BioNJ's IT Cyber Webinar

Securing the Future: Cyber Insurance, Data Privacy & FDA Perspectives for 2025

Click here to watch the recorded webinar which offers a comprehensive exploration of how cybersecurity risks are shaping the life sciences industry. 

Biotech Can Give Our Economy the Boost It Needs

The key to a stronger, more vibrant and more secure American economy could be staring us right in the face. A groundbreaking new report circulating in Washington reveals that one of America's leading industries still has untapped potential to drive job creation, competitiveness, and long-term economic growth. That sector? Biotech. America's biotech industry already contributes $3.2 trillion to the economy — but could add much more with the right reforms. Healthcare spending accounts for more than 17% of U.S. gross domestic product, and life sciences companies are uniquely positioned to curb those costs. That's because the biopharmaceutical sector is our primary source of new medicines. Preventing or curing diseases like cancer and diabetes would avert trillions of dollars in future spending on hospitalizations and long-term care. At the same time, more breakthrough medicines would return productive workers to the workforce, a key driver of economic development. 

Bayh-Dole Coalition Releases Issue Brief on Harmful NIH Licensing Guidelines

The Bayh-Dole Coalition released an issue brief to highlight the disastrous impact of new National Institutes of Health licensing guidelines for NIH-made inventions. “The guidelines — specifically the requirement that prospective licensees explain to NIH how they’ll make any future products ‘available, affordable, acceptable and sustainable’ — reimposes the bureaucratic micro-management that Congress ended when passing the Bayh-Dole Act,” warned Joseph P. Allen, Executive Director of the Bayh-Dole Coalition. “This will have a dire impact on the commercialization of potentially life saving inventions made at NIH.” If companies rightly fear that NIH officials can revoke their licenses for failing to meet these arbitrary and ill-defined conditions so rival companies can copy their products, entrepreneurs will not license NIH inventions in the first place. This is a particularly dire threat to the innovative small businesses which drive American innovation.

FTC Releases Second Interim Staff Report on Prescription Drug Middlemen

The Federal Trade Commission published a second interim staff report on the prescription drug middleman industry, which focuses on pharmacy benefit managers’ (PBMs) influence over specialty generic drugs, including significant price markups by PBMs for cancer, HIV, and a variety of other critical drugs. Staff’s latest report found that the ‘Big 3 PBMs’ — Caremark Rx, Express Scripts and OptumRx — marked up numerous specialty generic drugs dispensed at their affiliated pharmacies by thousands of percent, and many others by hundreds of percent. Such significant markups allowed the Big 3 PBMs and their affiliated specialty pharmacies to generate more than $7.3 billion in revenue from dispensing drugs in excess of the drugs’ estimated acquisition costs from 2017-2022. The Big 3 PBMs netted such significant revenues all while patient, employer and other health care plan sponsor payments for drugs steadily increased annually. 

Innovation Celebration: BioNJ Event Set for Feb. 6

As featured in ROI-NJ

Jayne Gershkowitz, the Chief Patient Advocate for Amicus Therapeutics, will receive the Dr. Sol J. Barer Award for Vision, Innovation and Leadership at BioNJ’s Annual Dinner Meeting & Innovation Celebration. The dinner, considered the kickoff event of the year for the life sciences industry in New Jersey, always brings an overflow crowd of hundreds of biopharma professionals, academic leaders, Patients, advocates and service providers together to honor the groundbreaking medical innovation coming from the Garden State. 

“Because Patients Can’t Wait®, we are incredibly proud of our members who are helping patients live longer, better lives,” said BioNJ President and CEO Debbie Hart. “At BioNJ’s Annual Dinner Meeting & Innovation Celebration, we’ll come together to honor the remarkable dedication and transformative work of New Jersey’s life sciences community — a beacon of innovation and hope that turns Patients’ dreams into reality around the globe.

Murphy Pledges a Strong Finish for His Final Year in Trenton

As featured in NJBIZ

“I’m not done yet,” Gov. Phil Murphy stated during his State of the State Address at the State House in Trenton. “And we’re not done yet.” The annual address, Murphy’s seventh and next-to-last, comes as he begins his final year as New Jersey’s 56th governor....

“BioNJ was pleased to see that, in his State of the State Address, Gov. Murphy emphasized the importance of innovation to the health and success of New Jersey’s economy,” the organization said in a statement. “As we have over the course of the governor’s administration, we look forward to working with the governor and other policymakers as well as our members to continue earning the reputation as the ‘Medicine Chest of the World’ – and supporting the governor’s priority to ensure that our state is home to a growing number of innovators who are making their mark.”

BioNJ Pleased With Governor’s Nod Toward Life Science Industry in State of State Address

As featured in ROI-NJ

BioNJ CEO Debbie Hart was thrilled when she heard Gov. Phil Murphy address the life sciences industry during his recent State of the State address. While life sciences were far from the focus of the address, Hart appreciated the shout out when governor emphasize the role that our sector plays in enabling New Jersey to earn the reputation of being the “medicine chest of the world” – and that he highlighted that New Jersey holds the distinction of having “more engineers and scientists per capita than anywhere else on the planet.” “BioNJ was pleased to see that Gov. Murphy emphasized the importance of innovation to the health and success of New Jersey’s economy,” Hart said. “As we have over the course of the governor’s administration, we look forward to working with the governor and other policymakers as well as our Members to continue earning the reputation as the “Medicine Chest of the World” and supporting the governor’s priority to ensure that our State is home to a growing number of innovators who are making their mark.”

