|
Welcome to the latest edition of the BioLines Weekender...
Last week, Governor Murphy signed legislation that will prevent the use of copay accumulator and maximizer programs. The legislation, sponsored by Senate President Scutari, Senator Bramnick, Assembly Majority Leader Greenwald, and Assemblyman Freiman along with a variety of other legislators, requires that third-party discounts and payments apply to copayments, coinsurance, deductibles and other out-of-pocket costs.
BioNJ was pleased to support the movement of this bill, as this policy will ensure that the kind of assistance intended to reduce the costs that Patients confront is actually received by the Patients themselves. We are glad to see that Governor Murphy signed this prudent legislation ahead of delivering his final State of the State Address and congratulate him on making this kind of progress up to the final days of his second term.
Click here to read Governor Murphy's official press release on the bill, which includes BioNJ's statement.
Because Patients Can't Wait®,
Debbie Hart
President and CEO
BioNJ
| | BioNJ and Genmab were excited to be on hand to hear the Lt. Governor-Elect Dale Caldwell address a sellout crowd at the inaugural Best Awards Reception, a partnership between BINJE and the New Jersey Chamber of Commerce for the first annual celebration honoring BINJE’s 2026 Power Player List. | | |
Congratulations to BioNJ President and CEO Debbie Hart and These
BioNJ Members for Being Named to BINJE’s 2026 Power Player List!
Leaders Shaping the Future of Business in New Jersey!
| |
- Keith Banks, Hackensack Meridian Health
- Joe Boccassini, McCarter & English
- Tom Bracken, New Jersey Chamber of Commerce
- Vanessa Broadhurst, Johnson & Johnson
- Peter Connolly, New Jersey Manufacturing Extension Program
- Chris Cozic, Genmab
- Jose Cruz, Jones Lang Lasalle
- Robert Donnelly, Jr., Cushman & Wakefield
- Christopher Eisgruber, Princeton University
- Bob Garrett, Hackensack Meridian Health
- Chris Guiton, Johnson & Johnson
- Dr. Ali Houshmand, Rowan University
- Michael Intrator, CoreWeave
- Dr. Teik Lim, New Jersey Institute of Technology
| |
- Dan Loughlin, Jones Lang Lasalle
- Amy Mansue, Inspira Health
- Gil Medina, CBRE
- Jack Morris, Rutgers Cancer Institute
- Kevin Morrison, J.P. Morgan Chase
- Dr. Lamont Repollet, Kean University
- Michele Siekerka, New Jersey Business & Industry Association
- Dr. William F. Tate IV, Rutgers, The State University of New Jersey
- Amy Towers, Rutgers, The State University of New Jersey
- Patrick Walsh, WithumSmith+Brown
- Diane Wasser, EisnerAmper
| | |
OPINION: How New Jersey is Leading AI Innovation in Life Sciences
Across health and life sciences, artificial intelligence is elevating patient care and accelerating drug discovery, driving a powerful wave of innovation. With its deep industry strengths and growing AI ecosystem, New Jersey is uniquely positioned to lead this transformation. The Garden State is already a nationally recognized powerhouse in the field of biomedical innovation. Its universities, health systems, and biopharmaceutical businesses have long driven medical discovery and development. But recently, New Jersey has also established itself as a leader in artificial intelligence, with independent reports placing the state and the region among the country’s top AI centers. Transformation is already underway. In New Jersey, hospital teams are using AI to analyze vital signs, lab results and scans — spotting risks and urgent findings faster so clinicians can act quickly.
| | |
Governor Murphy Signs Legislation Bolstering Health Care Affordability and Accessibility
Governor Phil Murphy signed four bills to make health care more accessible and affordable for New Jersey residents. Together, the legislation will streamline access to critical health care services and prescription medications while enhancing New Jersey’s health care workforce. “BioNJ thanks Governor Murphy for the signing of legislation that will ensure that Patients receive the cost assistance intended for them. With these new policies, the Governor and Legislature have made significant progress towards achieving greater access and affordability for Patients,” said Debbie Hart, President & CEO of BioNJ. “We thank and congratulate Senate President Scutari, Assembly Majority Leader Greenwald, and all policymakers involved in developing and passing this legislation, which is a policy win on behalf of the life sciences ecosystem and Patient community across New Jersey.”
| | |
Murphy Signs Four Bills Aimed at Increasing Access and Affordability
In an effort to streamline access to critical health care services and prescription
medications while enhancing New Jersey’s health care workforce, Gov. Phil Murphy
signed four bills to make health care more accessible and affordable. “When people cannot access health care, small problems can turn into debilitating crises,” he said. “That is why my Administration has spent the past eight years laser focused on expanding access to critical health care services ― and making those services more affordable so our residents don’t have to choose between seeking out care and paying their bills. With these bill signings, we are breaking down barriers that prevent New Jerseyans from accessing affordable health care services and prescription medications.”
| | |
Genmab CEO to be Given Prestigious Dr. Sol J. Barer Award by BioNJ
Princeton-based BioNJ Member Genmab CEO Jan van de Winkel has been named the 2026 winner of the prestigious Dr. Sol J. Barer Award for Vision, Innovation and Leadership by BioNJ. The award, which will be presented by Barer himself, will be a highlight of BioNJ’s Annual Dinner Meeting and Innovation Celebration, Feb. 5, at the Hilton in East Brunswick. The event, considered the kickoff event of the year for the life sciences industry in New Jersey, always draws a top crowd. Hundreds of biopharma professionals, academic leaders, patients, advocates and service providers come together to honor the groundbreaking medical innovation coming from around the Garden State will be present. BioNJ CEO Debbie Hart said the event honors members who are helping patients live longer and better lives ― in accordance with the group’s motto: Because Patients Can’t Wait®.
| | |
BioNJ Announces Innovator Award Recipients
BioNJ announced its 2026 Innovator Award Honorees, who will be honored at the organization’s 33rd Annual Dinner Meeting & Innovation Celebration on Feb. 5 at the East Brunswick Hilton. The 2026 Innovator Award Honorees Include: Abbvie for the approval of Emrelis™; Bayer for the approvals of Hyrnuo® and Lynkuet®; Daiichi Sankyo for the approval of Datroway®; Eli Lilly for the approval of Inluriyo™; GSK for the approvals of Blujepa and Exdensur; Insmed for the approval of Brinsupri™; Johnson & Johnson for the approval of Imaavy™; Kyowa Kirin (in partnership with Kura Oncology) for the approval of Komzifti™; LEO Pharma for the approval of Anzupgo®; Merck & Co. for the approvals of Enflonsia™ and Keytruda Qlex™; Novartis for the approvals of Itvisma®, Rhapsido® and Vanrafia™; Otsuka Pharmaceutical for the approval of Voyxact®; PTC Therapeutics for the approval of Sephience™; Regeneron for the approval of Lynozyfic™; Sanofi for the approvals of Qfitlia™ and Wayrilz™.
| | |
New Jersey Technology Commission Awards Nearly $1.3M to 17 Startups Via Seed Grant Program
The New Jersey Commission on Science, Innovation and Technology it has awarded about $1.3 million in grants to 17 startups through the fourth round of its Clean Tech Research & Development Seed Grant Program. The awards will assist emerging companies accelerate development of their technologies and transform their discoveries from the research stage into commercially viable products and services. “New Jersey’s startups are among the very best in the nation and truly place the State at the forefront of innovation,” said CSIT Chair and BioNJ Founding President and CEO Debbie Hart. “The Clean Tech Research & Development Seed Grant Program reinforces the State’s commitment to its small businesses and nurtures advancements across a range of innovation areas aimed at reducing greenhouse gas emissions. We have seen early stage companies leverage CSIT funding 15X in follow-on funding and accelerate their development trajectory.
| | |
It Has Been a Busy Year for New Jersey’s Life Sciences Sector
“Last year was truly remarkable for New Jersey’s life sciences sector. We’ve celebrated nearly 20 ribbon cuttings, expansions and groundbreakings — each one a testament to the State’s vitality and growth," said BioNJ President and CEO Debbie Hart. “Even as the broader market faced headwinds, these milestones reflect unwavering optimism and momentum. Companies such as Genmab, Ferring and Ascendis have all expanded their New Jersey footprints, signaling strong confidence in the State’s innovation ecosystem. This remarkable momentum is attracting global companies and major investments to New Jersey. For example, Enzene Biosciences, an Indian company, chose Hopewell for its U.S. headquarters after evaluating multiple states, giving glowing reviews of New Jersey’s advantages.”
| | |
Putting Patients First:
The Value of Medical Innovation -
Recent Stories in the News
| | | |
America's Biotech Leadership Depends on the States
For decades, America has led the global biotech industry — thanks, in part, to state-level policies that encourage research and manufacturing investments. But other countries, including China, are sparing no expense in the bid to overtake us. Beijing has officially made biotechnology a national strategic priority and is pouring billions into state-backed research and manufacturing efforts. All states should consider impactful biotech policies that grow and strengthen our domestic biotechnology industry. If states fail to utilize and replicate what are considered to be the best and most successful policies in biotech-focused economic development, the United States will soon lose its long-term leadership in developing medicines and medical technologies, which underpin our health, our economy, and our national security.
