We All Need to Worry About Medicaid Cuts: Here’s Why

Congress is debating hundreds of billions of dollars in cuts to Medicaid, putting access to health care at risk for 1.8 million New Jerseyans. They include children, pregnant women, seniors, veterans and people with disabilities. But make no mistake — we all will feel the impact if these drastic cuts are enacted. Medicaid matters. It’s the safety net program that ensures the most vulnerable will have health care coverage and access to medical care. It’s an essential part of our state’s health care system, covering 1 in 3 children, 1 in 3 people with disabilities and nearly 1 in 3 expectant mothers. They could face losing their coverage, or seeing their medical services greatly limited, if Congress approves the massive package of $880 billion in cuts.

Forget Foreign Price Controls — Here's the Serious Medicaid Reform Plan

Today, Medicaid is one of the fastest-growing drivers of federal-state spending, with annual costs exceeding $800 billion. As the program balloons and oversight falters, it's rightly under scrutiny. The real question is what Washington does next: tackle the structural problems head-on or fall for a shortcut that shifts costs without fixing them. One path is a serious plan led by conservatives in Congress. It would restore fiscal integrity to Medicaid without sacrificing access or innovation. These targeted reforms would realign incentives, tighten eligibility and curb state-level abuse ― saving taxpayers over $1 trillion in the next decade. And they're backed by a strong majority of voters. The other is a budget stunt: a "Most Favored Nation" (MFN) drug pricing scheme that would hand U.S. pricing authority to foreign governments.

Early Signals of the IRA on Orphan Drugs

The Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program’s (DPNP) well-intended Orphan Drug Exclusion (ODE) aimed to prevent the selection of orphan drugs used to help people living with rare diseases. However, there are concerns about the ODE’s impact on incentives for ongoing rare disease clinical development. Developers of drugs with a single orphan designation may be less likely to pursue a second orphan designation in an additional rare disease because current application of the ODE by the Centers for Medicare and Medicaid Services (CMS) would restore the drug’s eligibility for DPNP selection. The National Pharmaceutical Council analyzed patterns of orphan drug designations over time to explore this potential early signal of the IRA’s impact on orphan drug development.

The 340B Drug Purchasing Program and Commercial Insurance Premiums

Proponents describe the 340B drug purchasing program as a simple transfer of economic gains from pharmaceutical manufacturers to covered entities, costless to others across the health system. But over $124 billion of 340B drug spending coursed through the broader healthcare ecosystem in 2023, generating tens of billions of dollars in profits for thousands of 340B covered entities, pharmacies, and various supply chain intermediaries, potentially creating significant incentives for inefficiency across all types of care. This research explores whether such 340B-driven inefficiencies impact the overall cost of employer-based health insurance. There are many reasons to suspect such a connection: 340B rewards hospital consolidation, which can lead to higher prices, encourages hospital-affiliated outpatient care (as opposed to community care), and 340B eats into employer drug rebates when covered entities take discounts for themselves.

Contributing Factors to the Growing Gap in Access Between the U.S. and Europe

While the U.S. continues to lead in terms of new drug launches, there's a growing gap in access between the U.S. and Europe. What factors are contributing to this disparity, and what potential solutions can be explored to ensure more equitable access to new medicines? This is something that IQVIA tracks each year in our report, looking at novel active substances, and how many have been launched, in which parts of the world in the last five years there were 267 novel active substances launched in the U.S., and that compares to 182 launched in Europe. We also note, importantly, that China launched 192 of these novel active substances in the past five years so actually more than were launched in in the European main other countries, EU four plus the UK is what we look at.

Identifying the Influential Dynamic Inputs in Cost-Effectiveness Analyses

Arguments for incorporating a drug’s pricing dynamics into cost-effectiveness analysis have become even more compelling since the passage of the Inflation Reduction Act, and this study suggests which dynamic inputs have the greatest influence on a cost-effectiveness estimate. The incorporation of drug dynamics, especially post-loss-of-exclusivity drug prices, can substantially influence cost-effectiveness estimates, with potentially larger impacts on the cost-effectiveness of chronically administered treatments than for 1-time administration treatments. By omitting drug dynamics, conventional, static cost-effectiveness estimates may be a misrepresentation of costs and therefore opportunity costs.

Medicaid at Risk: Patients, Providers and the Impact of Proposed Cuts

Op-ed featured in NJBIZ

“My diagnosis is debilitating. When I was first diagnosed, the fatigue was so bad, it took all my energy just to eat a meal,” says Sarah J., a patient and advocate living with EFPG, a form of vasculitis. “How are people with a diagnosis like this expected to fulfill Medicaid work requirements, or complete the paperwork to secure an exemption?” 

Medicaid is a crucial program that provides millions of low-income individuals and people living with disabilities with access to health care, treatment and essential services. The program covers 1-in-5 households, or approximately 80 million people across the country – including 40% of all children and 60% of all nursing home residents. It also reimburses hospitals, community health organizations, and physicians for the care and treatment they provide.  

Trump’s Efforts to Impact Prescription Drug Prices Meet Skepticism, Resistance in N.J.

As featured in BINJE

President Donald Trump wants to lower U.S. drug costs by linking prices to those paid in other developed countries — connecting the two in a “most favored nation” trading game. It’s unclear how serious he is — and how feasible the prospect is. But it was enough to catch the attention of the leaders of leading advocacy groups for the life science industry. “This concept, which intends to link prescription drug prices that are paid in the United States to those in other nations, is a deeply flawed attempt to enable the government to control prices which economic assessments have shown will not only decimate innovation in the life sciences — but will also essentially mimic policymaking in nations that generate a fraction of the diversity of treatments and cures that American companies have been able to bring to patients,” said BioNJ President and CEO Debbie Hart.

BioNJ Leader Debbie Hart Opposed to Trump Drug-Price Plan

As featured in ROI-NJ

Debbie Hart, President and CEO of BioNJ, objected to President Donald J. Trump’s plan to cut drug prices in the United States by tying some pharmaceuticals in this country to lower prices in other countries. The president signed an executive order to pursue this effort, known as the “most favored nation” policy. Lowering the cost of drugs that Americans pay to a level that other nations pay has long been an issue that’s largely been championed by Democratic politicians. “New Jersey is home to one of the most productive centers of biomedical innovation in the world,” said BioNJ President and CEO Debbie Hart. “I’m very hopeful that policymakers in D.C. will appreciate that the implementation of a policy concept like this would not only inhibit our State’s ability to innovate — it will mean that Patients will have access to fewer new treatments and cures.”

