Assessment of the SBIR and STTR Programs at the National Institutes of Health

This report examines the observable impact of the National Institutes of Health (NIH) Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) programs based on key metrics of innovation and commercialization, including publications, patents, clinical trials, drugs, medical devices and follow-on funding from venture capitalists. NIH SBIR/STTR–funded firms have produced a number of clinically significant drugs and devices. Although it is difficult to prove that SBIR/STTR funding affected the ability of these firms to develop and produce these important drugs and devices, the awardee firms have had better commercialization outcomes relative to firms that did not receive this funding.

Part D Shift, IRA Penalties and Access Risks

Kirsten Axelsen is an economist specializing in Medicare reimbursement, payer negotiations and innovative reimbursement contracts. She’s a fellow of the Aspen Institute and a visiting scholar with the American Enterprise Institute. She joins host Duane Schulthess to unpack bipartisan pressure on drug prices, the Part D redesign’s rapid shift of catastrophic costs to plans and the resulting premium versus coverage tradeoffs and PDP exits. Axelson explains why forecasting IRA impacts is uncertain, how nine versus thirteen-year timelines tilt incentives toward biologics, and why price controls can weaken both generic entry and biosimilar uptake. The discussion explores MFN-style ideas and trade uncertainties, vertical integration around biosimilars and practical fixes from EPIC-like timelines to building a faster, more connected U.S. clinical-trial ecosystem with better participant support.

Genmab Receives FDA Breakthrough Therapy Designation for Rinatabart Sesutecan (Rina-S) in Advanced Endometrial Cancer (EC)

Princeton-based BioNJ Member Genmab A/S announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to rinatabart sesutecan (Rina-S), an investigational folate receptor alpha (FRα)-directed, TOPO1-inhibitor antibody-drug conjugate (ADC), for the treatment of adult patients with recurrent or progressive endometrial cancer (EC) who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy. BTD aims to expedite the development and review of investigational medicines by the U.S. FDA for serious or life-threatening diseases in cases where preliminary clinical evidence shows that a therapy may provide substantial improvements over available therapies. The designation was supported by previously published results from the endometrial cancer monotherapy dose expansion B2 cohort of the multi-part, Phase 1/2 RAINFOL™-01 trial (NCT05579366), evaluating the safety and efficacy of Rina-S in solid tumors.

BeOne Medicines Announces Positive Topline Results for Sonrotoclax in Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Hopewell-based BioNJ Member BeOne Medicines Ltd announced positive topline results from a Phase 1/2 study (BGB-11417-201) of sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, in adult patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase inhibitor (BTKi) and anti-CD20 therapy. The BGB-11417-201 (NCT05471843) study is a global, multicenter, single-arm, open-label, Phase 1/2 study, which enrolled 125 adult patients with R/R MCL post-treatment with anti-CD20 therapy and a BTK inhibitor. In Part 1, 22 patients received daily treatment with either 160 mg or 320 mg of sonrotoclax to assess the safety and tolerability of sonrotoclax and identify the recommended dose for Part 2. In Part 2, 103 patients were enrolled to receive the recommended daily dose of sonrotoclax (320 mg), following ramp-up, to assess the efficacy and safety of sonrotoclax.

European Commission Approves Tablet Formulation of BeOne Medicines’ BRUKINSA for All Approved Indications

Hopewell-based BioNJ Member BeOne Medicines Ltd. announced that the European Commission has approved a new film-coated tablet formulation of BRUKINSA (zanubrutinib) for all approved indications. "Developed to meet the real-world needs of patients, the new BRUKINSA tablet formulation aims to simplify treatment, reduce pill burden, and enhance ease of administration, reflecting our continuous focus on patient-centered innovation,” said Giancarlo Benelli, Senior Vice President and Head of Europe, BeOne. “With more than 200,000 patients treated globally and the broadest label of any BTK inhibitor in Europe, BRUKINSA's differentiated clinical profile continues to make an impact for people facing certain B-cell cancers." The recommended dose of BRUKINSA continues to be 320 mg daily. The BRUKINSA tablets are 160 mg each, allowing patients to halve their daily pill intake from four pills to two.

Teva Announces FDA Approval and Launch of Generic Saxenda (liraglutide injection) – First Generic GLP-1 Indicated for Weight Loss

Parsippany-based BioNJ Member Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced the FDA approval and U.S. launch of a generic version of Saxenda (liraglutide injection). “With this approval, and by launching a generic for Saxenda (liraglutide injection), we will provide patients in the U.S. the first ever generic GLP-1 product specifically indicated for weight loss,” said Ernie Richardsen, Senior Vice President, Head of U.S. Commercial Generics at Teva. “This is the fifth first-to-market entry of a Teva generic this year and is an important addition to Teva's diverse complex generics portfolio, demonstrating once again our proven ability to sustain a world class Generics Powerhouse.”

Teva’s Emrusolmin Granted U.S. FDA Fast Track Designation for Treatment of Multiple System Atrophy

Parsippany-based BioNJ Member Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Teva’s investigational therapy emrusolmin (TEV-56286) for the treatment of Multiple System Atrophy (MSA). Emrusolmin is part of a strategic collaboration with MODAG GmbH, a privately held German biotech company, and is currently being evaluated in a Phase 2 trial to assess its efficacy and safety. The U.S. FDA granted Orphan Drug designation to emrusolmin for MSA in 2022. Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer at Teva, said “The promising potential of emrusolmin is a testament to what we are building at Teva – a pipeline that truly meets patients’ needs and strategic partnerships that drive innovation.”

Pfizer and BioNTech Announce Topline Data Demonstrating Robust Immune Response With Their LP.8.1-Adapted COVID-19 Vaccine 2025-2026 Formula

BioNJ Member Pfizer Inc., with a site in Parsippany, and BioNTech SE announced positive topline results from an ongoing Phase 3 clinical trial cohort evaluating the safety, tolerability, and immunogenicity of a 30-µg dose of the LP.8.1-adapted monovalent COMIRNATY® (COVID-19 Vaccine, mRNA) 2025-2026 Formula in adults aged 65 and older and in adults aged 18 through 64 with at least one underlying risk condition for severe COVID-19. The preliminary data show a robust increase in neutralizing antibodies targeting the LP.8.1 sublineage of SARS-CoV-2 following vaccination. These clinical findings reinforce pre-clinical data that supported the recent U.S. Food and Drug Administration (FDA) approval of the LP.8.1-adapted COVID-19 vaccine, which demonstrated improved immune responses against multiple circulating SARS-CoV-2 sublineages.