| | |
Pharmaceutical Industry Evades Drug Price Transparency, Again
Drug manufacturers and pharmacy benefit managers received a holiday gift from President Trump: They still will not have to publicly post the actual prices of prescription drugs, more than five years after federal law required them to do so. Net drug prices ― the amounts that health insurance companies and PBMs pay to drugmakers, after factoring in rebates ― are highly valuable data that undergird the entire economic foundation of the U.S. pharmaceutical industry. But the decision from the Trump administration, rolled out in a new proposed rule, means that drug pricing data will likely remain locked out of public view for the foreseeable future. The release of drug prices has been in purgatory since 2020, as the government has repeatedly deferred the requirement under the so-called Transparency in Coverage rule.
| | |
Secretary Lutnick’s Royalty Grab: Bad for America — and the Administration
Commerce Secretary Howard Lutnick is urging the White House to turn a proposal he floated into an Executive Order that would weaken the economy and cost the government tens of billions of dollars in foregone tax revenue. It’s bad policy, and even worse politically. The Trump Administration would be wise to reject it. Secretary Lutnick is convinced that the government is being short-changed when academic institutions make patentable inventions under federal grants, which are primarily licensed to entrepreneurial small companies that take great risk and expense to turn them into real-world products. The Secretary wants the government to seize 50% of the royalties that universities receive when resulting products are sold ― sales that bolster our economy while promoting public well-being.
| | |
2025 U.S. Policy Highlights: Most Favored Nation
In this special 2025 U.S. Policy Highlights edition of the Vital Health Podcast, we look back at our most important discussions on Most Favored Nation (MFN) drug pricing and its knock-on effects for jobs, state budgets and the generic supply chain. Over 2025, proposals to link U.S. prices to those in other countries have collided with inflation pressures, tariff debates and reshoring efforts, creating new uncertainty for manufacturers, payers and policymakers. In an environment where expectations about future returns are shifting, and the rules of the game are still being defined, this episode is designed as a year-end guide to what MFN-style policies could mean in practice and how to think about the tradeoffs.
| | |
2025 U.S. Policy Highlights: Inflation Reduction Act (IRA)
In this special 2025 U.S. Policy Highlights edition of the Vital Health Podcast, we look back at our most important discussions on the Inflation Reduction Act (IRA) and its ripple effects across drug development, Medicare, and patient access. Over the past year, the biopharma industry and the broader healthcare system have undergone a period of rapid change as new rules surrounding drug pricing reshape how therapies are developed, financed, and delivered. In a landscape where policies are still being interpreted and adjusted, and where the long-term impact on innovation and access is far from certain, this episode serves as a year-end guide to what has changed and how to think about the road ahead.
| | |
PTC Therapeutics Announces Approval of Sephience™ (sepiapterin) for the Treatment of Children and Adults Living With Phenylketonuria (PKU) in Japan
Warren-based BioNJ Member PTC Therapeutics, Inc. announced that Sephience™ (sepiapterin) has been approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) for the treatment of children and adults living with phenylketonuria (PKU). The label includes individuals of all ages and the full spectrum of disease severity. Sephience™ is indicated for the treatment of adult and pediatric patients with phenylketonuria (PKU). Sephience is a natural precursor of the enzymatic co-factor BH4, a critical co-factor for phenylalanine hydroxylase (PAH). Through its mechanism of action, Sephience is able to effectively reduce blood phenylalanine (Phe) levels and has the potential to treat a broad range of PKU patients. Sephience is approved in the European Union / European Economic Area region, the United States and Japan.
| | |
BeOne Medicines Granted U.S. FDA Fast Track Designation for BGB-B2033 as Treatment for Hepatocellular Carcinoma
Hopewell-based BioNJ Member BeOne Medicines Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted the Company Fast Track Designation for BGB-B2033, its GPC3x4-1BB bispecific antibody for the treatment of adult patients with hepatocellular carcinoma (HCC) with disease progression on or after prior systemic treatment. BeOne is currently conducting a global, multi-center Phase 1 clinical trial (NCT06427941) to explore the safety and anti-tumor activity of BGB-B2033, both alone and in combination with PD-1 inhibitor TEVIMBRA® (tislelizumab). Hepatocellular Carcinoma (HCC) is the sixth most common cancer worldwide and the fourth leading cause of cancer-related death. HCC accounts for 80% of all primary liver cancers, with the number of new cases expected to double between 2022 and 2050.
| | |
ZIIHERA Plus TEVIMBRA and Chemotherapy: A Potential New Standard for First-Line HER2+ Advanced GEA
Hopewell-based BioNJ Member BeOne Medicines Ltd. announced full results from the Phase 3 HERIZON-GEA-01 trial evaluating ZIIHERA® (zanidatamab), a HER2-targeted bispecific antibody, in combination with chemotherapy, with and without PD-1 inhibitor TEVIMBRA® (tislelizumab), as a first-line treatment for HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). HERIZON-GEA-01 met the dual primary endpoint of progression-free survival (PFS), demonstrating statistically significant and clinically meaningful improvements in both experimental arms compared to the control arm. ZIIHERA plus chemotherapy showed a clinically meaningful survival benefit with a mOS of 24.4 months, a strong trend toward statistical significance at the time of this first interim analysis for OS.
| | |
BeOne Medicines’ Novel BCL2 Inhibitor, Sonrotoclax, Achieves First-in-World Approval in R/R MCL and R/R CLL/SLL
Hopewell-based BioNJ Member BeOne Medicines Ltd. announced the first-in-world approval of sonrotoclax, its foundational, next-generation BCL2 inhibitor, for adult patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) and R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) globally. The approval, granted in China, is supported by data demonstrating deep and durable responses and manageable tolerability, underscoring sonrotoclax’s emerging role as a foundational medicine across B-cell malignancies. The approval was based on parallel submissions of data from two studies. In the Phase 1/2 single-arm study of patients with R/R MCL treated with 320 mg of sonrotoclax (n=103), overall response rate (ORR) as assessed by independent review committee (IRC) was 52.4% (95% CI, 42.4-62.4).
| | |
Bristol Myers Squibb Announces Positive Topline Results from Phase 3 SCOUT-HCM Trial Evaluating Camzyos (mavacamten) in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
Princeton-based BioNJ Member Bristol Myers Squibb announced positive topline results from SCOUT-HCM, a Phase 3 trial evaluating Camzyos (mavacamten) in the first study of a cardiac myosin inhibitor (CMI) in adolescents (ages 12 years to <18 years) with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The trial met its primary endpoint, demonstrating a statistically significant reduction from baseline in Valsalva left ventricular outflow tract (LVOT) gradient at Week 28 versus placebo, indicating Camzyos was effective in improving LVOT obstruction. Statistical significance was also met for multiple secondary endpoints, including those for clinically meaningful aspects of the disease. Safety results in the trial were consistent with the established safety profile of Camzyos in adults, and no new safety signals were reported in this new, younger population. The study continues with active treatment and long-term extension periods.
| | |
Pfizer’s BRAFTOVI® Regimen With Additional Chemotherapy Backbone Increased Response Rates for Certain Patients With Metastatic Colorectal Cancer
BioNJ Member Pfizer Inc., with a site in Parsippany, announced positive results from Cohort 3, a separate randomized cohort of the pivotal BREAKWATER trial, evaluating BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and FOLFIRI (fluorouracil, leucovorin, and irinotecan) in patients with previously untreated metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. At the time of this analysis, the BRAFTOVI combination regimen with FOLFIRI and cetuximab demonstrated a clinically meaningful and statistically significant improvement in confirmed objective response rate (ORR) assessed by blinded independent central review (BICR) compared to patients receiving standard-of-care treatment FOLFIRI with or without bevacizumab (64.4% vs 39.2%, odds ratio =2.76, p=0.001).
| | |
Myqorzo and Redemplo Approved in China
The National Medical Products Administration in China has approved two Morristown-based BioNJ Member Sanofi-licensed innovative medicines, Myqorzo (aficamten) for the treatment of obstructive hypertrophic cardiomyopathy (oHCM), and Redemplo (plozasiran) for the reduction of triglyceride levels, in adult patients with familial chylomicronaemia syndrome (FCS) on the basis of dietary control. Myqorzo is a selective, small-molecule cardiac myosin inhibitor to improve functional capacity and relieve symptoms in patients with oHCM, in which the myocardium, the heart muscle, becomes abnormally thick. Redemplo is a small-interfering RNA (siRNA) medicine, suppressing the production of apoc-III, an important target for reducing triglycerides in patients with FCS.
