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July 11, 2025

Welcome to the latest edition of the BioLines Weekender...


Congratulations to BioNJ member Genmab on the opening of its new state-of-the-art facility at the Princeton Forrestal Innovation Center in Plainsboro. This achievement marks a significant investment in New Jersey’s innovation ecosystem and reinforces the State’s position as a global hub for life sciences. Genmab’s expansion is a testament to its remarkable growth — from just 150 employees in 2020 to over 1,000 today. Genmab’s deep New Jersey roots, from its beginnings as a Medarex spin-off to its emergence as a global leader in Patient-centered science, continue to shape a legacy of innovation, impact and hope for Patients around the world. BioNJ was excited to be on hand for this important milestone.


Meanwhile, BioNJ is proud to announce that the 2025 BioNJ Gives Back will take place on Wednesday, December 10.


Following the success of last year’s event — where 200 BioNJ Members came together to create BioBears for pediatric Patients — this year’s initiative, “Totes of Hope: Hospital Care Kits,” offers another powerful opportunity to give back. Participants will decorate canvas tote bags with inspiring messages and artwork, then fill them with comforting essentials. Each tote will serve as a heartfelt gesture of support for Patients of all ages — bringing hope, comfort, and connection when it’s needed most.


Please mark your calendars and save the date! Each location will be limited to 100 volunteers. Registration will open soon.


December 10, 2025

9:00 a.m.-11:00 a.m.

Insmed, 700 US Highway 202/206, Bridgewater


2:00 p.m.-4:00 p.m.

Sanofi, M Station, 100 Morris Street, Morristown

 

We warmly invite your organization to consider sponsoring this meaningful community initiative in support of patients across New Jersey. Click here for details. Thank you.


Because Patients Can't Wait®,

Debbie Hart

President and CEO

BioNJ

Upcoming BioNJ Events

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Webinar: From Price Controls to Production Lines: How Policy Is Reshaping Biopharma Strategy

Free for BioNJ Members!

Register

July 31, 2025

BioNJ Member Café

For BioNJ Members Only!

Register

September 4, 2025

BioNJ Manufacturing Summit

Register

September 10, 2025

BioNJ IT/Cybersecurity Webinar

Save the Date

September 17, 2025

BioNJ C-Suite Summit

Save the Date

October 30, 2025

BioNJ Annual Dinner Meeting & Innovation Celebration

Save the Date

February 5, 2026

LSWC 2025 Life Sciences Workforce Trends Report: Partner Marketing Toolkit

The Life Sciences Workforce Collaborative has released the 2025 Life Sciences Workforce Trends Report, a must-read for industry, academic and policy leaders navigating today's evolving workforce landscape. Developed with TEConomy Partners, and supported by InnovATEBIO, this seventh biennial edition draws on data from 500+ hiring surveys, 200+ executive interviews, and 2.9 million job postings to uncover actionable insights on hiring, talent needs, upskilling, AI and STEM engagement.


Through BioNJ’s engagement, several of our Members took part in the survey. We invite you to view a summary of industry job postings in New Jersey by clicking here. We sincerely appreciate the participation and support of all who contributed.

Putting Patients First:

The Value of Medical Innovation -

Recent Stories in the News

Saving Lives Globally While Finding Cures in NJ

New Jersey’s life sciences companies ― including our biopharmaceutical, medical technology and diagnostics companies ― have been saving patients’ lives worldwide for over a century by discovering new treatments and cures right here in New Jersey. That’s why our State is regarded as the “Medicine Chest of the World.” Life sciences companies like these have driven incredible medical advances for generations. Recently, they have cured hepatitis C for the first time in history, developed vaccines for cervical cancer, Ebola, and COVID-19, developed the first treatment to delay the onset of Alzheimer’s, developed the first-ever gene therapy to treat sickle cell disease and made strides in treating rare diseases and cancer treatments. New Jersey’s life sciences sector is curing diseases and improving human health for patients everywhere.

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

Universities play a pivotal role in America’s technology economy, serving as a crucial source of research, inventions, patents, start-up technology companies and regional economic and employment growth. The Bayh-Dole Act has played an instrumental role in spurring academic technology transfer activities that serve as vital drivers of American innovation.

BioNJ News

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Governor Murphy Signs Package of Bills to Support Innovative Businesses in New Jersey

Governor Murphy signed a three-bill package to help support New Jersey’s thriving innovation ecosystem by enabling entrepreneurs to start and grow their businesses in the Garden State. “Over the course of our administration, we have firmly established New Jersey as a global leader in technology and innovation,” said Governor Murphy. “BioNJ commends the Governor and Legislature for passing several pieces of legislation that will enhance New Jersey’s competitiveness and foster innovation-driven growth. The expansion of the Angel Investor Tax Credit program, along with novel policies to incentivize the development of manufacturing in New Jersey ― including the Next New Jersey Manufacturing Program and New Jersey Innovation Evergreen Act ― are prudent measures to support continued growth of our life sciences sector,” said Debbie Hart, President and CEO of BioNJ. “We appreciate the receptivity that the Governor and Legislature both demonstrated regarding opportunities for the State to sustain our reputation as being the Medicine Chest of the World. BioNJ remains committed to working alongside policymakers to advance innovation in New Jersey, Because Patients Can’t Wait®.” 

Rep. Sherrill and Harshbarger Reintroduce Bipartisan Bill to Modernize Prescription Information

U.S. Representatives Mikie Sherrill (NJ-11) and Diana Harshbarger (TN-01) reintroduced the bipartisan Prescription Information Modernization Act, legislation designed to update how prescribing information (PI) is distributed to pharmacists and physicians. This long-overdue reform would allow the Food and Drug Administration (FDA) to finalize a proposed rule permitting drug manufacturers to send prescribing information electronically instead of on printed paper — a change that would improve patient safety and reduce waste. Currently, prescribing information — detailed technical documents intended for healthcare providers, not patients — must be printed and distributed on paper. These documents average 45 pages per prescription and are often bulky, outdated and discarded soon after arrival. This outdated system, established in 1962, creates significant waste and environmental harm, with roughly 90 billion sheets of paper printed annually to comply with the mandate. This legislation has drawn support from leading pharmacy and healthcare advocacy organizations, including BioNJ.

Genmab, Continuing its Rapid Growth in N.J., Cuts Ribbon on New Site in Plainsboro

As Featured in BINJE

Global biotech giant Genmab, which has been rapidly expanding its team in New Jersey since arriving in the State in 2020, cut the ribbon on a new state-of-the-art facility at the Princeton Forrestal Innovation Center in Plainsboro. The new facility, located on a 125-acre innovation campus, features state-of-the-art workspaces designed to foster cross-functional collaboration and attract top regional talent. The Danish company, which specializes in innovative antibody medicines to transform treatments for cancer and other serious diseases, has grown from approximately 150 employees in 2020 to more than 1,000 today. Debbie Hart, the CEO of BioNJ, said “Genmab’s roots in New Jersey run deep — from its origins as a Medarex spin-off to its rise as a global leader in innovation and patient-centered science,” she said. “As Genmab expands its presence here, it’s not just growing a business — it’s building a legacy of innovation and compassion.”

