New Study: Entities that Don’t Make Medicines Get Half of What is Spent on Those Medicines

Half of every dollar spent on brand medicines goes to entities that play no role in the research, development or manufacturing of those medicines, according to a new analysis by Berkeley Research Group (BRG). The report’s findings highlight a growing problem: spending on medicines is padding the profits of middlemen and subsidizing many parts of the health care system, often at the expense of patients. So, where exactly is the money going? It’s going to middlemen like PBMs and insurers who are aggressively consolidating their control over health care; mandatory government fees and rebates; hospitals, clinics and for-profit pharmacies in the 340B markup program; and patient assistance programs designed to help patients in a commercial insurance market that increasingly covers less while charging patients more.

NYT Exposes Hospitals, Middlemen Make Millions Off a Hospital Markup Program

A ground-breaking New York Times investigation reveals how a for-profit federal contractor helps hospitals abuse the 340B program to charge huge markups on medicines. 340B has become a tool for profit, benefiting large hospital systems and private corporations far more than the patients it was designed to serve. Here is what the New York Times uncovered: 340B hospital markups drive billions in profit for hospitals, middlemen. Virginia King, a cancer patient from Santa Fe, NM, received a cancer medicine whose price was drastically marked up by the hospital. The hospital paid only $2,700 for the drug through the 340B program yet billed her insurance $22,700. 340B, which began as a small program to help safety-net providers expand care for needy patients, has seen explosive growth with little evidence of patient benefit.

OPINION: Let Us Make Some Deals

As featured in NJBIZ

As the “medicine chest of the world,” New Jersey has brought new life-altering therapies and cures to patients for decades. Unfortunately, continued medical innovation is under threat from flawed antitrust policies that depart significantly from time-tested competition standards. Collectively, our industry supports more than 116,000 jobs across more than 5,600 establishments in New Jersey and has raised $4.1 billion in venture capital investments from 2019 to 2023. The BioNJ community is dedicated to ensuring a vibrant ecosystem where science is supported, companies are created, drugs are developed and patients are paramount. But achieving this mission is no small feat: The drug development process is a high-stakes journey, typically spanning 10 to 15 years and costing $2 billion to $3 billion to bring a new medicine to market with only 12% of drug candidates entering clinical trials ultimately receiving approval for patient use.

BioNJ Event Honors Innovators in Life Sciences’ Ecosystem

As featured in New Jersey Business Magazine

The State’s life sciences industry honored its own at BioNJ’s annual Dinner Meeting & Innovation Celebration. Held at the Hilton East Brunswick, the gala represented a who’s who of New Jersey’s life sciences ecosystem, including biopharma leaders, patient advocacy champions, heads of research institutions and of course the organizations supporting R&D companies.

BioNJ Celebrates Life Sciences Industry, Honors Innovators

As featured in NJBIZ

New Jersey’s life sciences community is celebrating another year of groundbreaking medical advancements. In welcoming attendees at BioNJ’s 32nd Annual Dinner Meeting & Innovation Celebration, Debbie Hart, President & CEO of BioNJ, praised the “passion and dedication to create a brighter, healthier future for countless lives” from New Jersey’s many “trailblazers, visionaries and tireless champions of health and science” who are “continuing to set the standard for excellence nationwide.” Reflecting on the past 12 months, Hart mentioned several high points, like advancements in the cell and gene therapy field, AI-driven drug development and the advancement of legislation to expand access to biomarker testing for New Jersey patients.

BioNJ President & CEO, Debbie Hart Honored on ROI-NJ 2025 ROI Influencers: Power List

They are the lifeblood of the business industry – and keepers of the faith in the State. This list is the best of the best of chambers of commerce, industry groups and those all-important non-profits. Congratulations to Debbie Hart and all the other honorees for making the ROI-NJ 2025 ROI Influencers: Power List.

BioNJ President & CEO, Debbie Hart Honored on the 2025 NJBIZ Power 100 List

The NJBIZ editorial staff believe the individuals honored here represent the best the State has to offer. They are talented and intelligent professionals, skilled strategists, gifted educators and sharp leaders. They also represent the State’s vibrant diversity on many levels. Congratulations to Debbie Hart and all the other honorees for making the 2025 NJBIZ Power 100 List.

PTC Therapeutics Announces FDA Acceptance and Priority Review for Vatiquinone NDA for the Treatment of Children and Adults with Friedreich's Ataxia

Warren-based BioNJ Member PTC Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for vatiquinone for the treatment of children and adults living with Friedreich's ataxia (FA). The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of Aug. 19, 2025. The vatiquinone NDA is based on data from the placebo-controlled MOVE-FA study as well as results from two long-term studies including pediatric and adult FA patients. Data from these three studies demonstrate significant, durable and clinically meaningful evidence of slowing disease progression on key aspects of disease. In addition, these studies demonstrate that vatiquinone is safe and well tolerated in all age groups studied.

FDA Grants Priority Review to Insmed's Brensocatib for Treatment of Bronchiectasis With PDUFA Target Action Date Set for August 12, 2025

Bridgewater-based BioNJ Member Insmed announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for brensocatib for patients with non-cystic fibrosis bronchiectasis. In its Day 60 communication to Insmed, the FDA granted Priority Review to the NDA and set a target action date of August 12, 2025, under the Prescription Drug User Fee Act (PDUFA). At present, the FDA has not indicated whether an advisory committee will be convened to discuss the application. Brensocatib has the potential to become the first and only approved treatment for bronchiectasis and the first in a new class of medicines called dipeptidyl peptidase 1 (DPP1) inhibitors for the treatment of neutrophil-mediated diseases.

