KFF Tracking Poll on Health Information and Trust: The Public’s Views on Measles Outbreaks and Misinformation

As the U.S. grapples with rising measles cases across multiple states and the highest number of cases since 2019, about half of adults (51%) and parents (47%) say they are at least “somewhat worried” about the outbreak of measles, including roughly one in seven adults who are “very worried” (14% of all adults, 13% of parents). Concern is notably higher among Black and Hispanic adults – six in ten of each group express worry compared to 46% of White adults. Roughly half of adults (56%) and parents with children under 18 (48%) are aware that the number of U.S. measles cases is higher this year than in recent years. Partisanship plays a major role in whether people are aware that measles cases are on the rise and whether they are worried about the most recent outbreak. 

Understanding the Use of Medicines in the U.S. 2025: IQVIA Report

Areas of focus in this year’s report range from looking at how medicine usage patterns have shifted, to the impact of out-of-pocket costs and benefit designs on patients, to the complex nature of drug pricing. Dynamics that have become apparent during 2024 have driven significant revisions to the outlook, and in this report the drivers of change in medicine spending over the next five years are deconstructed to enable better understanding. This examination includes the impact of novel obesity and diabetes medicines which have been significant drivers of growth, and the uptake of other novel medicines expanding into new patient populations and becoming established as backbone therapies.

The Ultimate Life Science Meetup: BioNJ’s BioPartnering Conference to Host 15th Annual Event Next Week

As Featured in BINJE

BioNJ CEO Debbie Hart still remembers a lunch she had with Anthony Marucci nearly two decades ago. Marucci, the CEO of Hampton-based Celldex Therapeutics, was describing a unique challenge in the state. New Jersey was filled with a number of global bio companies and hundreds of research startups that aimed to be just like them — or become a part of them — but the two rarely got a chance to get together. Soon after, the first BioPartnering Conference — one that promised not only panel discussions, but one-on-one conversations between big and small companies, founders and investors — was born. Next week, the event will celebrate its 15th year, when the Liberty Science Center in Jersey City hosts the all-day conference May 13. “It’s bigger and better than I could have ever imagined,” she said. “Last year, we had nearly 600 attendees from 22 states and nine countries.”

Murphy, NJIT and NJEDA Unveil NJII Venture Studio

As Featured in ROI-NJ

New Jersey Institute of Technology (NJIT) and the New Jersey Economic Development Authority (NJEDA) marked a milestone in the state’s innovation economy with a ribbon-cutting ceremony for the NJII Venture Studio. NJII Venture Studio aims to launch 10 companies over the next five years, with each venture receiving up to $1 million in funding. The studio will accelerate and commercialize high-tech and information technology developed by NJIT, NJII and NJIT’s corporate partners, alongside other academic contributors to the advancement of the industry. The Venture Studio will provide start-ups with training, office space and guidance on operations and management.

Why CoreWeave Will Add New Dimension to Upcoming BioPartnering Conference

As Featured in BINJE

BioNJ founder Debbie Hart had plenty of hopes and dreams 15 years ago when the organization began one of its signature events, the BioPartnering Conference. Here’s one thing she never thought of then: Having an artificial intelligence company join as a major sponsor. That scenario will play out next Tuesday at the Liberty Science Center when CoreWeave will join JPMorgan Chase and Morgan Lewis as premier sponsors of the event. Hart said having an AI company join the conference shows how New Jersey is staying ahead of the curve in life sciences. “We are so delighted to add CoreWeave, because they add a whole new dimension to the event,” she said. “AI obviously is impacting every aspect of the business world. Understanding how CoreWeave — a company that is building itself in New Jersey — can help these other Jersey companies is important. We are all part of the innovative economy in the State.”

Genmab to Submit Supplemental Biologics License Application (sBLA) to U.S. Food and Drug Administration for Epcoritamab Plus Rituximab and Lenalidomide (R2) in Patients With Relapsed/Refractory Follicular Lymphoma (FL)

Princeton-based BioNJ Member Genmab A/S announced its intention to submit in the first half of 2025 a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for subcutaneous epcoritamab, a bispecific antibody being investigated in combination with rituximab and lenalidomide (R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), following at least one prior systemic therapy. The decision to submit the sBLA is supported by positive topline results from the Phase 3 EPCORE FL-1 trial evaluating epcoritamab plus R2 versus R2 alone in adult patients with R/R FL. Based on an interim analysis conducted by an Independent Data Monitoring Committee (IDMC) review, the study met one of its dual primary endpoints of ORR (Complete Response plus Partial Response, p-value < 0.0001).

ADMA Biologics Announces U.S. FDA Approval of Innovative Production Yield Enhancement Process

Ramsey-based BioNJ Member ADMA Biologics, Inc. announced U.S. FDA approval of its innovative yield enhancement production process. This innovative process has demonstrated an ability to increase production yields by approximately 20% from the same starting plasma volume. “This approval represents a pivotal milestone for ADMA, unlocking the opportunity for meaningful acceleration in our revenue and earnings trajectory beginning in late 2025 and accelerating further into 2026 and beyond,” said Adam Grossman, President and CEO of ADMA. “Looking ahead, we are excited to continue to advance our internal R&D platform — further optimizing production capabilities and progressing novel pipeline programs, most notably SG-001, our pre-clinical, investigative hyperimmune globulin targeting S. pneumonia, which exemplify our commitment to product and process innovation.”