| | |
Sanofi to Acquire Dynavax, Adding a Marketed Adult Hepatitis B Vaccine and Phase 1/2 Shingles Candidate to the Pipeline
Morristown-based BioNJ Member Sanofi announced that it has entered into an agreement to acquire Dynavax Technologies Corporation (Dynavax), a publicly traded vaccines company with a marketed adult hepatitis B vaccine (HEPLISAV-B®) and differentiated shingles vaccine candidate. The acquisition augments Sanofi’s presence in adult immunization by bringing together Dynavax’s vaccines with Sanofi’s global scale, development capabilities and commercial reach. Dynavax’s adult hepatitis B vaccine HEPLISAV-B is currently marketed in the U.S. and is differentiated by its two-dose regimen over one month, which enables high levels of seroprotection faster than other hepatitis B vaccines, which are given in three doses over six months. The acquisition also includes Dynavax’s shingles vaccine candidate (Z-1018), which is currently in phase 1/2 clinical development and additional vaccine pipeline projects.
| | |
Sanofi’s Tzield Accepted for Priority Review in the U.S. for Young Children With Stage 2 Type 1 Diabetes
Morristown-based BioNJ Member Sanofi has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental biologic license application (sBLA) for Tzield (teplizumab-mzwv) to expand the current age indication from eight years and above, to as young as one year old and above to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D. The sBLA is supported by the positive interim one-year data from the ongoing PETITE-T1D phase 4 study (clinical study identifier: NCT05757713), evaluating the safety and pharmacokinetics of Tzield in young children. The target action date for the FDA decision is April 29, 2026. Interim data for the PETITE-T1D Phase 4 study was published in Diabetologia.
| | |
Sanofi’s Teizeild Approved in the EU for Patients With Stage 2 Type 1 Diabetes
Morristown-based BioNJ Member Sanofi announced the European Commission has approved Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients eight years of age and older with stage 2 T1D. This follows the positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use. Teizeild is the first T1D disease-modifying therapy approved in the EU, marking a significant milestone in the treatment of this progressive autoimmune disease. The approval is based on positive results from the TN-10 phase 2 study (clinical study identifier: NCT01030861) demonstrating that Teizeild delayed the onset of stage 3 T1D by a median of two years compared to placebo, in adults and children aged eight years and older with stage 2 T1D.
| | |
Sanofi and Taiho Announce Sales Transfer of Anticancer Agent JEVTANA® Intravenous Infusion 60 mg
Morristown-based BioNJ Member Sanofi K.K. and BioNJ Member Taiho Pharmaceutical Co., Ltd. announced that the sales of the anticancer agent Jevtana® I.V. Infusion 60 mg (generic name: cabazitaxel; hereinafter “Jevtana”) will be transferred from Sanofi to Taiho in Japan effective April 1, 2026. Jevtana is an anticancer agent which was approved and launched in Japan in 2014, indicated for patients with castration-resistant prostate cancer previously treated with a docetaxel-containing regimen. The agent inhibits cell division by promoting tubulin polymerization and stabilizing microtubules, thereby suppressing the proliferation of cancer cells. On April 1, 2026, Taiho will assume responsibility for the sales and marketing, and medical information activities for Jevtana in Japan, while Sanofi will continue to be the marketing authorization holder and will also continue to manufacture the product.
| | |
Dupixent® (dupilumab) Approved in Japan for Children Aged 6 to 11 Years With Bronchial Asthma
BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, and Morristown-based BioNJ Member Sanofi announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent® (dupilumab) for the treatment of bronchial asthma in children aged 6 to 11 years with severe or refractory disease whose symptoms are inadequately controlled with existing therapy. This expands the previous approval in Japan in this indication for patients aged 12 years and older. The approval in Japan is based on data from the overall population and those with a type 2 inflammation phenotype (defined by raised blood eosinophils and/or fractional exhaled nitric oxide) in VOYAGE, a global Phase 3 trial evaluating Dupixent in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma.
| | |
Biologics License Application for Subcutaneous Formulation of “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease Accepted in China
Nutley-based BioNJ Member Eisai Co., Ltd. and BioNJ Member Biogen Inc. announced that the Biologics License Application (BLA) for the subcutaneous formulation (subcutaneous autoinjector: SC-AI) of “LEQEMBI®”, an anti-amyloid beta (Aβ) protofibril antibody, has been accepted by the National Medical Products Administration (NMPA) in China. If approved, the SC-AI of 500 mg (two 250 mg injections) could be used to administer a once-weekly dose at home from the initiation of treatment, as an alternative to the current IV administration every two weeks in a hospital setting. The potential approval of SC-AI would expand the option for patients and care partners to receive LEQEMBI treatment at home. The injection time for each autoinjector (250 mg injection) is approximately 15 seconds.
| | |
Eisai and Nuvation Bio Enter into Exclusive Licensing Agreement for Taletrectinib in Europe and Additional Countries Outside the U.S., China and Japan
Nutley-based BioNJ Member Eisai Co., Ltd. and Nuvation Bio Inc. announced an exclusive license and collaboration agreement that significantly expands the long-term global footprint of taletrectinib (generic name, marketed as IBTROZI® in the U.S. and Japan). Taletrectinib is a highly selective, next-generation oral treatment currently approved for patients living with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) in the U.S., China and Japan. Eisai will now have exclusive development, registration and commercialization rights for taletrectinib for the treatment of ROS1+ NSCLC in Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam and India. Nuvation Bio will continue to lead global development and retain full U.S. commercial rights, maintaining its strong focus on U.S. launch activities and ongoing pivotal studies of taletrectinib across early- and late-stage ROS1+ NSCLC.
| | |
Gilead Sciences Exercises Option to License Assembly Biosciences’ Helicase-Primase Inhibitor Programs for Recurrent Genital Herpes
BioNJ Member Gilead Sciences, with a site in Parsippany, and Assembly Biosciences, Inc. announced Gilead has exercised its combined option to exclusively license Assembly Bio’s herpes simplex virus (HSV) helicase-primase inhibitor programs, including long-acting investigational candidates ABI-1179 and ABI-5366 for recurrent genital herpes. These represent the first programs Gilead will advance under the ongoing Assembly Bio R&D collaboration, reinforcing the companies’ commitment to building a novel antiviral pipeline and driving long-term growth through innovative therapies addressing significant unmet needs. Genital herpes, caused by HSV, is a chronic infection that leads to painful lesions, psychological and social stigma, and an increased risk of HIV acquisition. Over four million people in the U.S. and major European countries experience recurrent genital herpes, with HSV type 2 (HSV-2) infections typically associated with multiple recurrences each year.
| |
Lilly's Taltz (ixekizumab) and Zepbound (tirzepatide) Used Together Delivered Superior Efficacy in First-of-its-Kind Phase 3b Trial for Adults With Active Psoriatic Arthritis and Obesity or Overweight
BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced positive topline results from the novel TOGETHER-PsA open-label Phase 3b trial evaluating the concomitant use of Taltz (ixekizumab) and Zepbound (tirzepatide) compared to Taltz alone in adults with active psoriatic arthritis (PsA) and obesity or overweight with at least one weight-related condition. At 36 weeks, treatment with concomitant Taltz and Zepbound met the primary and all key secondary endpoints for superiority to Taltz monotherapy. TOGETHER-PsA is the first controlled study to evaluate an incretin therapy used with a PsA biologic. An estimated 65% of adults with PsA in the U.S. also have obesity (BMI ≥30 kg/m²) or overweight (BMI 27-29.9 kg/m²) with at least one additional weight-related comorbidity, highlighting a need for integrated treatment approaches that address the full burden of their diseases.
| |
Lilly to Acquire Ventyx Biosciences to Advance Oral Therapies Targeting Inflammatory-Mediated Diseases
BioNJ Member Eli Lilly and Company, with a site in Branchburg, and Ventyx Biosciences, Inc. announced entry into a definitive agreement for Lilly to acquire Ventyx. Ventyx is developing a pipeline of small molecule therapeutics, including NLRP3 inhibitors, designed to treat inflammation across a broad range of disease states with high unmet need. These include opportunities across cardiometabolic disorders, neurodegenerative diseases and inflammatory disorders. The company's clinical-stage programs target key immune pathways with the goal of offering improved efficacy and safety compared to existing treatments. The transaction is not subject to any financing condition and is expected to close in the first half of 2026, subject to approval by Ventyx stockholders and satisfaction of other customary closing conditions, including regulatory approvals.
| |
Merck Initiates Phase 3 KANDLELIT-007 Trial Evaluating Calderasib (MK-1084), an Investigational Oral KRAS G12C Inhibitor, in Combination With KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) in Certain Patients With Advanced NSCLC
Rahway-based BioNJ Member Merck & Co. announced the initiation of KANDLELIT-007, a Phase 3 clinical trial evaluating calderasib (MK-1084), an investigational oral selective KRAS G12C inhibitor, in combination with KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) for the first-line treatment of patients with KRAS G12C-mutant, advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). This randomized, unblinded open-label, multicenter clinical trial (NCT07190248) will evaluate calderasib given orally once daily in combination with KEYTRUDA QLEX administered subcutaneously, compared with subcutaneous KEYTRUDA QLEX in combination with intravenous pemetrexed and chemotherapy (carboplatin or cisplatin), in newly diagnosed patients with KRAS G12C-mutant advanced or metastatic nonsquamous NSCLC. The trial will enroll approximately 675 patients globally.