Kyowa Kirin and Kura Oncology Announce Positive Ziftomenib Monotherapy Registrational Trial and Positive FDA Feedback for Upcoming Frontline Combination Trial Designs

BioNJ Member Kyowa Kirin Co., Ltd., with a site in Princeton, and Kura Oncology, Inc. announced positive topline results from KOMET-001, the Phase 2 registration-directed trial of ziftomenib, a highly selective, once-daily, oral investigational menin inhibitor, in patients with relapsed/refractory (R/R) NPM1-mutant (NPM1-m) acute myeloid leukemia (AML). Kura is on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ziftomenib in the second quarter of 2025. The companies also announced they plan to initiate a single protocol containing two independently powered, randomized, double-blind, placebo-controlled, registrational Phase 3 trials to evaluate ziftomenib in combination with both intensive and non-intensive combination regimens in patients with newly diagnosed NPM1-m and KMT2A-rearranged (KMT2A-r) AML, following successful interactions with the FDA.

U.S. FDA Approves Pfizer’s ADCETRIS® Combination Regimen for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application (sBLA) for ADCETRIS® (brentuximab vedotin) in combination with lenalidomide and a rituximab product for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy. The approval is based on efficacy and safety data from the Phase 3 ECHELON-3 study, which demonstrated a statistically significant and clinically meaningful improvement in overall survival in patients with relapsed/refractory DLBCL who received ADCETRIS in combination with lenalidomide and rituximab.

Pfizer and Astellas’ PADCEV® (enfortumab vedotin-ejfv) plus KEYTRUDA® (pembrolizumab) Shows Long-Term Efficacy in First-Line Treatment of Locally Advanced or Metastatic Urothelial Cancer (la/mUC)

BioNJ Member Pfizer, with a site in Peapack, and Astellas Pharma Inc. announced additional follow-up results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) evaluating the efficacy and safety of PADCEV ® (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate, plus KEYTRUDA® (pembrolizumab), a PD-1 inhibitor, in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The results showed a sustained overall survival (OS) and progression-free survival (PFS) benefit consistent with the findings of the primary analysis after an additional 12 months of follow-up (median follow-up of 29.1 months). Results showed enfortumab vedotin plus pembrolizumab reduced the risk of death by 49% versus chemotherapy (hazard ratio [HR] = 0.51, 95% confidence interval [CI], 0.43-0.61).

Pfizer’s TALZENNA® in Combination With XTANDI® Improves Survival Outcomes in Metastatic Castration Resistant Prostate Cancer

BioNJ Member Pfizer, with a site in Peapack, announced positive results from the Phase 3 TALAPRO-2 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), an androgen receptor pathway inhibitor (ARPI), demonstrating a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo plus XTANDI in patients with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations. The TALAPRO-2 study evaluated two sets of patients, unselected (cohort 1) and selected for HRR gene-mutations (cohort 2). Overall survival was a prespecified, alpha-protected key secondary endpoint.

Pfizer’s BRAFTOVI® Combination Regimen Significantly Improved Progression-Free Survival and Overall Survival in Phase 3 BREAKWATER Trial

BioNJ Member Pfizer, with a site in Peapack, announced positive topline results from the progression-free survival (PFS) analysis of the Phase 3 BREAKWATER study of BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX® ) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation. The trial showed a statistically significant and clinically meaningful improvement in PFS, one of its dual primary endpoints, as assessed by blinded independent central review (BICR) compared to patients receiving chemotherapy with or without bevacizumab. Further, the BRAFTOVI combination regimen demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), a key secondary endpoint in the trial.

Nucala (mepolizumab) application for COPD accepted for review in China

Warren-based BioNJ Member GSK plc announced that the China National Medical Products Administration has accepted for review the new drug application for the use of Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. IL-5 is a key cytokine (protein) in type 2 inflammation which is an underlying driver in many diseases. This type of inflammation is detected in up to 40% of patients with COPD and is a major cause of symptoms and exacerbations that can lead to hospitalization and/or emergency room visits. COPD affects more than 390 million people globally, with research estimating that approximately 100 million people in China live with COPD, which accounts for almost 25% of the global COPD cases.

Penmenvy, GSK’s 5-in-1 Meningococcal Vaccine, Approved by U.S. FDA to Help Protect Against MenABCWY

Warren-based BioNJ Member GSK plc (announced that the U.S. Food and Drug Administration has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25 years. The vaccine targets five major serogroups of Neisseria meningitidis (A, B, C, W, and Y) which commonly cause invasive meningococcal disease (IMD). The vaccine combines the antigenic components of GSK’s two well-established meningococcal vaccines, Bexsero (Meningococcal Group B Vaccine) and Menveo (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine). The regulatory application was supported by positive results from two phase III trials [NCT04502693; NCT04707391], which evaluated the vaccine’s safety, tolerability, and immune response in over 4,800 participants aged 10-25 years. The safety data demonstrated that the vaccine has a safety profile consistent with GSK’s licensed meningococcal vaccines.

Ferring Highlights Commitment to C. Diff Infection Community on the Second Anniversary of the Launch of REBYOTA® (fecal microbiota, live – jslm)

Parsippany based BioNJ Member Ferring Pharmaceuticals is celebrating the second anniversary of the launch of REBYOTA® (fecal microbiota, live – jslm), the first microbiome-based therapy approved by the U.S. Food and Drug Administration (FDA) for the prevention of recurrent C. difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for C. diff infection. Launched on January 23, 2023, REBYOTA has been administered to thousands of patients and offers an effective, well-tolerated therapy with convenient administration as a single dose by a healthcare professional in one visit. “Access to FDA-approved treatments to prevent recurrent C. difficile infection remains critical for halting the vicious cycle of debilitating symptoms and suffering affecting patients with this infectious disease,” said Dr. Paul Feuerstadt, Yale School of Medicine and PACT-Gastroenterology Center.