Lexicon Pharmaceuticals Announces Submission of Additional Data to U.S. FDA Supporting the Benefit-Risk Profile of Zynquista® in Type 1 Diabetes

BioNJ Member Lexicon Pharmaceuticals, with a site in Bridgewater, announced that the company has submitted additional clinical data to the U.S. Food and Drug Administration (FDA) from ongoing third-party funded, investigator-initiated studies supporting the potential resubmission of the New Drug Application for Zynquista^® (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin for glycemic control in adults with type 1 diabetes (T1D). The submission of additional clinical data follows a complete response letter issued by the FDA in December 2024 that cited concerns of increased risk of diabetic ketoacidosis. Based on subsequent discussions with FDA regarding potential regulatory paths forward, Lexicon has been granted a Type D meeting and has submitted data from three ongoing studies of sotagliflozin conducted by the Steno Diabetes Center (STENO1), the Joslin Diabetes Center (SUGARNSALT) and the University of Dundee (SOPHIST) supporting the benefit-risk profile of Zynquista in T1D.

Lactiga Wins NIH Backing for First-in-Class Breastmilk-Derived Antibody in Inflammatory Bowel Disease

North Brunswick-base BioNJ Member Lactiga US, Inc., announced it has received an award from the National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases, to advance the development of its secretory IgA (sIgA) antibody for inflammatory bowel disease (IBD). Lactiga's innovation centers on secretory IgA (sIgA) purified from human breastmilk to address dysregulated immune systems triggering inflammation. The therapy will be intended to act at the intestinal mucosa, with the potential to neutralize luminal antigens, strengthen epithelial barrier function, and minimize adverse events. "It's no coincidence that the dominant antibody regulating our gut immune system is the same one found in breastmilk," said Rik Mehta, Pharm.D., J.D., Co-Founder and CEO of Lactiga. "Our mission is to tackle chronic disease by creating medicines that build on the natural attributes of our body's own immune system, moving past the concerns with synthetically engineered or recombinant approaches."

Pfizer and BioNTech’s COMIRNATY Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19

BioNJ Member Pfizer Inc., with a site in Parsippany, and BioNTech SE announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY LP.8.1; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. The FDA approval is based on the cumulative body of evidence supporting the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine, including clinical trial data supporting the approval for children 5 through 11 years of age.

Sanofi’s SAR402663 Earns Fast Track Designation in the U.S. for Neovascular Age-Related Macular Degeneration

Ridgefield-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration (FDA) has granted fast track designation to SAR402663, an investigational one-time intravitreal gene therapy for the treatment of neovascular age-related macular degeneration (AMD). The fast-track designation process aims to facilitate the development and expedite the review of medicines to treat serious conditions and fill unmet medical need. The FDA created this process to help deliver important new drugs to patients earlier and it covers a broad range of serious illnesses. SAR402663 delivers genetic material encoding soluble FLT01 designed to inhibit vascular endothelial growth factor (VEGF). Sanofi is currently evaluating SAR402663 in a phase 1/2 (clinical study identifier: NCT06660667), for the treatment of patients with neovascular AMD.

Tzield Approved in China as First Disease-Modifying Therapy for Adult and Pediatric Patients With Stage 2 Type 1 Diabetes

Ridgefield-based BioNJ Member Sanofi announced the Chinese National Medical Products Administration (NMPA) has approved Tzield (teplizumab) as the first disease-modifying therapy in autoimmune type 1 diabetes (T1D) indicated to delay the onset of stage 3 T1D in adult and pediatric patients aged eight years and older with stage 2 T1D. The review was completed under priority review, following the recognition by NMPA of Tzield’s innovative profile and the benefit it brings to pediatric patients. The approval is based on the positive results from the TN-10 phase 2 study, which demonstrated Tzield's ability to delay the onset of stage 3 T1D, compared to placebo. The pivotal study demonstrated that a once-daily, single and consecutive 14-day course of Tzield delayed the median onset of stage 3 T1D by 48.4 months vs 24.4 months observed in the placebo group.

Sanofi’s Amlitelimab Met All Primary and Key Secondary Endpoints in the COAST 1 Phase 3 Study in Adults and Adolescents With Atopic Dermatitis

Ridgefield-based BioNJ Member Sanofi announced positive results from the global COAST 1 Phase 3 study (clinical study identifier: NCT06130566) showed that amlitelimab, a fully human non-T cell depleting monoclonal antibody that targets OX40-ligand (OX40L), dosed either every four weeks (Q4W) or every 12 weeks (Q12W), met all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful skin clearance and disease severity compared to placebo at Week 24 in patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD). Amlitelimab was well-tolerated, with no new safety concerns identified in this study. The key endpoints were measured at Week 24 in patients who received amlitelimab either Q4W or Q12W.

Eisai Presents Clinical Study Results of Novel Orexin Receptor Agonist E2086 for Narcolepsy at World Sleep 2025

Nutley-based BioNJ Member Eisai Co., Ltd. announced that the results from a Phase Ib clinical trial (NCT06462404) of its in-house developed novel selective orexin 2 receptor agonist E2086. These data demonstrate that once-daily dosing of E2086 has the potential to improve daytime wakefulness in individuals with narcolepsy type 1 (NT1). This randomized, double-blind, single-dose, multiple crossover, Phase Ib clinical trial was conducted in the United States and Canada to evaluate the efficacy, safety, and tolerability of E2086 in people meeting criteria for NT1, compared with placebo and an existing treatment (modafinil). There were a total of 21 patients in the clinical trial (21 patients received the study medication, 19 patients completed the trial). Participants received a single dose of one of five treatments (E2086 5 mg, 10 mg, 25 mg, placebo, or modafinil) shortly after waking, efficacy assessments were conducted for each treatment.

Eisai Initiated Rolling Supplemental Biologics License Application to the U.S. FDA for LEQEMBI® IQLIK™ (lecanemab-irmb) as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer’s Disease Under Fast Track Status

Nutley-based BioNJ Member Eisai Co., Ltd. and Biogen Inc. announced that Eisai has initiated the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector (SC-AI), LEQEMBI IQLIK, as a weekly starting dose after the FDA granted Fast Track Status. 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). The sBLA is based on evaluation of subcutaneous (SC) lecanemab administration across a range of doses and as part of sub-studies within the Phase 3 Clarity AD open-label extension (OLE), following the 18-month core study in individuals with early AD.