BioAegis Therapeutics Announces Site Activation and Patient Recruitment Underway in 13 Countries in Phase 2b Clinical Trial of Gelsolin, an Immune Regulator, for the Treatment of Acute Respiratory Distress Syndrome (ARDS)

North Brunswick-based BioNJ Member BioAegis Therapeuticsannounces that patient recruiting is underway across all 13 targeted countries for its Phase 2 study of rhu-pGSN for the treatment of ARDS. (NCT05947955). The Company’s portfolio is built around gelsolin (GSN), a highly conserved and critical immune regulatory protein which controls dysfunctional inflammation without suppressing immune function. The randomized, double-blind, placebo-controlled trial of rhu-pGSN added to standard of care will evaluate the efficacy (survival without organ failure on Day 28) of six doses of rhu-pGSN administered intravenously to hospitalized moderate-to-severe ARDS subjects (P/F ratio ≤150) caused by infection. It will also measure the safety and tolerability of treatment along with secondary outcomes.

PTC518 PIVOT-HD Study Achieves Primary Endpoint

Warren-based BioNJ Member PTC Therapeutics, Inc. announced results from the Phase 2 PIVOT-HD study of PTC518 (votoplam) in Stage 2 and Stage 3 Huntington's disease (HD) patients. The study met its primary endpoint of reduction in blood Huntingtin (HTT) protein levels (p<0.0001) at Week 12 and favorable safety and tolerability. In addition, the 12-month data from the Stage 2 patients are consistent with the previously reported dose-dependent lowering of HTT protein and dose-dependent trends across clinical scales. Results from the full 12-month cohort demonstrate dose-dependent lowering in blood HTT levels, with 23% at the 5mg dose level for both Stage 2 and 3 patients and 39% and 36% at the 10mg dose level for Stage 2 and 3 patients, respectively. 

PTC Therapeutics Receives Positive CHMP Opinion for Sephience™ (sepiapterin) for the Treatment of Children and Adults Living With Phenylketonuria (PKU)

Warren-based BioNJ Member PTC Therapeutics, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the marketing authorization application for Sephience™ (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU). The opinion includes a broad label inclusive of all ages and disease severities. Launch planning in Europe is well underway with priorities in Germany and other key European markets where named patient access will be immediately available. PTC expects the European Commission to ratify the marketing authorization for Sephience in approximately two months. The decision will be applicable to all 27 European Union member states, as well as Iceland, Norway and Liechtenstein. Review of approval applications is ongoing in several other countries including Japan and Brazil. 

Tevogen Bio Finalizes Agreement for Cell Therapy Production Facility

Warren-based BioNJ Member Tevogen Bio entered an agreement with CD8 Technology Services LLC, securing up to $50 million for its dedicated research and manufacturing facility intended to support both in-house pre-clinical research and GMP cell therapy production capabilities. Tevogen Bio will provide the primary staff and operations for the facility, which is a key component of the company’s long-term strategy to accelerate development timelines, maintain operational agility, and control cost. Dr. Ryan Saadi, Tevogen Bio’s founder and CEO said the agreement will allow the company to overcome significant capital barriers of entry that are typically faced in building GMP capabilities at scale. The agreement has an initial term of 12 months and will automatically renew and aligns with the previously announced topline forecasts. 

Celldex Presents Histology Data from Phase 2 Study of Barzolvolimab in EoE Supporting Potential of Mast Depleting Agent in This Difficult to Treat Disease

Hampton-based BioNJ Member Celldex announced the presentation of histology data from the company’s ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE). Biopsies taken during screening demonstrate the presence of high numbers of intraepithelial mast cells in participants with active EoE and correlate with eosinophil counts, supporting the hypothesis that treating EoE with barzolvolimab—a mast cell depleting agent—could provide promising therapeutic benefit. Celldex announced in February 2025 that enrollment to the Phase 2 study is complete and that clinical results are expected in the second half of 2025. EoE is the most common type of eosinophilic gastrointestinal disease, a chronic inflammatory disease of the esophagus characterized by the infiltration of eosinophils. Chronic inflammation can result in trouble swallowing, chest pain, vomiting and impaction of food in the esophagus – a medical emergency.

Tris Pharma to Unveil Positive Phase 3 Results Including a Strong Safety Profile Showcasing the Potential of Cebranopadol, an Investigational First-in-Class Dual-NMR Agonist for the Treatment of Pain

Monmouth Junction-based BioNJ Member Tris Pharma, Inc. (Tris) announced data from cebranopadol, the company’s investigational dual-NMR agonist for the treatment of moderate-to-severe pain. “We’re excited to present positive results from one of the pivotal Phase 3 clinical trials of cebranopadol in acute pain, as well as multiple safety studies, that reinforce the promise of cebranopadol to address the critical need for safe and effective treatment options,” said Ketan Mehta, founder and CEO at Tris Pharma. “Cebranopadol’s first-in-class mechanism of action continues to prove itself as a uniquely effective and well-tolerated approach to pain management, combining the effects of both the NOP and MOP receptors to deliver potent analgesia with reduced risk of typical opioid-related side effects.”