Trump Drug Pricing Order Draws NJ Pharma Industry Backlash

As featured in NJBIZ

The May 12 presidential directive instructs Health and Human Services Secretary Robert Kennedy Jr. to develop direct-to-consumer purchasing programs for manufacturers to sell pharmaceutical products to U.S. patients at “the most-favored-nation price.” After that, the administration hopes to begin negotiating with drugmakers on new costs. If nothing comes of those talks, the government will then impose a “most favored nation” pricing model to cap U.S. prices at the lowest rates paid by other similarly wealthy countries, according to Trump. Debbie Hart, President and CEO of BioNJ, shared “BioNJ will continue to connect with members of multiple state congressional delegations to convey why this is misguided policymaking and how it will fail to redound to the benefit of anyone other than our nation’s economic competitors who are aggressively pursuing policies to foster innovation in their own life sciences sector rather than inhibit it.”

In Time of Uncertainty, Life Science Leaders Determined to Emerge Stronger Than Ever

Tariffs, the push to reshore manufacturing, IPOs (or lack of them), federal funding (or the threat of losing it) and a whole bunch of rules and regulations that seemingly change by the day — or on a whim. The 15th annual BioPartnering Conference by BioNJ at Liberty Science Center Tuesday —one that brings approximately 600 industry leaders, founders, investors and service providers — certainly took place in the midst of change and potential change in the not-appreciated-enough life sciences industry. But that’s OK, said BioNJ CEO Debbie Hart. And it’s certainly nothing new in a sector that is used to wild rides. “We’ve seen this movie before — although maybe not as dramatic as this one,” she said. “But this is a resilient industry. We’ll come back stronger than before because of our powerful ecosystem.” That ecosystem certainly was on display in Jersey City.

Whoa Canada! BioQuebec Leader Talks Relationship With U.S., New Jersey in Era of Trump and Tariffs

BIOQuébec CEO Benoît Larose brought 12 companies to the BioNJ Biopartnering Conference Tuesday at the Liberty Science Center in Jersey City. The companies were eager to talk about financing from investors and partnerships with other founders. And they were eager to talk about the potential of setting up a shop in New Jersey, too. President Donald Trump? That was a harder topic of conversation, Larose said. Canadiens, Larose said, don’t find talk about trade wars — or becoming the 51st state —very entertaining. “We’re beyond chuckling,” the affable Larose said. “Generally speaking, I don’t think Canadians find anything funny about being acquired. That may have united Canadians in a way which never happened before.” The issues, however, haven’t caused a rift in the North American life science ecosystem.

NJ Biotech Companies Face Headwinds

As featured in New Jersey Business Magazine

Against the backdrop of uncertainty stemming from federal government changes as well as the investor sector and other sources, nearly 600 attendees — including 100 investors — learned about life sciences industry trends and heard from 93 presenting biotechnology companies at BioNJ’s 15th Annual BioPartnering Conference held yesterday at the Liberty Science Center in Jersey City. The Trump administration and its associated policies were front-and-center at the conference, with BioNJ President and CEO Debbie Hart telling the audience that Trump’s Most Favored Nation Policy (MFN) executive order focused on reducing pharmaceutical drug prices “wasn’t as bad as it could have possibly been; not as bad as perhaps we expected. We’re going to hold hope that we’re going to get through this and we’re going to get through this in one piece … Hopefully, today will be a path forward for that.”

Exclusive: Study Finds NOL Program Fuels $28B in Economic Impact

As featured in NJBIZ

A new report assesses the economic impact of the New Jersey Economic Development Authority‘s Technology Business Tax Credit Certificate Transfer Program ― aka the Net Operating Loss Program. Established in 1999, the NOL program allows unprofitable small-to-mid-sized technology and biotech companies in the Garden State to monetize future tax benefits by selling net operating losses and research and development tax credits. It’s aimed at providing immediate liquidity to enable reinvestment into operations, research, talent acquisition and growth initiatives. Up to $75 million in funding is available annually under the NOL program. “Widely hailed as a financial lifeline for early stage businesses not yet generating profits, the NOL Program has empowered innovation, fueled job creation, and reinforced New Jersey’s enduring reputation as a national leader in biotechnology and life sciences,” said Debbie Hart, president and CEO of BioNJ. 

U.S. FDA Approves EMRELIS™ (telisotuzumab vedotin-tllv) for Adults With Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) With High c-Met Protein Overexpression

BioNJ Member AbbVie, with a site in Madison, announced that EMRELIS™ (telisotuzumab vedotin-tllv) has been granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (OE) who have received a prior systemic therapy. High c-Met protein overexpression is defined as ≥ 50% of tumor cells with strong (3+) staining as determined by an FDA-approved test. This indication is approved based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EMRELIS is a c-Met-directed antibody-drug conjugate (ADC) and the first and only treatment approved for this patient population. 

AbbVie and ADARx Pharmaceuticals Announce Collaboration and License Option Agreement to Develop Next-Generation siRNA Therapies Across Multiple Therapeutic Areas

BioNJ Member AbbVie, with a site in Madison, and ADARx Pharmaceuticals, a late clinical-stage biotechnology company developing next-generation RNA therapeutics, today announced a collaboration and license option agreement to develop small interfering RNA (siRNA) therapeutics across multiple disease areas, including neuroscience, immunology and oncology. siRNA represents a class of molecules capable of regulating gene expression and protein production. Unlike traditional modalities such as antibodies and small molecules, siRNA regulates the expression of genes. These molecules are designed to prevent the production of disease-causing proteins by targeting the messenger RNA (mRNA) that encodes for such proteins. The strategic collaboration will leverage ADARx's RNA discovery expertise and proprietary siRNA technology, which has the potential to enable sustained and precise mRNA silencing.

Brensocatib Shows Consistent Efficacy and Safety Across Three Prespecified Subgroups in New Data from Landmark ASPEN Study

Bridgewater-based BioNJ Member Insmed Incorporated presented 11 new abstracts at the American Thoracic Society 2025 International Conference, including three prespecified subgroup analyses from the Phase 3 ASPEN trial of brensocatib in non-cystic fibrosis bronchiectasis (NCFBE), signaling the consistency of efficacy and safety outcomes across diverse clinical profiles. Three prespecified subgroup analyses from ASPEN showed brensocatib reduced pulmonary exacerbations, prolonged time to first exacerbation, and reduced lung function decline compared with placebo with a similar safety profile as the overall trial in the following populations: adolescents, maintenance macrolide use and blood eosinophil level. "These new analyses from ASPEN — the largest Phase 3 trial in bronchiectasis to date — demonstrated consistent efficacy and safety across three key patient groups, reinforcing the potential of brensocatib to deliver meaningful clinical benefit where no approved treatments currently exist," said Dr. Martina Flammer, Chief Medical Officer, Insmed.