NJ Company News

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Lynozyfic™ (linvoseltamab-gcpt) Receives FDA Accelerated Approval for Treatment of Relapsed or Refractory Multiple Myeloma

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody. Lynozyfic was granted accelerated approval based on response rate and durability of response in the LINKER-MM1 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Lynozyfic is the first FDA-approved BCMAxCD3 bispecific antibody that can be dosed every two weeks starting at week 14, and every four weeks if a very good partial response (VGPR) or better is achieved following completion of at least 24 weeks of therapy.

Amicus Therapeutics Announces Approval of Pombiliti® (cipaglucosidase alfa) + Opfolda® (miglustat) in Japan

Princeton-based BioNJ Member Amicus Therapeutics announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) for the treatment of adult patients with late-onset Pompe disease (LOPD). "We are delighted that we will now be able to offer a compelling new treatment option to patients living with late-onset Pompe disease in Japan. We are grateful to the MHLW and to Japan’s Pompe community, including the patients, families and physicians who participated in our clinical studies, for their collaboration,” said Bradley Campbell, President and Chief Executive Officer, Amicus Therapeutics, Inc. Pombiliti + Opfolda is a two-component therapy. Pombiliti is a recombinant human GAA enzyme (rhGAA) naturally expressed with high levels of bis-M6P (Mannose 6-Phosphate), designed for increased uptake into muscle cells. 

Sephience™ (sepiapterin) Granted Marketing Authorization by the European Commission for the Treatment of Children and Adults Living With Phenylketonuria (PKU)

Warren-based BioNJ Member PTC Therapeutics, Inc. announced that Sephience™ (sepiapterin) was granted marketing authorization by the European Commission for the treatment of children and adults living with phenylketonuria (PKU). The authorization includes a broad label inclusive of all ages and disease severities. The European approval is based on the highly statistically significant results from the Phase 3 APHENITY trial as well as evidence of durable treatment effect and the ability of study participants to liberalize their diet in the APHENITY long-term extension study. The marketing authorization is applicable to all 27 European Union member states as well as Iceland, Norway and Liechtenstein. The Sephience European launch will be initiated in Germany in the first half of July. A New Drug Application (NDA) for sepiapterin remains on schedule for its FDA target action date of July 29, 2025. 

Soligenix Announces Synthetic Hypericin Successfully Manufactured at Sterling Pharma Solutions

Princeton-based BioNJ Member Soligenix, Inc. announced that it has successfully completed the transfer of the manufacturing process for its synthetic hypericin active ingredient under its partnership agreement with Sterling Pharma Solutions (Sterling). The transfer from Europe to the United States (U.S.) included the optimization and implementation of a commercially viable, scalable production process for this important active ingredient, which is used in the topical drug product formulations HyBryte™ and SGX302 being developed for the treatment of cutaneous T-cell lymphoma (CTCL) and psoriasis, respectively. Synthetic hypericin is a potent photosensitizer that is topically applied to skin lesions. Soligenix and Sterling have enabled cGMP (current good manufacturing practice) manufacturing for clinical trials with the intent of establishing a long-term commercial manufacturing collaboration.

Genmab Grows Workforce, Expands NJ Campus

Genmab is doubling down on the Garden State. The global biotechnology company specializes in antibody medicines. Locally, it recently marked the grand opening of its expanded U.S. site at the Princeton Forrestal Innovation Center. “This new site reflects Genmab’s strong commitment to New Jersey – not just as a place to grow our business, but as a hub of innovation, top talent and collaboration,” said Chris Cozic, Executive Vice President and Chief People Officer, Genmab. “This expansion positions us to sustainably grow our workforce in a way that supports our pipeline, capabilities and long-term ambitions,” added Cozic. “The Princeton Forrestal Innovation Center gives the flexibility and infrastructure to support that growth while staying rooted in the vibrant talent and innovation ecosystem that New Jersey offers.”

Final Data from Teva’s PEARL Real-World Study Reinforce the Long-term Effectiveness of AJOVY® (fremanezumab) for the Prevention of Chronic and Episodic Migraine

Parsippany-based BioNJ Member Teva Pharmaceutical Industries Ltd. announced that the final analysis of the pan-European PEARL Phase 4 migraine prevention study showed that AJOVY (fremanezumab), an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, delivered sustained effectiveness over a two-year period in reducing frequency, duration and severity of migraine attacks in patients with chronic and episodic migraine. Investigators concluded that the findings underscore the sustained effectiveness and the robust injection adherence rates to long-term fremanezumab treatment in migraine prevention. PEARL, a 24-month real-world observational study assessed the impact of fremanezumab for migraine prevention in 1,140 patients, predominantly female (87.25%) with 33.1% living with episodic migraine (EM), and 66.9% with chronic migraine (CM).

Chugai Files for Additional Tumor-Agnostic Indication of Alecensa for ALK Fusion / Rearrangement Gene-Positive Solid Tumors Including Pediatric Patients

BioNJ Member Chugai Pharmaceutical, with a site in Berkeley Heights, announced that it has filed a regulatory application with the Ministry of Health, Labour and Welfare (MHLW) for an additional indication of its anti-cancer agent/ALK inhibitor Alecensa® (generic name: alectinib) for ALK fusion / rearrangement gene-positive unresectable advanced or recurrent solid tumors, including pediatric patients. The application for this additional indication is based on the results of the TACKLE study, an investigator initiated Japanese Phase II clinical study evaluating the efficacy and safety of Alecensa in pediatric and adult patients with rare cancers harboring ALK gene abnormalities (fusion / rearrangement genes, activating mutations and gene copy number amplification) in unresectable advanced or recurrent settings. 

Chugai and Gero Enter into Joint Research and License Agreement to Develop Novel Therapies for Age-Related Diseases

BioNJ Member Chugai Pharmaceutical, with a site in Berkeley Heights, and Gero PTE. LTD. announced that they have entered into a joint research and license agreement to develop novel therapies for age-related diseases. In this collaboration, Chugai will create novel antibody drug candidates using its proprietary antibody engineering technologies for new drug targets discovered by Gero through analysis of human datasets using their unique AI target discovery platform. Under this agreement, Gero grants Chugai exclusive worldwide rights for the creation, research, development, manufacturing and commercialization of antibodies for the identified targets. In addition to an upfront payment, Chugai will potentially pay up to approximately 250 million USD in total if predetermined development or sales milestones are achieved. If Chugai successfully launches a product, it will also pay royalties on sales to Gero.

Boehringer Ingelheim Initiates Phase II Study of BI 1815368, a Potential First-in-Class Oral Treatment for Diabetic Macular Edema

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, announced the start of the THULITE Phase II clinical study (NCT06962839). It will investigate the efficacy, safety and tolerability of BI 1815368 as a potential oral treatment to improve vision in people with diabetic macular edema (DME). DME is a leading cause of vision loss in people with diabetes. It affects more than 21 million people globally — impacting up to 10% of those living with diabetes. Current treatments for DME require frequent visits to a retina specialist for eye injections, with each visit addressing only one eye at a time. This places considerable burden on patients and caregivers, especially when both eyes require treatment. In DME, fluid leaks into the macula, the central part of the retina responsible for sharp vision needed for everyday tasks. BI 1815368 has the potential to treat and prevent fluid leakage by reducing the permeability of newly formed blood vessels.