FDA Approves LEQEMBI® IQLIK^TM (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer’s Disease

Nutley-based BioNJ Member Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIK™, for maintenance dosing. LEQEMBI IQLIK is a subcutaneous autoinjector (SC-AI) developed by Eisai, containing 360 mg/1.8 mL (200 mg/mL) that can be administered in approximately 15 seconds. LEQEMBI IQLIK autoinjector is indicated for maintenance dosing to treat Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease in the U.S. After 18 months of LEQEMBI (lecanemab-irmb) intravenous (IV) treatment at 10 mg/kg every two weeks, patients may either continue IV infusions at 10 mg/kg once every four weeks or start the new weekly 360 mg subcutaneous injection using the LEQEMBI IQLIK autoinjector.

Ministry of Health, Labour and Welfare Grants Orphan Drug Designation in Japan to Anticancer Agent Tazemetostat for Unresectable INI1-Negative Epithelioid Sarcoma

Nutley-based BioNJ Member Eisai Co., Ltd. announced that it has received orphan drug designation for anticancer agent the EZH2 inhibitor tazemetostat hydrobromide (generic name, product name “Tazverik Tablets 200 mg”, “tazemetostat”) for unresectable INI1-negative epithelioid sarcoma that has progressed after chemotherapy, from the Ministry of Health, Labour and Welfare (MHLW). Epithelioid sarcoma is a type of soft tissue sarcoma that is a rare cancer estimated to account for about 1% of all soft tissue sarcoma. Only 174 cases were registered from major hospitals across Japan over a 10-year period from 2006 to 2015. Loss of INI1,which is a negative regulator of EZH2, is observed in over 90% of epithelioid sarcoma cases, leading to EZH2 activation that is believed to drive tumor onset and malignant progression.

Austria and Germany to Become the First Markets in the European Union (EU) to Launch LEQEMBI (lecanemab)

Nutley-based BioNJ Member Eisai Co., Ltd. and Biogen Inc. announced that the anti-amyloid beta (Aβ) monoclonal antibody “LEQEMBI” has been launched in Austria on August 25, 2025 and will be launched in Germany on September 1, 2025. LEQEMBI received the European Commission (EC) approval in April 2025 as the first therapy that targets an underlying cause of Alzheimer’s disease (AD). It is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to AD (collectively referred to as early AD) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology. Germany and Austria will mark the first launches in the EU.

Lilly's Jaypirca (pirtobrutinib), the First and Only Approved Non-Covalent (reversible) BTK Inhibitor, Significantly Improved Progression-Free Survival in Patients With Treatment-Naïve CLL/SLL

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced positive topline results from the Phase 3 BRUIN CLL-313 clinical trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, versus chemoimmunotherapy (bendamustine plus rituximab), in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions. The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemoimmunotherapy, as assessed by an independent review committee (IRC), indicating one of the most compelling effect sizes ever observed for a single agent BTK inhibitor in a front-line CLL study. Overall survival (OS), a key secondary endpoint, was not yet mature at this analysis, but was trending strongly in favor of pirtobrutinib and will be tested for statistical significance at the time of the primary OS analysis, which is anticipated to occur in 2026.

Lilly's Olomorasib Receives U.S. FDA's Breakthrough Therapy Designation for the Treatment of Certain Newly Diagnosed Metastatic KRAS G12C-Mutant Lung Cancers

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib, in combination with anti-PD-1 therapy KEYTRUDA (pembrolizumab), for the first-line treatment of patients with unresectable advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation and PD-L1 expression ≥ 50%, as determined by FDA approved tests. Olomorasib is a potent and highly selective second-generation inhibitor of KRAS G12C with preliminary evidence of central nervous system (CNS) activity. Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval.

Lilly's Oral GLP-1, Orforglipron, is Successful in Third Phase 3 Trial, Triggering Global Regulatory Submissions This Year for the Treatment of Obesity

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced positive topline results from the Phase 3 ATTAIN-2 trial, evaluating orforglipron, an investigational oral GLP-1 receptor agonist, in adults with obesity or overweight and type 2 diabetes. In the trial, all three doses of orforglipron met the primary and all key secondary endpoints, delivering significant weight loss, meaningful A1C reductions, and improvements in cardiometabolic risk factors at 72 weeks. For the primary endpoint, orforglipron 36 mg, taken once per day without food and water restrictions, lowered weight by an average of 10.5% (22.9 lbs) compared to 2.2% (5.1 lbs) with placebo using the efficacy estimand.¹ With the completion of ATTAIN-2, Lilly now has the full clinical data package required to initiate global regulatory submissions for orforglipron.

Lilly's Verzenio (abemaciclib) Increases Overall Survival in HR+, HER2-, High-Risk Early Breast Cancer With Two Years of Therapy

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced positive topline results from the primary overall survival (OS) analysis of the Phase 3 monarchE trial. Treatment with two years of Verzenio plus endocrine therapy (ET) demonstrated a statistically significant and clinically meaningful improvement in OS compared to ET alone in patients with hormone receptor positive (HR+), HER2-, node-positive, high-risk early breast cancer. The seven-year landmark analysis also demonstrated sustained benefit in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), reinforcing the consistency and durability of treatment effect across endpoints. With all patients having completed or discontinued the two-year course of Verzenio, the overall safety profile of Verzenio was unchanged and consistent with previous reports.

FDA Grants HERNEXEOS® Breakthrough Therapy Designation for First Line Use in HER2 (ERBB2)-Mutant Advanced NSCLC

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, announced HERNEXEOS® (zongertinib tablets) has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for first-line treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations. HERNEXEOS was recently approved by the U.S. FDA for adult patients with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. This indication is approved under accelerated approval based on objective response rate and duration of response.