Novo Nordisk A/S: Septerna and Novo Nordisk to Collaborate on Oral Small Molecule Medicines for Obesity and Other Cardiometabolic Diseases

Plainsboro-based BioNJ Member Novo Nordisk and Septerna, Inc. announced an exclusive global collaboration and license agreement to discover, develop and commercialize oral small molecule medicines for obesity, type 2 diabetes and other cardiometabolic diseases. The companies will initially commence four development programs for potential small molecule therapies directed to one or more select G protein-coupled receptor (GPCR) targets, including the GLP-1, GIP and glucagon receptors. GPCRs represent the largest and most diverse family of cell membrane receptors, with hundreds of different GPCRs regulating physiological processes in nearly every organ system of the human body. Using its proprietary Native Complex Platform™, Septerna aims to unlock the full potential of GPCR therapies. The company is focused on the discovery and development of a pipeline of oral small molecules for multiple therapeutic areas, initially focused on endocrinology, immunology and inflammation, and metabolic diseases.

Novo Nordisk A/S: Once-Weekly Sogroya® (somapacitan) is an Efficacious and Well-Tolerated Long-Acting Growth Hormone in Children With Growth Disorders: Results from REAL8 Phase 3 Basket Study

Plainsboro-based BioNJ Member Novo Nordisk presented data from the Phase 3 REAL8 basket study, which showed that once-weekly Sogroya® (somapacitan) was non-inferior to the once-daily growth hormone Norditropin® (somatropin) in improving yearly growth rate (as measured by height velocity [HV] at Week 52) in pre-pubertal children born small for gestational age (SGA), or with Noonan syndrome (NS), or with idiopathic short stature (ISS). In addition, superiority was achieved for once-weekly Sogroya® versus daily growth hormone in children with NS2, as well as compared to lower doses of daily growth hormone in children born SGA. REAL8 data showed that Sogroya® was well-tolerated, with no safety or tolerability issues identified compared to once daily growth hormone. Insulin-like growth factor 1 (IGF-1) response in patients treated with once-weekly Sogroya® was similar to those treated with daily growth hormone.

Positive Results from Phase III TALENTACE Study of Tecentriq and Avastin for Unresectable Hepatocellular Carcinoma

BioNJ Member Chugai Pharmaceutical, with a site in Berkeley Heights, announced that the Phase III TALENTACE study, evaluating the efficacy and safety of Tecentriq® (atezolizumab), Avastin® (bevacizumab), and on-demand transarterial chemoembolization (TACE) in people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic treatment, met its primary endpoint with positive results. The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS*), and the other primary endpoint of overall survival (OS) is immature at the prespecified first interim analysis. Meanwhile, a clinically meaningful PFS by RECIST v1.1** was also observed. Detailed findings from this study will be presented at an upcoming academic congress.

Chugai Obtains First Regulatory Approval in Japan for Vabysmo for Additional Indication of Angioid Streaks, a Cause of Vision Loss

BioNJ Member Chugai Pharmaceutical, with a site in Berkeley Heights, announced that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for anti-VEGF/anti-Ang-2 bispecific antibody Vabysmo® Intravitreal Injection 120 mg/mL [generic name: faricimab (genetical recombination)], for an additional indication of the treatment of choroidal neovascularization associated with angioid streaks. Vabysmo is the first approved drug in Japan for the treatment of this disease. “We are very pleased that we can offer Vabysmo as the first approved treatment in Japan for choroidal neovascularization associated with angioid streaks. This disease is known to cause vision impairment and has a poor prognosis. We expect that treatment with Vabysmo will contribute to maintaining and improving vision for patients,” said Dr. Osamu Okuda, Chugai’s President and CEO.

Chugai Receives Regulatory Approval for “ELEVIDYS” as a Gene Therapy Product for Duchenne Muscular Dystrophy in Japan

BioNJ Member Chugai Pharmaceutical, with a site in Berkeley Heights, announced that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for ELEVIDYS® Intravenous Infusion [generic name: delandistrogene moxeparvovec] (hereinafter, "ELEVIDYS"), as a regenerative medicine product for the treatment of Duchenne muscular dystrophy (DMD) under the conditional and time-limited approval pathway in Japan. The approved patient population are ambulatory patients with DMD who do not have a deletion of any portion or the entirety of exon 8 and/or exon 9 in the DMD gene, are negative for anti-AAVrh74 antibodies, and are 3 years to less than 8 years of age. For the confirmation of anti-AAVrh74 antibody negativity prior to administration, the Elecsys anti-AAVrh74 assay can be used.

Chugai Files for Additional Indication of Tecentriq for the Treatment of Thymic Carcinoma

BioNJ Member Chugai Pharmaceutical, with a site in Berkeley Heights, announced that it filed a regulatory application with the Ministry of Health, Labour and Welfare (MHLW) for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq® Intravenous Infusion [generic name: atezolizumab (genetical recombination)] for an additional indication of thymic carcinoma. Tecentriq received orphan drug designation for this indication from the MHLW on March 31 this year, and the applications will be reviewed under priority review. This filing is based on the results from a phase II MARBLE study initiated by investigators, which evaluated the efficacy and safety of Tecentriq in combination with carboplatin and paclitaxel as first-line treatment for patients with unresectable thymic carcinoma. In this study, the overall response rate, which was the primary endpoint, was 56.3% (95% CI: 41.2-70.5).

Global Phase III Trials Demonstrate that Nerandomilast Slowed Lung Function Decline in IPF and PPF, With Similar Discontinuation Rates to Placebo

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, announced detailed findings from the Phase III FIBRONEER™-IPF and FIBRONEER™-ILD trials. These studies evaluated nerandomilast, an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B), in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), respectively, with and without background antifibrotic therapy. Results were published in the New England Journal of Medicine. Nerandomilast is an investigational agent and has not been approved for use; its efficacy and safety has not been established. Both trials met the primary endpoint at both doses, 9 mg and 18 mg, as measured by a reduction in the absolute change from baseline in forced vital capacity (FVC) [mL] decline at week 52 versus placebo. FVC is a measure of lung function.

Otsuka Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)

Princeton-based BioNJ Member Otsuka Pharmaceutical, Co. Ltd. and Otsuka Pharmaceutical Development & Commercialization, Inc. announce the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sibeprenlimab, an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with immunoglobulin A nephropathy (IgAN). APRIL plays a key role in the pathogenesis of IgAN as explained by the 4-hit process, in which pathogenic galactose-deficient IgA (Gd-IgA1) is produced, leading to the synthesis of autoantibodies against Gd-IgA1, immune complex formation, and deposition in the glomerular mesangium. Sibeprenlimab is a single-dose prefilled syringe for subcutaneous injection every four weeks intended for self-administration, providing patients the convenience of at-home delivery. The BLA is supported by the Phase 3 VISIONARY clinical trial (NCT05248646), which met its primary endpoint at the prespecified interim analysis, and results from the Phase 2 ENVISION clinical trial (NCT04287985).