Pfizer Announces Positive Topline Phase 3 Results for HYMPAVZI™ in Hemophilia A or B with Inhibitors

BioNJ Member Pfizer Inc., with a site in Peapack, announced positive topline results from the Phase 3 BASIS study (NCT03938792) evaluating HYMPAVZI™ (marstacimab) for adults and adolescents living with hemophilia A or B with inhibitors. The study met the primary endpoint and key secondary bleeding endpoints demonstrating the superiority of once-weekly subcutaneous HYMPAVZI in improving key bleeding outcomes compared to on-demand treatment in a patient population where less burdensome treatment approaches are needed. The BASIS trial demonstrated that prophylactic treatment with HYMPAVZI resulted in a statistically significant and clinically relevant reduction in annualized bleeding rate (ABR) of treated bleeds in people living with severe hemophilia A or hemophilia B with inhibitors.

U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs Within Bristol Myers Squibb’s Cell Therapy Labels

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved label updates for both of its CAR T cell therapies, Breyanzi® (lisocabtagene maraleucel; liso-cel) for the treatment of large B cell lymphoma (LBCL) and other lymphomas and Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of multiple myeloma. These label updates reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs that had been in place since each product was initially approved. Despite the transformative potential of cell therapy, only about 2 in 10 eligible patients receive it, due to the confluence of complex logistical and geographic barriers affecting patients and providers.

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

East Hanover-based BioNJ Member Novartis announced topline results from a pre-specified interim analysis of the Phase III PSMAddition trial. The trial met its primary endpoint with a statistically significant and clinically meaningful benefit in radiographic progression-free survival (rPFS) with a positive trend in overall survival (OS) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC) treated with radioligand therapy (RLT), Pluvicto™ (lutetium (177Lu) vipivotide tetraxetan), in combination with standard of care (SoC) versus SoC alone. In PSMAddition, the SoC is a combination of androgen receptor pathway inhibitor (ARPI) therapy and androgen deprivation therapy (ADT). Almost all mHSPC patients ultimately progress to metastatic castration-resistant prostate cancer (mCRPC). There is a need for additional treatment options with novel mechanisms of action that further delay progression, prolong OS and improve disease control compared to the current SoC, while showing a favorable safety and tolerability profile.

Riliprubart Earns Orphan Drug Designation in the U.S. for Antibody-Mediated Rejection in Solid Organ Transplantation

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to riliprubart for the investigational treatment of antibody-mediated rejection (AMR) in solid organ transplantation. This designation reflects BioNJ Member Sanofi’s commitment to addressing a critical unmet need in transplant medicine, where AMR remains a significant challenge with no FDA-approved treatments available. The FDA grants orphan drug designation to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the U.S. Riliprubart is currently being explored in multiple clinical studies across different indications in transplant and neurology. A Phase 2 clinical study is currently ongoing, exploring its potential in kidney transplant recipients (NCT05156710). The study includes two patient cohorts: those at risk of developing rejection and those with active forms of antibody-mediated rejection.

Dupixent Approved in the U.S. as the Only Targeted Medicine to Treat Patients With Bullous Pemphigoid

Morristown-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP). BP primarily affects elderly patients, and is characterized by intense itch, painful blisters and lesions, as well as reddening of the skin. It can be chronic and relapsing with underlying type 2 inflammation. The blisters and rash can form over much of the body and cause the skin to bleed and break down, resulting in patients being more prone to infection and affecting their daily functioning. Available treatment options are limited and can add to overall disease burden by suppressing a patient’s immune system. The FDA approval is based on data from the pivotal ADEPT Phase 2/3 study that evaluated the efficacy and safety of Dupixent compared to placebo in adults with moderate-to-severe BP.

Sarclisa Recommended for EU Approval by the CHMP to Treat Transplant-Eligible Newly Diagnosed Multiple Myeloma

Morristown-based BioNJ Member Sanofi announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. A final decision is expected in the coming months. The positive CHMP opinion is based on part one results from the two-part, double-randomized, German-speaking Myeloma Multicenter Group (GMMG)-HD7. GMMG-HD7 is the first Phase 3 study to demonstrate a deep and rapid response with an anti-CD38-based induction regimen in transplant-eligible (TE) NDMM patients, with a higher proportion of patients with minimal residual disease (MRD) negativity benefit post-induction, alongside a significant progression-free survival (PFS) benefit from first randomization, regardless of maintenance therapy and without consolidation.

FDA Approves Updated Label for Lilly's Kisunla (donanemab-azbt) With New Dosing in Early Symptomatic Alzheimer's Disease

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that the U.S. Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for Kisunla (donanemab-azbt), Lilly's once-monthly amyloid-targeting therapy for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment (MCI) as well as people in the mild dementia stage of AD, with confirmed amyloid pathology. In the TRAILBLAZER-ALZ 6 study, the modified titration schedule significantly lowered the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) versus the original dosing schedule at 24 and 52 weeks, while still achieving similar levels of amyloid plaque removal and P-tau217 reduction. The new recommended dosing regimen involves a more gradual titration, and the TRAILBLAZER-ALZ 6 study significantly lowered the incidence of ARIA-E by 41% at 24 weeks and by 35% at 52 weeks versus the original dosing schedule. 

Lilly's Oral GLP-1, Orforglipron, Showed Compelling Efficacy and a Safety Profile Consistent With Injectable GLP-1 Medicines, in Complete Phase 3 Results Published in The New England Journal of Medicine

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced detailed results from ACHIEVE-1, a Phase 3 trial evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Orforglipron is the first oral small molecule (non-peptide) glucagon-like peptide-1 (GLP-1) receptor agonist, taken without food and water restrictions, to successfully complete a Phase 3 trial. At 40 weeks, all three doses (3 mg, 12 mg, 36 mg) of orforglipron achieved the primary endpoint of superior A1C reduction. In addition, the 12 mg and 36 mg doses showed clinically meaningful and statistically significant reductions in body weight vs. placebo. In the study, orforglipron had a safety profile similar to the established GLP-1 class, and the most frequently reported adverse events were gastrointestinal-related. 

Lilly’s Once-Weekly Insulin Efsitora Alfa Demonstrated A1C Reduction and a Safety Profile Consistent With Daily Insulin in Multiple Phase 3 Trials

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced detailed results from QWINT-1, QWINT-3, and QWINT-4 Phase 3 clinical trials evaluating the safety and efficacy of investigational once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes who used insulin for the first time, previously used daily basal insulin, and previously used daily basal insulin and mealtime insulin, respectively. In each trial, once-weekly efsitora met the primary endpoint of non-inferior A1C reduction compared to daily basal insulin. The complete results from these studies were presented at the American Diabetes Association (ADA) 85th Scientific Sessions 2025. In QWINT-1, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine at week 52 for the efficacy estimand.