Tris Pharma Announces Positive Results from ALLEVIATE-1 Phase 3 Clinical Trial of Cebranopadol, an Investigational First-in-Class Oral Dual-NMR Agonist, for the Treatment of Moderate-to-Severe Acute Pain

Monmouth Junction-based BioNJ Member, Tris Pharma, Inc. announced positive topline results from its ALLEVIATE-1 pivotal Phase 3 clinical trial evaluating cebranopadol, an investigational therapy, for the treatment of moderate-to-severe acute pain in patients following abdominoplasty surgery. These results add to the growing body of data underscoring the promising efficacy and safety profile of cebranopadol, a first-in-class pain therapy involving dual-nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonism. This dual-NMR agonist has the potential to deliver significant pain relief comparable to opioids with minimized risk of significant side effects, dependence and addiction by leveraging the body’s pain biology modulation processes, synergizing the analgesic and safety characteristics of the NOP receptor with the analgesic advantages of the MOP receptor.

Taiho Pharmaceutical, Taiho Oncology and Cullinan Therapeutics Announce Primary Endpoint Met in Phase 2b Trial of Zipalertinib in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Received Prior Therapy

Princeton-based BioNJ Member Taiho Pharmaceutical Co., Ltd., Taiho Oncology, Inc. and Cullinan Therapeutics, Inc., announced the REZILIENT1 trial, a Phase 1/2 clinical trial of zipalertinib (development code: CLN-081/TAS6417) monotherapy in patients with non-small cell lung cancer (NSCLC) harboring the epidermal growth factor receptor (EGFR) exon 20 insertion mutations who have received prior therapy, met its primary endpoint of overall response rate. The safety profile was generally consistent with previous data presentations. These results are based on the Phase 2b part of this study. Pending discussions with the U.S. Food and Drug Administration (FDA), the companies plan to submit for U.S. regulatory approval in the second half of 2025. REZILIENT1 is a Phase 1/2 clinical trial (NCT04036682) to evaluate efficacy and safety of zipalertinib in patients with NSCLC harboring EGFR exon 20 insertion mutations who have received prior therapy. The topline results obtained at this time are based on the Phase 2b part of this study.

Taiho Oncology Presents Real-World Findings for LONSURF® at the ASCO Gastrointestinal Cancers Symposium

Princeton-based BioNJ Member Taiho Oncology, Inc. announced that it will share real-world data about the crucial role of LONSURF® (trifluridine/tipiracil) in a combination treatment for metastatic colorectal cancer (mCRC).Taiho will present findings from real-world retrospective studies demonstrating that pairing LONSURF with bevacizumab, rather than administering LONSURF alone, improves clinical outcomes for the mCRC patient population, including Black patients. Orally administered LONSURF pairs the chemotherapy trifluridine, a nucleoside metabolic inhibitor, with tipiracil hydrochloride, a thymidine phosphorylase inhibitor that prolongs trifluridine’s ability to stay active in the body. In the U.S., LONSURF’s indication in mCRC is for use alone or in combination with bevacizumab, an anti-angiogenic drug. The larger of the two studies included 3,680 adult patients with mCRC, 3,151 of whom received LONSURF alone and 529 of whom received LONSURF plus bevacizumab.

HyBryte™ Expanded Treatment Continues to Demonstrate Positive Outcomes in Early Stage Cutaneous T-Cell Lymphoma

Princeton-based BioNJ Member Soligenix announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ (synthetic hypericin) treatment for up to 12 months in patients with early stage cutaneous T-cell lymphoma. The trial is sponsored by Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania who was a leading enroller in the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study for the treatment of early stage CTCL. To date, nine patients have been enrolled and treated with HyBryte™ over a time period of up to 54 weeks. Patients have responded positively to HyBryte™ therapy, with over 70% (5 of the 6 subjects who have completed at least 18 weeks of therapy) already achieving "Treatment Success".  

Pfizer’s Sasanlimab in Combination With BCG Improves Event-Free Survival in Patients With BCG-Naïve, High-Risk Non-Muscle Invasive Bladder Cancer

BioNJ Member Pfizer, with a site in Peapack, announced positive topline results from its pivotal Phase 3 CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). The study met its primary endpoint of event-free survival (EFS) by investigator assessment, demonstrating a clinically meaningful and statistically significant improvement with sasanlimab in combination with BCG (induction and maintenance) as compared to BCG alone (induction and maintenance). Pfizer plans to discuss these data with global health authorities to support potential regulatory filings. Sasanlimab also continues to be investigated in combination with Pfizer’s antibody drug conjugate (ADC) portfolio in advanced solid tumors.

Pfizer’s BRAFTOVI® Combination Regimen Demonstrates Improved Response in Patients With BRAF V600E-Mutant Metastatic Colorectal Cancer

BioNJ Member Pfizer, with a site in Peapack, announced positive results from the Phase 3 BREAKWATER trial evaluating BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. At the time of this analysis, the BRAFTOVI combination regimen demonstrated a clinically meaningful and statistically significant improvement in confirmed objective response rate (ORR) assessed by blinded independent central review (BICR) compared to patients receiving chemotherapy with or without bevacizumab (60.9% vs 40.0%, odds ratio =2.443, p=0.0008). The estimated median duration of response as assessed by BICR was 13.9 months (95% Confidence Interval [CI]: 8.5-not estimable [NE]) with BRAFTOVI plus cetuximab and mFOLFOX6 and 11.1 months (95% CI: 6.7-12.7) with chemotherapy with or without bevacizumab. 

FDA Approves Lilly's Omvoh® (mirikizumab-mrkz) for Crohn's Disease, Expanding its Use to the Second Major Type of Inflammatory Bowel Disease

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that the U.S. Food and Drug Administration (FDA) has approved Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease in adults. Omvoh is now approved in the U.S. for two types of inflammatory bowel disease (IBD), following its October 2023 approval as a first-in-class treatment for moderately to severely active ulcerative colitis (UC) in adults. Omvoh works to reduce inflammation within the gastrointestinal tract by targeting a specific protein, interleukin-23p19 (IL-23p19), which is a key contributor to intestinal inflammation. Omvoh is the first biologic treatment in more than 15 years to have disclosed two-year Phase 3 efficacy data in Crohn's disease at the time of approval.