Sarclisa is the First Anti-CD38 Treatment in Combination With Standard-of-Care VRd Approved in China for Patients With Newly Diagnosed Multiple Myeloma Ineligible for Transplant

Bridgewater-based BioNJ Member Sanofi announced the National Medical Products Administration (NMPA) in China 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. Olivier Nataf, Global Head, Oncolog said “When Sanofi entered China more than four decades ago, we did so with the intention of bringing potentially transformative therapies to Chinese patients. This approval, occurring just weeks after Sarclisa’s first in the country, represents tremendous progress towards advancing this mission. Now, patients with multiple myeloma and their providers have access to two new Sarclisa-based regimens that have the potential to improve outcomes across lines of therapy.”

Dupixent sBLA Accepted for FDA Priority Review for the Targeted Treatment of Bullous Pemphigoid

Bridgewater-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous pemphigoid (BP). The sBLA is supported by data from a pivotal study evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP. The primary endpoint was met, with five times more Dupixent patients achieving sustained disease remission compared to those on placebo. Sustained disease remission was defined as complete clinical remission with completion of oral corticosteroids (OCS) taper by week 16 (off OCS treatment and only treated with Dupixent for at least 20 weeks) without relapse and no rescue therapy use during the 36-week treatment period. The study also showed that Dupixent significantly reduced disease severity, itch, and use of OCS compared to placebo.

Mitsubishi Tanabe Pharma America Announces Publication of Three-Year Outcomes from Phase 2b BeyoND Study of Investigational ND0612 in Parkinson’s Disease

BioNJ Member Mitsubishi Tanabe Pharma, with a site in Jersey City, announced the publication of three-year outcomes in Parkinsonism and Related Disorders from the extension phase of the ongoing Phase 2b BeyoND long-term safety and tolerability study (NCT02726386) evaluating investigational ND0612 in people with Parkinson’s disease (PD) experiencing motor fluctuations. ND0612 is being studied as a 24-hour, continuous, subcutaneous infusion of liquid levodopa/carbidopa (LD/CD). The three-year results from the extension phase of BeyoND were found to be consistent with the previously-reported 12-month data from the core study period, suggesting treatment with ND0612 to be generally well tolerated. Additionally, exploratory data from a small sample size of participants with available motor diary data indicate the potential of ND0612 to provide a sustained reduction in daily OFF time with a corresponding increase in Good ON time.  

Bristol Myers Squibb Announces Opdivo® Plus Chemotherapy as the First and Only Neoadjuvant-Only Immuno-Oncology Therapy to Demonstrate Statistically Significant and Clinically Meaningful Overall Survival in Resectable Non-Small Cell Lung Cancer

Princeton-based BioNJ Member Bristol Myers Squibb announced the final analysis of overall survival (OS) from the Phase 3 CheckMate -816 study, which evaluated Opdivo® (nivolumab) in combination with platinum-doublet chemotherapy as a neoadjuvant treatment for adult patients with resectable (tumors ≥ 4 cm or node positive) non-small cell lung cancer (NSCLC). The results showed a statistically significant and clinically meaningful improvement in OS, a key secondary endpoint, compared to neoadjuvant chemotherapy alone. The results build on the previously reported primary endpoints of event-free survival (EFS) and pathological complete response (pCR), which also met statistical significance. The safety profile of Opdivo in combination with chemotherapy was consistent with previously reported studies, with no new safety signals observed.

Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo® (nivolumab) Plus Yervoy® (ipilimumab) as a First-Line Treatment Option for Adult Patients With Unresectable or Advanced Hepatocellular Carcinoma

Princeton-based BioNJ Member Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC), based on results from the Phase 3 CheckMate -9DW trial. The CHMP opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines in the European Union (EU). “Hepatocellular carcinoma is the predominant type of liver cancer globally, including in the European Union, and when diagnosed at the advanced or unresectable stage, prognosis and overall survival remain sub-optimal with conventional therapy,” said Dana Walker, M.D., M.S.C.E., Vice President, Opdivo Global Program Lead, Bristol Myers Squibb.

Bristol Myers Squibb Announces Positive Topline Results for Breyanzi® (lisocabtagene maraleucel) in Adult Patients With Relapsed or Refractory Marginal Zone Lymphoma

Princeton-based BioNJ Member Bristol Myers Squibb announced the Phase 2 TRANSCEND FL trial evaluating Breyanzi® (lisocabtagene maraleucel) in adult patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma met its primary endpoint in the marginal zone lymphoma (MZL) cohort. Results showed Breyanzi demonstrated a statistically significant and clinically meaningful overall response rate (ORR) in these patients. The study also met the key secondary endpoint of complete response rate (CRR). In the topline analysis, Breyanzi continued to demonstrate durable responses and a consistent safety profile with no new safety signals observed. This study marks the fifth cancer type in which Breyanzi has demonstrated clinically meaningful benefit, representing the broadest array of B-cell malignancies of any CD19-directed CAR T cell therapy and furthering evidence of Breyanzi’s best-in-class and best-in-disease profile.

New Five-Year Sotyktu (deucravacitinib) Data Show Consistent Safety and Durable Response Rates in Moderate-to-Severe Plaque Psoriasis

Princeton-based BioNJ Member Bristol Myers Squibb announced new five-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. The safety profile of Sotyktu remained consistent through five years with more than 5,000 patient-years of exposure in the trial, with no new safety signals identified. In patients who were treated continuously with Sotyktu , clinical response rates were maintained from Year 1 to Year 5, including Psoriasis Area and Severity Index (PASI) 75, PASI 90 and static Physician’s Global Assessment (sPGA) 0/1 (clear/almost clear). Clinical efficacy outcomes were sustained in patients who were continuously treated with Sotyktu for PASI 75 (72.1%, Year 1; 67.3%, Year 5), PASI 90 (45.9%, Year 1; 46.3%, Year 5) and sPGA 0/1 (57.5%, Year 1; 52.6%, Year 5).

Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Breyanzi for Relapsed or Refractory Follicular Lymphoma

Princeton-based BioNJ Member Bristol Myers Squibb announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation. The CHMP adopted a positive opinion based on data from the global, Phase 2 TRANSCEND FL study, the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL). 

Boehringer’s Nerandomilast Meets Primary Endpoint in Phase III Study FIBRONEER™-ILD, in Progressive Pulmonary Fibrosis

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, announced that the FIBRONEER™-ILD trial met its primary endpoint, which was the absolute change from baseline in FVC (mL) at week 52 versus placebo. FVC is a measure of lung function. Initial data readouts of the FIBRONEER™-trials support a generally consistent safety and tolerability profile when compared to the Phase II IPF study, with overall adverse events comparable to those seen in the placebo group. Nerandomilast is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B). As it has not been approved for use, safety and efficacy have not been established. It is being investigated as part of the FIBRONEER™ global program, which includes two Phase III studies — FIBRONEER™-IPF in people living with IPF and FIBRONEER™-ILD5 in people living with PPF. 

Most Patients on Lilly's Omvoh® (mirikizumab-mrkz) for Crohn's Disease Achieved Sustained Clinical Remission and Endoscopic Response at Two Years

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced results from the VIVID-2 open-label extension study, which showed the majority of patients with moderately to severely active Crohn's disease receiving two years of continuous treatment with Omvoh® (mirikizumab-mrkz) achieved long-term clinical and endoscopic outcomes, including those (43.8%) with previous biologic failure. 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. Participants randomized to Omvoh in the Phase 3 VIVID-1 study who achieved endoscopic response after one year of treatment continued Omvoh maintenance treatment in VIVID-2.

Early Detection is a Game Changer: Novartis Makes Bold Play to Prioritize Breast Health and Inspire a New Wave of Breast Cancer Screenings

East Hanover-based BioNJ Member Novartis announced the launch of the "Your Attention, Please" campaign, which seeks to inspire people in the U.S. to prioritize breast health, increase annual rates of breast cancer screenings, and ultimately, reduce the deadly impact of breast cancer — the second most common cancer and the second leading cause of cancer death among women in the United States. Despite the viral attention breasts attract in the media and pop culture, only one in two women receive their annual screenings, which can catch cancer when it is most treatable. To inspire people across generations to prioritize their breast health, Novartis, in collaboration with actor, comedian, and breast cancer survivor Wanda Sykes, actress and musician Hailee Steinfeld, and patient advocacy organizations nationwide, is urging people to understand their breast cancer risk and prioritize screenings.

Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced that the U.S. Food and Drug Administration has accepted for review the resubmission of the Biologics License Application (BLA) for linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy or those who received three prior lines of therapy and are refractory to the last line of therapy. Acceptance of the BLA resubmission follows the resolution of third-party fill/finish manufacturing issues, which was the sole approvability issue identified by the FDA in the previous submission. The BLA is supported by data from the pivotal LINKER-MM1 trial investigating linvoseltamab in R/R MM, and linvoseltamab is also under review by the European Medicines Agency (EMA) for the same patient population.

EYLEA HD® (aflibercept) Injection 8 mg Positive Phase 3 Results in Patients with Macular Edema following Retinal Vein Occlusion Presented at Angiogenesis Meeting

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced the first presentation of positive results from the Phase 3 QUASAR trial investigating EYLEA HD® (aflibercept) Injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO), including those with central, branch and hemiretinal vein occlusions. The data will support the submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) in the first quarter of 2025. The QUASAR trial met its primary endpoint at 36 weeks, with both groups of EYLEA HD patients dosed every 8 weeks achieving non-inferior visual acuity gains compared to those receiving EYLEA® (aflibercept) Injection 2 mg dosed every 4 weeks.

U.S. FDA Approves EMBLAVEO™ (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections With Limited or No Treatment Options

BioNJ Member AbbVie, with a site in Madison, announced that the U.S. Food and Drug Administration has approved EMBLAVEO™ (aztreonam and avibactam), as the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic. It is approved in combination with metronidazole, for patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI), including those caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. Gram-negative bacterial infections are among the most challenging for healthcare professionals to control due to high antimicrobial resistance (AMR).

U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review

BioNJ Member Gilead Sciences, with a site in Morris Plains, announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir — the company’s twice-yearly injectable HIV-1 capsid inhibitor — for the prevention of HIV as pre-exposure prophylaxis (PrEP). The FDA will review the applications under priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 19, 2025. Acceptance of the NDAs follows receipt of Breakthrough Therapy Designation for lenacapavir for PrEP granted by the FDA in October 2024. The Breakthrough Therapy Designation process is intended to expedite the development and regulatory review of investigational treatments for serious or life-threatening conditions that, based on preliminary clinical evidence, have the potential to substantially improve clinical outcomes compared with available therapy.

Novo Nordisk A/S: Once-weekly Mim8 is Well-Tolerated and Efficacious in Children Living With Haemophilia A With and Without Inhibitors

Plainsboro-based BioNJ Member Novo Nordisk announced interim results from the Phase 3 FRONTIER3 trial of 70 children (aged 1-11 years old) with haemophilia A with and without inhibitors. The trial initially assessed once-weekly prophylaxis treatment (regular treatment to prevent prolonged and spontaneous bleeding) with investigational Mim8 before giving participants the option to change to once-monthly dosing after 26 weeks. The data showed that Mim8 was well-tolerated and efficacious in children with haemophilia A with and without inhibitors. In part one of the FRONTIER3 study, participants with haemophilia A received once-weekly doses of Mim8 administered under the skin for 26 weeks. In part two, participants had the option to continue with once-weekly dosing or move to once-monthly dosing for the remaining 26 weeks.