Sandoz Launches Pyzchiva® Autoinjector, First Commercially Available in Europe for Ustekinumab Biosimilars

Princeton-based BioNJ Member Sandoz announced the European launch of its Pyzchiva® (ustekinumab) autoinjector. This is the first ustekinumab biosimilar in Europe commercially available in an autoinjector. Developed and registered by Samsung Bioepis, Pyzchiva® is approved for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis for patients aged six years and older, weighing over 60 kg. The Pyzchiva® autoinjector supports a more comfortable self-administration experience with accurate automatic dosing, less frequent injection pain, a compact design, and flexible storage options, offering the potential for improved adherence to patient treatment plans. Europe has the highest prevalence of psoriasis worldwide, affecting an estimated 6.4 million people. Inflammatory bowel diseases, such as Crohn’s disease, are also common in Europe, affecting an estimated 2.5 to 3 million people.

Bristol Myers Squibb Receives European Commission Approval for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission (EC) has approved a new Opdivo^® (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). Opdivo SC, or nivolumab for subcutaneous use co-formulated with recombinant human hyaluronidase (rHuPH20), has been approved for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of intravenous nivolumab plus Yervoy^® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. The positive EC decision is based on results from the CheckMate -67T clinical trial and additional data that demonstrated comparable pharmacokinetics (PK) and safety profiles between Opdivo SC and IV Opdivo. 

Bristol Myers Squibb Receives European Commission Approval for Perioperative Regimen of Neoadjuvant Opdivo® (nivolumab) and Chemotherapy Followed by Adjuvant Opdivo for Resectable, High-Risk Non-Small Cell Lung Cancer With PD-L1 Expression ≥1%

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission (EC) has approved the perioperative regimen of neoadjuvant Opdivo® (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%. The decision is based on results from the CheckMate -77T study, which evaluated the perioperative regimen of neoadjuvant Opdivo with platinum-doublet chemotherapy followed by surgery and adjuvant Opdivo monotherapy, compared to neoadjuvant platinum-doublet chemotherapy and placebo followed by surgery and adjuvant placebo in adult patients with resectable NSCLC. The trial met its primary endpoint of event-free survival (EFS), showing that the risk of disease recurrence, progression or death was reduced by 42% (EFS Hazard Ratio [HR] 0.58; 95% Confidence Interval [CI]: 0.43 to 0.78; P=0.00025) in patients treated in the Opdivo arm, compared to the chemotherapy and placebo arm, after a median follow-up of 25.4 months.

U.S. FDA Oncologic Drugs Advisory Committee Votes in Favor of the Benefit-Risk Profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for High-Risk Smoldering Multiple Myeloma

Raritan-based BioNJ Member Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted (6-2) in favor of the benefit-risk profile of single-agent DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM). An application for the approval of DARZALEX FASPRO® for adult patients with HR-SMM was submitted to the FDA in November 2024. The vote highlights a pivotal moment in the care of patients most likely to develop active multiple myeloma (MM), potentially altering the course of disease and treatment. DARZALEX FASPRO® is a foundational therapy in MM, and if approved in this indication, would provide a potential path for earlier intervention. No treatments are approved specifically to treat high-risk smoldering multiple myeloma.

Icotrokinra Results Show Significant Skin Clearance in Patients With Difficult-to-Treat Scalp and Genital Psoriasis

New Brunswick-based BioNJ Member Johnson & Johnson announced new data from the Phase 3 ICONIC-TOTAL study investigating icotrokinra (JNJ-2113), the first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor. The study evaluated adults and adolescents 12 years of age and older with body surface area as low as 1% and at least moderate plaque psoriasis (PsO) affecting high-impact skin sites. Data show 57% of patients treated with once daily icotrokinra achieved the study’s primary endpoint with an Investigator’s Global Assessment (IGA) score of 0/1 (clear or almost clear skin) and a ≥2-grade improvement from baseline at Week 16 compared to 6% of patients receiving placebo (P<0.001). Icotrokinra demonstrated high rates of skin clearance in patients with scalp psoriasis as 66% achieved a scalp-specific Investigator’s Global Assessment (ss-IGA)c score of 0/1 compared to 11% receiving placebo (P<0.001) at Week 16.

IDeate-Esophageal01 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Certain Patients With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Rahway-based BioNJ Member Merck & Co. announced the first patient has been dosed in the IDeate-Esophageal01 Phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus investigator’s choice of chemotherapy in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) with disease progression following treatment with a platinum-containing systemic therapy and an immune checkpoint inhibitor. Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Basking Ridge-based Daiichi Sankyo and being jointly developed with Merck. ESCC accounts for nearly 90% of esophageal cancers globally with a five-year overall survival rate around 15% to 20% and has a worse prognosis for those diagnosed at an advanced stage of the disease.

FDA Approves Merck’s WELIREG® (belzutifan) for the Treatment of Adults and Pediatric Patients 12 Years and Older With Locally Advanced, Unresectable, or Metastatic Pheochromocytoma or Paraganglioma (PPGL)

Rahway-based BioNJ Member Merck & Co. announced the U.S. Food and Drug Administration (FDA) has approved WELIREG® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). Pheochromocytoma and paraganglioma are rare tumors that come from the same tissue, but pheochromocytoma form in the adrenal gland and paraganglioma form outside the adrenal gland. These tumors can be caused by certain genetic syndromes or mutations. The approval is based on data from the single-arm LITESPARK-015 clinical trial, where the primary endpoint was objective response rate (ORR).

Merck Announces Phase 3 KEYNOTE-B96 Trial Met Primary Endpoint of Progression-Free Survival (PFS) in Patients With Platinum-Resistant Recurrent Ovarian Cancer Whose Tumors Expressed PD-L1 and in All Comers

Rahway-based BioNJ Member Merck & Co. announced that the Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, met its primary endpoint of progression-free survival (PFS) for the treatment of patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 and in all comers. The study also met a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1. The study is evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab for these patients. The trial is continuing and OS for the full study population will be evaluated at a future analysis. At pre-specified interim analyses conducted by an independent Data Monitoring Committee, the KEYTRUDA-based regimen demonstrated a statistically significant and clinically meaningful improvement in PFS regardless of PD-L1 status compared to placebo plus chemotherapy with or without bevacizumab.

Lilly to Expand its Pain Pipeline With Acquisition of SiteOne Therapeutics

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced announced a definitive agreement for Lilly to acquire SiteOne. The transaction includes STC-004, a Phase 2 ready Nav1.8 inhibitor being studied for the treatment of pain. STC-004 may represent a next-generation, non-opioid treatment for patients suffering from chronic pain. "The global burden of chronic pain continues to increase, and an effective non-opioid treatment remains elusive," said Mark Mintun, Lilly group vice president Neuroscience Research and Development. "Lilly is eager to continue the development of STC-004 with the outstanding SiteOne team as part of our efforts to advance novel, addiction-free pain therapies. Innovation in pain management is critical to address the unmet needs of millions of patients around the world."  