Ozempic® Receives EU Recommendation in Peripheral Arterial Disease, Cementing the Broad Benefits of Semaglutide for People With Type 2 Diabetes and Comorbidities

Plainsboro-based BioNJ Member Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly semaglutide) label to reflect the positive data from the STRIDE peripheral artery disease (PAD) functional outcomes trial. STRIDE is the only dedicated PAD functional outcomes trial with a glucagon-like peptide-1 receptor agonist (GLP-1 RA). PAD is a manifestation of atherosclerotic cardiovascular disease (ASCVD) where a build-up of fatty deposits in the artery walls restricts blood supply to muscles, which can cause debilitating symptoms, physical limitations and poor quality of life. Following the positive opinion from the CHMP, Novo Nordisk expects the European Commission to implement the label update within approximately two months.

Mim8 Prophylaxis Treatment Shown to be Well-Tolerated When Switching from Emicizumab in People With Haemophilia A in New Phase 3 Data Presented at the ISTH 2025 Congress

Plainsboro-based BioNJ Member Novo Nordisk presented results from the Phase 3b FRONTIER5 trial showing that a direct switch to investigational Mim8 (denecimig) prophylaxis from emicizumab treatment, without a washout period or Mim8 loading dose, was well-tolerated with no safety concerns in adults and adolescents living with haemophilia A, with or without inhibitors. Additionally, a FRONTIER5 Patient-Reported Outcomes (PROs) assessment found the Mim8 pen-injector easy to use, with an overall strong user preference for the pen-injector compared to the previous emicizumab injection system. In the study, the first Mim8 maintenance dose was administered on the next planned emicizumab dosing day. Patients were given the option of switching to once-monthly, once every two weeks or once-weekly dosing frequencies of Mim8, regardless of their prior dosing frequency.

CagriSema 2.4 mg / 2.4 mg Demonstrated 22.7% Mean Weight Reduction in Adults With Overweight or Obesity in REDEFINE 1, Published in New England Journal of Medicine

The New England Journal of Medicine (NEJM) published results from Plainsboro-based BioNJ Member Novo Nordisk’s Phase 3 REDEFINE 1 trial evaluating the efficacy and safety of investigational CagriSema plus lifestyle interventions for weight loss in adults with obesity or overweight who have a weight-related medical complication and without diabetes.1 REDEFINE 1 met its co-primary endpoints and achieved statistically significant and clinically meaningful weight loss at 68 weeks in patients taking CagriSema versus placebo. CagriSema is an investigational product that combines the GLP-1 RA, semaglutide, with an amylin analogue, cagrilintide. The REDEFINE 1 trial found that treatment with CagriSema resulted in greater weight loss of 22.7% at 68 weeks versus 2.3% in the placebo group if all patients adhered to treatment.

Gilead Finalizes Agreement With the Global Fund to Accelerate Access to Twice-Yearly Lenacapavir for HIV Prevention for Up to Two Million People in Primarily Low- and Lower-Middle-Income Countries

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced a strategic partnership agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) to supply lenacapavir — Gilead's twice-yearly injectable HIV-1 capsid inhibitor — for the prevention of HIV as pre-exposure prophylaxis (PrEP). Through the agreement, Gilead will supply enough doses to reach up to two million people over three years in countries supported by the Global Fund, at no profit to Gilead. In October 2024, Gilead signed non-exclusive, royalty-free voluntary licensing agreements to manufacture and supply high-quality generic versions of lenacapavir in 120 high-incidence, resource-limited countries, which are primarily low- and lower-middle-income countries (LLMICs). Until licensed generic versions are available and can fully meet demand in LLMICs, Gilead also committed to providing Gilead-supplied lenacapavir for PrEP at no profit.

Gilead Sciences and Kymera Therapeutics Enter Into Exclusive Option and License Agreement to Develop Novel Oral Molecular Glue CDK2 Degraders

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, and Kymera Therapeutics, Inc. announced that they have entered into an exclusive option and license agreement to accelerate the development and commercialization of a novel molecular glue degrader (MGD) program targeting cyclin-dependent kinase 2 (CDK2) with broad oncology treatment potential including in breast cancer and other solid tumors. CDK2-directed MGDs are a new type of drug designed to remove CDK2 – a key contributor in tumor growth – rather than just inhibiting its function. Traditional inhibitors of CDK2 prevent it from working but often interfere with similar proteins, which can cause undesired side effects. MGDs have the potential to provide more precise, safe and effective treatments for cancers that rely on CDK2 activity by selectively removing this protein from cells.

AbbVie and Ichnos Glenmark Innovation (IGI) Announce Exclusive Global Licensing Agreement for ISB 2001, a First-in-Class CD38×BCMA×CD3 Trispecific Antibody

BioNJ Member AbbVie, with a site in Madison, and IGI Therapeutics SA, a wholly owned subsidiary of New York-based Ichnos Glenmark Innovation, Inc. (IGI), today announced an exclusive licensing agreement for IGI's lead investigational asset, ISB 2001, developed using IGI's proprietary BEAT® protein platform, for oncology and autoimmune diseases.

"Multispecifics including trispecific antibodies represent a new frontier in immuno-oncology with the potential to deliver deeper, more durable responses by engaging multiple targets simultaneously," said Roopal Thakkar, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, AbbVie. "This partnership with IGI reflects our unwavering commitment to advancing novel therapies for patients with multiple myeloma, a disease where significant unmet need remains despite recent progress."

AbbVie to Acquire Capstan Therapeutics, Further Strengthening Commitment to Transforming Patient Care in Immunology

BioNJ Member AbbVie, with a site in Madison, and Capstan Therapeutics, Inc. announced a definitive agreement under which AbbVie will acquire Capstan, including CPTX2309, a potential first-in-class in vivo tLNP anti-CD19 CAR-T therapy candidate, currently in Phase 1, in development for the treatment of B cell-mediated autoimmune diseases. Additionally, AbbVie will acquire Capstan's proprietary tLNP platform technology designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo. B cells contribute to the pathogenesis of autoimmune diseases. CD19 is a cell surface receptor expressed on B cells and is a clinically validated target for B cell depletion using ex vivo CAR-T cell therapy in autoimmune diseases. CPTX2309, a product of Capstan's proprietary technology platform that includes hepatic de-targeting, delivers an mRNA payload encoding an anti-CD19 CAR preferentially to reprogram CD8-expressing cytotoxic T cells. 

FDA Approves BRAVECTO® QUANTUM (Fluralaner for Extended-Release Injectable Suspension) from Merck Animal Health

Rahway-based Merck Animal Health, a division of BioNJ Member Merck & Co., announced the U.S. Food and Drug Administration (FDA) approval of BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension) – a new, once-yearly1 injectable product to treat and protect dogs from fleas and ticks. The product is expected to be available at veterinary clinics and hospitals nationwide by August 2025. BRAVECTO QUANTUM was first approved in Australia and New Zealand in 2023, followed by the European Union (EU) in 2024 and now the U.S. in 2025. In total, BRAVECTO QUANTUM is currently approved in more than 50 countries worldwide. BRAVECTO QUANTUM kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and for the treatment and control of tick infestations – Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick) and Rhipicephalus sanguineus (brown dog tick) for 12 months in dogs and puppies 6 months of age and older.