| | |
Merck to Complete Acquisition of Cidara Therapeutics
Rahway-based BioNJ Member Merck & Co. announced the successful completion of the cash tender offer, through a subsidiary, for all the outstanding shares of common stock of Cidara Therapeutics, Inc. “The acquisition of Cidara strengthens and complements our expanding respiratory portfolio and exemplifies our business development strategy of investing where compelling science and value meet,” said Robert M. Davis, chairman and chief executive officer, Merck. “CD388, a potentially first-in-class, long-acting antiviral with strain-agnostic properties, underscores that approach. We look forward to building on Cidara’s progress and further evaluating the potential of this candidate for the prevention of symptomatic influenza in certain individuals at high risk of complications.”
| | |
Johnson & Johnson Unveils New Data Showing Nipocalimab is the First and Only Investigational FcRn Blocker With Potential to Reduce Systemic Lupus Erythematosus (SLE) Activity in a Phase 2 Study
New Brunswick-based BioNJ Member Johnson & Johnson announced positive topline results from the Phase 2b JASMINE (NCT04882878) study of adults living with systemic lupus erythematosus (SLE) and the initiation of a Phase 3 program. The JASMINE study met the primary endpoint (percentage of patients achieving Systemic Lupus Erythematosus Responder Index [SRI-4] composite response at Week 24 with statistical significance compared with placebo), and key secondary and exploratory endpoints, including those indicating the potential of nipocalimab for steroid sparing. Nipocalimab had a safety and tolerability profile consistent with previous Phase 2 studies, with no new safety signals identified. These data represent the first positive results of an investigational FcRn blocker treatment in this chronic, debilitating autoantibody-driven disease that impacts an estimated 3 to 5 million people worldwide, and 450,000 in the U.S.
| | |
Johnson & Johnson Submits Application to the European Medicines Agency for TECVAYLI®▼ (teclistamab) in Combination With DARZALEX® (daratumumab) Subcutaneous Formulation for Patients With Relapsed/Refractory Multiple Myeloma
Raritan-based BioNJ Member Johnson & Johnson announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication extension of TECVAYLI®▼(teclistamab) in combination with DARZALEX® subcutaneous (daratumumab SC) formulation for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy. The combination of teclistamab and daratumumab SC work in a complementary manner by targeting both BCMA and CD38 to prime and activate the immune system, supporting the potential to improve patient outcomes by enhancing immune-mediated response earlier in the treatment journey. The submission is supported by data from the Phase 3 MajesTEC-3 study.
| |
RYBREVANT® (amivantamab-vmjw) Longer-Term Results Show Promising and Durable Responses in Difficult-to-Treat Colorectal Cancer
Raritan-based BioNJ Member Johnson & Johnson announced announced new longer follow-up results from the investigational Phase 1b/2 OrigAMI-1 study evaluating amivantamab-vmjw, a bispecific antibody targeting epidermal growth factor receptor (EGFR) and MET, in combination with FOLFOX or FOLFIRI chemotherapy in patients with RAS/BRAF wild-type metastatic colorectal cancer. The encouraging anti-tumor activity, durable responses, and low rates of treatment-related discontinuations observed in this study support further investigation in ongoing Phase 3 studies in first- and second-line colorectal cancer. Colorectal cancer is the third most commonly diagnosed cancer worldwide, and a leading cause of cancer-related death.2 While traditionally seen in older adults, incidence is rising in people under 50.3 More than half of patients will eventually develop metastatic disease, with liver involvement in roughly 70 percent of cases.
| |
U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Enables the Simplest, Shortest Administration Time for a First-Line Combination Regimen When Combined With LAZCLUZE® (lazertinib)
New Brunswick-based BioNJ Member Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) approved RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously (SC) administered therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw). Based on the results from the Phase 3 PALOMA-3 study (NCT05388669), RYBREVANT FASPRO™ delivered consistent results to RYBREVANT®, meeting both co-primary pharmacokinetic (PK) endpoints as measured by amivantamab levels in the blood [Ctrough on Cycle (C) 2 Day (D) 1 or C4D1 and C2 area under the curve (AUCD1-D15)].
| |
Johnson & Johnson Completes $3.05B Acquisition of Halda Therapeutics to Redefine Cancer Treatment
New Brunswick-based BioNJ Member Johnson & Johnson announced the successful completion of its $3.05 billion acquisition of Halda Therapeutics OpCo, Inc., a clinical-stage biotechnology company with a proprietary Regulated Induced Proximity TArgeting Chimera (RIPTAC) platform to develop oral, targeted therapies for multiple types of solid tumors, including prostate cancer. With this acquisition, Johnson & Johnson adds HLD-0915, a clinical-stage therapy for prostate cancer, building on the company’s nearly two decades of innovation in this disease area. HLD-0915 is a once-daily oral therapy that uses a novel RIPTAC platform with a precision cancer cell-killing approach that can overcome mechanisms of resistance to treatment.
| | |
Johnson & Johnson Submits Application to the European Medicines Agency for TECVAYLI®▼ (teclistamab) in Combination With DARZALEX® (daratumumab) Subcutaneous Formulation for Patients With Relapsed/Refractory Multiple Myeloma
New Brunswick-based BioNJ Member Johnson & Johnson announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication extension of TECVAYLI®▼(teclistamab) in combination with DARZALEX® subcutaneous (daratumumab SC) formulation for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy. The combination of teclistamab and daratumumab SC work in a complementary manner by targeting both BCMA and CD38 to prime and activate the immune system, supporting the potential to improve patient outcomes by enhancing immune-mediated response earlier in the treatment journey. The submission is supported by data from the Phase 3 MajesTEC-3 study.
| |
RYBREVANT® (amivantamab-vmjw) Longer-Term Results Show Promising and Durable Responses in Difficult-to-Treat Colorectal Cancer
Raritan-based BioNJ Member Johnson & Johnson announced announced new longer follow-up results from the investigational Phase 1b/2 OrigAMI-1 study evaluating amivantamab-vmjw, a bispecific antibody targeting epidermal growth factor receptor (EGFR) and MET, in combination with FOLFOX or FOLFIRI chemotherapy in patients with RAS/BRAF wild-type metastatic colorectal cancer. The encouraging anti-tumor activity, durable responses, and low rates of treatment-related discontinuations observed in this study support further investigation in ongoing Phase 3 studies in first- and second-line colorectal cancer. Colorectal cancer is the third most commonly diagnosed cancer worldwide, and a leading cause of cancer-related death.2 While traditionally seen in older adults, incidence is rising in people under 50.3 More than half of patients will eventually develop metastatic disease, with liver involvement in roughly 70 percent of cases.
| |
U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Enables the Simplest, Shortest Administration Time for a First-Line Combination Regimen When Combined With LAZCLUZE® (lazertinib)
New Brunswick-based BioNJ Member Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) approved RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously (SC) administered therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw). Based on the results from the Phase 3 PALOMA-3 study (NCT05388669), RYBREVANT FASPRO™ delivered consistent results to RYBREVANT®, meeting both co-primary pharmacokinetic (PK) endpoints as measured by amivantamab levels in the blood [Ctrough on Cycle (C) 2 Day (D) 1 or C4D1 and C2 area under the curve (AUCD1-D15)].
| |
Johnson & Johnson Completes $3.05B Acquisition of Halda Therapeutics to Redefine Cancer Treatment
New Brunswick-based BioNJ Member Johnson & Johnson announced the successful completion of its $3.05 billion acquisition of Halda Therapeutics OpCo, Inc., a clinical-stage biotechnology company with a proprietary Regulated Induced Proximity TArgeting Chimera (RIPTAC) platform to develop oral, targeted therapies for multiple types of solid tumors, including prostate cancer. With this acquisition, Johnson & Johnson adds HLD-0915, a clinical-stage therapy for prostate cancer, building on the company’s nearly two decades of innovation in this disease area. HLD-0915 is a once-daily oral therapy that uses a novel RIPTAC platform with a precision cancer cell-killing approach that can overcome mechanisms of resistance to treatment.
| | |
Johnson & Johnson Submits Application to the European Medicines Agency for TECVAYLI®▼ (teclistamab) in Combination With DARZALEX® (daratumumab) Subcutaneous Formulation for Patients With Relapsed/Refractory Multiple Myeloma
New Brunswick-based BioNJ Member Johnson & Johnson announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication extension of TECVAYLI®▼(teclistamab) in combination with DARZALEX® subcutaneous (daratumumab SC) formulation for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy. The combination of teclistamab and daratumumab SC work in a complementary manner by targeting both BCMA and CD38 to prime and activate the immune system, supporting the potential to improve patient outcomes by enhancing immune-mediated response earlier in the treatment journey. The submission is supported by data from the Phase 3 MajesTEC-3 study.