Lilly's Kisunla (donanemab) Receives Marketing Authorization in Australia for the Treatment of Early Symptomatic Alzheimer's Disease

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that the Australian Therapeutic Goods Administration (TGA) has granted marketing authorization for Kisunla (donanemab), an injection for intravenous infusion every four weeks to treat mild cognitive impairment and mild dementia due to Alzheimer's disease in adults who are Apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. Kisunla is the first amyloid-targeting therapy for people with Alzheimer's registered in Australia and the only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed. Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. Kisunla can help remove the excessive buildup of amyloid plaques and help slow the cognitive and functional decline in patients with early symptomatic Alzheimer's disease.

Teva Celiac Disease Candidate Granted Fast Track Designation by U.S. FDA

Parsippany-based BioNJ Member Teva Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for investigational TEV-53408, an anti-IL-15 antibody, for the treatment of people with celiac disease on a gluten-free diet. TEV-53408 is currently being evaluated in a Phase 2a trial to assess the efficacy and safety in adults with celiac disease. TEV-53408 is an antibody designed to inhibit the activity of the cytokine, interleukin-15 (IL-15), to prevent intestinal damage and associated symptoms in individuals with celiac disease. This potential treatment is a testament to the growing strength of Teva’s innovative pipeline and dedication to advancing treatments for immunological conditions, including celiac disease, which affects approximately 1% of the global population.

Teva and Biolojic Design Initiate IND-enabling Studies of BD9, a Multibody Designed to Explore the Treatment of Atopic Dermatitis and Asthma

Parsippany-based BioNJ Member Teva Pharmaceuticals and Biolojic Design Ltd. announced that Teva initiated IND-enabling studies with BD9, a dual-specific multibody targeting both TSLP (Thymic stromal lymphopoietin) and IL-13. Teva has an exclusive license to develop BD9 for the treatment of TH2-driven inflammatory diseases such as atopic dermatitis and asthma. Teva’s development of BD9 demonstrates the company’s commitment to applying cutting-edge science to address unmet medical needs. By simultaneously blocking two key drivers of TH2-driven inflammation, BD9 has the potential to improve outcomes for patients with conditions such as atopic dermatitis and asthma, where current treatments fall short. The initiation of IND-enabling studies marks a critical milestone in translating this scientific innovation into a potential therapeutic option, paving the way for clinical trials and ultimately bringing hope to underserved patient populations. 

PIVOT-PO Phase III Study for Tebipenem HBr Stopped Early for Efficacy Following Review by Independent Data Monitoring Committee

Warren-based BioNJ Member GSK plc and Spero Therapeutics announced that the pivotal Phase III PIVOT-PO trial evaluating tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, will stop early for efficacy (NCT06059846). The decision follows a recommendation from an Independent Data Monitoring Committee (IDMC), based on a planned interim analysis of data from 1,690 patients enrolled in the study. If approved, tebipenem HBr would be the first oral carbapenem antibiotic for patients in the US who suffer from cUTIs, adding to GSK’s innovative anti-infectives portfolio and helping address the challenges of antimicrobial resistance (AMR). The trial met the primary endpoint of non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in hospitalised adult patients with cUTI, including pyelonephritis, on overall response (composite of clinical cure plus microbiological eradication) at the test-of-cure visit. 

Nucala (mepolizumab) Approved by U.S. FDA for Use in Adults With Chronic Obstructive Pulmonary Disease (COPD)

Warren-based BioNJ Member GSK plc announced that the U.S. Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype. FDA’s 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 in a wide spectrum of COPD patients with an eosinophilic phenotype. Preventing exacerbations is a key goal of COPD management.3 Exacerbations are devastating for patients, known to cause irreversible lung damage, worsening of symptoms and increased mortality. The incidence of adverse events was similar between placebo and mepolizumab groups.

Blenrep (belantamab mafodotin) Combinations Receive Positive CHMP Opinion in Relapsed/Refractory Multiple Myeloma

Warren-based BioNJ Member GSK plc announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Blenrep for the treatment of adults with relapsed or refractory multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide. An approval decision by the European Commission is expected in the third quarter of 2025. The CHMP opinion follows the approval of Blenrep combinations by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in April and Japan’s Ministry of Health, Labour and Welfare earlier this month.

Blenrep (belantamab mafodotin) Combinations Approved in Japan for Treatment of Relapsed/Refractory Multiple Myeloma

Warren-based BioNJ Member GSK plc announced the approval of Blenrep combinations by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of adults with relapsed or refractory multiple myeloma. The approval is based on positive results from the DREAMM-7 and DREAMM-8 phase III trials evaluating Blenrep in combination with bortezomib plus dexamethasone (BVd) and in combination with pomalidomide plus dexamethasone (BPd), respectively, in patients with multiple myeloma who have received at least one prior therapy. The approval follows an orphan drug designation for Blenrep in Japan, which was granted based on its ability to address high unmet need for patients with multiple myeloma. Superior efficacy results from the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma support MHLW approval of Blenrep combinations.

GSK to Acquire Efimosfermin, a Phase III-Ready Potential Best-in-class Specialty Medicine to Treat and Prevent Progression of Steatotic Liver Disease (SLD)

Warren-based BioNJ Member GSK plc and Boston Pharmaceuticals announced that they have entered into an agreement under which GSK will acquire Boston Pharmaceuticals’ lead asset, efimosfermin alfa. Efimosfermin is a phase III-ready, potential best-in-class, investigational specialty medicine to treat and prevent progression of steatotic liver disease (SLD). Efimosfermin is a novel, once-monthly fibroblast growth factor 21 (FGF21) analog therapeutic in clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), including cirrhosis, and future development in alcohol-related liver disease (ALD), both forms of SLD. Given efimosfermin’s direct antifibrotic mechanism of action and GSK’s data-driven insights from work in human genetics and disease phenotyping, it has potential to address more advanced stages of SLD and opportunity in combination with GSK’990, a siRNA therapeutic in development for other subsets of patients with SLD.

Sanofi’s $130M Morristown Flagship Puts People First

When BioNJ Member Sanofi decided to move its New Jersey flagship from Bridgewater to Morristown, it worked to raise the bar on the office space. Following its debut last week, it feels like mission accomplished. The $130 million investment marks the company’s latest piece in a worldwide, science-driven, best-in-class workplace portfolio and boosts its U.S. presence. It also highlights the kinds of environments – internal as well as external surroundings – driving office occupancy. “Sanofi is an intrinsic part of the health care ecosystem of the United States, where we pioneer advancements in our labs, produce medicines and vaccines that improve people’s lives, and grow our talented workforce,” CEO Paul Hudson said. “These flagship offices are designed to inspire creativity, collaboration and innovation — all in the service of patients.”