Soligenix Announces Publication Describing Long-Term High Temperature Stability of Protein Subunit Vaccines for Ebola and Related Viruses

Princeton-based BioNJ Member Soligenix, Inc. announced a publication describing the extended stability of ebolavirus vaccines using its ThermoVax® platform. Bivalent and trivalent vaccines, constructed from antigens against Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus and the CoVaccine HT™ antigen, were formulated in a single vial and subjected to long-term storage at up to 40°C (104°F). After two years of storage, all vaccines were unchanged and had equivalent potency as when initially manufactured. In collaboration with Axel Lehrer, Ph.D., Professor at the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawaiʻi at Mānoa, the manuscript entitled "Thermostable Bivalent & Trivalent Filovirus Vaccines from Insect Cells: Potency Demonstrated after 3 Months and 2 Years", has been accepted for publication and is available online in Vaccine.

Libtayo® (cemiplimab) Plus Chemotherapy Results at Five Years Reinforce Significant and Durable Improvements in Survival Outcomes for Advanced Non-small Cell Lung Cancer

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced five-year follow-up results on overall survival (OS) from the Phase 3 EMPOWER-Lung 3 trial, which evaluated Libtayo^® (cemiplimab) plus platinum-based chemotherapy versus chemotherapy alone as a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations. “After more than five years of follow-up, the EMPOWER-Lung 3 trial continues to demonstrate sustained survival – with an impressive overall survival probability of 19.4% at five years – when Libtayo is added to chemotherapy in patients with advanced non-small cell lung cancer,” said Ana Baramidze, M.D., Ph.D., Head of Clinical Research Department at Todua Clinic, Tbilisi, Georgia.

Regeneron Announces Positive Results from Phase 3 Trial in Generalized Myasthenia Gravis

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced that the primary and key secondary endpoints were met in the Phase 3 NIMBLE trial assessing investigational cemdisiran monotherapy in adults with generalized myasthenia gravis (gMG). Cemdisiran is an siRNA that reduces circulating levels of complement factor 5 (C5) and, as monotherapy in this trial, was associated with an average of 74% inhibition of complement activity. The trial also assessed a combination of cemdisiran and pozelimab, a C5 antibody; this combination (“cemdi-poze”), which resulted in nearly 99% inhibition of complement activity, also met the primary and key secondary endpoints, though cemdisiran monotherapy was numerically better across these endpoints. The NIMBLE trial evaluated adults with symptomatic gMG who have antibodies to the acetylcholine receptor (anti-AChR) and may be receiving standard of care immunosuppressants based on the investigator’s discretion.

Gilead Announces Partnership With PEPFAR to Deliver 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 partnership with the U.S. State Department and the United States President’s Emergency Plan for AIDS Relief (PEPFAR) to deliver lenacapavir — Gilead's twice-yearly injectable HIV-1 capsid inhibitor — for the prevention of HIV as pre-exposure prophylaxis (PrEP). This is a key component of Gilead’s larger coordinated efforts, now bringing together the resources and expertise of both PEPFAR and the Global Fund, to further advance access to lenacapavir for PrEP for up to two million people over three years in countries supported by both organizations. This milestone marks Gilead’s latest progress in executing its ambitious access strategy to enable broad, sustainable access to lenacapavir for PrEP in primarily low- and lower-middle-income countries (LLMICs), if approved. 

European Commission Authorizes Twice-Yearly Yeytuo (Lenacapavir) for HIV Prevention

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, has been granted marketing authorization for Yeytuo (lenacapavir) — the company’s twice-yearly injectable HIV-1 capsid inhibitor — for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk who weigh at least 35kg. Yeytuo is the first and only twice-yearly PrEP option to be approved for use in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein. The marketing authorization application (MAA) was reviewed under an accelerated timeline based on the assessment by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) that twice-yearly Yeytuo is a product of major interest for public health.

RYBREVANT® (amivantamab-vmjw) Plus LAZCLUZE® (lazertinib) Prevents Acquired Resistance Versus Osimertinib in First-Line EGFR-mutated Non-Small Cell Lung Cancer

Raritan-based BioNJ Member Johnson & Johnson announced new analyses from the Phase 3 MARIPOSA study showing that first-line treatment with RYBREVANT^® (amivantamab-vmjw) plus LAZCLUZE^® (lazertinib) significantly reduces the development of epidermal growth factor receptor (EGFR)- and MET-driven resistance compared with osimertinib in patients with EGFR-mutated non-small cell lung cancer (NSCLC) with exon 19 deletion (ex19del) or L858R mutations. These resistance data build on the combination’s previously reported and unmatched overall survival benefit in a chemotherapy-free regimen, which is projected to exceed four years, one year beyond the median observed with osimertinib and underscore its potential to change the biology of the disease by preventing acquired resistance. Resistance to third-generation EGFR tyrosine kinase inhibitors (TKIs), such as osimertinib given alone or with chemotherapy, remains a common and major barrier to long-term disease control.

U.S. FDA Approval of INLEXZO™ (gemcitabine intravesical system) Set to Transform How Certain Bladder Cancers are Treated

Raritan-based BioNJ Member Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approved INLEXZO™ (gemcitabine intravesical system), a new, potentially practice-changing approach for treating patients with certain types of bladder cancer, addressing the need for additional options following unsuccessful BCG therapy and for patients refusing or ineligible for bladder removal surgery (radical cystectomy). INLEXZO™, previously referred to as TAR-200, is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. INLEXZO™ is designed for patients seeking bladder preservation and is the first and only intravesical drug releasing system (iDRS) to provide extended local delivery of a cancer medication into the bladder.

New Data from the DanGer Shock Randomized Control Trial, Published in The New England Journal of Medicine, Confirms the Long-Term Survival Benefit of the Impella CP Heart Pump

New Brunswick-based BioNJ Member Johnson & Johnson announced late breaking clinical science data published in the New England Journal of Medicine (NEJM), finds at up to 10 years, when compared to standard care, routine use of Impella CP® in patients who have had a heart attack with cardiogenic shock leads to an absolute mortality reduction of 16.3% (95% CI: 0.54 to 0.92)1. When compared to the control arm at 10 years, Impella CP patients gained an average of 600 additional days alive (95% CI: 235 – 966 days). These new findings from the long-term follow up of patients in the investigator-initiated DanGer Shock randomized controlled trial (RCT) were presented at ESC by the trial’s principal investigator, Jacob Møller, M.D.