U.S. FDA Accepts New Drug Application for Merck’s Doravirine/Islatravir, an Investigational, Once-Daily, Oral, Two-Drug Regimen for Treatment of Adults With Virologically Suppressed HIV-1 Infection

Rahway-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for doravirine/islatravir (DOR/ISL), an investigational, once-daily, oral, two-drug regimen for adults with HIV-1 infection that is virologically suppressed on antiretroviral therapy. The NDA is based on findings at Week 48 of two pivotal Phase 3 clinical trials (MK-8591A-051 and MK-8591A-052) where DOR/ISL was demonstrated to be non-inferior to baseline antiretroviral therapy (bART) in the open-label trial MK-8591A-051 and non-inferior to bictegravir/emtrictabine/tenofovir alafenamidei [BIC/FTC/TAF (50mg/200mg/25mg)] in the double-blind trial MK-8591A-052. Across both trials, the safety profile of DOR/ISL was generally comparable to comparator baseline antiretroviral regimens in trial MK-8591A-051 and BIC/FTC/TAF in trial MK-8591A-052.

Merck to Acquire Verona Pharma for $10 Billion, Gaining Access to Its COPD Medication

Rahway-based BioNJ Member Merck & Co. announced that it will acquire Verona Pharma approximately $10 billion. Merck will pay $107 per American depository share for the London-based Verona, a premium of 23% to Verona’s last closing price on the Nasdaq. Verona’s U.S.-listed shares jumped 20% in premarket trading. Through this acquisition Merck will add Ohtuvayre® which is for patients with chronic obstructive pulmonary disease, also known as “smoker’s lung.” Ohtuvayre is the first novel inhaled mechanism for the treatment of COPD in more than 20 years and combines bronchodilator and non-steroidal anti-inflammatory effects. Ohtuvayre is also being evaluated in clinical trials for the treatment of non-cystic fibrosis bronchiectasis. “This acquisition of Verona Pharma reflects the commitment we have to delivering innovative treatments to patients and our ability to execute on our science-led and value-driven business development strategy,” Robert Davis, Chairman and cCEO, Merck, said.

FDA Grants Priority Review for WINREVAIR™ (sotatercept-csrk) to Update Label Based on Results from ZENITH Trial

Rahway-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval to update the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR™ (sotatercept-csrk). In 2024, WINREVAIR was approved for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 PH) to increase exercise capacity, improve WHO* functional class (FC), and reduce the risk of clinical worsening events. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of Oct. 25, 2025. The sBLA is based on data from the Phase 3 ZENITH trial. The ZENITH trial was the first PAH Phase 3 outcome study to use a primary endpoint comprised entirely of major morbidity and mortality events. 

Merck Announces Phase 3 HYPERION Study of WINREVAIR™ (sotatercept-csrk) Met Primary Endpoint in Recently Diagnosed Adults With Pulmonary Arterial Hypertension (PAH)

Rahway-based BioNJ Member Merck & Co. announced positive topline results from the Phase 3 HYPERION study evaluating WINREVAIR™ (sotatercept-csrk) versus placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension (PAH, WHO* Group 1) functional class (FC) II or III at intermediate or high risk of disease progression. HYPERION met its primary endpoint of time to clinical worsening (TTCW) as measured by a composite endpoint of all-cause death, the need for non-planned PAH-related hospitalization > 24 hours, atrial septostomy, lung transplantation, or PAH deterioration. In HYPERION, WINREVAIR added on top of background therapy (72.2% of patients on double therapy) within 12 months after initial diagnosis of PAH demonstrated a statistically significant and clinically meaningful reduction in the risk of clinical worsening events when compared to placebo.

GSK Completes Acquisition of Efimosfermin, a Potential Best-in-Class Specialty Medicine to Treat and Prevent Progression of Steatotic Liver Disease (SLD)

Warren-based BioNJ Member GSK plc announced the completion of its previously announced acquisition of efimosfermin alfa from Boston Pharmaceuticals. Efimosfermin is a phase III-ready, potential best-in-class investigational specialty medicine aimed at treating and preventing the progression of SLD. Efimosfermin is a novel, once-monthly fibroblast growth factor 21 (FGF21) analog therapeutic in clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), including cirrhosis, and future development in alcohol-related liver disease (ALD), both forms of SLD. Currently, MASH and ALD have limited treatment options and are the leading causes of liver transplant in the US, representing a significant burden and cost on healthcare utilisation. GSK, based on its work in human genetics and disease phenotyping, believes efimosfermin has potential to address more advanced stages of SLD due to its direct antifibrotic mechanism of action, and sees opportunity in combination with GSK’990, a siRNA therapeutic in development for other subsets of patients with SLD.

Japan’s Ministry of Health, Labour and Welfare Accepts Regulatory Application to Expand Use of GSK’s RSV Vaccine, Arexvy, in Adults Aged 18-49 at Increased Risk of Severe RSV Disease

Warren-based BioNJ Member GSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted the company’s regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to include adults aged 18-49 at increased risk of severe RSV disease. Arexvy was the first vaccine approved in Japan for adults aged 60 years and older for the prevention of RSV disease, and for those aged 50 years and older at increased risk for severe RSV disease. RSV is a common, contagious virus affecting the lungs and breathing passages impacting an estimated 64 million people of all ages globally every year. RSV can exacerbate certain medical conditions, and lead to severe illness resulting in hospitalisation and even death.

Linerixibat Accepted for Review by the European Medicines Agency for Cholestatic Pruritus in Patients With Primary Biliary Cholangitis (PBC)

Warren-based BioNJ Member GSK plc announced that the European Medicines Agency has accepted for review the marketing authorisation application (MAA) for the use of linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter (IBAT), for the treatment of cholestatic pruritus in patients with PBC, a rare autoimmune liver disease. Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK, said “The EMA acceptance of this file marks another significant step forward in the progress of linerixibat, following FDA acceptance earlier this month. We believe linerixibat has the potential to bring relief to patients living with relentless itch associated with PBC, a condition that often disrupts sleep, and for which there are currently few effective treatment options available.”

Supplemental New Drug Application Submitted to U.S. FDA for CAPLYTA® (lumateperone) With Data Demonstrating Significant Schizophrenia Relapse Prevention Compared to Placebo

Titusville-based BioNJ Member Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based upon long-term data evaluating the safety and efficacy of CAPLYTA® (lumateperone) for the prevention of relapse in schizophrenia. CAPLYTA® is the newest addition to Johnson & Johnson’s portfolio of schizophrenia therapies, which now offers the broadest range of oral and long-acting injectable treatment options to support each patient’s individual treatment journey. The submission is supported by positive results from a Phase 3, double-blind, multicenter, placebo-controlled, randomized withdrawal trial, which on the primary endpoint found time to relapse during the 26-week double-blind treatment phase was significantly longer in patients receiving CAPLYTA® compared to those receiving placebo (p=0.0002). Treatment with CAPLYTA® was also associated with a 63 percent reduction in risk of relapse versus placebo (hazard ratio [95% CI] = 0.37, [0.22, 0.65]).