Sanofi Completes Acquisition of DR-0201

Bridgewater-based BioNJ Member Sanofi announces the completion of its acquisition ofDR-0201, a targeted bispecific myeloid cell engager, from Dren Bio, Inc., a private clinical-stage biopharmaceutical company. The acquisition bolsters Sanofi’s ambition to become the foremost immunology company and broadens the company’s leading immunology pipeline. DR-0201, now named SAR448501, has shown robust B-cell depletion in pre-clinical and early clinical studies. The potential first-in-class targeted bispecific myeloid cell engager targets and engages specific tissue-resident and trafficking myeloid cells to induce deep B-cell depletion via targeted phagocytosis. Recent pre-clinical and early clinical study data in autoimmune diseases suggest that deep B-cell depletion has the potential to reset the adaptive immune system, leading to sustained treatment-free remission in patients with refractory B-cell mediated autoimmune diseases such as lupus, where significant unmet medical needs remain.

Sanofi to Acquire Vigil Neuroscience, Inc., Adding a New Investigational Medicine to Treat Alzheimer’s Disease to the Neurology Pipeline

Bridgewater-based BioNJ Member Sanofi announced that it has entered into an agreement to acquire Vigil Neuroscience, Inc., a publicly traded clinical-stage biotechnology company focused on developing novel therapies for neurodegenerative diseases. This acquisition in neurology, one of Sanofi’s four strategic disease areas, enhances Sanofi’s early stage pipeline and includes VG-3927, which will be evaluated in a phase 2 clinical study in Alzheimer’s disease. VG-3927 is an oral small molecule TREM2 agonist. Activating TREM2 is expected to enhance the neuroprotective function of microglia in Alzheimer’s disease. In neurodegenerative diseases such as Alzheimer’s disease, microglial activation is dysregulated, leading to debris accumulation, chronic inflammation and neurodegeneration in the central nervous system. Activation of TREM2 has shown to promote the migration of microglial cells to sites of injury, enhance their capability for phagocytosis, proliferation and survival.

BeOne Receives Positive CHMP Opinion for TEVIMBRA® as a First-Line Treatment for Nasopharyngeal Cancer

Hopewell-based BioNJ Member BeOne announced announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of TEVIMBRA® (tislelizumab), in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic NPC. The extension of indication for NPC is based on results from BeOne’s RATIONALE-309 (NCT03924986), a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate the efficacy and safety of TEVIMBRA, in combination with gemcitabine plus cisplatin, as first-line treatment in adult patients with recurrent or metastatic NPC.

BeiGene Launches BeOne; Newest Chapter in Biopharma Firm’s Evolution

Hopewell-based BioNJ Member BeiGene announced its new name and its redomiciliation to Switzerland, marking a significant milestone in the biopharmaceutical firm’s evolution. The company is now known as BeOne Medicines Ltd.. The transition to the BeOne name across the firm’s worldwide operations on six continents will happen in phases. “BeOne represents more than a name change — it’s not only a reflection of who we are today as a leading global oncology company, but also our ambition to redefine what’s possible in oncology as we unite patients, families, scientists, physicians, governments, and other oncology public health stakeholders around the world in our shared mission against cancer,” John Oyler, Co-founder, Chairman and CEO at BeOne, said. "BeOne has built a differentiated and sustainable advantage through strategic investments to bolster its internal research, clinical development and manufacturing capabilities."

New Drug Approval for In-House Developed Anti-Insomnia Drug DAYVIGO® (Lemborexant) in China

Nutley-based BioNJ Member Eisai Co., Ltd. announced that the in-house-discovered and developed orexin receptor antagonist DAYVIGO® (brand name in China: “达卫可®“ generic name: lemborexant) has been approved in China for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Eisai plans to launch this medicine in China in the second quarter of fiscal year 2025. DAYVIGO is a dual orexin receptor antagonist that inhibits orexin neurotransmission regulating sleep-wake rhythm by binding competitively to the two subtypes of orexin receptors (OX1R and OX2R). DAYVIGO acts on the orexin neurotransmitter system and is believed to facilitate sleep onset, sleep maintenance, and wake by regulating sleep-wake rhythm.

Pfizer and Astellas’ XTANDI™ (enzalutamide) Shows Long-Term Overall Survival in Metastatic Hormone-Sensitive Prostate Cancer

BioNJ Member Pfizer Inc., with a site in Peapack, and Astellas Pharma Inc. announced longer-term follow-up results from an open-label extension of the Phase 3 ARCHES (NCT02677896) study, reporting a five-year follow up of overall survival (OS) benefits and a 30% reduction in the risk of death in men with metastatic hormone-sensitive prostate cancer (mHSPC) treated with XTANDI™ (enzalutamide), an androgen receptor pathway inhibitor (ARPI), plus androgen deprivation therapy (ADT) compared to placebo plus ADT. In patients with high-volume disease (HR: 0.70; 95% CI: 0.56-0.88) a 36-month improvement in median OS was observed. Additional clinically relevant subgroups of patients were evaluated, showing consistently improved survival: low-volume disease (HR: 0.71; 95% CI, 0.49-1.05); patients who had previously received docetaxel therapy (HR: 0.67; 95% CI, 0.43- 1.05) and those who had not received prior docetaxel therapy (HR: 0.71; 95% CI, 0.57-0.88).

Pfizer Enters into Exclusive Licensing Agreement With 3SBio

BioNJ Member Pfizer Inc., with a site in Peapack, announced it has entered into an exclusive global, ex-China, licensing agreement with 3SBio, Inc. (01530.HK), a leading Chinese biopharmaceutical company, for the development, manufacturing and commercialization of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, currently undergoing several clinical trials in China for non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors. SSGJ-707 has shown initial efficacy and safety data in a promising class of cancer medicines. 3SBio plans to initiate the first Phase 3 study in China in 2025. Under the terms of the agreement, 3SBio and its subsidiaries Shenyang Sunshine Pharmaceutical Co., Ltd. and 3S Guojian Pharmaceutical (Shanghai) Co., Ltd. will grant Pfizer an exclusive global license to develop, manufacture and commercialize SSGJ-707 worldwide, excluding China. 

ASCENT-03: Trodelvy® Demonstrates Highly Statistically Significant & Clinically Meaningful Improvement in Progression Free Survival in Patients With First-line Metastatic Triple-Negative Breast Cancer Who Are Not Candidates for Checkpoint Inhibitors

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced positive topline results from the Phase 3 ASCENT-03 study of Trodelvy® (sacituzumab govitecan-hziy). The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are not candidates for PD-1/PD-L1 inhibitors, meaning they are PD-L1 negative or are ineligible to receive immunotherapy. Together with the recently announced positive results from the ASCENT-04 study evaluating Trodelvy plus Keytruda® in patients with previously untreated PD-L1+ metastatic TNBC, Trodelvy now has the potential to be the backbone treatment for all patients across first-line mTNBC. 