BeiGene’s Tevimbra Combination Granted EC Approval in Small Cell Lung Cancer

Hopewell-based BioNJ Member BeiGene, Ltd., which recently changed its name to BeOne Medicines Ltd., has announced that its Tevimbra (tislelizumab) has been approved by the European Commission (EC) as part of a first-line combination treatment for an aggressive form of lung cancer. The drug has been specifically authorised in combination with etoposide and platinum chemotherapy to treat adult patients with extensive-stage small cell lung cancer (SCLC). SCLC grows and spreads at a much faster rate than other types of lung cancer, and accounts for approximately 15% of all cases of the disease. Around 70% of SCLC patients are diagnosed with extensive-stage disease, which is associated with a particularly poor prognosis. The EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on data from the late-stage RATIONALE-312 trial, in which the Tevimbra combination was associated with a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo plus chemotherapy in the intent-to-treat population.

Insmed Reports First-Quarter 2025 Financial Results and Provides Business Update

Bridgewater-based BioNJ Member Insmed Incorporated provided a business update. "In the first quarter of 2025, Insmed demonstrated executional excellence across our commercial and clinical programs, while simultaneously preparing for critical near-term milestones, including our Phase 2 data readout of TPIP in PAH, and our anticipated FDA approval of brensocatib for bronchiectasis," said Will Lewis, Chair and CEO of Insmed. "Against the backdrop of an evolving regulatory environment, brensocatib's FDA review process remains on track, and we are relentlessly focused on preparing for a frictionless launch for the patients counting on us to succeed. This momentum is anticipated to continue as we expect to unveil data from our Phase 2 BiRCh study of brensocatib in chronic rhinosinusitis without nasal polyps by year-end 2025 and our Phase 3 ENCORE study of ARIKAYCE in all MAC lung disease patients in the first half of 2026."

Soligenix Announces Recent Accomplishments

Princeton-based BioNJ Member Soligenix announced its recent accomplishments and financial results. "Our strategic focus remains on advancing our clinical programs, and we anticipate several significant development milestones. These include top-line results in 2026 from our actively enrolling Phase 3 confirmatory study of HyBryte™ (synthetic hypericin) for early-stage cutaneous T-cell lymphoma (CTCL). Furthermore, we expect to report top-line results in the second half of this year from our ongoing Phase 2 studies of SGX945 (dusquetide) in Behçet's disease and SGX302 (synthetic hypericin) in mild-to-moderate psoriasis," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.  

Bristol Myers Squibb Announces Topline Results from Phase 3 ARISE Trial Evaluating Cobenfy (xanomeline and trospium chloride) as an Adjunctive Treatment to Atypical Antipsychotics in Adults With Schizophrenia

Princeton-based BioNJ Member Bristol Myers Squibb announced topline results from the Phase 3 ARISE trial evaluating the efficacy and safety of Cobenfy (xanomeline and trospium chloride) as an adjunctive treatment to atypical antipsychotics in adults with inadequately controlled symptoms of schizophrenia. In the Phase 3 trial, adjunctive Cobenfy treatment demonstrated a 2.0-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo with an atypical antipsychotic at Week 6, which did not reach the threshold for statistical significance for the primary endpoint (P = 0.11). Preliminary analyses suggest that Cobenfy as an adjunctive treatment to an atypical antipsychotic was associated with improvements in symptoms of schizophrenia compared to placebo plus an atypical antipsychotic for certain patients. 

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

BioNJ Member Pfizer Inc., with a site in Peapack, announced results from the pivotal Phase 3 CREST trial of sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with standard of care (SOC) Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). The trial met its primary endpoint of event-free survival (EFS) by investigator assessment, demonstrating a clinically meaningful and statistically significant improvement with sasanlimab in combination with BCG (induction and maintenance) as compared to BCG alone (induction and maintenance): Hazard Ratio (HR) of 0.68; 95% Confidence Interval (CI), 0.49-0.94; 2-sided p=0.019; median EFS not yet reached. These findings show a 32% reduction in risk of disease-related events, including high-grade disease recurrence or progression, with the sasanlimab combination regimen as compared with SOC treatment alone. 

KEYTRUDA® (pembrolizumab) as Perioperative Treatment With Standard of Care (SOC) Adjuvant Therapy Significantly Improved Event-Free Survival Compared to SOC Alone in Patients With Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

Rahway-based BioNJ Member Merck & Co. announced results from the Phase 3 KEYNOTE-689 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, as a perioperative treatment regimen for patients with stage III or IVA, resected, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Results at the first interim analysis of the trial showed KEYTRUDA significantly improved event-free survival (EFS) as part of a perioperative treatment regimen with adjuvant standard of care (SOC) radiotherapy with or without cisplatin compared to adjuvant standard of care (SOC) radiotherapy with or without cisplatin alone in patients with resectable LA-HNSCC. The study also showed a statistically significant improvement in major pathological response (mPR) rate, a key secondary endpoint, in patients with CPS ≥10 (difference in mPR rates: 13.7% [95% CI, 9.7-18.7]; p<0.00001), CPS ≥1 (9.8% [95% CI, 7.0-13.3]; p<0.00001) and in the ITT population (9.3% [95% CI, 6.7–12.8, P<.00001), compared to adjuvant radiotherapy alone.

Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI™ (ustekinumab-aekn) With Stelara® (ustekinumab)

Parsippany-based BioNJ Member Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Alvotech announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI™ (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara® (ustekinumab). As of April 30, 2025, SELARSDI is available and interchangeable in all presentations matching the reference product, including the treatment of adults and pediatric psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease and ulcerative colitis. Approved presentations of SELARSDI are 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection, 45 mg/0.5 mL in a single-dose vial for subcutaneous injection and 130 mg/26 mL in a single-dose vial for intravenous infusion.

Novo Nordisk Semaglutide Data Shows New Health Benefits Across Serious Chronic Diseases

Plainsboro-based BioNJ Member Novo Nordisk A/S announced that new data spanning the company’s industry-leading portfolio across metabolic and cardiovascular health will be presented. The data will further extend the wide-ranging evidence base for semaglutide through real-world evidence studies and additional analysis of the landmark cardiovascular outcomes trial, SELECT, as well as part 1 of the Phase 3 ESSENCE trial in metabolic dysfunction-associated steatohepatitis (MASH). Ludovic Helfgott, Executive Vice President of Product & Portfolio Strategy at Novo Nordisk, shared “Our investment into the understanding and treatment of obesity continues to reveal new insights, with semaglutide showing its potential to improve health in obesity, heart disease and liver disease. Our data shows that semaglutide provides early protection against heart disease even before significant weight loss occurs and that for people in treatment, our digital support solutions have the potential to enhance weight loss further.”

Lynozyfic™ (linvoseltamab) Approved in the European Union for the Treatment of Relapsed/Refractory Multiple Myeloma

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced that the European Commission (EC) has granted conditional marketing approval of Lynozyfic™ (linvoseltamab) to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). The indication is specific to those who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy. Lynozyfic is a bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing. Lynozyfic is the first BCMAxCD3 therapy approved that can be dosed every four weeks due to a response-adapted regimen if a very good partial response (VGPR) or better is achieved following completion of at least 24 weeks of therapy.

Gilead’s Livdelzi® (Seladelpar) Demonstrated Consistent Efficacy and Safety Regardless of Prior Treatment History in New Data Presented at EASL 2025

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced new data from multiple analyses which reinforce that Livdelzi® (seladelpar), known as Lyvdelzi® in the European Union, is effective and generally well-tolerated for the treatment of primary biliary cholangitis (PBC) and also provides sustained biochemical response in adults with PBC regardless of prior treatment history. Another analysis provides evidence supporting that Livdelzi delivered clinically and statistically significant improvements in pruritus. An interim analysis from ASSURE (NCT03301506), an ongoing, open-label, long-term study, reinforces the efficacy and safety profile of Livdelzi in people with PBC, including those with prior fibrate or obeticholic acid use. This analysis assesses participants from the pivotal Phase 3 placebo-controlled RESPONSE (NCT04620733) study and after participant rollover into the open-label ASSURE study, with or without prior fibrate or obeticholic acid use.

Final Data from the Phase 3 MYR301 Study Demonstrated Longer Treatment With Bulevirtide Was Associated With Sustaining Undetectability After Stopping Treatment

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, final results from the pivotal Phase 3 MYR301 study revealing that 36% (23 out of 64) of adults living with chronic hepatitis delta virus (HDV) treated with the first-in-class entry inhibitor bulevirtide at either a 2 mg or 10 mg dose maintained virologic suppression for almost two years after stopping treatment after achieving undetectable HDV RNA at end of treatment (EOT). In participants who sustained undetectability for one year after end of therapy, no relapses occurred in the second year of follow-up. In addition, sustained post-treatment undetectable HDV RNA was more frequent in participants with longer on-treatment HDV RNA undetectability at end of treatment: 90% (9/10) of those who had HDV RNA undetectability for ≥ 96 weeks at end of treatment remained HDV undetectable off-treatment. 

TREMFYA® (guselkumab) Positioned to Become the First and Only IL-23 Inhibitor to Offer Subcutaneous Induction in Ulcerative Colitis as Demonstrated in New Data Through 24 Weeks

New Brunswick-based BioNJ Member Johnson & Johnson announced new data from the Phase 3 ASTRO study evaluating TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adults with moderately to severely active ulcerative colitis (UC). The ASTRO Week 24 data build on the Week 12 SC induction data that showed statistically significant and clinically meaningful improvements compared to placebo across all clinical and endoscopic measures consistent with the U.S. Food and Drug Administration (FDA)-approved intravenous (IV) induction regimen evaluated in this population, in the Phase 3 QUASAR study. TREMFYA® is the first and only IL-23 inhibitor to demonstrate robust results with a fully SC regimen. Data at Week 24 show patients treated with TREMFYA® 400 mg SC induction followed by SC maintenance dose regimens of either 100 mg every eight weeks (q8w) or 200 mg every four weeks (q4w) demonstrated statistically significant and clinically meaningful improvements across all clinical and endoscopic measures compared with patients receiving placebo.