Lilly to Acquire Scorpion Therapeutics' Mutant-Selective PI3Kα Inhibitor Program

BioNJ Member Eli Lilly and Company, with a site in Branchburg, and Scorpion Therapeutics, Inc., announced a definitive agreement for Lilly to acquire Scorpion's PI3Kα inhibitor program STX-478. STX-478 is a once-daily oral, mutant-selective PI3Kα inhibitor currently being evaluated in a Phase 1/2 clinical trial for breast cancer and other advanced solid tumors. STX-478 could represent the next generation of PI3Kα targeting agents by selectively targeting the pathway in cancerous but not healthy cells, thus overcoming a key limitation of currently available medicines that target the PI3Kα pathway. This approach could potentially offer better disease control through deeper pathway inhibition, as well as improved tolerability. 

BeiGene Announces Global Licensing Agreement for MAT2A Inhibitor

Hopewell-based BioNJ Member BeiGene, a global oncology company that intends to change its name to BeOne Medicines Ltd., announced it has entered into a global licensing agreement with CSPC Zhongqi Pharmaceutical Technology Co., Ltd. for SYH2039, a novel methionine adenosyltransferase 2A (MAT2A)-inhibitor being explored for solid tumors. SYH2039 targets solid tumors that have a mutation called MTAP deletion, which is estimated to be present in approximately 15 percent of all cancer types with the most common including glioblastoma, pancreatic cancer and non-small cell lung cancer. “This MAT2A inhibitor is a valuable addition to our solid tumor pipeline, and we’re eager to explore its potential, particularly in combination with our internally developed PRMT5 inhibitor, BGB-58067. Together, these assets hold promise for advancing treatment across a range of solid tumors,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene.

Gilead and LEO Pharma Enter into Strategic Partnership to Accelerate Development of Oral STAT6 Program With Potential in Multiple Inflammatory Diseases

BioNJ Member Gilead Sciences, with a site in Morris Plains, and Madison-based LEO Pharma announced a strategic partnership to accelerate the development and commercialization of LEO Pharma’s small molecule oral STAT6 (signal transducer and activator of transcription 6) programs for the potential treatment of patients with inflammatory diseases. STAT6 is the specific transcription factor required for IL-4 and IL-13 cytokine signaling, which are clinically validated targets for Th2 mediated inflammatory conditions such as atopic dermatitis, asthma, and COPD, amongst many others. Targeting STAT6 has shown potential preclinically to treat a broad population of patients and provide an oral alternative to those currently treated with injectable biologics. Under this partnership, Gilead will acquire LEO Pharma’s comprehensive preclinical oral STAT6 small molecule inhibitors and targeted protein degraders. 

Sarclisa Obtains First Approval in China for the Treatment of Adult Patients With Relapsed or Refractory Multiple Myeloma

Bridgewater-based BioNJ Member Sanofi announced the National Medical Products Administration (NMPA) in China has approved Sarclisa, an anti-CD38 medicine, in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. This approval is based on results from the pivotal ICARIA-MM phase 3 study, using the China-based IsaFiRsT real-world study as bridging data. The ICARIA-MM study demonstrated Sarclisa in combination with Pd significantly reduced the risk of disease progression or death by 40% (HR 0.596, 95% CI 0.44-0.81, p=0.001), and resulted in a clinically meaningful, 6.9-month improvement in overall survival (OS) (HR=0.78; log-rank 1-sided P=0.0319), compared to Pd alone. 

Sarclisa Approved in the EU as the First Anti-CD38 Therapy in Combination With Standard-of-Care VRd to Treat Transplant-Ineligible Newly Diagnosed Multiple Myeloma

Bridgewater-based BioNJ Member Sanofi announced that following the adoption of a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), the EU has approved Sarclisa in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplant (ASCT), based on data from the IMROZ Phase 3 study. With the expanded marketing authorization, Sarclisa is the first anti-CD38 therapy in combination with VRd in this patient population in the EU. In September 2024, the US Food and Drug Administration (FDA) approved Sarclisa in combination with VRd for the treatment of adult patients with NDMM who are not eligible for ASCT, representing the first global approval for Sarclisa in the front-line setting.

Adjuvant Libtayo® (cemiplimab) Significantly Improves Disease-Free Survival (DFS) After Surgery in High-Risk Cutaneous Squamous Cell Carcinoma (CSCC) in Phase 3 Trial

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced

positive results from the Phase 3 C-POST trial, which demonstrated that adjuvant treatment with PD-1 inhibitor Libtayo® (cemiplimab) led to a statistically significant and clinically meaningful improvement in the primary endpoint of disease-free survival (DFS) in patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery. C-POST enrolled 415 patients with high-risk CSCC who were randomized to receive either Libtayo or placebo for up to 48 weeks. The primary endpoint was DFS, defined as time from randomization to the first documented disease recurrence or death due to any cause. At the first prespecified interim analysis for DFS with a median duration of follow-up of 24 months (range: 2-64 months), Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death, compared to placebo (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001).

Regeneron Collaborates with Truveta and Leading American Health Systems to Massively Extend its DNA Sequence-Linked Healthcare Database to Further Advance Scientific Innovation and Healthcare Delivery

Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced a strategic collaboration with Truveta, Inc. and its collective of U.S. health systems to advance innovation and data-driven discovery across the life sciences, public health and healthcare delivery ecosystem. Regeneron will provide a strategic investment of $119.5 million as part of Truveta’s Series C financing round and collaborate with Truveta to launch the Truveta Genome Project. This project will extend Regeneron’s world-leading DNA sequence-linked healthcare database with an ambitious new effort to sequence up to ten million additional de-identified patient volunteers, all with linked electronic health records (EHRs). This novel resource is designed to unlock profound insights into how genetics impact health and has the potential to ultimately lead to new genetic-based therapies and optimized healthcare services.