Regeneron Enters into Asset Purchase Agreement to Acquire 23andMe® for $256 Million; Plans to Maintain Consumer Genetics Business and Advance Shared Goals of Improving Human Health and Wellness

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced it has been named the successful bidder in the bankruptcy auction for substantially all of the assets of 23andMe Holding Co., a leading human genetics and biotechnology company. Regeneron intends to acquire 23andMe’s Personal Genome Service®, Total Health and Research Services business lines, together with its Biobank and associated assets, and for 23andMe to continue all consumer genome services uninterrupted. “Regeneron was one of the first biotech companies to bet its future on the power of DNA, fueling our drug discovery efforts so as to deliver some of the world’s leading and most innovative medicines,” said George D. Yancopoulos, M.D. Ph.D., co-Founder, Board co-Chair, President and CSO of Regeneron.

LEO Pharma Announces Positive Topline Phase 2b Results for Temtokibart in Moderate-to-Severe Atopic Dermatitis

Madison-based LEO Pharma A/S announced positive topline results of the Phase 2b trial with temtokibart, an investigational IL-22RA1 antagonist, for the potential treatment of adults with moderate-to-severe atopic dermatitis (AD). The study was a phase 2b, randomized, double-blind, placebo-controlled, multi-site, parallel-group, dose-finding trial to evaluate the efficacy and safety of different doses of subcutaneously administered temtokibart, also called LEO 138559, in adult subjects with moderate-to-severe AD. The phase 2b trial achieved positive results for the primary endpoint based on percentage change in EASI (Ecze-ma Area and Severity Index) from baseline to Week 16 for 3 highest doses in adults with moderate-to-severe AD. The treatment was generally well-tolerated, with no dose dependency, and the majority of adverse events observed were non-serious, mild or moderate in severity, and not considered treatment related.

Hikma Pharmaceuticals and Bio-Thera Solutions Announce FDA approval of STARJEMZA® (ustekinumab-hmny) Injection, a Biosimilar Referencing STELARA® (ustekinumab) Injection

Berkeley Heights-based Hikma Pharmaceuticals PLC and Bio-Thera Solutions, Ltd announced that the U.S. Food and Drug Administration (FDA) has approved STARJEMZA® (ustekinumab-hmny) Injection, a biosimilar referencing Stelara® (ustekinumab) Injection. STARJEMZA® is Bio-Thera’s third FDA approved product. Bio-Thera and Hikma entered into a license and commercialization agreement for STARJEMZA® in August 2021. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Hikma is responsible for the commercialization of STARJEMZA® in the United States. The FDA approval of STARJEMZA®, originally known as BAT2206, was based on a comprehensive analytical, non-clinical, and clinical data package submitted by Bio-Thera to the FDA.

Mitsubishi Tanabe Pharma America Announces U.S. FDA Acceptance of New Drug Application Resubmission for Investigational ND0612 for the Treatment of Motor Fluctuations in Parkinson’s Disease

Jersey City-Based Mitsubishi Tanabe Pharma America, Inc. (MTPA) announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) resubmission for investigational ND0612, a 24-hours/day, continuous, subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD), for the treatment of motor fluctuations in people living with Parkinson’s disease (PD). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date in the fourth quarter of 2025. The NDA is supported by data from the pivotal, Phase 3, multi-center, randomized, double-blind double-dummy (DBDD) BouNDless trial (NCT04006210), which evaluated the effectiveness and safety of ND0612 in people with PD experiencing motor fluctuations, as well as long-term safety data from the ongoing Phase 2b BeyoND study (NCT02726386) of ND0612, with some study participants in their eighth year of follow-up.

Mitsubishi Tanabe Pharma America Announces Completion of Enrollment for its Phase 3 INSPIRE Study of Investigational Dersimelagon in Patients With EPP and XLP

Jersey City-Based Mitsubishi Tanabe Pharma America, Inc. (MTPA) announced that patient enrollment has been completed for the INSPIRE (Increased Sun Exposure Without Pain In Research Subjects With EPP Or XLP) clinical study (NCT06144840). INSPIRE is a global, randomized, double-blind, placebo-controlled phase 3 study investigating the efficacy, safety, and tolerability of dersimelagon (MT-7117) in adults and adolescents with erythropoietic protoporphyria (EPP) or X-linked protoporphyria (XLP). Dersimelagon is a novel orally-administered, small molecule under study for its potential to increase the time in sunlight before patients experience prodromal symptoms (i.e., the appearance of initial symptoms such as burning, tingling, itching, or stinging). Topline data from the INSPIRE study is expected this fall.

EPP and XLP are rare inherited disorders of the heme biosynthetic pathway that are characterized by severe pain in the skin with exposure to sunlight and some forms of artificial light.

BD Launches Landmark Cell Analyzer Featuring Breakthrough Spectral and Real-Time Cell Imaging Technologies

Franklin Lakes-based BD (Becton, Dickinson and Company) (NYSE: BDX) announced the global commercial launch of the world's first cell analyzer featuring breakthrough spectral and real-time cell imaging technologies, enabling more researchers across a wider range of applications to uncover deeper insights and dynamics from cells once invisible in flow cytometry experiments ― with increased ease and throughput. BD SpectralFX™ Technology maximizes the number of colors that can be used in flow cytometry, allowing scientists to analyze up to 50 or more characteristics of a single cell at one time, with optimal resolution and sensitivity, which is ideal for scientists pursuing novel biomarker discovery. BD CellView™ Image Technology enables high-speed fluorescent and label-free imaging of single cells, revealing precise spatial and morphological insights – like the location of a virus or protein within a single cell, or the microscopic interaction between two cells ― that can be visually confirmed and analyzed in real time.

Rutgers Hires William Tate as Next President: Why Current LSU President Checks All Boxes

William Tate IV, the current President at Louisiana State University, was announced as the next president of Rutgers University, following a joint meeting of and approval by the school’s Board of Governors and Board of Trustees. Mr. Tate, 56, signed a five-year contract to lead the school. He will formally assume the position July 1, succeeding President Jonathan Holloway, whose last day is June 30. While he will not be formally in the role of president, it is expected that Mr. Tate will be included in discussions involving three other open positions that are key to the university: chancellor at Rutgers-Newark and general counsel and athletic director at Rutgers-New Brunswick. It is unclear how quickly those jobs will be filled.