New Nipocalimab Data Published in mAbs Journal Details Differentiated Molecular Design, Clinical Profile and Potential of Nipocalimab to Treat IgG-Driven Alloantibody and Autoantibody Diseases

New Brunswick-based BioNJ Member Johnson & Johnson announced the publication of data detailing the differentiated molecular properties of nipocalimab, an investigational neonatal Fc receptor (FcRn) blocker, in mAbs. This publication highlights the selective, targeted and high-affinity binding properties of nipocalimab which support its differentiated potential as a treatment option for immunoglobulin G (IgG)-driven alloantibody and autoantibody diseases. “There is a critical need for additional approved, targeted and effective treatments with proven safety profiles to help alleviate the burden of severe IgG-driven autoantibody diseases, like generalized myasthenia gravis,” said Pushpa Narayanaswami, M.D., FAAN, Vice Chair of Clinical Operations, Department of Neurology at the Beth Israel Deaconess Medical Center, Boston M.A. and Professor of Clinical Neurology at Harvard Medical School, and an author of the publication.

WELIREG® (belzutifan) Receives First European Commission Approval for Two Indications

Rahway-based BioNJ Member Merck & Co. announced that the European Commission (EC) has conditionally approved WELIREG® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as monotherapy for: 1) The treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated, localized renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), and for whom localized procedures are unsuitable; and 2) The treatment of adult patients with advanced clear cell RCC that progressed following two or more lines of therapy that included a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and at least two vascular endothelial growth factor (VEGF) targeted therapies.

Merck Announces Phase 3 waveLINE-010 Trial Initiation Evaluating Zilovertamab Vedotin, an Investigational Antibody-Drug Conjugate, for the Treatment of Patients With Previously Untreated Diffuse Large B-Cell Lymphoma

Rahway-based BioNJ Member Merck & Co. announced the initiation of waveLINE-010, a pivotal Phase 3 clinical trial evaluating zilovertamab vedotin in combination with rituximab plus cyclophosphamide, doxorubicin and prednisone (R-CHP) compared to rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) alone, for the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Zilovertamab vedotin is Merck’s investigational antibody-drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1). Global recruitment of the waveLINE-010 trial has begun, with patients now enrolling. WaveLINE-010 is a randomized, open-label Phase 3 trial which is enrolling an estimated 1,046 patients globally. The primary endpoint is progression-free survival (PFS), and secondary endpoints include complete response (CR) rate at the end of the treatment, overall survival, event-free survival, duration of CR and safety.

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. 

Datopotamab Deruxtecan Recommended for Approval in the EU by CHMP for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

Basking Ridge-based Daiichi Sankyo announced Datopotamab deruxtecan (Dato-DXd) has been recommended for approval in the European Union (EU) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the TROPION-Breast01 Phase 3 trial published in the Journal of Clinical Oncology.

Galderma’s Nemluvio® (nemolizumab) Granted Marketing Authorization in the United Kingdom and Switzerland for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis

Cranbury-based Galderma announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency and Swissmedic have granted the marketing authorization of nemolizumab for the treatment of both atopic dermatitis and prurigo nodularis in the UK and Switzerland, respectively. Specifically, the approvals are for nemolizumab’s subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors in adults and adolescents 12 years of age and older with a body weight of at least 30kg, who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. These are the first approvals from countries within the Access Consortium framework, an international collaborative initiative comprised of regulatory authorities which work together to address shared challenges.

Galderma’s Nemluvio® (nemolizumab) approved in the European Union for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis

Cranbury-based Galderma announced that the European Commission has approved Nemluvio for both moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union (EU). Nemluvio is now approved for subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31. IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis, and fibrosis in prurigo nodularis.

IMCAS 2025: New Galderma Phase IIIb Data Reinforce Rapid Onset and Long-Lasting Aesthetic Improvement With RelabotulinumtoxinA (Relfydess™)

Cranbury-based Galderma announced results from its new Phase IIIb RELAX clinical trial demonstrating the rapid onset and the long-lasting duration of aesthetic efficacy, as well as high patient satisfaction and increased confidence, using a single-dose of RelabotulinumtoxinA (Relfydess) to treat frown lines (glabellar lines). Developed and manufactured by Galderma, RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator created with PEARL Technology that is designed to preserve molecule integrity to deliver a highly active, innovative, complex-free molecule. Previously announced data from the Phase III READY clinical trial program demonstrated rapid onset as soon as Day 1 (reported by up to 39% of subjects) and long-lasting efficacy for 6 months (maintained by up to 75% of subjects) when using RelabotulinumtoxinA to treat frown lines and crow’s feet (lateral canthal lines).  

LEO Pharma Achieves Positive DELTA TEEN Trial Results With Anzupgo® (delgocitinib) Cream in Adolescents With Moderate to Severe Chronic Hand Eczema (CHE)

Madison-based LEO Pharma announced the positive results of the DELTA TEEN trial. DELTA TEEN is a pivotal Phase 3 clinical trial with Anzupgo® (delgocitinib) 20mg/g cream, a topical pan-Janus kinase (JAK) inhibitor, for the potential treatment of adolescents (aged 12-17) with moderate to severe Chronic Hand Eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate. This is the fifth Phase 3 Anzupgo trial to achieve primary and all key secondary endpoints, validating the results of the previous clinical trials from the DELTA program. DELTA TEEN expands LEO Pharma’s growing portfolio of scientific evidence for the treatment of moderate to severe CHE, offering insight into a new patient population. Currently, no treatment options are approved specifically for moderate to severe CHE in the adolescent population.