Novo Nordisk Successfully Completes Phase 1b/2a Trial With Subcutaneous Amycretin in People With Overweight or Obesity

Plainsboro-based BioNJ Member Novo Nordisk announced topline results from a Phase 1b/2a clinical trial with amycretin, a unimolecular GLP-1 and amylin receptor agonist intended for once weekly subcutaneous administration. The trial investigated safety, tolerability, pharmacokinetics, and proof-of-concept after once-weekly subcutaneous administrations of amycretin in 125 people with overweight or obesity. The trial was a combined single ascending dose, multiple ascending dose and dose-response trial investigating three different maintenance doses with a total treatment duration of up to 36 weeks. The primary endpoint was treatment emergent adverse events. The safety profile of amycretin was consistent with incretin-based therapies. The most common adverse events with amycretin were gastrointestinal and the vast majority were mild to moderate in severity.

Teva and Alvotech Announce Filing Acceptance of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to Simponi® and Simponi Aria® (golimumab)

Parsippany-based BioNJ Member Teva Pharmaceutical and Alvotech announced that the U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, Alvotech’s proposed biosimilar to Simponi® and Simponi Aria® (golimumab), which are prescribed to treat a variety of inflammatory conditions. These are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimumab. The FDA review process for these applications is anticipated to be completed in the fourth quarter of 2025. Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva, added, “Biosimilars are ushering a new treatment paradigm and have become an integral staple in the healthcare ecosystem. Teva’s strategic partnership with Alvotech underscores our commitment to continue to bring cost-saving options to more patients and deliver better outcomes for those with inflammatory conditions.”

Teva Announces Collaboration to Commercialize Formycon’s Biosimilar Candidate to Eylea® (aflibercept) in Major Parts of Europe and in Israel

Parsippany-based BioNJ Member Teva Pharmaceutical announced that it has entered into a strategic collaboration with Klinge Biopharma GmbH and Formycon AG (FSE: FYB) for the semi-exclusive commercialization of FYB203, Formycon's biosimilar candidate to Eylea® (aflibercept) in Europe, excluding Italy, and in Israel. This collaboration combines Teva’s deep commercial experience in biosimilars and its extensive distribution network and broad sales and marketing reach across Europe, with Formycon’s capabilities in the development of biosimilar medicines for highly regulated countries. Klinge has in licensed the exclusive global commercialization rights to FYB203 from Formycon. Under the terms of the agreement, Teva will lead the commercialization of FYB203 in the designated regions, to be marketed under the brand name AHZANTIVE®, subject to regulatory approval.

FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease

Nutley-based Eisai BioNJ Member and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for once every four weeks lecanemab-irmb (U.S. brand name: LEQEMBI®) intravenous (IV) maintenance dosing. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) in the U.S. After 18 months of once every two weeks initiation phase, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks may be considered or the regimen of 10 mg/kg once every two weeks may be continued. The sBLA is based on modeling of observed data from the Phase 2 study (Study 201) and its long-term extension (LTE) as well as the Clarity AD study (Study 301) and its LTE study. 

FDA Accepts LEQEMBI® (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer’s Disease

Nutley-based Eisai BioNJ Member and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Biologics License Application (BLA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. LEQEMBI is indicated for the treatment of Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). A Prescription Drug User Fee Act (PDUFA) action date is set for August 31, 2025. The BLA is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modeling of observed data. If LEQEMBI subcutaneous maintenance dosing is approved by the FDA, LEQEMBI will be the only treatment for AD that can be administered subcutaneously at home using an autoinjector (AI). 

Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 LEAP-015 Trial Evaluating LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy in Patients With Certain Types of Gastroesophageal Adenocarcinoma

BioNJ Members, Nutley-based Eisai and Rahway-based Merck & Co., announced results from the Phase 3 LEAP-015 trial evaluating LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, plus KEYTRUDA® (pembrolizumab), the anti-PD-1 therapy from Merck, in combination with chemotherapy (LENVIMA plus KEYTRUDA-based regimen), for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal adenocarcinoma. “Locally advanced unresectable or metastatic gastroesophageal adenocarcinoma remains a challenging disease to treat and a leading cause of cancer death worldwide,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, MSD Research Laboratories. “These study results add to our understanding of this combination and will inform our future research as we strive to improve outcomes for more patients with cancer.”

Merck Receives Positive EU CHMP Opinion for CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Pneumococcal Vaccination in Adults

Rahway-based BioNJ Member Merck & Co. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. The CHMP’s recommendation will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU), Iceland, Liechtenstein and Norway, and a final decision is expected by the second quarter of 2025. CAPVAXIVE is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease (IPD) cases. 

FDA Grants Priority Review to Merck’s Application for WELIREG® (belzutifan) for the Treatment of Patients With Advanced Pheochromocytoma and Paraganglioma (PPGL)

Rahway-based BioNJ Member Merck & Co. announced the U.S. Food and Drug Administration has accepted for priority review a supplemental new drug application seeking approval of WELIREG® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha inhibitor, for the treatment of adult and pediatric patients (12 years and older) with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma. The sNDA is based on objective response rate and duration of response data from the Phase 2 LITESPARK-015 trial, which will be presented at an upcoming medical meeting. WELIREG is the first and only HIF-2α inhibitor therapy approved in the U.S. for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors not requiring immediate surgery, based on results from the Phase 2 LITESPARK-004 trial. 

Merck’s GARDASIL® Receives Expanded Approval for Males in China

Rahway-based BioNJ Member Merck & Co. announced that the National Medical Products Administration (NMPA) of China approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for use in males 9-26 years of age to help prevent certain HPV-related cancers and diseases. The approval makes GARDASIL the first HPV vaccine approved for use in males in China. GARDASIL is now indicated in China to prevent anal cancers caused by HPV Types 16 and 18, genital warts (condyloma acuminata) caused by HPV Types 6 and 11, and the following precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18: grade 1, grade 2 and grade 3 anal intraepithelial neoplasia (AIN). GARDASIL is a vaccine indicated in females 9 through 45 years of age. 