| |
RYBREVANT® (amivantamab-vmjw) Longer-Term Results Show Promising and Durable Responses in Difficult-to-Treat Colorectal Cancer
Raritan-based BioNJ Member Johnson & Johnson announced announced new longer follow-up results from the investigational Phase 1b/2 OrigAMI-1 study evaluating amivantamab-vmjw, a bispecific antibody targeting epidermal growth factor receptor (EGFR) and MET, in combination with FOLFOX or FOLFIRI chemotherapy in patients with RAS/BRAF wild-type metastatic colorectal cancer. The encouraging anti-tumor activity, durable responses, and low rates of treatment-related discontinuations observed in this study support further investigation in ongoing Phase 3 studies in first- and second-line colorectal cancer. Colorectal cancer is the third most commonly diagnosed cancer worldwide, and a leading cause of cancer-related death.2 While traditionally seen in older adults, incidence is rising in people under 50.3 More than half of patients will eventually develop metastatic disease, with liver involvement in roughly 70 percent of cases.
| |
U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Enables the Simplest, Shortest Administration Time for a First-Line Combination Regimen When Combined With LAZCLUZE® (lazertinib)
New Brunswick-based BioNJ Member Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) approved RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously (SC) administered therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw). Based on the results from the Phase 3 PALOMA-3 study (NCT05388669), RYBREVANT FASPRO™ delivered consistent results to RYBREVANT®, meeting both co-primary pharmacokinetic (PK) endpoints as measured by amivantamab levels in the blood [Ctrough on Cycle (C) 2 Day (D) 1 or C4D1 and C2 area under the curve (AUCD1-D15)].
| |
Johnson & Johnson Completes $3.05B Acquisition of Halda Therapeutics to Redefine Cancer Treatment
New Brunswick-based BioNJ Member Johnson & Johnson announced the successful completion of its $3.05 billion acquisition of Halda Therapeutics OpCo, Inc., a clinical-stage biotechnology company with a proprietary Regulated Induced Proximity TArgeting Chimera (RIPTAC) platform to develop oral, targeted therapies for multiple types of solid tumors, including prostate cancer. With this acquisition, Johnson & Johnson adds HLD-0915, a clinical-stage therapy for prostate cancer, building on the company’s nearly two decades of innovation in this disease area. HLD-0915 is a once-daily oral therapy that uses a novel RIPTAC platform with a precision cancer cell-killing approach that can overcome mechanisms of resistance to treatment.
| | |
European Commission Approves TREMFYA® (guselkumab) for the Treatment of Children With Plaque Psoriasis, Marking the First Pediatric Indication for an IL-23 Inhibitor
New Brunswick-based BioNJ Member Johnson & Johnson announced that the European Commission (EC) has extended the marketing authorization for TREMFYA® (guselkumab) as a subcutaneous treatment to treat moderate to severe plaque psoriasis (Pso) in children and adolescents from the age of 6 years who are candidates for systemic therapy. This milestone makes guselkumab the first IL-23 inhibitor approved for any pediatric indication, building on EC approval in adults living with moderate to severe plaque Pso in 2017. Almost one-third of Pso cases begin in childhood, and the inflamed, scaly plaques caused by chronic disease may be itchy or painful and can be highly stressful for children, leading to a potential long-term impact on those affected.
| | |
Novo Nordisk Files for FDA Approval of CagriSema, the First Once-Weekly Combination of GLP 1 and Amylin Analogues for Weight Management
Plainsboro-based BioNJ Member Novo Nordisk announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-weekly CagriSema (cagrilintide 2.4 mg and semaglutide 2.4 mg) injection, to be used with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight in the presence of at least one weight-related comorbid condition. CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg, and the GLP-1 receptor agonist, semaglutide 2.4 mg. If approved, CagriSema would become the first injectable GLP-1 receptor agonist and amylin analogue combination treatment.
| | |
FDA Approves Novo Nordisk’s Wegovy Pill
The U.S. Food and Drug Administration (FDA) has approved Plainsboro-based BioNJ Member Novo Nordisk’s once-daily Wegovy® pill, the first oral GLP-1 medicine for obesity in the US. Wegovy® pill is used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off. Wegovy® pill is also indicated to reduce the risk of major adverse cardiovascular events (MACE) such as death, heart attack or stroke in adults with overweight or obesity and established cardiovascular disease. The FDA approval of Wegovy® pill is based on the results from the OASIS 4 Phase 3 clinical trial, which was a 64-week medical study that included 307 adults with obesity or overweight with one or more weight-related comorbidities, without diabetes.
| | |
Nucala (mepolizumab) Approved in China for Use in Adults With Chronic Obstructive Pulmonary Disease (COPD)
Warren-based GSK plc announced that China’s National Medical Products Administration (NMPA) has approved Nucala (mepolizumab) as add-on maintenance treatment of adult patients with inadequately controlled COPD characterized by raised blood eosinophils. The approval was based on data from the positive MATINEE and METREX phase III trials. Across these trials, mepolizumab showed a clinically meaningful and statistically significant reduction in the annualized rate of moderate/severe exacerbations versus placebo plus standard of care in a wide spectrum of COPD patients with an eosinophilic phenotype. The incidence of adverse events was similar between placebo and mepolizumab groups. Mepolizumab is the first and only monthly biologic approved in China and evaluated in COPD patients with a BEC starting as low as 150 cells/µL.
| | |
Exdensur (depemokimab) Approved in Japan for Severe Asthma and Chronic Rhinosinusitis With Nasal Polyps
Warren-based GSK announced the approval of Exdensur (depemokimab) by Japan’s Ministry of Health, Labour and Welfare (MHLW) as a treatment for bronchial asthma (limited to severe or refractory patients whose asthma symptoms cannot be controlled with existing treatments) and CRSwNP (limited to patients inadequately controlled with standard treatment). The MHLW approval was based on data from the SWIFT and ANCHOR Phase III trials, which demonstrated the sustained efficacy of a twice-yearly dose of depemokimab versus placebo, both plus standard of care. In SWIFT-1 and SWIFT-2, treatment with depemokimab resulted in significant reductions in asthma exacerbations. Additionally, ANCHOR-1 and ANCHOR-2 showed significant improvements in nasal polyp size and nasal obstruction, two key measures of disease severity.
| | |
GSK Announces Positive Results from B-Well 1 and B-Well 2 Phase III Trials for Bepirovirsen, a Potential First-in-Class Treatment for Chronic Hepatitis B
Warren-based GSK plc announced positive results from its two pivotal Phase III trials, B-Well 1 [NCT05630807] and B-Well 2 [NCT 05630820], evaluating bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB) in over 1,800 patients from 29 countries. CHB is a major health challenge affecting over 250 million people worldwide and is the leading cause of liver cancer. The current standard of care ― nucleos(t)ide analogues ― often requires lifelong therapy and the functional cure rates remain low, typically only 1%. Functional cure for CHB is when the virus can no longer be detected in the blood, as measured by the sustained loss of hepatitis B surface antigen ― a viral protein that signals ongoing infection ― and undetectable hepatitis B virus DNA for at least 24 weeks after a finite course of treatment.
| | |
GSK’s Shingrix (Recombinant Zoster Vaccine) Prefilled Syringe Presentation Approved by the European Commission
Warren-based GSK plc announced the European Commission’s (EC) approval of Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) in a prefilled syringe. The current vaccine presentation comprises two vials, one with a lyophilised powder antigen and another with a liquid adjuvant. The lyophilised powder antigen requires reconstitution, where the suspension in the adjuvant vial is withdrawn and injected into the antigen vial. The new prefilled syringe simplifies the vaccine administration process for healthcare professionals by removing the need to undertake these steps prior to administration. This approval is based on data confirming technical comparability between the prefilled syringe and the existing vaccine presentation. The new presentation does not involve a change in indication or dosing.
| | |
U.S. FDA Grants Ipsen’s IPN60340 (ICT01) Breakthrough Therapy Designation in First Line Unfit Acute Myeloid Leukemia
BioNJ Member Ipsen, with a site in Basking Ridge, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for IPN60340 in combination with venetoclax and azacitidine (Ven-Aza) in first line unfit acute myeloid leukemia, an aggressive blood cancer affecting older adults. IPN60340 is an investigational first-in-class monoclonal antibody targeting BTN3A, a key immune-regulatory molecule broadly expressed across cancer. Breakthrough Therapy Designation is intended to expedite the development and review of medicines for serious or life-threatening conditions with evidence of a substantial clinical improvement. IPN60340 previously received Orphan Drug Designations from the U.S. Food and Drug Administration and European Medicines Agency in July 2025.
| | |
Ipsen Expands Early Development Pipeline With Simcere Zaiming’s Innovative Antibody Drug Conjugate
BioNJ Member Ipsen, with a site in Basking Ridge, announced an exclusive licensing agreement for global rights outside of Greater China, for SIM0613, an antibody-drug conjugate (ADC) with best-in-class potential. Targeting the LRRC15 protein, SIM0613 is designed for enhanced tumor penetration and differentiated anti-tumor activity in solid tumors with the highest unmet needs.