First Disclosure of Global Interim Phase 2 Data for BioNTech and Bristol Myers Squibb PD-L1xVEGF-A Bispecific Antibody Pumitamig (BNT327/BMS986545) in Patients With Extensive-Stage Small Cell Lung Cancer Shows Encouraging Antitumor Activity

Princeton-based BioNJ Member Bristol Myers Squibb Company and BioNTech SE presented interim data from a global randomized Phase 2 trial (NCT06449209) evaluating pumitamig (also known as BNT327 or BMS986545), an investigational bispecific antibody targeting PD-L1 x VEGF-A, plus chemotherapy in patients with extensive-stage small cell lung cancer (“ES-SCLC”). The data from a Phase 2 trial conducted in China (NCT05844150) showed encouraging anti-tumor responses with a positive trend in the secondary endpoint progression free survival. Pumitamig plus chemotherapy demonstrated a manageable safety profile with no new safety signals and a low discontinuation rate. The interim analysis included 43 patients with untreated extensive-stage small cell lung cancer (Cohort 1) who received pumitamig in combination with standard of care chemotherapy in two dose levels. 

Novartis to Acquire Tourmaline Bio, Complementing Cardiovascular Pipeline With Pacibekitug for the Treatment of Atherosclerotic Cardiovascular Disease (ASCVD)

East Hanover-based BioNJ Member Novartis announced that it has entered into an agreement to acquire Tourmaline Bio, Inc. Pacibekitug complements Novartis’ cardiovascular strategy by targeting IL-6, a key upstream cytokine that promotes systemic inflammation, thus addressing a critical unmet need. With Phase 21 trials already well advanced, Novartis will acquire a Phase 3 ready asset which will complement its existing cardiovascular disease portfolio. Pacibekitug is an investigational anti-IL-6 IgG2 human monoclonal antibody designed to mitigate systemic inflammation implicated in ASCVD and has demonstrated high affinity binding to IL-6. The Phase 2 TRANQUILITY 90-day study results which were released on May 20, 2025, showed that pacibekitug reduced median high-sensitivity C-reactive protein (hs-CRP) levels by 85% through day 90 at a dose of 15 mg once monthly and by 86% at a dose of 50 mg delivered quarterly, with overall incidence rates of adverse events and serious adverse events comparable to placebo.

AbbVie Announces Updated Results from Phase 2 EPCORE® NHL-6 Study Evaluating the Potential for Outpatient Monitoring of Epcoritamab in Patients With Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)

BioNJ Member AbbVie, with a site in Madison, announced updated results from the Phase 2 EPCORE® NHL-6 trial (NCT05451810) evaluating the feasibility of dosing and monitoring patients in the outpatient setting for the first full dose of epcoritamab monotherapy, a T-cell engaging bispecific antibody administered subcutaneously, in adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of systemic therapy. Results from the study demonstrated that the incidence and severity of cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) following treatment with epcoritamab were consistent with previous epcoritamab studies in R/R DLBCL. In the study, 88 patients received the first full dose (48 mg) of epcoritamab monotherapy. Of these, 81 patients (92%) were monitored in the outpatient setting and seven (8%) in the inpatient setting.

AbbVie to Acquire Gilgamesh Pharmaceuticals' Bretisilocin, a Novel, Investigational Therapy for Major Depressive Disorder, Expanding Psychiatry Pipeline

BioNJ Member AbbVie, with a site in Madison, and Gilgamesh Pharmaceuticals Inc. announced a definitive agreement under which AbbVie will acquire Gilgamesh's lead investigational candidate, currently in clinical development for the treatment of patients with moderate-to-severe major depressive disorder (MDD). Psychedelic compounds, including 5-HT2A receptor agonists, have gained recognition as potential treatments for mental health disorders, such as MDD, because of their demonstrated rapid, robust and durable antidepressant effects. However, existing agents in this class are hampered by their long duration of psychoactive experience. Bretisilocin, a 5-HT2A receptor agonist and 5-HT releaser, is a novel, next-generation psychedelic compound designed to address development challenges observed within this class of compounds. Bretisilocin has been shown to exert a shorter duration of psychoactive experience, while retaining an extended therapeutic benefit.

CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) Demonstrates Positive Immune Responses in Children and Adolescents at Increased Risk of Pneumococcal Disease

Rahway-based BioNJ Member Merck & Co. announced positive results from the Phase 3 STRIDE-13 trial evaluating CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine). The trial evaluated the safety, tolerability and immunogenicity of CAPVAXIVE compared to PPSV23 (pneumococcal 23-valent polysaccharide vaccine) in children and adolescents aged 2 to <18 years who have completed a primary pediatric pneumococcal vaccination regimen and have one or more chronic medical conditions that put them at an increased risk of pneumococcal disease. The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B is approved under accelerated approval based on immune responses as measured by OPA.

Merck’s Investigational Oral PCSK9 Inhibitor Enlicitide Decanoate Met All Primary and Key Secondary Endpoints in Adults With Hypercholesterolemia in Pivotal CORALreef Lipids Study

Rahway-based BioNJ Member Merck & Co. announced positive topline results from the Phase 3 CORALreef Lipids trial evaluating the safety and efficacy of enlicitide decanoate, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hypercholesterolemia on a moderate or high intensity statin (or with documented statin intolerance). The CORALreef Lipids trial successfully met all primary and key secondary endpoints. Treatment with enlicitide resulted in statistically significant and clinically meaningful reduction in low-density lipoprotein cholesterol (LDL-C) compared to placebo at Week 24. Statistically and clinically significant reductions were also seen for enlicitide versus placebo across all key secondary endpoints including in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and lipoprotein(a) [Lp(a)]. 

Ifinatamab Deruxtecan Demonstrated Clinically Meaningful Response Rates in Patients With Extensive-Stage Small Cell Lung Cancer in IDeate-Lung01 Phase 2 Trial

Results from the IDeate-Lung01 Phase 2 trial showed that ifinatamab deruxtecan (I-DXd) demonstrated clinically meaningful response rates in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC). Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Basking Ridge-based Daiichi Sankyo and Rahway-based BioNJ Member Merck & Co. SCLC is aggressive and progresses rapidly to the distant metastatic stage, which has a low five-year survival rate. While conventional standard of care treatments for patients with advanced SCLC may help improve outcomes, there is a need for additional subsequent treatment approaches.