IMAAVYTM (nipocalimab-aahu) Showed Greater Sustained Disease Control Versus Approved FcRn Blockers for Generalized Myasthenia Gravis (gMG) at Multiple Timepoints Over 24 Weeks in Newly Published Indirect Treatment Comparison (ITC)

New Brunswick-based BioNJ Member Johnson & Johnson announced new data from an indirect treatment comparison (ITC) that showed consistent and sustained disease control with IMAAVY™ (nipocalimab-aahu) versus other approved FcRn blockers in adults with generalized myasthenia gravis (gMG). Based on the ITC, which included the pivotal Phase 3 Vivacity-MG3 study data, IMAAVY showed comparable onset of symptom relief at Week 1 and showed consistent and sustained disease control with greater or statistically significant improvement of MG-ADL scores versus the published Phase 3 data of other marketed FcRn blockers at several timepoints up to 24 weeks of treatment. Results were consistent across multiple ITC methods. Unlike cyclic therapies that require clinical evaluation and symptom relapse prior to initiating subsequent treatment cycles, IMAAVY has a biweekly dosing regimen that may allow for a schedule that patients and healthcare providers can plan around.

Johnson & Johnson Launches First and Only Daily Disposable Multifocal Toric Contact Lens1 - ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM

New Brunswick-based BioNJ Member Johnson & Johnson announced the launch of ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM, the first and only daily disposable contact lens for people with both astigmatism and presbyopia. This pioneering contact lens provides patients crisp, clear, stable vision at all distances and in all lighting conditions, along with comfort that lasts all day. The lens is now available in the U.S. and Canada, and the launch of ACUVUE OASYS MAX 1-Day for ASTIGMATISM is expected later this summer. Based on extensive studies, 95% of people wearing ACUVUE OASYS MAX 1-DAY MULTIFOCAL for ASTIGMATISM contact lenses reported their vision was clear during their daily activities, while 87% saw clearly while driving at night. Additionally, 92% of wearers said their eyes felt comfortable throughout the entire day.

Quest Diagnostics Tops NJ Life Sciences Employer List

BioNJ Members top NJ life sciences employer list: With 3,750 employees, Secaucus-based Quest Diagnostics ranks first on the latest NJBIZ list of life sciences organizations in New Jersey. The ranking is based on the number of employees in the Garden State. New Jersey Institute of Technology holds second place with 2,678 workers in Newark. Parsippany-based Ferring Pharmaceuticals occupies the fourth spot with 693 workers. Brent Ragans oversees the company, which produces products for reproductive medicine, maternal health, uro-oncology, orthopedics and gastroenterology. PTC Therapeutics Inc. rounds out the top five, operating from Warren with 390 employees. The company, founded in 1998, focuses on treatments for children and adults with rare diseases.

Hikma Receives FDA Approval for TYZAVANTM (Vancomycin Injection, USP) in the U.S.

Berkeley Heights-based Hikma Pharmaceuticals announced the approval of a novel formulation of the first-of-its-kind, ready-to-infuse formulation of vancomycin, under the brand name TYZAVANTM (Vancomycin Injection, USP), by the U.S. Food and Drug Administration. TYZAVANTM is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved: (i) septicemia; (ii) infective endocarditis; (iii) skin and skin structure infections; (iv) bone infections; and (v) lower respiratory tract infections. The name TYZAVANTM stands for “time-saving vancomycin,” reflecting its purpose: delivering timely, simplified treatment when every minute counts. TYZAVANTM is the only FDA-approved vancomycin product commercially available for all patients that is available at room temperature and requires no compounding, thawing, activation or dilution—reducing preparation steps and supporting faster treatment.

Idorsia’s QUVIVIQ Expands into China as Simcere Receives NDA Approval – Idorsia and Simcere Update Their Licensing Agreement

Idorsia Ltd., with a site in Cherry Hill, announced that Simcere Pharmaceuticals Group Ltd. has received approval for QUVIVIQ® (daridorexant) from the Chinese National Medical Products Administration for the treatment of adult patients with insomnia characterized by difficulty falling asleep and/or maintaining sleep, with no psychotropic drug control labeling. In addition, Idorsia has reached an agreement with Simcere to update the terms of the licensing agreement for QUVIVIQ in China. André C. Muller, Chief Executive Officer of Idorsia, said, “I want to congratulate everyone at Simcere and the team that supported them from Idorsia. Together they have been able to take our drug from pre-IND, through to local Phase 1 and Phase 3, and then filing, resulting in this approval at an incredible pace of 2.5 years since the signing of the license agreement.”

Idorsia's Breakthrough Synthetic Glycan Vaccine Platform Validated for the First Time in Humans

Idorsia Ltd., with a site in Cherry Hill, announced a milestone in the development of its first bacterial vaccine based on the company’s synthetic glycan chemistry platform. The Clostridioides difficile (C. dfficile) vaccine is based on a synthetic glycan mimicking a surface glycan antigen and covers more than 90% of all existing strains of C. difficile bacteria and also targets the spores. Initial data showed that the vaccine is well-tolerated and showed immunogenicity in a Phase 1 study. C. difficile is a spore-forming and toxin-producing bacterium. It is the leading cause of antibiotic-associated diarrhea in developed countries. It infects the gastrointestinal tract when there is an imbalance in the gut flora, resulting, for example, from the use of antibiotics. 

DATROWAY® Approved in the U.S. as First TROP2 Directed Therapy for Patients With Previously Treated Advanced EGFRMutated Non-Small Cell Lung Cancer

DATROWAY® has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic EGFRmutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Basking Ridge-based Daiichi Sankyo and AstraZeneca. The approval follows Priority Review and Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) based on subgroup results from the TROPION-Lung05 Phase 2 and TROPIONLung01 Phase 3 trials.

Amarin Announces Exclusive License and Supply Agreement with Recordati to Commercialize VAZKEPA® (Icosapent Ethyl) in Europe

Bridgewater-based Amarin Corporation announced that the company has entered into an exclusive long-term license and supply agreement with Recordati S.p.A. to commercialize VAZKEPA® (icosapent ethyl) across 59 countries, focused in Europe. This Agreement capitalizes on the early stage success of VAZKEPA in Europe by partnering with Recordati to accelerate the depth and reach of the product for patients at risk of a cardiovascular event. As a result of the Agreement, Amarin will streamline its global operations, which further strengthens the Company’s financial position. “We are pleased to place VAZKEPA, a drug with proven, meaningful cardiovascular benefit when added to statins, in the hands of a partner with the capabilities and experience in the cardiovascular space in Europe as Recordati,” said Odysseas Kostas, M.D., Chairman, Amarin Board of Directors.

Evotec Joins NURTuRE-AKI Consortium to Gain Multi-Omics-Based Molecular Understanding of Acute Kidney Injury

Princeton-based Evotec SE announced that it has joined the NURTuRE-AKI consortium for establishing a patient cohort for acute kidney injury (AKI), NURTuRE-AKI. This initiative will enable Evotec to identify key mechanisms that trigger AKI and to support the discovery of highly innovative treatments for AKI patients based on a molecular understanding of the disease. NURTuRE-AKI focuses on adult and pediatric cardiac surgery patients who are at high risk of developing AKI as well as patients undergoing AKI-to-CKD progression. The longitudinal study design includes biological sampling and clinical data collection at multiple time points for each patient. Blood, urine and research biopsy samples will be subjected to state-of-the-art omics analyses, forming the most comprehensive patient cohort for AKI and AKI-to-CKD worldwide. 