“Today’s announcement underscores our bold vision to lead innovation and shape the future of oncology,” said Christelle Huguet, PhD EVP and Head of Research & Development, Ipsen. “By advancing first- and best-in-class therapies early, we maximize the potential to transform patient outcomes globally. The addition of the SIM0613 ADC is testament to this ambition — pioneering science that opens new possibilities for those who need it most and builds on Ipsen’s rapidly evolving research and early development portfolio, with over 20 programs added since 2020.”
| | |
Ferring Pharmaceuticals Partners With Theralase to Investigate Combination Therapy for Bladder Cancer
Parsippany-based BioNJ Member Ferring Pharmaceuticals and Theralase Technologies Inc. have agreed to a collaborative clinical development agreement. The collaboration showcases their shared commitment to advancing innovative therapies for patients with bladder cancer. It builds on Theralase’s existing clinical program (NCT03945162) with a new cohort investigating its investigational light-activated small molecule Ruvidar (TLD-1433) in combination with Ferring’s intravesical non-replicating gene therapy ADSTILADRIN (nadofaragene firadenovec-vncg). This combination is for adult patients diagnosed with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without papillary tumors. The new cohort of patients will explore the potential benefit of combining two innovative and complementary mechanisms of action. ADSTILADRIN is the first and only intravesical gene therapy approved by the U.S. Food and Drug Administration (FDA).
| | |
AbbVie and RemeGen Announce Exclusive Licensing Agreement to Develop A Novel Bispecific Antibody for Advanced Solid Tumors
BioNJ Member AbbVie, with a site in Madison, and RemeGen announced an exclusive licensing agreement for the development, manufacturing and commercialization of RC148, a novel investigational Programmed Cell Death-1 (PD-1)/Vascular Endothelial Growth Factor (VEGF)-targeted bispecific antibody. RC148 is currently being developed by RemeGen as a monotherapy and in combination regimens across multiple advanced solid tumors. PD-1/VEGF-targeted bispecific antibodies represent a new class of cancer therapies that aim to help the immune system fight tumors more effectively and potentially overcome tumor resistance mechanisms by blocking both PD-1 and VEGF simultaneously. Additionally, given their potential to modulate both immune suppression and foster a favorable tumor microenvironment for antibody-drug conjugate (ADC) activity, PD-1/VEGF bispecific antibodies are also being explored in combination with ADCs.
| | |
TROPION-Lung17 TROP2 Biomarker Directed Phase 3 Trial of DATROWAY® Initiated in Patients With Previously Treated Advanced Nonsquamous Non-Small Cell Lung Cancer
Basking Ridge-based Daiichi Sanko announced the first patient has been dosed in the TROPIONLung17 phase 3 trial evaluating DATROWAY® (datopotamab deruxtecan) compared to docetaxel in patients with TROP2 NMR positive locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) without actionable genomic alterations previously treated with immunotherapy and platinum-based chemotherapy. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC). The current standard first-line treatment for advanced NSCLC without actionable genomic alterations is immunotherapy with or without platinum-based chemotherapy. However, most patients will eventually experience disease progression and traditional chemotherapy remains the current standard of care in the second-line and beyond settings.
| | |
ENHERTU® Approved in China as First HER2 Directed Medicine for Patients With HER2 Low or HER2 Ultralow Metastatic Breast Cancer Following Disease Progression After One or More Endocrine Therapies
Basking Ridge-based Daiichi Sanko announced that ENHERTU® (trastuzumab deruxtecan) has been approved in China for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer that has progressed on one or more endocrine therapies in the metastatic setting. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. Breast cancer is the second most common cancer in women in China. Approximately 357,000 cases of breast cancer were diagnosed in China in 2022, with nearly 75,000 deaths. HR positive, HER2 negative is the most common breast cancer subtype, accounting for approximately 70% of all breast cancers.
| | |
ENHERTU® Granted Breakthrough Therapy Designation in the U.S. as Post-Neoadjuvant Therapy for Patients with HER2 Positive Early Breast Cancer
Basking Ridge-based Daiichi Sanko announced that ENHERTU® (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for adult patients with HER2 positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence. The FDA granted this BTD based on results from the DESTINY-Breast05 Phase 3 trial published in The New England Journal of Medicine, marking the ninth pivotal trial of ENHERTU to be published in the prestigious journal. ENHERTU has received 10 BTDs, with six BTDs for breast cancer, including HER2 positive early breast cancer, second-line HER2 positive metastatic breast cancer, later-line HER2 positive metastatic breast cancer, later-line HER2 low metastatic breast cancer and HER2 low or HER2 ultralow metastatic breast cancer.
| | |
DESTINY-Endometrial02 Phase 3 Trial of ENHERTU® Initiated as Adjuvant Therapy in Patients With HER2 Expressing Endometrial Cancer
Basking Ridge-based Daiichi Sanko announced that the first patient has been dosed in the DESTINYEndometrial02 Phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) with or without radiotherapy compared to standard of care chemotherapy with or without radiotherapy as an adjuvant treatment (after surgery) in patients with HER2 expressing (IHC 3+/2+) endometrial cancer. DESTINY-Endometrial02 is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F) and the European Network of Gynecological Oncological Trial Groups (ENGOT), with the French cooperative group (GINECO) as the lead ENGOT group. While surgery is the recommended initial treatment for endometrial cancer, further treatment in the adjuvant setting is determined by the stage of disease and risk of recurrence.
| | |
Lupin Signs Exclusive Licensing Agreement With Gan & Lee Pharmaceuticals for Novel GLP-1 Receptor Agonist
Somerset-based Lupin Limited announced that it has entered into an exclusive License, Supply and Distribution agreement with Gan & Lee Pharmaceuticals for a novel fortnightly GLP-1 receptor agonist, Bofanglutide. The agreement strengthens Lupin’s diabetes portfolio and accelerates its presence in the obesity segment. Bofanglutide injection is a fortnightly (once in two weeks) GLP-1 receptor agonist developed by Gan & Lee, intended for treating adults with type 2 diabetes and aiding weight management in overweight or obese individuals. As a potential first-in-class global fortnightly GLP-1 agonist, clinical data demonstrate that the weight loss results of Bofanglutide are comparable to or better than those of existing GLP-1 alternatives while offering the convenience of once in two weeks versus once a week for other injectable alternatives, and maintaining safety and tolerability consistent with the GLP-1 class
| | |
Idorsia’s JERAYGO (aprocitentan) Approved in Canada for the Treatment of Resistant Hypertension
Idorsia Ltd, with a site in Cherry Hill, announces that Health Canada has granted marketing authorization for JERAYGO™ (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products. The recommended dose is 12.5 mg orally once daily. The dose can be increased to 25 mg once daily for patients tolerating the 12.5 mg dose and in need of tighter blood pressure (BP) control. Hypertension remains a leading global health challenge and the number one modifiable risk factor for early morbidity and mortality. Despite advances in treatment, many patients still struggle with uncontrolled blood pressure, leaving them at significantly higher risk of heart attack, stroke, kidney failure and premature death.
| | |
Idorsia’s Daridorexant in Women During Menopausal Transition Age With Insomnia
Idorsia Ltd, with a site in Cherry Hill, announces the publication of “Efficacy and safety of daridorexant for the treatment of insomnia disorder in women during menopausal transition age: Insights from a randomized controlled trial” in Maturitas. This new analysis of the efficacy and safety of daridorexant in women aged 47–55 years with insomnia disorder ― a population representative of the menopausal transition ― is based on data from the Phase 3 randomized controlled trial (NCT03545191) published in Lancet Neurology and provides important insights into the management of insomnia in midlife women. One of the most prevalent and burdensome yet under-researched symptoms reported by women in the menopausal transition is sleep disturbance.
| | |
Idorsia Initiates a Proof-of-concept Trial With its Oral First-in-Class Selective CCR6 Antagonist
Idorsia Ltd, with a site in Cherry Hill, announces the initiation of a Phase 2 proof-of-concept trial evaluating IDOR-1117-2520 for participants with moderate-to-severe psoriasis. IDOR-1117-2520 is Idorsia’s first-in-class, oral, selective CCR6 receptor antagonist designed to block the CCR6/CCL20 axis and prevent the migration of disease-driving Th17 immune cells. Psoriasis is a chronic, immune-mediated skin condition driven by the IL-23/Th17 pathway, characterized by elevated CCL20 and CCR6-positive cells in affected skin. There is a significant need for oral drugs with innovative mechanisms of action that address Th17-driven conditions such as psoriasis. The 12-week exploratory Phase 2 proof-of-concept trial will evaluate whether CCR6 blockade improves psoriasis by preventing pathogenic immune cells from reaching the skin.
| | |
Sandoz Confirms European Commission Approval of Ondibta® (insulin glargine), Strengthening Overall Biosimilars Leadership and Position in Diabetes
Princeton-based Sandoz announced that the European Commission has granted marketing authorization for Ondibta® (insulin glargine), a solution for injection in a pre-filled pen developed and registered by Gan & Lee Pharmaceuticals. Ondibta® is approved for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above1 and is confirmed to match the reference medicine, Lantus® SoloStar®* insulin pen, in terms of safety, quality and efficacy2. The approval paves the way for an expected launch of Ondibta® by early 2027, which has the potential to increase competition, improve affordability and enhance access to insulin treatment options for people living with diabetes in Europe.