New Drug Application Initiated With U.S. FDA for TAR-200, the First and Only Intravesical Drug Releasing System for Patients With BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer

Raritan-based BioNJ Member Johnson & Johnson announced it has initiated the submission of an original New Drug Application with the U.S. Food and Drug Administration (FDA) for TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. This submission is being reviewed by the FDA through the Real-Time Oncology Review (RTOR) program, which allows the FDA to review data before the complete application is formally submitted and helps ensure treatments are available for patients as soon as possible. The submission of this innovative intravesical drug releasing system is supported by data from the Phase 2b SunRISe-1 registration study.

SPRAVATO® (esketamine) Approved in the U.S. as the First and Only Monotherapy for Adults With Treatment-Resistant Depression

Titusville-based BioNJ Member Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants. MDD is one of the most common psychiatric disorders, with an estimated 21 million adults in the U.S. living with the disease. About one-third of adults will not respond to oral antidepressants alone, which has a significant negative impact on the quality of life of those affected. MDD has a high economic burden, with nearly half of it attributable to treatment-resistant depression (TRD).

Findings from Pivotal Nipocalimab Phase 3 Study in a Broad Antibody Positive Population of People Living With Generalized Myasthenia Gravis (gMG) Published in The Lancet Neurology

New Brunswick-based BioNJ Member Johnson & Johnson announced The Lancet Neurology has published results from the pivotal Phase 3 study of nipocalimab, an investigational FcRn blocker, evaluated in a broad population of antibody positive (anti-AChR+, anti-MuSK+, anti-LRP4+) adults with generalized myasthenia gravis (gMG). The Vivacity-MG3 study met its primary endpoint demonstrating statistically significant and clinically meaningful improvement over 24 weeks in the MG-ADL score. Nipocalimab had a tolerable safety profile, with adverse events leading to discontinuation rates similar to placebo (5.1% with nipocalimab vs. 7.1% with placebo). gMG is a chronic, life-long, rare, autoantibody-driven disease, for which there currently is no cure. gMG impacts an estimated 700,000 people worldwide.

Johnson & Johnson Strengthens Neuroscience Leadership With Acquisition of Intra-Cellular Therapies, Inc.

New Brunswick-based BioNJ Member Johnson & Johnson (NYSE: JNJ) and Bedminster-based Intra-Cellular Therapies, Inc. announced that they have entered into a definitive agreement under which Johnson & Johnson will acquire all outstanding shares of Intra-Cellular Therapies, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders. With this agreement, Johnson & Johnson adds Intra-Cellular Therapies’ CAPLYTA® (lumateperone), a once-daily oral therapy approved to treat adults with schizophrenia, as well as depressive episodes associated with bipolar I or II disorder (bipolar depression), as a monotherapy and adjunctive therapy with lithium or valproate. The acquisition also includes ITI-1284, a promising Phase 2 compound being studied in generalized anxiety disorder (GAD) and Alzheimer’s disease-related psychosis and agitation, as well as a clinical-stage pipeline that further complements and strengthens Johnson & Johnson’s current areas of focus.

Bristol Myers Squibb Presents Results from CheckMate -8HW Analysis Evaluating Opdivo® (nivolumab) Plus Yervoy® (ipilimumab) Compared to Opdivo Monotherapy

Princeton-based BioNJ Member Bristol Myers Squibb (announced results of an analysis from the three-arm Phase 3 CheckMate -8HW trial evaluating Opdivo^® (nivolumab) plus Yervoy^® (ipilimumab) versus Opdivo monotherapy across all lines of therapy, including first-line, for the treatment of microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC). At a median follow-up of 47 months, Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in the dual-primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) versus Opdivo monotherapy (HR 0.62; 95% CI 0.48–0.81; P = 0.0003).Previous results from CheckMate -8HW, evaluating Opdivo plus Yervoy versus investigator’s choice of chemotherapy, demonstrated that Opdivo plus Yervoy reduced the risk of disease progression or death by 79%.

Depemokimab Accepted for Review by the European Medicines Agency for Use in Asthma With Type 2 Inflammation and CRSwNP

Warren-based BioNJ Member GSK announced that the European Medicines Agency has accepted for review the Marketing Authorization Application for the use of depemokimab in two indications.The submitted indications are for add-on maintenance treatment of asthma in adult and adolescent patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype who are inadequately controlled on medium to high dose corticosteroids (ICS) plus another asthma controller and also as an add-on treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). Depemokimab, a monoclonal antibody that targets interleukin-5 (IL-5), is the first ultra-long-acting biologic to be evaluated in Phase III trials and be accepted for regulatory review for use in these conditions. 

Depemokimab Applications Accepted for Review in China and Japan for Asthma With Type 2 Inflammation and CRSwNP

Warren-based BioNJ Member GSK announced that new drug applications have been accepted for review by the China National Medical Products Administration and submitted to the Japanese Ministry of Health, Labour and Welfare for use of depemokimab in two indications. In China, the submitted indications are for an add-on maintenance treatment of asthma in adult and adolescent patients aged 12 and older with type 2 inflammation characterised by blood eosinophil count, and add-on maintenance treatment of adult patients with inadequately controlled CRSwNP. In Japan, the submitted indications are for treatment of severe or refractory bronchial asthma and CRSwNP inadequately controlled with standard treatment. Depemokimab, a monoclonal antibody that targets interleukin-5 (IL-5), is the first ultra-long-acting biologic to be evaluated in phase III trials and be accepted for regulatory review for use in these conditions.

European Commission Expands Jemperli (dostarlimab) Plus Chemotherapy Approval to All Adult Patients With Primary Advanced or Recurrent Endometrial Cancer

Warren-based BioNJ Member GSK announced the European Commission has approved Jemperli (dostarlimab) in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy. This approval broadens the previous indication for Jemperli plus chemotherapy in the European Union (EU) to include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors, which represent approximately 75% of patients diagnosed with endometrial cancer and who have limited treatment options. Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said, “For the first time, all patients with primary advanced or recurrent endometrial cancer in the EU have an approved immuno-oncology-based treatment that has shown a statistically significant and clinically meaningful overall survival benefit.”