TREMFYA® (guselkumab) Delivers Sustained Clinical and Endoscopic Remission in Ulcerative Colitis Through Two Years

New Brunswick-based BioNJ Member Johnson & Johnson announced new data from the TREMFYA® (guselkumab) Phase 3 QUASAR long-term extension (LTE) study in adults with moderately-to-severely active ulcerative colitis (UC). Data from the QUASAR LTE study demonstrate patients treated with TREMFYA® sustained clinical and endoscopic efficacy at Week 92: 1) 72% of patients were in clinical remission with 99% of those patients remaining corticosteroid free for 8 or more weeks through Week 92; 2) 43% of patients were in endoscopic remission; 3) Among patients achieving endoscopic improvement at Week 44, 84% maintained endoscopic improvement through Week 92. Patients treated with TREMFYA® sustained clinical and endoscopic remission regardless of prior biologic and/or JAK inhibitor treatment history.

Johnson & Johnson Receives FDA approval for IMAAVY^TM (nipocalimab-aahu), a New FcRn Blocker Offering Long-lasting Disease Control in the Broadest Population of People Living With Generalized Myasthenia Gravis (gMG)

New Brunswick-based BioNI Member Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved IMAAVY™ (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG). The approval, which follows FDA Priority Review designation, offers a new treatment option in a proven class with the potential for lasting disease control in the broadest population of people living with gMG (adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody positive). gMG is a chronic, debilitating autoantibody disease for which significant unmet patient need exists for additional efficacious therapies with demonstrated safety profiles that offer sustained disease control. Anti-AChR and anti-MuSK antibody positive individuals comprise ≥90% of the total antibody-positive gMG population.

Johnson & Johnson’s TAR-200 Monotherapy Achieves High Disease-Free Survival of More Than 80 Percent in BCG-Unresponsive, High-Risk Papillary NMIBC

New Brunswick-based BioNJ Member Johnson & Johnson announced first results from Cohort 4 of the Phase 2b SunRISe-1 study evaluating TAR-200—an intravesical gemcitabine releasing system—for patients with certain types of bladder cancer. These first results show the promise of TAR-200 in this patient population with more than an 80 percent disease-free survival (DFS) rate without the need for reinduction and 94 percent of patients able to preserve their bladder. The high DFS and bladder preservation rate combined with the well-tolerated safety profile in these patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with papillary-only disease (high-grade Ta or T1) show the potential of TAR-200 as a meaningful alternative to surgery.

Johnson & Johnson’s TAR-200 Monotherapy Demonstrates Highest Complete Response Rate With Sustained Clinical Benefits in Patients With Certain Types of Bladder Cancer

New Brunswick-based BioNJ Member Johnson & Johnson announced new data from Cohort 2 of the pivotal Phase 2b SunRISe-1 study evaluating TAR-200—an intravesical gemcitabine releasing system—for patients with certain types of bladder cancer. The findings demonstrate the highest complete response rate without reinduction with more than half of responders remaining cancer-free for at least 12 months. These results highlight the potential of TAR-200 as a breakthrough for people with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors who are ineligible or refuse radical cystectomy (RC). As of March 2025, 82.4 percent of the 85 enrolled patients in the study achieved a complete response (CR) (95 percent confidence interval [CI], 72.6-89.8), meaning their cancer was undetectable following treatment. 

RINVOQ® (upadacitinib) Receives U.S. FDA Approval for Giant Cell Arteritis (GCA)

BioNJ Member AbbVie, with a site in Madison, announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib), 15 mg, once daily, for the treatment of adults with giant cell arteritis (GCA). This comes after the European Commission recently granted marketing authorization of RINVOQ for the treatment of GCA in adult patients. The approvals are supported by results of the pivotal Phase 3 SELECT-GCA clinical trial, which met the primary endpoint of sustained remission (46.4% of patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission from week 12 to week 52, compared to 29.0% of patients receiving placebo in combination with a 52-week steroid taper regimen; p=0.002). During the 52-week, placebo-controlled period, the safety profile of RINVOQ was generally consistent with that observed in other approved indications. 

Boehringer’s New Zongertinib Data Demonstrates Durable and Clinically Meaningful Results in Patients With HER2 (ERBB2)-Mutant Advanced NSCLC

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, reported new and updated data from the Beamion LUNG-1 trial evaluating zongertinib in previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC). The data was published in The New England Journal of Medicine. Data from the most recent analysis showed durable response and clinically meaningful results with zongertinib in previously treated patients with advanced NSCLC who have HER2 mutations within the tyrosine kinase domain (TKD) (N=75). The ORR was 71% (95% CI: 60-80), with 7% complete response, 64% partial response, and 96% disease control in previously treated patients. Additionally, zongertinib had intracranial activity in previously treated patients (n=27, who were evaluable) with brain metastases, with 41% achieving response and 81% disease control.

Lilly Plans to Expand Purdue University Collaboration With Up to a $250 Million Investment to Accelerate Pharmaceutical Innovation

BioNJ Member Eli Lilly and Company, with a site in Branchburg, and Purdue University announced a significant expansion of their long-standing alliance, with Lilly's planned investment of up to $250 million in the collaboration over the next eight years. This partnership, which has the potential to be the largest ever industry-academic agreement of its kind in the United States, will seek to accelerate innovation at every stage of the pharmaceutical pipeline. The Lilly-Purdue 360 Initiative aims to achieve several key goals, including discovering and accelerating the delivery of medicines to patients; bridging the gap between laboratory discoveries and clinical applications; creating more resilient, efficient and sustainable supply chains; and deploying innovative, scalable approaches to workforce development.