DEBRA Research and LEO Pharma Announce Strategic Partnership to Advance Treatments for Rare Skin Diseases

DEBRA Research GmbH, a non-profit organization dedicated to advancing research, advocacy and support for those affected by Epidermolysis Bullosa (EB) and Madison-based LEO Pharma announced a non-exclusive strategic partnership. This collaboration aims to enhance scouting capabilities and provide additional capacity to accelerate the development of life-changing therapies for EB. The partners are committed to driving transformative progress for EB patients and their families, and to deliver innovative medicines for this serious skin disease with no approved treatment options. Leveraging LEO Pharma’s extensive experience and trusted legacy in the medical dermatology space, along with DEBRA Research’s dedicated focus on patient care and pharma experience, the partnership will specifically focus on helping patients suffering from EB by accelerating development of new medicines.

LinusBio Launches Autism Diagnostic that Tests Single Strand of Hair

LinusBio, a leader in precision exposome medicine based in North Brunswick, today announced ClearStrand-ASD™, a first-of-its-kind diagnostic aid for autism spectrum disorder (ASD). ClearStrand-ASD is a biochemical test that identifies a molecular signature predictive of autism in a strand of hair. It is designed to help physicians rule out the condition in children between one and 36 months of age when autism is a concern. The test provides a negative predictive value (NPV) of 92.5% and can help providers identify children who are unlikely to be on the autism spectrum. Results may help inform decisions to refer a child for early intervention and for diagnostic evaluation by an autism specialist. ClearStrand-ASD is a first-in-class biomarker test that analyzes an individual’s metabolism of essential and non-essential elements over time. 

Dr. Reddy’s Enters Into Collaboration With Henlius for Commercialization of HLX15 (daratumumab), a Biosimilar Candidate to Darzalex® & Darzalex Faspro® in the U.S., and Europe

Princeton-based Dr. Reddy’s Laboratories announced that it has entered into a license agreement with Shanghai Henlius Biotech, Inc. related to the development and commercialization of HLX15, Henlius’s investigational daratumumab biosimilar candidate to Darzalex® and Darzalex Faspro®. HLX15 is a recombinant anti-CD38 fully human monoclonal antibody injection, with intravenous as well as subcutaneous formulations. HLX15 is being developed as a biosimilar of Darzalex® & Darzalex Faspro®*, which are indicated for the treatment of multiple myeloma. The agreement combines Dr. Reddy’s global commercial presence with Henlius’ proven capabilities in developing biosimilars for markets worldwide. Under the terms of the agreement, Henlius will be responsible for development, manufacturing and commercial supply, and may receive up to a total of $131.6 million, including an upfront payment of $33 million and milestone payments.

BD to Separate Biosciences and Diagnostic Solutions Business to Enhance Focus, Drive Growth

Becton Dickinson announced plans to split from its bioscience and diagnostic solutions arms to become a more focused company. The news was announced alongside The Franklin Lakes-based firm’s Q1 FY25 earnings released after the markets closed. The new BD will comprise four distinct segments namely, Medical Essentials, Connected Care, BioPharma Systems and Interventional. Following the separation, the New BD is expected to have revenue of $17.8 billion for Fiscal 2024, while the separated Bioscience and Diagnostic Solutions business would have proforma revenue of $3.4 billion. “Our BD 2025 strategy has transformed the company into a faster-growing, more profitable organization positioned at the forefront of long-term growth trends in health care, and we believe it’s an exciting next step in unlocking significant potential value for all our stakeholders,” Tom Polen, Chairman, CEO and President of BD said.

Vyluma Announces Acceptance of Drug Application for NVK002 by China’s National Medical Products Administration (NMPA)

Bridgewater-based Vyluma announced that the National Medical Products Administration (NMPA) of China has accepted the drug application from Zhaoke Ophthalmology Limited for its lead compound, NVK002 (low-dose atropine 0.01%), as a potential treatment for myopia progression in children. NVK002, developed by Vyluma and licensed to Zhaoke, is a proprietary, investigational, preservative-free eye drop administered nightly, targeting pediatric patients with myopia. Acceptance of the drug application by the NMPA marks an essential step in introducing NVK002 as a potential therapeutic option for managing myopia in children across China. The drug application is based on the first Phase III clinical trial (“Mini-CHAMP”) conducted by Zhaoke in China. 

UroGen Announces Results from Subgroup Analyses of the Pivotal ENVISION Trial Evaluating Impact of Baseline Tumor Burden and Focality on Response to UGN-102

Princeton-based UroGen Pharma Ltd. announced results from the subgroup analyses of the pivotal ENVISION study evaluating the impact of tumor burden and focality on the response to UGN-102, an investigational drug in development for treatment of LG-IR-NMIBC. Analyses of pre-specified subgroups showed comparable CR rates and DOR patterns across different levels of tumor burden (defined as the sum of the diameters of all visible tumors) and number of tumors at baseline in patients treated with UGN-102. The ENVISION study included 240 patients with recurrent LG-IR-NMIBC who received at least one dose of UGN-102 and 95% (228 patients) received all six weekly intravesical instillations of UGN-102. In this pre-specified analysis CR rates were 82.8% for patients with a tumor burden ≤3 cm (n=149/180) compared to 73.2% for those with a tumor burden >3 cm (n=30/41). 

JLL: Life Sciences Sector Thriving; Accounts for Nearly 30% of Leases Signed in N.J. During 2024

New Jersey’s life sciences arena was active in 2024, as a broad spectrum of companies pursued office, R&D/lab and bio manufacturing opportunities. In fact, a new report from JLL shows that nearly 30% of leases signed in the state during the past year involved pharmaceutical/life sciences companies, which was the largest volume of activity among the various business sectors. This was also the third consecutive year in which life sciences was the most active segment in New Jersey.