Merck Provides New Results for VERQUVO® (vericiguat) in Patients With Chronic Heart Failure and Reduced Ejection Fraction

Rahway-based BioNJ Member Merck & Co. announced results evaluating VERQUVO® (vericiguat) in adult patients with stable chronic heart failure and reduced ejection fraction (HFrEF). The Phase 3 VICTOR trial comparing the efficacy of VERQUVO to placebo in patients with HFrEF without a recent worsening heart failure event treated with guideline-directed medical therapy (GDMT) did not reach statistical significance for its primary endpoint of combined time to first event of cardiovascular death or hospitalization for heart failure. In a separate pre-specified pooled analysis of patient-level data from the complementary Phase 3 VICTOR and VICTORIA trials, VERQUVO reduced the risk of the composite primary endpoint of cardiovascular death or heart failure hospitalization across these patients with a broad range of disease severity.

Made Scientific Partners With Hemogenyx Pharmaceuticals to Advance Leukemia Therapy

Princeton-based BioNJ Member Made Scientific, a cell therapy contract development and manufacturing organization (CDMO), and Hemogenyx Pharmaceuticals, a clinical-stage biopharmaceutical company, announced a new partnership to advance HG-CT-1, a CAR-T cell therapy for the treatment of relapsed/refractory acute myeloid leukemia (r/r AML).

Under this agreement, Hemogenyx will use Made Scientific’s expertise and its GMP-compliant facilities in Newark and Princeton for the technology transfer and manufacturing of HG-CT-1. The partnership is a crucial step in advancing Hemogenyx’s ongoing Phase I clinical trial for adult patients and could support the future inclusion of a pediatric cohort. Early clinical data from the trial has shown promising results, building confidence in both the therapy’s safety and potential efficacy.

48 N.J. Organizations Make Forbes’ Best-in-State Employers 2025 List

Forty-eight New Jersey-based companies have been named in Forbes’ America’s Best-in-State Employers 2025 list. According to Forbes, the survey measures leading companies from around the United States to identify those best-liked by employees. The list was created by partnering with market research firm Statista to anonymously survey over 160,000 full- and part-time workers at companies across the United States with more than 500 employees. Congratulations to these BioNJ Members for being named to the list: Hackensack Meridian Health, Inspira Health Network, Johnson & Johnson, Merck & Co., New Jersey Institute of Technology, Novartis, Princeton University, Rowan University, Rutgers University and Sanofi.

CorMedix Completes $300M Acquisition of BioNJ Member Melinta Therapeutics

CorMedix Inc. completed its acquisition of Melinta Therapeutics LLC for approximately $300 million, the Berkeley Heights-based biopharmaceutical company announced. Melinta is a Parsippany-based private commercial-stage company that focuses on therapies for acute and life-threatening illnesses. The deal also includes an additional payment of up to $25 million for the U.S. Food and Drug Administration approval of the expanded indication of Rezzayo. That condition applies if the milestone is achieved by June 30, 2029. The medication is a treatment for invasive fungal infections in adults undergoing allogeneic blood and marrow transplantation. In addition to Rezzayo, Melinta’s marketed-product portfolio includes: Minocin, Vabomere, Orbactiv, Baxdela, Kimyrsa and Toprol-XL. 

SK Bioscience Submits IND for Phase 3 Trial of 2-Dose Varicella Vaccine Reflecting Global Standard Shift

Paramus-based SK Bioscience announced that it has submitted an IND (Investigational New Drug application) to the Ministry of Food and Drug Safety for a global Phase 3 clinical trial of SKYVaricella to add the 2-dose (two-shot) indication, aligning with evolving international standards that increasingly recommend two doses to provide stronger, longer-lasting protection against varicella. The trial will evaluate the immunogenicity and safety of two doses in roughly 800 children aged 12 months to 12 years, with completion targeted by 2027. Varicella vaccines have effectively reduced disease and complications with a single dose, which has been the standard in many countries. However, breakthrough infections may occur over time and international standards are shifting toward a 2-dose schedule to provide stronger, longer-lasting immunity and reduce community transmission.

Idorsia to Collaborate With Two Leading Academic Medical Centers to Launch IMPACT-HTN – a US Initiative to Transform Care for Patients With Difficult-to-Control Hypertension

Idorsia Ltd, with a site in Cherry Hill, announces a first-of-its-kind initiative with the Stanford Hypertension Center and Duke Heart Center to launch IMPACT-HTN, a new three-phase program to transform and modernize the management of difficult-to-control hypertension. Patients requiring multiple medications for difficult-to-control hypertension face increasing challenges with care coordination, evaluation of underlying causes, and worsening outcomes. The initiative, led by Dr. Vivek Bhalla of the Stanford University School of Medicine and Dr. Sreekanth Vemulapalli of Duke University School of Medicine, is expected to generate real-world evidence, standardize clinical decision-making and deliver scalable tools that leverage AI technology to help identify patients with difficult-to-control hypertension who may benefit from innovative therapies that utilize new pathways, including Idorsia's once-daily TRYVIO™ (aprocitentan), the first systemic hypertension treatment to target a new pathway in over 30 years.

FDA Accepts Bayer Magnetic Imaging Agent Application for Review

Pharmaceutical giant Bayer, which has offices in Morristown and Whippany, said that a new drug application for its investigational contrast agent gadoquatrane has been accepted for review by the Food and Drug Administration. The application for gadoquatrane has been filed for contrast-enhanced magnetic resonance imaging of the central nervous system and other body regions in adults and pediatric patients including newborns. If approved, gadoquatrane would become the lowest dose macrocyclic gadolinium-based contrast agent (GBCA) available in the U.S. The submitted dose is 0.04 mmol (millimole) gadolinium per kilogram body weight, corresponding to a 60% reduction compared to macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight.

Nokia Holds Groundbreaking for New HQ at HELIX, New Brunswick

While construction is already underway in New Brunswick on the future 370,000-square-foot home of Nokia Bell Labs, a groundbreaking ceremony was held today at the site – situated directly across from the New Brunswick Train Station – officially commemorating the project. The historic R&D company credited with the development of the transistor, laser and other significant technological breakthroughs, will be relocating its headquarters from Murray Hill to the new site, occupying the entire second phase of the New Jersey Health + Life Science Exchange (HELIX). The 10-story building will be one of the most advanced electronics labs in North America. Nokia is expected to relocate approximately 1,000 employees from its Murray Hill campus – which it has called home for more than 80 years – to the new building, set to be completed by 2028.