| | |
Genmab Partners With Anthropic to Accelerate Research and Development Through Agentic Artificial Intelligence
Princeton-based BioNJ Member Genmab announced a partnership with Anthropic to advance and enhance the company’s research and development (R&D) processes through the adoption of cutting-edge artificial intelligence (AI) capabilities. Under the agreement, Genmab and Anthropic will design and deploy custom, Claude-powered agentic AI solutions to support Genmab's clinical development priorities. Genmab's teams will use Claude to accelerate data processing, analysis, and document generation within defined guardrails and with human oversight to streamline complex operational activities, enhance agility and improve consistency in supporting Genmab’s clinical programs as they progress toward key regulatory milestones. Genmab continues to advance several late-stage investigational antibody medicines across solid tumors and hematological malignancies and is investing in state-of-the-art digital and AI-driven capabilities that will further support the expansion and execution of its growing pipeline.
| | |
Johnson & Johnson Submits OTTAVA™ Robotic Surgical System to the U.S. Food and Drug Administration
New Brunswick-based BioNJ Member Johnson & Johnson announced that the company has submitted the OTTAVA™ Robotic Surgical System to the U.S. Food and Drug Administration (FDA) in an application for De Novo classification. Leveraging data from the Investigational Device Exemption (IDE) study, the company has applied for marketing authorization in multiple procedures in general surgery within the upper abdomen. First cases in the OTTAVA IDE study were completed in early 2025 at Memorial Hermann-Texas Medical Center. OTTAVA’s unique unified architecture, surgical instrumentation powered by Ethicon expertise, and future connection to the Polyphonic™ digital ecosystem are designed to address the unmet needs of surgeons and their teams. The company filed data from the completed clinical trial with the aim of showcasing safety and effectiveness and supporting the system’s ability to perform a variety of procedures.
| | |
NVIDIA and Lilly Announce Co-Innovation AI Lab to Reinvent Drug Discovery In the Age of AI
BioNJ Member Eli Lilly & Company, with a site in Branchburg, and NVIDIA announced a first-of-its-kind AI co-innovation lab focused on applying AI to tackle some of the most enduring challenges in the pharmaceutical industry. The lab brings together Lilly’s world-leading expertise in discovering, developing and manufacturing medicines with NVIDIA’s leadership in AI, accelerated computing and AI infrastructure. The two companies will invest up to $1 billion in talent, infrastructure and compute over five years to support the new AI co-innovation lab. The lab will co-locate Lilly domain experts in biology, science and medicine with top AI model builders and engineers from NVIDIA, allowing them to work side by side to generate large-scale data and build powerful AI models that can accelerate medicine development, using NVIDIA BioNeMo™ as the critical platform.
| | |
New Jersey Launches AI Innovation Challenge Hoping Solutions Can Address State’s Problems
New Jersey is launching the AI Innovation Challenge, a statewide effort to speed the use of artificial intelligence for social and public good. Backed by the NJ Economic Development Authority (NJEDA) under Gov. Phil Murphy’s AI Moonshot, this challenge provides funding, mentorship and resources for teams and start-ups building AI-driven solutions to tackle problems across the State. New Jersey is moving quickly to embrace the possibilities of AI. Last December, the New Jersey Artificial Intelligence Hub ― founded in partnership with Princeton University, the State of New Jersey, Microsoft and CoreWeave ― said it will launch an AI Accelerator, powered by the global innovation platform Plug and Play, early this year.
| | |
Princeton at the Heart of Global Stem Cell Breakthrough for Diabetic Care
New Jersey’s reputation as the “Medicine Chest of the World” reached a new milestone as BioNJ Member Made Scientific, Inc., a leading cell therapy manufacturer, joined forces with partners in Israel and Florida to bring a revolutionary stem cell treatment to the U.S. market. The three-way collaboration between Cytora Therapeutics, Made Scientific and Zeo ScientifiX aims to treat non-healing diabetic foot ulcers (DFUs) using a unique source of regenerative power: the human mouth. At the center of this global deal is Made Scientific’s state-of-the-art, 60,000-square-foot facility in Princeton. Under the agreement, the New Jersey site will serve as the exclusive U.S. manufacturing hub, responsible for the Good Manufacturing Practice (GMP) production and quality control of the therapy. The facility recently underwent a significant 12,000-square-foot expansion in 2025 to accommodate the high-throughput demands of late-phase and commercial-stage cell therapies.
| | |
Autolus Tests Cellares’ Automated CAR T Manufacturing Tech
As demand for CAR T therapies strain traditional manufacturing, Autolus Therapeutics has tapped BioNJ Member Cellares to evaluate whether that company’s automated Cell Shuttle platform can support expanded commercial production. Cellares will partner with Autolus Therapeutics to assess if the platform can help meet rising demand for the company’s U.S. Food and Drug Administration-approved CAR T therapy ― Aucatzyl (obecabtagene autoleucel).
Cellares operates its first commercial-scale IDMO Smart Factory in Bridgewater ― with additional facilities under construction in Europe and Japan. Aucatzyl is approved in the United States, the U.K. and Europe for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Autolus is also studying the therapy in clinical trials aimed at expanding its use into pediatric B-ALL and autoimmune diseases, such as lupus and multiple sclerosis.
| | |
ResearchwithNJ is a free online portal that connects entrepreneurs, businesses and investors with the research being done at eight of New Jersey's universities to foster innovation and collaboration. The site showcases STEM experts, facilities, publications, intellectual property and news from Kean, Hackensack Meridian, Montclair, NJIT, Princeton (including Princeton Plasma Physics Lab), Rowan, Rutgers and Stevens aiming to facilitate technology transfer and the creation of new businesses and products. It is a key initiative to showcase the State's STEM research assets and promote New Jersey as a center for innovation. Visit www.researchwithnj.com for more information.
| | Academia/Institutions/Incubators | | | |
NJDOL Announces $9 Million in Grants to Grow Apprenticeship and Pre-Apprenticeship Programs
The New Jersey Department of Labor and Workforce Development (NJDOL) Office of Apprenticeship has announced a total of $9 million in available funding through a second round of FY26 Growing Apprenticeship in Nontraditional Sectors (GAINS) and Pre-Apprenticeship in Career Education (PACE) grants to foster the creation and expansion of apprenticeship and pre-apprenticeship programs throughout the State. Under the Murphy administration, the state has invested more than $110 million through grant programs to create and develop work-based learning, pre-apprenticeship, and apprenticeship programs. This has supported the creation of 972 new Registered Apprenticeship programs in New Jersey — a 159% increase — and enabled 26,577 new apprentices to be onboarded. The State currently has 10,575 active apprentices in 1,583 programs.
| | |
New Jersey Innovation Authority Established With Law Signed by Gov. Murphy
Governor Phil Murphy signed into law A5728/S4485, establishing the New Jersey Innovation Authority (NJIA). The legislation codifies the New Jersey State Office of Innovation (OOI) as an Authority within the Department of the Treasury, building upon OOI’s success over the past seven-plus years to modernize services for residents, businesses and other New Jersey institutions. The General Assembly advanced the bill, which was sponsored by Assemblymen Chris Tully and William F. Moen Jr. and Assemblywoman Eliana Pintor Marin. New Jersey is the first state in the nation to enshrine a state innovation office into law, cementing human-centered, agile technology approaches as a cornerstone of New Jersey’s legacy in innovation.
| | |
Rutgers Alzheimer’s Research Center Receives $1.5M to Launch Physician-Scientist Program
The Rutgers Krieger Klein Alzheimer’s Research Center has received a $1.5 million philanthropic gift from the Norman and Mary Pattiz Foundation to establish a physician-scientist research program. The gift will support early disease detection and drug development to advance dementia treatment. The program, led by Michal Schnaider Beeri, Director of the Herbert and Jacqueline Krieger Klein Alzheimer’s Research Center in the Rutgers Brain Health Institute and Core Member of the Institute for Health, Health Care Policy and Aging Research, is designed to accelerate discovery to treatment in dementia. The program will train physician-scientists to focus on drug development and early disease detection when intervention has the greatest potential to alter long-term outcomes.
| | |
Atlantic Health Treats First Patient in Northeast for Brain Tumor With New Cellular Immunotherapy
Atlantic Health said that it is treating the first patient in the Northeast using a new cell therapy to treat glioblastoma, an aggressive primary brain tumor, as part of a Phase 2 clinical trial. Glioblastoma, formerly known as glioblastoma multiforme, is a type of cancer that can result in death in fewer than six months without treatment. The Phase 2 trial is evaluating the safety, tolerability and efficacy of DOC1021, an investigational patient-derived double-loaded dendritic cell therapy, in combination with standard-of-care (SOC) treatment versus SOC alone in adult patients newly diagnosed with glioblastoma (IDH-wildtype), who have undergone maximal safe surgical resection.