NJEDA, Nokia Bell Labs to Bring Latest Strategic Innovation Center to the HELIX

The N.J. Economic Development Authority announced that it is investing $25 million in partnership with Nokia Bell Labs to create the state’s latest strategic innovation center — an entity that will be comprised of the NJ Nokia Bell Labs Innovation Center and Bell Labs Venture Studio. The center will aim to enable startups to accelerate and commercialize intellectual property from Nokia Bell Labs and local universities with an emphasis in the fields of communication, artificial intelligence, cloud computing and optical and wireless networks. The NJ Nokia Bell Labs Innovation Center will be located at HELIX 2, as part of the Health & Life Science Exchange complex going up in New Brunswick. It is expected to open by 2028. The NJ Nokia Bell Labs Innovation Center will be a 13,500 square-foot co-working office and lab space and offer specialized equipment to support the companies’ ongoing research.

Governor Murphy and Princeton University President Eisgruber Announce Microsoft and CoreWeave as Founding Partners in NJ AI Hub

Governor Phil Murphy and Princeton University President Christopher L. Eisgruber announced that Microsoft and CoreWeave will join the State and Princeton as founding partners in the NJ AI Hub. The NJ AI Hub will serve as a state-of-the-art, collaborative ecosystem that integrates world-class research, innovation, education and workforce development. As part of this investment in the NJ AI Hub, Microsoft will leverage its TechSpark program to provide expertise and resources for AI skilling and workforce development to create opportunities for innovation in New Jersey and the region. The NJ AI Hub will help position New Jersey as a leading East Coast center for AI innovation. It will be located along Route 1 — New Jersey’s innovation corridor — at 619 Alexander Road in West Windsor, in space provided by Princeton University. 

Microsoft and CoreWeave Announced as Founding Partners in the NJ AI Hub

Last winter, Gov. Phil Murphy and Princeton University President Christopher Eisgruber, announced the new NJ AI Hub. The AI Hub will bring together AI researchers, industry leaders, startup companies and other collaborators to advance research & development. It also will house dedicated accelerator space, advance the use of ethical AI for positive societal impact and promote workforce development to support new technology development. Last week, Microsoft and CoreWeave came on board as partners. “The addition of Microsoft and CoreWeave as founding partners of the NJ AI Hub demonstrates how government, higher education and the corporate sector are coming together to advance AI innovation and the regional innovation ecosystem — two of Princeton’s highest priorities,” President Eisgruber said. “I’m eager to see many of the state’s other excellent colleges and universities join this effort as its development continues.”

NJIT Launches AI Microcredential to Drive AI Literacy, Ethical Practices

New Jersey Institute of Technology (NJIT) will now offer an AI Literacy Microcredential that provides foundational knowledge and skills to thrive in an era shaped by artificial intelligence. The microcredential is designed to ensure that graduates are AI-literate, ethical in AI use and capable of leveraging AI tools effectively across various disciplines. Launching in spring 2025 through NJIT’s Learning and Development Initiative (LDI), the microcredential features ten non-credit two-hour courses and will be available free of charge to all NJIT students — regardless of level and major — and to the general public for a fee. The AI Literacy Microcredential is based off of NJIT-developed AI Core Competencies. The standards — developed by a multidisciplinary team of experts — emphasize practical applications of AI, ethical considerations and adaptability, enabling students to address real-world challenges and opportunities.

Cooper University Health Care, Rowan University Partner to Advance MedTech Innovation in Region

Cooper University Health Care and Rowan University leaders plan to create a joint innovation center to support a consortium of like-minded researchers and boost medical technology commercialization. Inspired by a 12-year relationship formed through Cooper Medical School of Rowan University, the Joint Health Sciences Center, and the South Jersey Institute for Population Health in Camden, the two institutions are looking to deepen support for researchers and clinicians who want to bring real-world solutions from the lab bench to the marketplace. Between its two medical schools, partnerships with area health systems, and $451 million in sponsored research awards in the last decade, Rowan has become a biomedical research powerhouse. A joint innovation center would allow its partners to share funding, resources and connections to develop technologies and companies, Rowan University President Ali Houshmand said.

Development of Prediction Model for Brain Amyloid-Beta Accumulation for Early Screening of Alzheimer’s Disease

Nutley-based Eisai BioNJ Member and Oita University announced the development of a machine learning model to predict amyloid beta (Aβ) accumulation in the brain, combining background data such as age, gender, smoking history and medical history, as well as general blood test and MMSE items. This model is expected to enable primary care physicians to predict the accumulation of brain Aβ, which is an important pathological factor of Alzheimer's disease (AD), during routine medical examinations and to facilitate simple early screening for AD. Currently, although brain Aβ accumulation can be detected by positron emission tomography (amyloid PET) and cerebrospinal fluid testing (CSF testing), the high cost and invasiveness of these tests are recognized as issues.

Johnson & Johnson to Resume U.S. VARIPULSE™ Cases

New Brunswick-based BioNJ Member Johnson & Johnson will resume the limited market release of VARIPULSE™ in the United States after a comprehensive investigation, following a voluntary pause, found the devices operate as intended. Johnson & Johnson will update the Instructions for Use (IFU) globally for the VARIPULSE™ Catheter to include enhanced guidance. The investigation into potential device-, procedure-, and patient-related factors concluded that VARIPULSE™ devices operate as intended and there is no difference in the performance of the available VARIPULSE™ system configurations globally. The investigation found the risk of neurovascular events may increase if a high number of ablations, the stacking of ablations, and/or ablations outside of the pulmonary veins are delivered.