GSK and Oxford Establish the GSK-Oxford Cancer Immuno-Prevention Programme to Advance Novel Cancer Research

Warren-based BioNJ Member GSK and the University of Oxford announced that they have entered a new research collaboration focused on the potential of cancer prevention through vaccination. The GSK-Oxford Cancer Immuno-Prevention Program will conduct translational research, exploring precancer biology to generate key insights on how cancer develops in humans that could inform new approaches to cancer vaccination. GSK will invest up to £50 million over a minimum of three years to support this early research. Evidence shows that most cancers take years or even decades to develop from normal cells to precancerous cells (or precancer) to cancer. Oxford University has world-leading expertise in the study of precancer biology including the identification and sequencing of neoantigens, or tumor-specific proteins that prompt the immune system to recognize cancer. 

GSK Enters Agreement to Acquire IDRx, Inc.

Warren-based BioNJ Member GSK and IDRx, Inc. announced that they have entered into an agreement under which GSK will acquire IDRx, a clinical-stage biopharmaceutical company dedicated to developing precision therapeutics for the treatment of GIST. The acquisition includes lead molecule, IDRX-42, a highly selective KIT TKI being developed as a first- and second-line therapy for the treatment of GIST. GIST typically presents in the GI tract with 80% of cases driven by mutations in the KIT gene that lead to the growth, proliferation, and survival of tumour cells (primary or activating mutations).1 90% of patients treated in the first-line develop new KIT mutations (secondary or resistance mutations) that typically lead to relapse with limited therapeutic options. Currently, there are no approved TKIs that inhibit the full spectrum of clinically relevant primary and secondary mutations in KIT.

AbbVie and Simcere Zaiming Announce Partnership to Develop a Novel Trispecific Antibody Candidate in Multiple Myeloma

BioNJ Member AbbVie, with a site in Madison, and Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group Ltd, announced an option to license agreement to develop SIM0500, an investigational new drug candidate. SIM0500 is currently in Phase 1 clinical trials in patients with relapsed or refractory multiple myeloma (MM), in both China and the U.S. SIM0500 is a humanized trispecific antibody that targets GPRC5D, BCMA, and CD3, developed independently by Simcere Zaiming using their T-cell engager polyspecific antibody technology platform. This molecule features a low affinity/high target-activating CD3 engaging arm and binding sites for the two tumor antigens: G-Protein-coupled receptor class 5 member D (GPRC5D) and B-cell maturation antigen (BCMA). SIM0500 has shown strong T cell cytotoxicity against multiple myeloma (MM) cells by leveraging a combination of various antitumor effects.

AbbVie and Neomorph Announce Collaboration to Develop Molecular Glue Degraders for Oncology and Immunology

BioNJ Member AbbVie, with a site in Madison, and Neomorph, Inc. announced a collaboration and option-to-license agreement to develop novel molecular glue degraders for multiple targets across oncology and immunology. Molecular glue degraders are a novel class of small molecules that are designed to selectively target and trigger degradation of proteins that drive cancer growth or immune system dysregulation, offering a more precise approach to treatment. Molecular glue degraders have the potential to target proteins that have historically been defined as "undruggable”. Protein degraders represent a groundbreaking advancement in the field of drug discovery and at AbbVie we are committed to advancing this technology forward," said Steven Elmore, Vice President, Small Molecule Therapeutics and Platform Technologies at AbbVie.

Kenox Pharmaceuticals Expands Capabilities to Strengthen Drug Development Offerings

Princeton-based Kenox Pharmaceuticals said it is adding small scale non-sterile GMP capabilities to support GLP pre-clinical studies to its comprehensive suite of drug development services. The expansion underscores Kenox’s commitment to accelerating the journey from molecule to clinic, providing its partners with the tools and expertise needed to bring life-changing therapies to market faster. Kenox specializes in pharmaceutical aerosol product development including soft mist inhalers, pressurized metered dose inhalers, dry powder inhalers, nebulizers, nasal sprays and ophthalmic products. The new expansion includes clean room for compounding, fill-finish and release of non-sterile nasal sprays, and dry powders. Additionally, Kenox is working on further expansion to enable small scale GMP batch manufacturing for clinical trials (Phase I and II) of both non-sterile and sterile OINDPs.

Evotec Receives Grant from Korean Government to Develop Novel Antibody-Based Treatments for Lung Diseases

Princeton-based Evotec announced that, together with Yonsei University and the Korean biotech company Zymedi, it will receive a US$ 4.5m grant from the Korea Institute of Advanced Technology (KIAT). The KIAT grant will fund the development of first-in-class biologic therapies to treat lung diseases, including asthma and idiopathic pulmonary fibrosis (IPF). The project will focus on the preclinical development of novel anti-inflammatory and anti-fibrotic antibodies directed against tRNA synthetases, an emerging therapeutic target class to treat diseases with a high unmet medical need. “The previously untapped biology of tRNA synthetases provides a versatile route for new drug development. I am very excited to launch the project with Evotec to develop novel therapeutic antibodies targeting disease-causing-activities by these enzymes” said Sunghoon Kim, Professor and Director, Institute of Artificial Intelligence and Biomedical Research at Yonsei University.

Datopotamab Deruxtecan Granted Priority Review in the U.S. for Patients With Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Basking Ridge-based Daiichi Sankyo and AstraZeneca’s Biologics License Application for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer who have received prior systemic therapies, including an EGFR-directed therapy. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca. The BLA and BTD are based on data from the TROPION-Lung05 phase 2 trial and supported by data from the TROPION-Lung01 Phase 3 trial. In addition, the BLA is supported by the TROPION-PanTumor01 Phase 1 trial.