India Biopharma Company Biocon Inaugurates First U.S. Manufacturing Facility in Cranbury

Biocon Limited announced the inauguration of its first U.S. manufacturing facility in Cranbury. The state-of-the-art plant, operated by its subsidiary Biocon Generics Inc (BGI), was formally launched by New Jersey Gov. Phil Murphy. Biocon acquired the Oral Solid Dosage (OSD) facility from Eywa Pharma Inc. in 2023 and has since invested more than $30 million to upgrade it. The plant has an annual production capacity of 2 billion tablets. This strategic investment will help the company diversify its manufacturing base and strengthen its supply chain to meet the growing demand for its products in the U.S. Kiran Mazumdar-Shaw, chairperson of Biocon Group, said the facility marks a “new chapter in our journey of global expansion” and reaffirms the company’s commitment to serving patients worldwide. The Cranbury facility is expected to enable faster access to essential therapies and improve supply reliability for patients across the United States.

Lilly Launches TuneLab Platform to Give Biotechnology Companies Access to AI-Enabled Drug Discovery Models Built Through Over $1 Billion in Research Investment

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced the launch of Lilly TuneLab, an artificial intelligence and machine learning (AI/ML) platform that provides biotech companies access to drug discovery models trained on years of Lilly's research data. Lilly estimates that this first release of AI models includes proprietary data obtained at a cost of over $1 billion, representing one of the industry's most valuable datasets used to train an AI system available to biotechnology companies. Lilly TuneLab is powered by Lilly's full drug disposition, safety and preclinical datasets representing experimental data obtained with hundreds of thousands of unique molecules. In return for access, selected biotech partners contribute training data, which fuels continuous improvement for the benefit of others in the ecosystem and ultimately patients.

FDA Grants Quest Diagnostics Breakthrough Device Designation for Haystack MRD Test

BioNJ Member Quest Diagnostics announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Haystack MRD test. The test identifies MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling. The new designation adds to growing evidence of the value of the Haystack MRD test for both clinical and pharmaceutical applications. It also aligns with a robust body of research supporting the potential of ctDNA-based MRD tests to detect residual or recurrent cancer from solid tumors. Quest introduced a clinical laboratory-developed test version of Haystack MRD in late 2024 and is broadening access for oncologists and pharmaceutical partners.

CoreWeave Ventures Launches to Back AI Start-Ups

BioNJ Member CoreWeave announced the launch of a new initiative CoreWeave Ventures. According to the Livingston-based company, the effort is aimed at investing in the future of AI. CoreWeave provides a cloud platform of cutting-edge software that is powering the next wave of AI. Now, CoreWeave Ventures will back founders and companies that are developing the platforms and technologies shaping the AI ecosystem, as well as the next frontier of computing. “We started CoreWeave with the conviction that AI’s true promise required a cloud platform built from the ground up to optimize for AI specific workloads,” said Brannin McBee, co-founder and chief development officer, CoreWeave. “It took audacity, humility, and the support of other believers who helped us create the cloud platform of choice for many of the largest AI labs and enterprises.” The company says that by providing investment resources, technical expertise and compute, CoreWeave Ventures will enable founders to bring new ideas to market faster.

CoreWeave Buys OpenPipe to Strengthen AI Agent Capabilities

In a strategic move to solidify its position as a leader in AI infrastructure, Livingston-based BioNJ Member CoreWeave, the “AI Hyperscaler,” announced a definitive agreement to acquire OpenPipe Inc., a platform specializing in training AI agents with reinforcement learning (RL). The acquisition builds on CoreWeave’s recent efforts to vertically integrate its technology stack, following its acquisition of AI developer platform Weights & Biases. The deal brings together CoreWeave’s high-performance AI cloud with OpenPipe’s advanced self-learning technology. OpenPipe has developed a widely used open-source RL toolkit for training agents, known as Agent Reinforcement Trainer (ART). This technology enables AI models to learn from experience, continuously increasing in accuracy, performance and reliability over time. The company’s tools are designed to democratize reinforcement learning for developers and enterprises, bridging the gap between a prototype and a production-ready system.

Revolutionary Science Meets Entrepreneurial Excellence

In an industry where walls are built faster than barriers are broken, Pop Test Oncology LLC, operating as Palisades Therapeutics, based in Cliffside Park, has pioneered a model that is reshaping pharmaceutical R&D. For 15 years, our unique brain trust platform through our collaborators, has generated over $50 million in non-dilutive funding with zero salaried employees — demonstrating that the future of drug development lies not in buildings, but brilliant minds working in concert. With 908 studies completed, our PT platform stands as one of the most extensively researched, multi-market initiatives spanning: oncology, immunotherapy, host directed antivirals, neuropsychiatric and metabolic disorders and agricultural biotechnology. The scale and versatility align with what pharmaceutical companies seek in high-value acquisition and partnership opportunities.

South Jersey’s Expanding Spirit of Entrepreneurialism

Replete with quality higher education institutions, lower labor costs, a lower overall cost of living and many untapped business opportunities, South Jersey is fertile ground for entrepreneurs focused on agriculture, tourism, healthcare and manufacturing, as well as those dedicated to microbusinesses or interested in an up-and-coming life sciences scene. Technology is also key. “Robotics, automation and doing things more efficiently for less money go hand-in-hand with manufacturing, agriculture and healthcare,” explains Christina M. Renna, President and CEO of the Chamber of Commerce of Southern New Jersey. “That’s where you’re going to see entrepreneurship thrive.” She adds, “Of course, on a smaller scale, when you look at our boardwalks, beaches and the hospitality industry, they are obviously a critical component of our [entrepreneurial] environment as well. Someone who is idealistic and wants to open their own small business has ample opportunities to do so [ranging], from the Jersey Shore to the City of Camden, to a boardwalk, or a Main Street.”

Princeton University Researchers and Jefferson Papers Receive NEH Grants

The National Endowment for the Humanities (NEH) has awarded three grants to Princeton University researchers and a major university project, totaling more than $800,000 in funding for a diverse range of humanities projects. The grants will support the study of ancient cultures, the use of digital tools in education, and the ongoing scholarly publication of the papers of a founding father. Johannes Haubold, a classics professor, received a $300,000 grant for his project, “Library of Babylonian Literature.” The funding will allow him and his collaborators to prepare six volumes of ten ancient Babylonian texts for publication. These texts, which date from as early as 2000 B.C.E., offer insight into the culture of ancient Babylonia, a civilization located in modern-day Iraq.