Kean University Earns Prestigious R2 Research Designation

Kean University has officially earned an R2 research university designation under the Carnegie Classification of Institutions of Higher Education, marking a significant milestone in the university’s rapid transformation into a premier research institution. Kean is now recognized among the top 8% of colleges and universities nationwide for research and doctorate production. “Reaching this tremendous milestone has been my goal since I became president, and I am incredibly proud of our faculty, staff and students who helped make it a reality,” said Kean University President Lamont O. Repollet, Ed.D. “This status is a shared accomplishment that reflects Kean’s strengths and our commitment to academic excellence. We are building a research culture that will shape the future of Kean and drive meaningful change for our students and communities.”

NJIT Renews Its R1 Research Status from Carnegie

New Jersey Institute of Technology (NJIT) has once again earned the prestigious R1 designation from the Carnegie Classification of Institutions of Higher Education, reaffirming its standing as a top-tier doctoral university with very high research activity. NJIT has demonstrated significant growth in key research metrics that contribute to the R1 designation. The university’s research expenditures have reached $165 million based on the Carnegie-measured three-year average (FY21-FY23), with FY24 reaching $178 million in total research expenditures. This investment fuels work across a wide range of disciplines. Furthermore, the number of doctoral degrees awarded has increased dramatically, with a three-year average of 97, a remarkable 60% jump over the previous three-year period. NJIT is home to 175 research institutes, centers and specialized labs, fostering a vibrant ecosystem of collaborative research.

NJBioFutures, a Workforce Development Initiative Around Cell and Gene Therapy, Launched by Council for County Colleges

Spurred by $1 million contribution from founding sponsor J&J, Pathways program aims to accelerate creation of industry-aligned curricula and state-of-art training facilities at three community colleges (Raritan Valley, Middlesex, Mercer). There were plenty of incredible life science numbers being thrown around Tuesday morning at Raritan Valley Community College during the launch of NJBioFutures, a unique workforce development program involving the State, the New Jersey Council of Community Colleges and Johnson & Johnson. While the NJBioFutures program will help create a pathway for a future career for thousands of students, it’s best measured by how it will impact single individuals – students such as Josue Martinez Hernandez, a first-generation college student at Raritan Valley from El Salvador.

Outlook Therapeutics Appoints New Board Chair

Iselin-based BioNJ Member Outlook Therapeutics announced it appointed Faisal Sukhtian as Chairman of the Board of Directors. Mr. Sukhtian will assume the role from Randy Thurman, who will remain on the board as Lead Independent Director. Mr. Sukhtian has served as a member of Outlook Therapeutics’ Board of Directors since 2017. Over the course of his career, he has amassed extensive experience in operations, strategy development and mergers and acquisitions in the biopharma and life sciences space. He currently serves as Executive Director at GMS Holdings and oversees a number of investments within the GMS Holdings portfolio. He also serves as the chairman of the Board of Genepharm; as a member of the Board of MS Pharma; as vice chairman of the Board of Agri Sciences; and as a member of the Board of Expert Petroleum.

Francisco Ballester to Retire; Peter Stenico Appointed President Region International

Princeton-based BioNJ Member Sandoz announced that Francisco Ballester, President Region International and member of the Sandoz Executive Committee, will retire and step down from the SEC on March 1, 2025. Since 2019, Mr. Ballester has been responsible in this role for driving business growth and access for patients in markets outside of North America and Europe, while developing highly diverse talents in the region. He is a member of the Health Management and Policy Advisory Council of the Miami Herbert Business School. Peter Stenico will succeed Mr. Ballester. Mr. Stenico was appointed Global Platform Head, Biosimilars in January 2023 and has led the Sandoz global biosimilar strategy. Previously, Mr. Stenico held the position of Country Head and General Manager for Sandoz in Germany and was also the former President of the German Generics Association.

Cosette Pharmaceuticals Appoints New VP Generics Commercial Operation

Bridgewater-based Cosette Pharmaceuticals announced it appointed Brad Leonard as Vice President, Generics Commercial Operations. In this role, Mr. Leonard will spearhead Cosette’s generics business, including Generics Sales, Marketing/Pricing, Customer Service and Demand Planning, as the company continues its expansion in these markets. “Cosette is in the midst of an exciting period of accelerated growth and portfolio expansion, and Brad is the right commercial leader to take our business to the next level,” Apurva Saraf, President and CEO, Cosette Pharmaceuticals, said. “Brad’s deep expertise in the pharmaceutical industry, combined with his track record of driving commercial success and fostering strategic partnerships, will be a catalyst for our continued momentum.”

Former Dr. Reddy’s Exec Named SVP of Operations at Cosette Pharmaceuticals

Women’s health pharmaceutical firm, Cosette Pharmaceuticals located in Bridgewater, has appointed Vincent Colicchio as Senior Vice President of Operations where he will be charged with leading the Bridgewater-based firm’s manufacturing, global supply chain and operational strategy. “As we rapidly diversify our product portfolio and expand our footprint, we continue to enhance our operational capabilities” Apurva Saraf, President and CEO, Cosette Pharmaceuticals, said. “Vin is an exceptional leader with deep expertise in leading complex operations with high-performing teams and driving efficiencies. His experience at large-scale U.S. manufacturing and global supply chain operations will play a critical role as we continue to advance our capabilities and expand our portfolio.”

Novo Nordisk

Purpose & Sustainability

Driving Change in Human and Planetary Health

In an increasingly complex and unpredictable world, the intersection of climate change, health inequity and the rising prevalence of serious chronic diseases presents an unprecedented risk to both human and planetary health. Recognizing the magnitude of these challenges, Novo Nordisk is aiming to expand the reach and societal impact of our life-changing medicines and preventive health initiatives while striving to reduce our CO2e emissions, plastic footprint and impact on nature.

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.