| | |
Synchrony Medical Secures $1M NJIEF Investment to Expand Respiratory Therapy in New Jersey
Synchrony Medical, a respiratory technology innovator, announced that it secured a $1 million investment from the New Jersey Innovation Evergreen Fund (NJIEF). The funding matches a previous investment from Edge Medical Ventures and is earmarked to scale the commercial launch of the company’s LibAirty™ Airway Clearance System across the United States. This injection of capital reinforces New Jersey’s standing as a premier hub for medtech, with Synchrony Medical establishing its U.S. headquarters in Jersey City. The move follows the system’s FDA 510(k) clearance in late 2024, positioning the company to address a massive unmet need for patients suffering from chronic lung conditions. The LibAirty™ system is a first-of-its-kind wearable vest designed for patients with COPD, bronchiectasis, and cystic fibrosis.
| | |
SIC Startups Projected to Generate $17B+ in 10 Years
The New Jersey Economic Development Authority (NJEDA) has released findings from an economic impact assessment of the Strategic Innovation Center (SIC) initiative, which brings together start-up founders, investors, academic institutions and private sector leaders to foster research and development in high-growth sectors, such as artificial intelligence (AI), the life sciences and advanced manufacturing. The results found that the State’s 12 SICs will catalyze new and sustained economic activity in key industries, creating economic opportunities, supporting and retaining innovative early stage companies, and driving long-term economic growth. The report quantifies the 10-year economic impact of each SIC and showcases how the NJEDA’s investments in development, operations and start-up financing will lead to widespread economic growth. Collectively, the NJEDA’s $190 million SIC commitment is projected to create $8.9 billion in direct economic impact of graduated start-up operations and research activities by year 10.
| | |
NJEDA Board Approves Over $12.5 Million in Funding to Support Innovative Medtech and Maternal Health Start-Ups
The New Jersey Economic Development Authority Board recently approved a $12.55 million commitment into two Strategic Innovation Centers (SICs) focused on medical technology and maternal health, facilitating startup creation and bolstering New Jersey’s innovation ecosystem. The New Jersey Accelerator for Innovation in Medtech (NJ AIM), a multi-location SIC in Camden and Mullica Hill, will support the research, development and commercialization of novel medical technologies and devices. The New Baby New Jersey SIC, which will be located in Trenton’s Maternal and Infant Health Innovation Center (MIHIC), will assist early stage companies advance groundbreaking maternal and infant health solutions. The NJ AIM and New Baby New Jersey SIC programs will include a combination of services, including workshops, mentorship sessions, business development services, education opportunities, access to unique equipment and industry partners and investment opportunities.
| | |
Bristol Myers Squibb Appoints Hampel to SVP to Accelerate Brain Health Innovation
Princeton-based BioNJ Member Bristol Myers Squibb has announced the appointment of Harald Hampel, M.D., Ph.D., as senior vice president, worldwide head of medical affairs, neuroscience. Dr. Hampel is one of the world’s most influential leaders in brain health, recognized for shaping how Alzheimer’s disease and other serious neurodegenerative and neuropsychiatric conditions are understood, studied and advanced. His work has helped move the neuroscience field toward biologically grounded diagnosis and precision medicine, as well as earlier, more decisive intervention — changes that are now redefining modern neuroscience. In his new role, Dr. Hampel will set and implement the worldwide medical strategy for BMS’ brain health ambition and neuroscience portfolio, serving as the company’s senior medical leader and external scientific voice in neuroscience.
| | |
Outlook Therapeutics Appoints Biotech Veteran Laura Cantrell to Navigate High-Stakes Strategy and Partnerships
Iselin-based BioNJ Member Outlook Therapeutics announced the strategic appointment of Laura Cantrell as Vice President of Corporate Strategy and Business Development. The move comes at a critical juncture for the company as it works to stabilize its U.S. regulatory path and expand its footprint in international markets. Reporting directly to CEO Bob Jahr, Ms. Cantrell will spearhead the firm’s business development, including strategic partnerships and licensing initiatives aimed at maximizing the value of its ophthalmic bevacizumab portfolio (treatment of retina diseases). Ms. Cantrell brings over 20 years of high-impact biotechnology experience to Outlook. Her track record includes senior roles at industry giants like Genentech/Roche, BeiGene and Medivation. Most notably, she was a core member of the team that facilitated Medivation’s $14 billion acquisition by Pfizer.
| | |
BD Taps Quest Diagnostics Veteran Shawn Bevec for Senior IR role
Franklin Lakes-based BD (Becton, Dickinson and Company), a leader in medical technology, announced on Wednesday the appointment of Shawn Bevec as senior vice president of investor relations. Mr. Bevec will lead the company’s communication strategy with the financial community, focusing on articulating BD’s long-term growth initiatives and shareholder value drivers. He will report to interim Chief Financial Officer Vitor Roque until a permanent CFO is named. The appointment comes at a pivotal time for BD. Just this week, the company announced a $110 million investment in its Nebraska manufacturing facilities to support the booming GLP-1 and biologics drug delivery markets. Mr. Bevec is expected to be a key voice in explaining these strategic pivots to Wall Street.
| | |
Evotec Appoints Dr. Sarah Fakih as EVP, Head of Global Communications and Investor Relations
Princeton-based Evotec SE announced the appointment of Dr. Sarah Fakih as Executive Vice President, Head of Global Communications and Investor Relations. In this strategic role, Dr. Fakih will lead Evotec’s newly integrated Global Communications and Investor Relations function. Reporting directly to CEO Dr. Christian Wojczewski, she will bring together both teams to strengthen alignment, clarity and engagement across stakeholders. The integration of Communications and Investor Relations supports Evotec’s focus on a clear and consistent articulation of its strategy, scientific leadership and value creation. Dr. Fakih brings more than 15 years of experience in life sciences, with a strong leadership track record in capital markets strategy and corporate messaging.
| | |
Phibro Animal Health Corporation Announces Leadership Transition
Teaneck-based Phibro Animal Health Corporation announced a leadership transition that will support the company’s continued growth and long-term strategic direction. Effective July 1, 2026, Jack Bendheim, current Chairman, Chief Executive Officer and President of Phibro will take on a new managerial role as Executive Chairman and Daniel Bendheim will assume the role of Chief Executive Officer and President of Phibro. Mr. Bendheim will continue to serve as the Chairman of the Board of Directors of the company. Mr. Bendheim joined the company in 1969 serving in various management and executive roles. He has served as the company’s President since 1988 and was appointed Chief Executive Officer in March 2014. He has guided the company through significant global expansion, portfolio growth and operational transformation.
| | |
2026 Life Sciences Outlook
The life sciences industry may be increasingly borderless, but confidence does not appear to be. According to BioNJ Member Deloitte’s 2026 Life Sciences Outlook Survey, more than 75% of responding biopharma and medtech executives are confident in their own organizations’ financial outlooks for the coming year. However, only 41% feel optimistic about the health of the global economy.
| | |
The Terra North Jersey STEM Fair
Volunteers Needed to Judge
The Terra North Jersey STEM Fair is a student-focused event that brings together middle and high school students from across New Jersey to showcase innovative science, technology, engineering, and math projects. It connects students with educators, industry professionals and judges to encourage real-world learning and STEM career exploration. They are currently seeking professionals to volunteer as judges for the STEM Fair entries. Click here to learn more.
| | |
EDA Office Hours to Detail Support for Emerging Tech, Life Science Companies
January 21, 2026
N.J. Economic Development Authority will host its first ‘office hours’ of 2026, a virtual event from 2-3 p.m. For more information and to register, click here. Office hours were created as a place to give entrepreneurs an opportunity to learn about EDA’s financing and incentives programs designed to support emerging technology and life science companies in New Jersey. Entrepreneurs can hear brief presentations, ask questions and connect with the EDA’s Innovation Team. The main programming lasts one hour. Extra time is left for additional questions and networking.
| | |
Technology: Real-Time AI System for Echocardiography Analysis and Quantification
January 28, 2026
Register to attend a free NIH webinar. Attendees will learn about a new AI enhanced real-time echocardiography device and method to improve the analysis and quantification of heart related conditions, by automatically extracting predictive biomarkers from an echocardiograph scan. Dr. Sameer Antani, a co-inventor and a Principal Investigator in the Computational Health Research Branch, in the Division of Intramural Research of the National Library of Medicine, at the National Institutes of Health, will discuss how this technology can be used to acquire biomarkers that could assist diagnosing a wide range of common cardiac diseases, as well as evaluating cardiac function in patient populations suffering from diseases such as sickle cell disease and other rare diseases.
| | |
Best Workforce Strategies Roundtable Kick-Off — Building the Life Sciences Workforce of the Future
January 30, 2026
The LSWC is excited to launch its first LSWC Best Workforce Strategies Roundtable with opening remarks from Caitlin Frazer, Executive Director of the National Security Commission on Emerging Biotechnology (NSCEB). Ms. Frazer will share an overview of the Commission’s workforce recommendations, recent policy developments, and insights from NSCEB’s national roadshows. We’ll then hear from John Balchunas, Workforce Director of The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and Linnea Fletcher, Executive Director of the InnovATEBIO National Biotech Education Center, two organizations highlighted in the NSCEB report, who will share strategies and lessons shaping the future biomanufacturing workforce.
| | |
Doing Business in Eurasia
Throughout Spring 2026 - 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 2026 - 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.
| | This e-newsletter was sent by BioNJ. | | | | |