Rutgers Initiative Attempts to Combat Vaccine Misinformation

An initiative born at Rutgers University is taking a shot at building vaccine confidence. Founded in March 2023 while longtime Johnson & Johnson executive Hajar Shirley was working on her doctorate, the Vaccine Equity Education Coalition is especially focused on connecting with marginalized communities that may lack access to primary care, providing them with information on the importance of life-saving vaccines and sharing details on how to access those shots. An experienced health care technology leader, researcher and educator, Shirley has a long track record of advancing strategic initiatives in both health care and higher education. A former global IT director at J&J, Shirley led worldwide efforts centered on improving patient-level access and chronic care management within the company’s diabetes care businesses.

NJ Innovation Hub Selects Portal Innovations to Manage Life Sciences Incubator at HELIX

Portal Innovations, a leading life sciences venture development engine, announced a partnership with The NJ Innovation Hub, a cornerstone of The Health & Life Science Exchange of New Jersey (HELIX NJ), to design and manage 30,000 square feet of innovation and lab incubation space in New Brunswick. Portal will help support life sciences startups and entrepreneurs from nearby research universities including Rutgers, Princeton and NJIT, by providing them with access to fully equipped lab space, seed capital and introductions to investors and pharma partners. Portal will manage the operations of the HELIX NJ incubator space and provide researchers and entrepreneurs access to world-class amenities including wet and dry lab space, innovative equipment, collaborative working areas and private offices.

Kean University, New Jersey City University Sign Letter of Intent for Merger

Kean University and New Jersey City University (NJCU) signed a letter of intent (LOI) today that advances a proposed historic merger that would integrate NJCU into Kean and enhance access to innovative and inclusive higher education across New Jersey. The planned merger, subject to regulatory and accreditation approvals and a formal definitive agreement to be entered into between the two institutions, would see Kean University assume NJCU and operate an additional location to be known as “Kean Jersey City.” It would preserve NJCU’s mission of serving first-generation, adult and historically underserved students while advancing Kean’s role as the State’s urban research university and a newly designated R2 research university. “This strategy honors the legacy of NJCU while elevating our shared commitment to access, equity and excellence,” said Kean University President Lamont O. Repollet, Ed.D.

Rider University Taps Loyack to Succeed Retiring President

Rider University announced the appointment of John Loyack as its next president. John Loyack will succeed Gregory Dell’Omo, who is retiring after serving in the role since 2015. The selection follows an exhaustive, national search by the Rider University board of trustees. “John Loyack is a transformative, mission-driven leader with a record of innovation, strategic growth and unwavering dedication to student success ― making him the ideal choice to lead Rider into its next chapter,” said Joan Mazzotti, chair of the Rider University board of trustees. Most recently, Mr. Loyack served as president of Alvernia University. At that Reading, Pa.-based school, Mr. Loyack oversaw a university-wide transformation and growth during his tenure (2019–2024). His background also includes more than 15 years of executive experience in the energy, manufacturing and nonprofit sectors.

NJEDA to Open Applications for New Jersey Innovation Fellows AI Cohort

The New Jersey Economic Development Authority (NJEDA) will open applications for the Artificial Intelligence (AI) cohort within the New Jersey Innovation Fellows Program (NJIF) program on Wednesday, June 18, 2025, at 10:00 a.m. The NJIF’s dedicated AI carveout will provide income replacement grants of up to $400,000 to eligible entrepreneur teams looking to launch AI-driven businesses, building on Governor Phil Murphy’s goal of establishing New Jersey as a leader in the emerging industry. The NJIF program supports entrepreneurs with unique startup ideas with access to “income replacement” grants. This resource creates an opportunity for the entrepreneurs to pursue unique startup business ventures with the security of initial income replacement funding and guidance during the two-year ideation and formation period of their business. In addition to financial support, the NJIF Program will provide comprehensive mentorship training led by Princeton University for each entrepreneurial team. The 24-month mentorship program will provide expert guidance in various fields, conduct workshops, and offer networking opportunities with the University’s academic and industry partners.

NJEDA Launches New Digital Platform to Connect State’s Innovation Ecosystem

The New Jersey Economic Development Authority (NJEDA) launched a new digital platform designed to connect entrepreneurs and investors. The platform, known as the Innovation Network Capital New Jersey (INC-NJ), will bring together the State’s innovation ecosystem, allowing emerging companies and funders to engage with one another and share various business and investment opportunities. Emerging New Jersey-based companies will be able to showcase their businesses and build relationships with investors through the INC-NJ platform. Investors can use INC-NJ to discover new companies that fit their investment criteria. All users will be able to view curated funding and incentive resources and learn about the latest industry news. NC-NJ will help scale the NJEDA’s efforts and allow many more entrepreneurs and investors to forge relationships. The new digital platform is also aligned with the Strategic Innovation Centers (SICs) launching across the State.

To Sharpen Focus on the Global Commercialization of Strategic Products and the External Partnership Model, LEO Pharma Makes Changes to Leadership

At Madison-based LEO Pharma A/S, we have made significant progress on our transformation journey. In light of this, we are announcing the following changes to our Executive Management team: We will split the current Product Strategy and International Operations into two functions. Frederik Kier has been appointed as EVP, International Operations. Lisa Elliott, currently Vice President, Global Assets and Payer Strategy at LEO Pharma, is promoted to interim head of Global Product Strategy. Mark Levick ― who is currently a member of LEO Pharma’s Board of Directors and Chair of LEO Pharma’s Innovation Committee ― will step in as interim EVP of Development. Finally, a new HR executive has been appointed and will join our Global Leadership Team as EVP, Head of Global People and Corporate Affairs on July 1.

Daiichi Sankyo has Been Awarded as the SX (Sustainability Transformation) Brands

Basking Ridge-based Daiichi Sankyo was selected and awarded the second consecutive year as "the SX (Sustainability Transformation) Brands", which is initiated by Ministry of Economy, Trade and Industry and Tokyo Stock Exchange, Inc. Under our 2030 Vision, the Daiichi Sankyo Group aims to become an innovative global healthcare company contributing to the development of a sustainable society and is actively promoting ESG management. In this year’s selection, we were recognized for clearly identifying the gap between our current state and our vision, and for integrating business strategy, human capital strategy, digital transformation (DX) and capital strategy into a cohesive overall strategy. In particular, our sustainability management—deeply rooted in our core business — was praised for addressing the global social issue of oncology drug discovery through our strengths in science and technology, resulting in the consistent achievement of strong business performance.

Alternative Funding Approaches for Early Stage Companies & Universities

June 4, 2025 | hosted by the LES Life Sciences Sector and NY-NJ Chapter

As traditional funding sources like federal agencies, private foundations, corporate licensing, and venture capital become harder to access, companies and universities must explore alternative financing strategies. This expert panel will discuss the current funding landscape, including VC trends, government and foundation support, and innovative approaches such as IP portfolio sales, pharmaceutical royalty transactions and patent licensing.

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.