Sandoz Enters Global Collaboration License Agreement With Henlius to Commercialize Leading Oncology Therapy, Ipilimumab, in Multiple Indications

Princeton-based BioNJ Member Sandoz announced that it has signed a global collaboration agreement with Shanghai Henlius Biotech, Inc. to commercialize a biosimilar of leading oncology therapy, ipilimumab. The agreement is milestone-based for a total consideration of up to USD 301 million, including an upfront payment of USD 31 million, and will target net reference-medicine sales of USD 2.5 billion. Under the terms of the agreement, Sandoz has exclusive commercial rights for a biosimilar of ipilimumab in Australia, Canada, Europe, Japan and the U.S. The core sequence patent for ipilimumab expired in March 2025 in the U.S. and will expire no later than February 2026 in the EU.

ENHERTU® Followed by THP Before Surgery Showed Statistically Significant and Clinically Meaningful Improvement in Pathologic Complete Response in Patients With High-Risk HER2 Positive Early Stage Breast Cancer in DESTINY-Breast11 Phase 3 Trial

Basking Ridge-based Daiichi Sankyo announce positive topline results from the DESTINY-Breast11 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) demonstrated a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) rate versus standard of care (dose-dense doxorubicin and cyclophosphamide followed by THP [ddAC-THP]) when used in the neoadjuvant setting (before surgery) in patients with high-risk, locally advanced HER2 positive early stage breast cancer. Pathologic complete response is defined as no evidence of invasive cancer cells in the removed breast tissue and lymph nodes following treatment. The secondary endpoint of event-free survival (EFS) was not mature at the time of this analysis; however, EFS data showed an early positive trend favoring ENHERTU followed by THP compared to standard of care. The trial will continue to follow EFS.

UroGen Announces FDA Advisory Committee for UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Princeton-based UroGen announced that the U.S. Food and Drug Administration (FDA) has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting on May 21, 2025 to review the new drug application (NDA) for UGN-102 (mitomycin) for intravesical solution, an investigational treatment for recurrent LG-IR-NMIBC. The ODAC meeting will provide an opportunity for independent clinicians and other experts to evaluate the UGN-102 data and make a recommendation to the FDA as to whether the NDA should be approved and under what conditions. UGN-102 is in development as a therapeutic option for patients with recurrent LG-IR-NMIBC, a condition for which there are no FDA-approved drugs. The NDA is supported by results from the pivotal Phase 3 ENVISION trial which demonstrated a 79.6% complete response (CR) rate at 3 months after first instillation of UGN-102, and duration of response of 82.5% at 12 months after 3-month CR by Kaplan-Meier analysis.

Palisades Therapeutics Unveils Breakthrough Multi-Mechanistic Data for PT150 and PT157 in Resistant Cancers

Cliffside Park-based Pop Test Oncology LLC dba Palisades Therapeutics released compelling preclinical data for clinical-stage PT150 and its early stage dimer PT157, demonstrating their superiority over existing glucocorticoid receptor (GR) antagonists like Relacorilant™. These findings position PT150 and PT157 as transformative therapies for taxane-resistant and AR/GR-driven cancers, including pancreatic, ovarian, liver, prostate, and colorectal malignancies. PT150 and PT157’s multi-target approach offers hope for durable remissions in resistant pancreatic, ovarian, liver and prostate cancers.

Late-breaking Exploratory Data Highlights the Impact of IQIRVO® (elafibranor) on Fatigue and Provides Mechanistic Insights into Anti-inflammatory and Symptom-related Effects in Patients With Primary Biliary Cholangitis

Ipsen, with a site in Basking Ridge, announced new data on IQIRVO® (elafibranor). Additional analyses from the ELATIVE® study (LBP-027) suggest that patients with primary biliary cholangitis (PBC) treated with IQIRVO had greater improvements in fatigue compared to placebo after 52 weeks, as measured by both the PROMIS Fatigue Short Form 7a questionnaire (42.9% IQIRVO versus 31.3% placebo) and PBC-40 fatigue domain (22.6% IQIRVO versus 15.4% placebo). Among patients with moderate-to-severe fatigue at baseline, more than twice as many patients treated with IQIRVO (66.7%) achieved clinically meaningful improvements compared to placebo (31.3%). Importantly, the data suggest that the positive effect of IQIRVO on fatigue occurs independently of its effect on pruritus. 

Years in the Making: Sun Pharma’s Decision to Build larger HQ in Princeton Proves Administration’s Efforts in India are Having Impact

The state rejoiced when Mumbai-based Sun Pharma announced it intended not only to stay in New Jersey, but to consolidate its presence with a new headquarters in Princeton. The pharmaceutical company’s new location — which comes with Emerge tax credits of up to $5.2 million — aims to create 220 new jobs and keep hundreds more jobs in the state, including the 230 that are at its current headquarters, officials said. Keeping the fourth-largest specialty generic pharmaceutical company in the world, one that already has more than 600 employees at various locations around the state, certainly was a winning moment — one that was built on nearly a decade of effort. Sun Pharma’s decision earlier this spring was evidence that the Gov. Phil Murphy administration’s efforts to increase its ties and connection to India are paying off.