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

Basking Ridge-based Daiichi Sankyo announced that DATROWAY ® (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca. DATROWAY is the second DXd ADC approved in the U.S. based on Daiichi Sankyo’s DXd ADC Technology. The approval by the U.S. Food and Drug Administration was based on results from the TROPIONBreast01 Phase 3 trial.

ENHERTU® Approved in the U.S. as First HER2 Directed Therapy for Patients With HER2 Low or HER2 Ultralow Metastatic Breast Cancer Following Disease Progression After One or More EndocrineTherapies

Basking Ridge-based Daiichi Sankyo and AstraZeneca’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting. 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. This approval, which is based on results from the DESTINY-Breast06 Phase 3 trial published in The New England Journal of Medicine, follows Priority Review and Breakthrough Therapy Designation by the FDA for ENHERTU in this indication.

Daiichi Sankyo Acquires Intellectual Property Rights for Anti-TA-MUC1 Antibody in DS-3939 from Glycotope GmbH

Basking Ridge-based Daiichi Sankyo announced that it will pay Glycotope $132.5 million to acquire intellectual property rights of the anti-tumor-associated mucin-1 (TA-MUC1) antibody, gatipotuzumab. Such payment by Daiichi Sankyo satisfies all potential clinical, regulatory and sales milestone payments, as well as royalties of products that include gatipotuzumab as part of a 2018 licensing agreement between the parties. The anti-TA-MUC1 is the antibody contained in DS-3939, an ADC being developed by Daiichi Sankyo. DS-3939 is a specifically engineered potential first-in-class TA-MUC1 directed medicine designed using Daiichi Sankyo’s proprietary DXd ADC technology.DS-3939 is currently being evaluated in a phase 1/2 clinical trial in patients with several types of advanced solid tumors including non-small cell lung, breast, urothelial, ovarian, biliary tract and pancreatic cancer.

Character Biosciences Collaborating With Bausch + Lomb

Jersey City-based Character Biosciences, a company specializing in genetics-guided drug discovery and development, has announced a collaboration with Bausch + Lomb, a leading global eye health company, to develop innovative treatments for patients with age-related macular degeneration (AMD). This relationship, initiated in 2024, brings together Bausch + Lomb’s experience in ophthalmology with Character Bio’s integrated patient data platform ​and AI-powered analytical engine​ to drive novel drug discovery and development. The partnership will initially focus on AMD, with the potential to expand into other eye conditions. Under the terms of this multi-target drug discovery collaboration agreement, Character Bio has received an upfront payment and annual research funding. The company is eligible for potential development and sales-related milestone payments, as well as tiered royalties on potential future product sales.

Mitsubishi Tanabe Pharma America Announces Real-World Data Analysis of Disease Progression With RADICAVA® (edaravone) in ALS

Jersey City-based Mitsubishi Tanabe Pharma America, Inc. announced the publication of a retrospective analysis of real-world data in the Journal of Comparative Effectiveness Research (JCER). The study suggests that, in patients with amyotrophic lateral sclerosis (ALS), treatment with intravenous (IV) RADICAVA^® (edaravone) was associated with fewer reported disease progression milestones and deaths compared to individuals not treated with the drug. “These data reinforce the utility of RADICAVA and build upon the growing evidence that expands our knowledge of edaravone in ALS,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. “By continuing to study RADICAVA in both its IV and oral suspension forms, we aim to expand our understanding of the medication and its limitations to better support the ALS community.”

Tevogen Bio Enters Agreement to Receive up to $10M of Non-Dilutive Grant Funding

Warren-based Tevogen Bio announced it signed a grant agreement with KRHP, receiving an initial contribution of $2M, with the intention of having an additional $8 million contributed at a future date, contingent on KRHP’s review of the company’s activities. The grant is intended to further Tevogen Bio’s mission to develop T cell therapeutics addressing the significant unmet needs of large patient populations for treatment of cancers and viral infections. Tevogen plans to deploy the funds in part to further expand efforts in AI and is currently working with Microsoft to broaden its AI-focused collaboration. “As we expand our AI efforts, this broader relationship with Microsoft represents a key milestone in our ongoing journey to revolutionize immunotherapy,” Mittul Mehta, CIO of Tevogen Bio and head of Tevogen.AI, said.

BioCentriq Partners With Orchestra Life Sciences to Advance Princeton Cell Therapy Facility Development

Princeton-based BioNJ Member BioCentriq announced a strategic partnership with Orchestra Life Sciences (OLS), a premier technical consultancy firm specializing in advanced therapy manufacturing solutions. BioCentriq said the collaboration supports its recently announced expansion in Princeton and focuses on its $12M CAPEX investment for facility optimization and digital integration to enhance the site’s cell therapy development, GMP manufacturing and testing capabilities. Orchestra Life Sciences will provide comprehensive technical expertise and strategic support for BioCentriq’s new 60,000 sq. ft. Princeton facility, which was announced in December 2024. The partnership encompasses multiple strategic initiatives, including the implementation of advanced manufacturing technologies, development of a fully integrated digital ecosystem, and optimization of facility design to meet the stringent regulatory requirements of cell therapy production under U.S. FDA and EU GMP Annex 1.

Outcomes Matter Innovations and Regional Cancer Care Associates Partner to Enhance Quality and Reduce Cancer Care Costs

Outcomes Matter Innovations has announced it entered into a co-development agreement with Regional Cancer Care Associates. This agreement will enable OMI proprietary technology to be utilized, enhanced and scaled by RCCA cancer treatment experts, one of the largest cancer physician networks in the United States. “RCCA in partnership with OMI will be optimizing OMI point of care decision support capabilities, enabling their physicians to make cancer treatment decisions that maintain or improve quality clinical outcomes, while significantly reducing cancer care cost. With this important agreement in place with RCCA, OMI continues to look towards the future and plans to announce more partnerships this year that will have a valuable impact on the health care landscape,” Dr. Andrew Pecora, founder, chairman and CEO of OMI, said.

