expanding the scope and sophistication of drug discovery efforts.

Coreweave Announces Partnership With Crowdstrike

Livingston-based BioNJ Member CoreWeave and CrowdStrike announced a major global partnership to power the secure AI cloud foundation for the agentic era and accelerate the march toward secure AGI. The collaboration combines CoreWeave’s high-performance AI Cloud with the CrowdStrike Falcon platform’s industry-leading protection to secure and accelerate the complex computing workloads that drive modern AI innovation. Building on CrowdStrike’s collaboration with NVIDIA to bring continuously learning AI agents for cybersecurity to the edge, the CrowdStrike-CoreWeave partnership extends that innovation into real-world production environments running on CoreWeave’s platform, built on NVIDIA’s AI infrastructure. The CrowdStrike-CoreWeave partnership expands CrowdStrike’s secure AI ecosystem by bringing together CrowdStrike’s cybersecurity leadership, CoreWeave’s purpose-built AI cloud and NVIDIA’s AI infrastructure to deliver the security, speed, intelligence and resilience that the agentic era demands.

CoreWeave Announces Acquisition of Marimo

Livingston-based BioNJ Member CoreWeave announced a definitive agreement to acquire Marimo Inc. Marimo is the creator of the open-source marimo notebook, an AI-native, reactive development environment for Python, purpose-built for AI and data workloads. The acquisition will integrate Marimo’s technology into the CoreWeave Cloud, supercharging Marimo’s cloud-hosted notebook offering and creating a unified developer experience that spans the entire AI lifecycle of training, inference, data movement and continuous iteration. The addition strengthens CoreWeave’s vertically integrated platform, empowering developers to build, scale and deploy applications faster and more efficiently. Together, CoreWeave and Marimo will empower all kinds of developers to harness the power of AI and data, ultimately ushering in the next generation of AI-native products.

World Economic Forum Honors Liberty Science Center’s SciTech Scity Healthcare Innovation Engine

The World Economic Forum (WEF) has awarded its 2025 Public-Private Collaboration Award to the Healthcare Innovation Engine, an initiative of SciTech Scity, Liberty Science Center’s 30-acre innovation campus under development in Jersey City. SciTech Scity’s Healthcare Innovation Engine was the only entity based in the United States to be recognized this year for convening world-leading public-private collaborations. Operating as a multi-stakeholder ecosystem, the engine supports health-care start-ups and clinical and operational pilots, and connects innovators with health-care providers, payers and policymakers.

NJIT Innovation Goes to Market: PureTrace Labs Launched to Bring Rapid PFAS Detection Technology to Market

The New Jersey Institute of Technology (NJIT) and the New Jersey Innovation Institute (NJII) have announced the official launch of PureTrace Labs, a start-up poised to revolutionize the detection of harmful PFAS — or “forever chemicals” — in the environment. This launch marks a significant milestone for NJIT’s innovation pipeline, as PureTrace Labs is the first official venture spun out of NJII’s Venture Studio, an initiative backed by an investment of up to $1 million. The new company will commercialize an NJIT-developed technology that can rapidly detect PFAS in water, soil, and packaging materials in under three minutes. PureTrace Labs is founded on the research of Hao Chen, professor of chemistry and environmental science at NJIT, who now serves as the company’s co-founder and chief scientific officer.

Rutgers Cancer Institute and RWJBarnabas Health Announce Landmark Data for HPV-Related Cancers

Researchers from Rutgers Cancer Institute and RWJBarnabas Health, along with colleagues from the National Cancer Institute, announced findings from two HPV-related studies that highlight the potential of novel T cell therapies to achieve long-lasting remission and complete tumor regression in patients with advanced epithelial cancers. The two studies show how different T cell approaches may achieve lasting remission in HPV-related cancers — underscoring the broader potential of cellular therapy to change the course of cancer treatment. In one study, researchers reported encouraging interim results from a Phase II clinical trial evaluating genetically engineered T cell receptor (TCR)-T cells targeting the HPV16 E7 oncoprotein (E7 T cells) in patients with metastatic HPV-associated cancers. Five had head and neck cancer, two had cervical cancer, two had anal cancer, and one had esophageal cancer.

Newsweek Names New Jersey’s Best Hospitals for 2026

Newsweek is recognizing the top health care facilities in the U.S. in its America’s Best-in-State Hospitals 2026. Of the more than 6,000 hospitals across all 50 states and the District of Columbia, 800 made this year’s ranking. Of those, 11 are in New Jersey. Those that made the ranking “consistently demonstrate excellence across medical specialties, safety and patient satisfaction,” according to the publication. According to Newsweek, New Jersey’s Best-in-State Hospitals for 2026 are: Morristown Medical Center; Englewood Hospital and Medical Center; Robert Wood Johnson University Hospital, New Brunswick; Hackensack University Medical Center; Overlook Medical Center; Saint Peter’s University Hospital; Cooper University Hospital; Penn Medicine Princeton Medical Center; Monmouth Medical Center; The Valley Hospital; and Holy Name Medical Center. 