Biotech Firm Kardigan Establishes East Coast Operations at 506 Carnegie Center

Kardigan, a heart health company modernizing cardiovascular drug development, signed a 21,489-square-foot lease at 506 Carnegie Center, a 280,000-square-foot class-A office complex in Princeton, owned by Boston Properties. Fresh from a $300 million funding round, Kardigan will establish its first presence on the East Coast as part of its plans to develop multiple targeted treatments, in parallel, to bring people with cardiovascular diseases closer to the cures they deserve.“Opening our first East Coast location in the heart of New Jersey’s broader life sciences hub is an important milestone for Kardigan,” Tassos Gianakakos, co-founder and CEO of Kardigan said. “506 Carnegie Center will provide our team with best-in-class space and access to industry-leading talent for further expansion as we continue to advance our late-stage portfolio of disease modifying medicines.”

Champions Oncology Launches Radiopharmaceutical Services Platform, Expands Isotope License, and Screens More Than 30 PDX Models

Hackensack-based Champions Oncology announced the full commercial launch of its radiopharmaceutical services platform. This milestone follows the expansion of the company's radioactive materials license, the completion of the radiochemistry infrastructure, and the successful screening of more than thirty PDX models in collaboration with pharmaceutical and biotech partners. Champions now offers fully integrated radiopharmaceutical workflows combining in vitro, ex-vivo biodistribution, and therapeutic efficacy studies across a wide range of isotopes. The company's platform is uniquely differentiated by its extensive bank of patient-derived xenograft (PDX) tumor models, enabling drug developers to evaluate radiolabeled agents in clinically relevant systems.

Digital Health

NJ Positioned to be a Global Leader as AI Revolutionizes Medical Innovation

New Jersey has long been recognized as the “Medicine Chest of the World”, often described as the “backbone” of the healthcare industry. For nearly 150 years, the State has been a pivotal place on Earth for saving lives and improving the quality of life for patients, families, and loved ones around the globe. The crown jewel of these transformative milestones – which also represents the beating heart of New Jersey’s workforce and economy – is our vibrant and robust life sciences ecosystem. Our State’s medical technology, biotech, diagnostics, pharmaceuticals and medical device companies have been at the forefront of groundbreaking medical innovations that have transformed global health, enabling patients to live longer, experience less pain and enjoy greater independence, all while improving their quality of life.

Johnson & Johnson Launches the Polyphonic AI Fund for Surgery to Advance Data-Driven Healthcare

New Brunswick-based BioNJ Member Johnson & Johnson MedTech launched the Polyphonic AI Fund for Surgery to help develop AI solutions that solve challenges before, during, and after surgery. Joined by a coalition of companies including NVIDIA and Amazon Web Services (AWS), the initiative builds on the company’s work to advance AI that will help redefine modern surgical practices and improve patient outcomes. The Polyphonic AI Fund for Surgery aims to ensure that innovation is both accelerated and responsibly governed and will focus on proposals that support AI model development, data engineering and management and AI governance. One of the initial initiatives of the Fund will be to leverage the QuickFire Challenge program, which will seek submissions from applicants and grant funding for selected awardees from academic and non-academic institutions, researchers, developers, start-ups and established companies.

CoreWeave to Acquire Core Scientific in $9B All-Stock Deal

AI infrastructure firm CoreWeave and Cloud announced it will purchase crypto-mining data center operator Core Scientific for roughly $9 billion in an all-stock transaction. “This acquisition accelerates our strategy to deploy AI and HPC workloads at scale,” Michael Intrator, CoreWeave’s chief executive officer, chairman of the board, and co-founder, said. “Verticalizing the ownership of Core Scientific’s high-performance data center infrastructure enables CoreWeave to significantly enhance operating efficiency and de-risk our future expansion, solidifying our growth trajectory. Owning this foundational layer of our platform will enhance our performance and expertise as we continue helping customers unleash AI’s full potential.”

Academia/Institutions/Incubators

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SJP begins construction of Nokia Bell Labs HQ at the HELIX

SJP Properties has begun construction on one of the more unique properties in State history: The 10-story, 370,000-square-foot Nokia Bell Labs headquarters at the HELIX in New Brunswick. The building not only will be a centerpiece of the three-building HELIX — a four-acre innovation district being created by DEVCO that will be a center for industry and academia to unite to collaborate in transformative research and development — it also will serve as the headquarters for one of the greatest labs in history. The H-2 property will feature highly efficient side core floor plates and varying slab-to-slab heights on some floors to accommodate experimentation. It will be the launchpad for acceleration in next-generation networks, advanced AI and software systems, industrial automation, and quantum and optical research.

RWJBarnabas Health & Rutgers Cancer Institute Help Develop Hodgkin’s Lymphoma Research

Researchers from RWJBarnabas Health and Rutgers Cancer Institute, New Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center, as well as Tufts Medical Center and The University of Manchester in the U.K., announced they have developed and validated the first individualized risk prediction model for adults diagnosed with early stage classic Hodgkin’s lymphoma. Known as the Early stage Hodgkin International Prognostication Index (E-HIPI), the model estimates two-year progression-free survival (PFS) and is designed to support more personalized treatment planning for clinicians and patients. The E-HIPI model was developed using data from over 3,000 adult patients enrolled in four pivotal international phase III clinical trials. To ensure its accuracy, it was tested and validated in two real-world registry cohorts that included more than 2,300 people with early stage classic Hodgkin’s lymphoma.

JLL to begin marketing plug-and-play lab suites at HELIX

Five pre-built and furnished lab/office suites on the 9th and 10th floors of the N.J. Innovation Hub and Health & Life Science Exchange in New Brunswick, are now being marketed by JLL.

The labs/suites will be in HELIX 1 – the first of three buildings of the transformative, $1.5 million-square-foot first-of-its-kind innovation district. Located in the heart of New Brunswick, the HELIX aims to bring together industry and academia to foster research, learning, and entrepreneurship.

The plug-and-play suites will do just that. Designed to support the rapid growth of emerging life science and tech companies and alleviate the time and financial burden that space moves entail, the new plug-and-play suites are situated on the 10th floor of H1 and are directly connected to New Jersey Innovation Hub space on the 9th floor. The suites will be move-in ready, enabling companies to quickly start science and conserve capital for more critical business initiatives.

NJIT No. 27 in Princeton Review's Best Value List, 5th Year in Top 50

For the fifth straight year, New Jersey Institute of Technology is a Top 50 Best Value College in The Princeton Review’s annual ranking of public institutions. At No. 27, NJIT is the only university in New Jersey included in the Top 50 Public School ranking. The university has been a staple of The Princeton Review’s broader list of Best Value Colleges since its inception in 2018. That too is a highly selective list: less than a third of the universities and colleges that the review considered made the cut this year. In addition, NJIT is now top 10 on The Princeton Review’s list of the Top 20 Best Career Placement among public schools. The combination of recognitions illustrates a high-quality education that opens the door to rewarding jobs.