Healthgrades Names 11 NJ Facilities to ‘Best Hospitals’ Lists

Healthgrades’ 250 Best Hospitals for 2025 includes 11 New Jersey health care facilities. Among these, four landed in the top 100 in the nation — and two made the top 50. The rankings recognize the top 5%, 2% and 1% of hospitals nationwide based on patient outcomes. To determine the three lists, the health care information site evaluated clinical performance for about 4,500 hospitals across more than 30 common procedures and conditions. Dr. Brad Bowman, chief medical officer and head of data science at Healthgrades, said the rankings are designed to help patients find top-performing hospitals in their area. “While there are several factors to consider when looking for a doctor, hospital quality is one that can have a critical impact on a patient’s overall quality of care,” Bowman added.

The Ultimate Incentive: TechUnited’s Price Feels Adopting Federal QSBS Policy for Startups Will Help State Attract Even More Investments and Entrepreneurs

BioNJ fully endorses and supports TechUnited's appeal to the Legislature to enact the Qualified Small Business Stock (QSBS) exemption. This legislation provides tax relief to early investors by exempting capital gains on the first $10 million (or 10 times the company’s basis) of a company's sale. Implementing this measure would significantly benefit New Jersey's start-up ecosystem, fostering growth and driving New Jersey’s innovation economy.

NJ Department of Labor (NJDOL) Program Provides Funding for PhD Fellows to Advance your R&D – Applications due by February 7th:

The NJDOL’s Innovation Research Fellowship Program (IRFP) provides funding up to $85K in Year 1 and $95K in Year 2 to companies to support a PhD fellow and advance the company’s R&D programs. Applications are due February 7th by 3pm. Click here for details and eligibility guidelines for both companies and Fellows in the Notice of Grant Opportunity

Y-mAbs Appoints Experienced Commercial Leader as Head of DANYELZA Business Unit

BioNJ Member Y-mAbs Therapeutics, Inc., with a site in Nutley, announced the appointment of Doug Gentilcore as Senior Vice President, Head of DANYELZA Business Unit. Mr. Gentilcore brings over two decades of strategic leadership experience in the pharmaceutical industry. Prior to joining Y-mAbs, he served as Chief Commercial Officer and then Chief Executive Officer of ARTMS, Inc., a global leader in the development of novel technologies and products which enable the high-quality and high-yield production of the world’s most-used diagnostic imaging isotopes. Upon the company’s acquisition by Telix Pharmaceuticals, Mr. Gentilcore returned to a full-time role at Implerem, LLC, a commercial pharmaceutical consulting firm he founded in 2019. Prior to ARTMS, Mr. Gentilcore was Vice President of Global Sales and Business Operations at Jubilant Radiopharma, where he led all commercial operations for the company. 

Kenvue Names Somaya Chief Data & Analytics Officer

Vikram Somaya has been named Chief Data and Analytics Officer at Kenvue, the soon-to-be Summit spinoff of BioNJ Member Johnson & Johnson that is the world’s largest pure-play consumer health company. With decades of experience in data, analytics and digital transformation, Mr. Somaya brings a wealth of expertise from his global leadership roles in the CPG industry. Kenuve Chief Technology & Data Officer Bernardo Tavares applauded the announcement. “Vikram brings to Kenvue a wealth of experience and expertise in global data and analytics, product development and AI,” he said. “With over 26 years of experience, he has a proven track record of building and scaling data-driven businesses across some of the world’s largest corporations and startups.”

BD Names Pamela Spikner as Chief Accounting Officer and Controller

Franklin Lakes-based BD announced that Pamela Spikner has been named Senior Vice President, Chief Accounting Officer and Controller. In this role, Ms. Spikner will be responsible for all accounting policy and financial reporting for the company. She will report to Chris DelOrefice, Executive Vice President and Chief Financial Officer. “Pam has a proven track record of leadership in corporate finance and accounting, with a deep passion for building and leading high-performing teams,” DelOrefice said. “Her more than 25 years of expertise will play a pivotal role in the continued leadership of the finance organization at BD.” Ms. Spikner joins BD from R1 RCM, Inc., which provides technology-enabled revenue cycle management solutions to health care providers, where she served as Chief Accounting Officer since July 2021.

Life Sciences Companies: Offsetting Payroll Taxes With R&D Tax Credits

An article published by BioNJ Member CohnReznick

Life sciences companies have experienced exponential growth through advancements in technology, scientific discoveries and continued research and development. Countless new companies are seizing growth opportunities in the space and contributing to a booming industry by making significant advancements in biomedicine and biotechnology. Life sciences companies invest billions annually in designing new drugs, medical devices, and testing methods. Despite these costly and time-consuming efforts, a significant number of products never reach commercial production.

Eisai Listed as a Global 100 Most Sustainable Corporation for the Ninth Time

Eisai Co., Ltd. announced that it has been listed in the 2025 Global 100 Most Sustainable Corporations in the World (Global 100). This marks Eisai’s ninth inclusion on the list. Ranked 35th, Eisai is the highest ranking among global pharmaceutical companies. Eisai was also the highest ranking among the three Japanese companies listed in the Global 100. The Global 100 evaluates the sustainability of more than 8,300 of the world’s major corporations based on various corporate initiatives in areas such as ESG (environment, society and governance). 

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.

44th Annual Coriell Institute Science Fair

March 15, 2025 | Hosted by Camden County College, Blackwood, NJ

Join us as a sponsor of the 44th Annual Coriell Institute Science Fair! Support middle and high school students from Camden, Gloucester, and Burlington counties as they embark on their journey to the Delaware Valley Science Fair and the Regeneron International Science and Engineering Fair (ISEF), where they can compete for over $8 million in awards and scholarships. Samantha Piccolo at spiccolo@coriell.org can provide more details.