Rutgers, RWJBarnabas Health, Stevens Receive $2.8M from NIH to Treat Epilepsy

Researchers from Rutgers Health and other institutions were awarded a grant for $2.8 million over the course of three years from the National Institutes of Health to improve implantable devices for epileptic patients. The grant will fund a program to develop the next generation of responsive neurostimulation devices that can be implanted in the brains of people affected with severe epileptic seizures to reduce or eliminate their occurrence. The researchers said an existing device is effective in reducing seizure frequency among patients, however, it eliminates seizures in 15% to 20% percent of them. In addition to Rutgers’ researchers, the study team includes interdisciplinary scientists in the field of AI and neuroscience from Stevens Institute of Technology and physician-scientists from Emory School of Medicine. The Stevens team will focus on developing computer algorithms and models for the project.

Rutgers Taps Biomedical Informatics Expert to Lead New Health AI Center

Rutgers University said it named Leslie Lenert, an internationally recognized expert in informatics, as the first director of its newly established Center for Biomedical Informatics and Health Artificial Intelligence (BMIHAI). The center, a unit of the Rutgers Institute for Health, Health Care Policy and Aging Research (IFH), aims to consolidate health-related data science and AI efforts under one umbrella. Mr. Lenert, who will also serve as a professor at the Robert Wood Johnson Medical School, was selected after an extensive national search. His career has focused on applying data science and interoperability tools to healthcare systems, leading to the creation of mobile health apps and other innovative tools that enhance patient care.

Kean University Awarded $455K Grant from National Science Foundation

Kean University’s mission to produce impactful public research while offering hands-on opportunities for students continues to grow. The school recently announced the latest addition to its research portfolio, a $455,019 grant from the National Science Foundation to study a fungus found on aspen trees, which may lead to development of natural, eco-friendly insect repellents.

The three-year project, which is being funded through the NSF’s Plant-Biotic Interactions program, will be led by Associate Professor Maria Shumskaya (principal investigator) and Assistant Professor Supratik Kar (co-principal investigator). George Chang, the dean of the Dorothy and George Hennings College of Science, Mathematics and Technology, said the grant exemplifies the high-impact research taking place at the school.

Kean University Launches Next Era of AI and Innovation

Kean University President Lamont O. Repollet, Ed.D., announced the launch of a new era for institution, embracing artificial intelligence and innovation while reaffirming that human relationships and values remain central to Kean’s mission. “Kean is driving discovery, expanding opportunities and preparing students to lead in a global society, positioning the University to harness the power of AI to boldly go where no university has gone before,” President Repollet said. He reflected on the university’s tremendous growth over the first five years of his time as president, including its designation as an R2 research university, record enrollment of nearly 19,000 students this fall, and rising levels of faculty research, grants and publications.

Stevens Institute Receives Historic $21M Investment from the Clark Foundation

Stevens Institute of Technology has received a transformative $21 million commitment from the A. James & Alice B. Clark Foundation – the largest investment in the university’s 155-year history. This support will enhance the Clark Scholars Program, launch the Clark Scholars Philanthropy Challenge Endowed Fund, and include a capital naming opportunity for a tower in the University Center Complex. The investment represents the culmination of a longstanding partnership between Stevens and the Clark Foundation, which has already produced remarkable results through the Clark Scholars Program. Graduates from the program have secured positions at leading companies including Lockheed Martin, Bank of America and Procter & Gamble, while others have earned fully funded Ph.D. fellowships at top institutions and consistently graduated with highest honors.

Hackensack Meridian CDI Gets $37.8M Grant for Drug Discovery

The head of the Hackensack Meridian Center for Discovery and Innovation (CDI) and his collaborators from multiple institutions will lead a drug discovery accelerator to pursue new antibiotics through new federal funding. The $37.8 million, 5-year grant was awarded to the Centers of Excellence for Translational Research (CETR) drug accelerator group led by David Perlin, Ph.D., chief scientific officer and executive vice president of the CDI. The award from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) follows several other major federal awards for drug-discovery teams led by Dr. Perlin, who brings together a host of institutions to collaborate and further the science. This newly funded CETR group will continue to unite experienced drug developers from academic and pharmaceutical/biotech teams: the CDI, Rutgers University, Merck and Prokaryotics.

NJEDA Opens Auction for Up to $60 Million in Business Tax Credits

The New Jersey Economic Development Authority on Tuesday opened the auction for up to $60 million in state tax credits available through the New Jersey Innovation Evergreen Fund Program and the Food Desert Relief Program. The New Jersey Innovation Evergreen Program (NJIEF) helps fund promising high-growth startups by matching private investment with state money raised from selling tax credits to large companies that want to support the state’s economic development efforts. Corporations can purchase credits for a minimum of 75% percent of face value to offset their state Corporation Business Tax or Insurance Premium Tax liability. For the 2025 auction year, $50 million in tax credits is available for purchase through the NJIEF. Eligible bidders purchase at least $500,000 in tax credits. Completed bid applications, including initiating a refundable deposit, must be received by 5 p.m. on Oct. 3, 2025. 

Johnson & Johnson Elects John Morikis, Retired Chairman, President and Chief Executive Officer of The Sherwin-Williams Company, to its Board of Directors

New Brunswick-based BioNJ Member Johnson & Johnson announced that John Morikis, retired Chairman, President and Chief Executive Officer of The Sherwin-Williams Company, has been elected to its Board of Directors. Mr. Morikis is the retired Executive Chairman, President and Chief Executive Officer of The Sherwin-Williams Company, a global leader in the manufacture, development distribution and sale of paint, coatings and related products. He joined Sherwin-Williams in 1984 as a management trainee in the Paint Stores Group. Over the next four decades, he advanced through key leadership roles, including Division President and Group President. From 2006 to 2016, Mr. Morikis served as President and Chief Operating Officer before being appointed Chief Executive Officer, a position he held for eight years.

2025 Female Founded Conference

November 15, 2025 | Hosted by Princeton University

This year’s conference celebrates the powerful intersection of innovation, entrepreneurship, and wellbeing — spotlighting female-founded companies that are redefining the future of healthcare. From cutting-edge wearables and digital health platforms to groundbreaking solutions in mental health and wellness, we’re showcasing a dynamic range of ventures improving lives across the health spectrum. While many of these companies focus on women’s health, the innovations represented span all areas of healthcare and wellbeing, driven by founders who are breaking barriers and building a healthier future for all.

Doing Business in Eurasia

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

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

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.