Evotec Receives $ 2.5 m Grant to Generate Next Generation Tuberculosis Treatments

Princeton-based Evotec SE announced the award of a US$ 2.5 m grant from The Gates Foundation (GF) to support the development of next-generation treatment regimens for tuberculosis (TB). This is the second grant awarded to Evotec by the GF focused on evaluating new and improved TB therapies using the company’s state-of-the-art translational platforms. The new funding builds on an ongoing five-year partnership which has already generated standardized preclinical data used to select shorter, safer, and more effective TB drug combinations. Under the new grant, Evotec will further characterize promising regimens using its fully integrated TB platform to accelerate the development of transformative TB treatments and significantly impact global health.

CoreWeave Acquires Weights & Biases to Scale AI Capabilities

BioNJ Member CoreWeave completed a key acquisition of leading AI developer platform Weights & Biases, the company announced May 5. The move marks the latest notable development from CoreWeave. The Jersey-born-and-based AI hyperscaler made its public debut on the Nasdaq Stock Market in late March. “Today’s announcement accelerates our ability to power AI innovation with the scale, performance, and expertise that meets the demands of accelerated computing,” said Michael Intrator, Co-founder and CEO of CoreWeave. “It also builds on our recent IPO, creating new vectors for growth and broadened capabilities as a combined company.” The organizations say that, together, they plan to deliver the leading AI Cloud Platform – purpose-built to develop, deploy and iterate AI faster.

North Brunswick Bioscience Hub Fuels NJ Innovation

A visit to North Brunswick can offer a glimpse into a key hub of life sciences and innovation in the Garden State. The New Jersey Bioscience Center, centrally located along Route 1, is a 50-acre site that includes five buildings and three pad sites with 300,000 square feet of life sciences space – such as the Incubator at North Brunswick, which has 27 wet labs and around 20 companies; Step-Out Labs at North Brunswick; as well as more office and lab space for growing firms and established companies at other on-site buildings. The Incubator offers entrepreneurs lab space starting at 900 square feet up to 1,300 square feet, conference rooms, private offices and the opportunity to collaborate with fellow entrepreneurs.

Work Begins on New Lab Space at College Park Campus in Princeton

Work has begun to add laboratory space to the College Park R&D campus in Princeton, following a full-building lease by leading cell therapy company BioCentriq, Inc., now rebranded as Made Scientific. The College Park R&D campus, owned by a joint venture of National Business Parks and ABS Partners Real Estate, is a six-building, 358,000-square-foot life science hub located along College Road East in Princeton. Ownership announced earlier this year that Made Scientific has leased the entire 56,845-square-foot, single-story lab building 201 College Road East bringing the campus to 87% leased. The renovation is designed to be divisible for up to three tenants; companies have the opportunity to have input into the design of the new lab spaces. The campus features an additional 31 acres available for build-to-suit opportunities of up to 350,000 square feet.

Rutgers and King Saud Universities Plan Education Collaboration

As part of its Governor-led economic mission to the Gulf Arab States, Gov. Phil Murphy and Choose New Jersey facilitated the signing of a Letter of Intent (LOI) between Rutgers University and King Saud University to establish academic collaboration in public policy research. The LOI establishes a framework for the two institutions to collaborate in the fields of public policy, management, business administration, urban planning, city development and other areas of study to increase economic and academic cooperation. “The future of New Jersey’s economic success is strengthened by our commitment to securing new international relationships,” said Murphy. “This collaboration will enhance bilateral academic exchange and open opportunities to support New Jersey’s educational resources and economic growth.”

Rutgers, King Saud University Sign Letter of Intent to Increase Collaboration

Officials from Rutgers University and King Saud University agreed to collaborate in executive education and research. The Rutgers Business School and the Edward J. Bloustein School of Planning and Public Policy, both nationally and internationally recognized, will lead the collaborative initiatives with King Saud University. The LOI establishes a framework for the two institutions to collaborate in the fields of public policy, management, business administration, urban planning, city development and other areas of study to increase economic and academic cooperation. The LOI also prioritizes research that can support continued development within New Jersey, attract businesses and increase investment in urban areas and downtowns. KSU was established in 1957 and is the first university in Saudi Arabia, as well as a leading institution for higher education, research and innovation. 

Kean, Rowan, in Expansion of Global Mission, Sign MOUs With Universities in UAE

Kean University and Rowan University sign Memoranda of Understanding with universities in Dubai. Kean with the University of Dubai, American University in Dubai and University of Wollongong in Dubai; Rowan with the American University of Ras Al Khaimah. The agreements establish academic partnerships, strengthening research capabilities between institutions. The school entered into MOUs with three universities, each a collaboration between research students and faculty members in academic areas of mutual interest, including opportunities for faculty and student exchange. The MOUs aim to create opportunities for undergraduate and graduate students to study, conduct and present research with the partner university. In addition to research & development, the Rowan University and American University of Ras Al Khaimah MOU will focus on strengthening cross-cultural ties between New Jersey and the UAE through student and faculty exchange programs and joint educational programs.