Stevens’ ACES Program Gets $100K Boost from J&J

Johnson & Johnson has donated $100,000 to Stevens Institute of Technology to support the Accessing Careers in Engineering and Science program. ACES launched in 2017. The initiative aims to streamline pathways to higher education in STEM for talented students from under-resourced communities. The Hoboken university program partners with 18 high schools in New Jersey and New York to identify and enroll qualified candidates to participate. The rigorous summer pre-college and year-round programming focuses on college readiness, career exploration as well as science, technology, engineering and math enrichment. The students receive scholarship funding to take part in the programs. The series includes mentorship and hands-on learning through career workshops, internships, college application support and more.

Funding

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NJEDA Now Accepting Applications for Next NJ Program – AI

Applications for the New Jersey Economic Development Authority’s (NJEDA) Next New Jersey Program – AI are now open. The program will drive economic growth, collaboration, and the development of AI infrastructure across the state by providing tax credits to eligible businesses investing in large-scale AI data centers and companies engaging in AI-related activities. The $500 million allocation to the Next New Jersey Program – AI will provide tax credits to eligible businesses to engage in building and fostering New Jersey’s fast-growing AI ecosystem. The program will be open to businesses or divisions primarily engaged in the AI industry or the large-scale AI data center industry. Businesses must commit to creating at least 100 new eligible full-time jobs and meet a minimum capital investment of $100 million to be eligible for tax credits. Additionally, the program requires that the business enter into a collaborative relationship with a New Jersey-based public or private research university, technology start-up, incubator, accelerator or similar entity.

People in the News

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NanoNewron Appoints Industry Veteran Marco Taglietti, M.D., as Chief Executive Officer to Lead the Company and the Development of Their Promising Alzheimer’s Compound

Union-based NanoNewron, LLC, announced that Marco Taglietti, M.D., has been appointed Chief Executive Officer. "NanoNewron is a company with an innovative technology, a very promising product and a great potential,” said Marco Taglietti, M.D. “I am honored and excited to be taking on the role of CEO. There is still a dire need for more effective treatments for Alzheimer’s Disease. Despite decades of research, the current treatments only offer temporary improvements in symptoms and just a modest slowdown of cognitive decline. Currently there is no treatment that blocks the underlying progression of cognitive deterioration in Alzheimer’s disease, let alone cure it. The product developed at NanoNewron, a powerful anti-TNF-alpha nanobody, promises to transform the treatment of Alzheimer’s in the same way that TNF-alpha inhibitors transformed the treatment of systemic inflammatory diseases such as Crohn’s Disease or Rheumatoid Arthritis.”

Phathom Pharmaceuticals Appoints Anne Marie Cook as Chief Legal Officer and Corporate Secretary

Florham Park-based BioNJ Member Phathom Pharmaceuticals, Inc. announced the appointment of Anne Marie Cook, J.D., as Chief Legal Officer and Corporate Secretary. Ms. Cook is an accomplished pharmaceutical legal executive with a proven track record advising pharmaceutical companies and broad expertise in corporate governance, commercial law, regulatory compliance, strategic transactions and legal strategy. Ms. Cook most recently served as Senior Vice President, General Counsel of Sage Therapeutics, Inc. and previously served in legal leadership roles at Aegerion, ViaCell and Biogen. “I’m delighted to welcome Anne Marie Cook to Phathom. Her experience and broad skills will be highly impactful as we work to build Phathom into a leading GI company in the coming years,” said Steven Basta, President and CEO, Phathom Pharmaceuticals.

Sun Pharma Names Ascroft North America CEO

Sun Pharmaceutical Industries Ltd. appointed Richard Ascroft as CEO of Sun Pharma North America. Mr. Ascroft succeeds Abhay Gandhi. According to a June 25 hiring announcement from the India-based parent company Gandhi, “played a pivotal role in the growth of the Sun Pharma North America business.” In his new position, Mr. Ascroft is responsible for advancing the Princeton-based company’s portfolio of medicines, generics, and over-the-counter products in the U.S. and Canada. Sun Pharma noted the new CEO will play an instrumental role in the upcoming commercial launches of new treatments for alopecia areata and squamous cell carcinoma. Mr. Ascroft joins Sun Pharma from Takeda Pharmaceuticals. At that company, he most recently served as senior vice president and business unit head of U.S. Plasma-Derived Therapies.

Cosette Pharmaceuticals Appoints Jeff Neubig as VP Quality and Regulatory Affairs

Bridgewater-based Cosette Pharmaceuticals announced that Jeff Neubig has been appointed as Vice President, Quality and Regulatory Affairs. Prior to joining Cosette, Mr. Neubig served as Vice President of Quality and Regulatory Affairs, North America at LTS Lohmann Therapy Systems, where he successfully oversaw multiple regulatory inspections with zero observations, provided regulatory guidance and wrote filings for IND, NDA and ANDA products, and led tech transfer and validation teams, among other achievements. Mr. Neubig brings over 35 years of experience in the pharmaceutical industry to Cosette, including over 25 years leading quality assurance, quality control and regulatory affairs teams, working with products from pre-clinical development all the way through commercial operations.

BD Appoints Bilal Muhsin as Executive Vice President and President of Future Connected Care Segment

Franklin Lakes-based BD (Becton, Dickinson and Company) announced that Bilal Muhsin has been named Executive Vice President and will become the President of BD’s future Connected Care segment. Mr. Mushin will serve as a member of the BD Executive Leadership Team reporting to Tom Polen, Chairman, CEO and President of BD and will lead the strategy development to support an effective transition into this new structure over the next several months. In this newly created role, Mr. Muhsin will be responsible for advancing BD’s future Connected Care strategy, including shaping organizational capabilities, driving and executing the commercial strategy, accelerating industry-leading innovation initiatives and ensuring operational and quality excellence.

ESG Best Practices: Tools from Which to Learn

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PTC Therapeutics 2024 Corporate Sustainability Report

Our mission at PTC Therapeutics is to deliver transformative therapies for children and adults living with serious diseases of high unmet need. Our values as a company are integral to help us achieve this mission and are woven into our approach to corporate responsibility. We focus on five key pillars in our corporate responsibility efforts: patients, people, community, environment and governance

Industry Events

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Introducing LSWC & 2025 Report: National Coordination for a Stronger Life Sciences Workforce

Webinar | July 25, 2025, 12:00 p.m.

Join the Life Sciences Workforce Collaborative (LSWC) on Thursday, July 25 at 12:00 PM ET for a free webinar exploring the future of the nation’s life sciences talent pipeline. This session will highlight the newly released 2025 National Life Sciences Workforce Trends Report, developed in partnership with TEConomy Partners, and outline how LSWC is building a national network to support scalable, sustainable workforce solutions. Learn how you can get involved and help strengthen the U.S. bioeconomy. 

Doing Business in Eurasia

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

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

Students 2 Science STEM Volunteer Opportunities

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

Partner Spotlight


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