NJCU Signs MOU With Mexican University to Bolster Higher Education Collaboration

New Jersey City University (NJCU) and Fundación Universidad de las Américas Puebla (UDLAP) have signed a memorandum of understanding (MOU) that establishes a framework to strengthen academic and educational collaboration between the institutions. Under the terms of the MOU, the institutions will seek to promote collaboration through student, academic, and administrative exchanges, study abroad programs, double degrees, exchanges of publications and reports, joint research activities, and the organization of academic conferences and seminars, in addition to joint organization of special technical or administrative programs. The MOU will remain in effect for three years. The agreement was a highlight of Murphy’s final economic mission with Choose New Jersey, organized in collaboration with the Statewide Hispanic Chamber of Commerce of New Jersey.

VC Innovation Lead Partner Named for SciTech Scity’s Healthcare Innovation Engine

Tech Council Ventures (TCV), an early stage venture fund investing in healthcare, technology, energy and the environment, has signed on as Venture Capital Innovation Lead Partner for the Healthcare Innovation Engine at Liberty Science Center’s SciTech Scity. Through the partnership, TCV will provide strategic guidance to start-up companies supported by the Engine and invest $250,000+ annually in one or more of them. The SciTech Scity Healthcare Innovation Engine is a multi-stakeholder initiative to accelerate the adoption of digital-first healthcare solutions through real-world pilot programs with start-ups. The Engine is the first statewide platform for digital health adoption in the U.S. and is launching pilots with uninsured patients in cardiovascular health, oncology, post ER-care, maternal health and adolescent mental health.

Celldex Appoints Lawver as SVP, CCO

Hampton-based BioNJ Member Celldex has announced the appointment of Teri Lawver as Senior Vice President, Chief Commercial Officer. Ms. Lawver is an accomplished global health care executive with 30 years of strategic, commercial launch and operating P&L leadership across the biopharmaceutical, medical device and consumer health technology sectors. She succeeds Richard Wright, who will retire from Celldex following more than a decade of dedicated leadership and service. Ms. Lawver brings extensive experience in immunology and inflammation, having overseen multiple first-in-class portfolio advances and blockbuster launches, including pivotal indications for REMICADE (infliximab), STELARA (ustekinumab) and TREMFYA (guselkumab).

Sun Pharma Announces Allen as VP, Corporate Affairs for North America

Princeton-based Sun Pharmaceutical Industries Limited announced the appointment of Jeremy Allen as Vice President, Corporate Affairs for North America. In this newly created position, Mr. Allen will lead Sun Pharma’s government affairs, public policy, advocacy and communications across the U.S. and Canada. A seasoned healthcare leader with more than 25 years of industry experience, Mr. Allen has an extensive background in developing and leading campaign-style policy initiatives. He joins Sun Pharma from Spark Therapeutics, where he led the U.S. government affairs and pricing and reimbursement functions. Prior to his time with Spark, Allen led the federal lobbying team at AHIP (formerly known as America’s Health Insurance Plans) and held government affairs roles at Vertex Pharmaceuticals and Johnson & Johnson.

Zoetis Appoints Digital Health Entrepreneur Stephanie Tilenius to Board of Directors

Parsippany-based Zoetis Inc. announced the appointment of Stephanie Tilenius to its board of directors. Ms. Tilenius brings extensive experience in digital health, artificial intelligence (AI) and the technology sector to the animal health company’s board. Ms. Tilenius is a serial entrepreneur who founded several health care companies, including Vida Health, Inc., a leading chronic care platform that she scaled nationally. She also recently founded a stealth company operating in the longevity AI space. Beyond her health care ventures, Ms. Tilenius held senior leadership roles at major technology firms, serving as Vice President of Global Commerce and Payments at Google and holding high-level positions at PayPal and eBay. She currently serves on the board of Seagate Technology Holdings plc and is a Venture Advisor to the AI Fund.

Executive MBA/MS in Healthcare Leadership Westchester Networking Event

November 19, 2025 | Hosted by Cornell Executive MBA/MS in Healthcare Leadership Program

Join Cornell's Executive MBA/MS in Healthcare Leadership program on Wednesday, November 19 at Hudson Grille in White Plains for an engaging, hands-on networking session focused on crafting an impactful 60-second pitch. This session will feature Nicole Woodward, Senior Associate Director from the Career Development Office for Cornell's Executive MBA Programs. Guests will also have the opportunity to connect with prospective candidates, admissions representatives, and accomplished alumni to learn how Cornell's EMBA/MS in Healthcare Leadership can accelerate your career while building meaningful connections.

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.