SJ Institute for Public Health Announces Grants for Population Health Research

The South Jersey Institute for Population Health (SJIPH) has opened its fourth funding cycle for research teams to conduct community-engaged projects to improve health outcomes in South Jersey. In its first three cycles, SJIPH awarded more than $1 million to projects in the South Jersey region. SJIPH, established in 2018 through a state grant received by the Rowan University / Rutgers – Camden Board of Governors, SJ Institute for Public Health announces grants for population health research supports collaborative research aimed at improving health outcomes in rural and urban communities in South Jersey. “Each funding cycle has produced incredible research projects that have aided in improving the health and wellbeing of South Jersey residents,” said Jeffrey Nash, CEO of the Joint Board of Governors.  

H. John Pounardjian Joins RWJBarnabas Health and Rutgers Cancer Institute

After a national search, RWJBarnabas Health and Rutgers Cancer Institute, the state’s only National Cancer Institute-designated Comprehensive Cancer Center, have appointed H. John Pounardjian, MBA, as chief financial and administrative officer and deputy director for administration and planning. Pounardjian will take over for Linda Tanzer, who will be retiring after 30 years in the position. In this position, Pounardjian will serve as a member of Rutgers Cancer Institute’s executive leadership team and the senior leader for administration, planning and finance. He will provide strategic guidance and direction regarding the optimization and development of entrepreneurial opportunities as well as administrative and operational efficiencies across all mission elements including the clinical, research, education and outreach enterprises.

Bristol Myers Squibb Names Gallman Executive VP, General Counsel and Chief Policy Officer

Princeton-based BioNJ Member Bristol Myers Squibb announced the appointment of Cari Gallman as Executive Vice President, General Counsel and Chief Policy Officer, effective immediately. She succeeds Sandra (Sandy) Leung, who is retiring after a 33-year career at the company. Ms. Gallman has extensive experience in pharmaceutical law and compliance. She will lead the law department, which includes intellectual property, commercial and regulatory law, litigation, securities and corporate governance, transactions, corporate security and compliance and ethics, as well as global and U.S. policy and government affairs. Ms. Gallman has held leadership positions at Bristol Myers Squibb for 10 years, most recently serving as Executive Vice President, Corporate Affairs.

Lilly Announces Transitions in Executive Leadership

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced executive leadership transitions that will further enhance the company's ability to drive sustained, long-term growth and ensure that its medicines continue to reach millions of people worldwide. Lilly has experienced significant growth over the past several years, particularly in the U.S. and cardiometabolic health businesses. To help drive this next wave of growth, Lilly is increasing its leadership focus on the U.S. business and global therapeutic areas. Ilya Yuffa, Executive Vice President and President, Lilly International, will become Executive Vice President and President, Lilly USA and Global Customer Capabilities. Patrik Jonsson, Executive Vice President and President, Lilly Cardiometabolic Health, and President, Lilly USA, will become Executive Vice President and President, Lilly International and will lead all markets outside the U.S. Kenneth Custer, Ph.D., General Manager of Lilly Canada, will be promoted to Executive Vice President and President, Lilly Cardiometabolic Health and will join Lilly's executive committee.

Lilly Announces Transitions in Executive Leadership

Ipsen, with a site in Basking Ridge, announced the appointment of Laura Réveillon, Ph.D. as EVP, Strategy & Transformation, effective May 14, 2025. She will serve on the Executive Leadership Team and report directly to Ipsen’s CEO, David Loew. Laura joins Ipsen from the Boston Consulting Group (BCG) where she was Partner, consulting across portfolio strategy, M&A, Go-to-Market, and operating model transformation projects. Over her 12-year tenure at BCG, Laura became a trusted partner for many pharmaceutical companies, having consulted with organizations ranging from small biotech firms to global pharma and MedTech companies. She has been exposed to a diversity of market dynamics, strategic contexts and corporate cultures proving a strong ability to navigate complex, high-stakes transformations across geographies and business models over her 20 year career in the broader healthcare industry.

Princeton Innovation Conference at Reunions

May 23, 2025 | Princeton University Office of Innovation

Discover how the Office of Innovation is supporting founders and entrepreneurs, engaging industry and investors, and advancing technology translation. Join us for fireside chats, panels, networking, and mingling on topics including AI, deep tech, strategic partnerships and industry engagement opportunities, energy and the environment, the humanities, and the arts. This event is open to our entire innovation ecosystem community, including alumni. 

Reverse Pitch: Meet the Investors Returns for Its Second Year

June 12, 2025 | Hosted by Princeton Innovation Center BioLabs

Flipping the innovation script, Princeton Innovation Center BioLabs and the New Jersey Economic Development Authority (NJEDA) will host an evening of networking and reverse pitches on Thursday, June 12, from 4 pm to 7 pm at Princeton Innovation Center BioLabs, 303A College Road East, in Princeton, NJ. This is an opportunity to hear directly from investors who will take center stage with a reverse pitch approach, discussing their mission and what they are looking for in an early- to mid-stage life science and biotech entrepreneur. Invitation-Only Event: Early- to mid-stage life sciences and biotech companies seeking funding and interested in attending are invited to fill out the form below to express their interest.

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.