Vital Health Podcast Features: Niklas Blomberg, Executive Director, EU Innovative Health Initiative

In this Vital Health Podcast, host Duane Schulthess sits down with Niklas Blomberg, the Executive Director of the EU Innovative Health Initiative (IHI). Together, they delve into the transformative journey from the Innovative Medicines Initiative to the broader, more inclusive Innovative Health Initiative. Mr. Blomberg shares his perspectives on fostering collaboration between pharmaceuticals, medical technologies, and diagnostics while elaborating on the challenges and strategies for integrating diverse sectors in healthcare research.

FTC Releases Interim Staff Report on Prescription Drug Middlemen

The Federal Trade Commission published an interim report on the prescription drug middleman industry that underscores the impact pharmacy benefit managers (PBMs) have on the accessibility and affordability of prescription drugs. The interim staff report, which is part of an ongoing inquiry launched in 2022 by the FTC, details how increasing vertical integration and concentration has enabled the six largest PBMs to manage nearly 95 percent of all prescriptions filled in the United States. This vertically integrated and concentrated market structure has allowed PBMs to profit at the expense of patients and independent pharmacists, the report details. 

The IRA Could Lead to Higher Out-Of-Pocket Costs for 3.5 Million Medicare Patients in 2026

The Inflation Reduction Act (IRA) gives the federal government unprecedented authority to determine the price of certain medicines in Medicare through the Medicare Drug Price Negotiation Program. The government has selected an initial group of 10 medicines whose prices will be limited to what the IRA calls a “maximum fair price” (MFP) beginning in 2026. Unfortunately, a new analysis from Milliman finds the IRA’s drug pricing provisions could undermine the benefits of the new out-of-pocket limit for millions of seniors and people with disabilities. As a direct result of these provisions, 3.5 million Part D patients taking a medicine subject to an MFP could see higher out-of-pocket costs in 2026.

PhRMA Launches Education Campaign on the Benefits of America’s IP System

Did you know that every low-cost generic medicine started out as a patented brand medicine Intellectual property (IP) is the foundation of biopharmaceutical innovation that brings lifesaving treatments and vaccines to people around the world. But it does something else, too. America’s IP system was set up to support a robust market for lower cost generics and biosimilars to keep medicine costs for patients and the health care system in check. That’s why the Pharmaceutical Research and Manufacturers of America (PhRMA) launched a new education campaign to highlight the many benefits of America’s world-leading system of IP protections. This unique system promotes innovation, competition, and choice — and ultimately lower costs at the pharmacy counter.

BioNJ Collaborates With Tech Council Ventures to Boost Life Sciences Innovation

As featured in ROI-NJ

BioNJ and Tech Council Ventures are teaming up to accelerate and facilitate life sciences deals. The partnership aims to work together to support and drive innovation in the sector, especially in regard to digital health, biotech, medical devices and therapeutics companies. By combining BioNJ’s deep-rooted network and commitment to patient access with Tech Council Ventures’ investment expertise, the collaboration will create robust opportunities through their strengths and connections for early-stage companies to thrive and expand in New Jersey.

New Jersey: The State of Manufacturing

As featured in New Jersey Business Magazine

Manufacturing has played a critical role in New Jersey’s history. During the early 1800s, a time of great growth and prosperity for the State, manufacturing led the way. Paterson became a textile center and later became known for producing trains and silk. Trenton produced clay products, iron and steel. Camden, Elizabeth, Jersey City, Newark and Passaic all became major manufacturing centers during the 1800s. Between 1900 and 1930, New Jersey’s population more than doubled, and manufacturing became a $4 billion industry. Today, there are more than 9,000 manufacturers currently operating in the State, employing approximately 236,000 people, and accounting for $54 billion in GDP, according to statistics from the New Jersey Department of Labor (DOL). BioNJ President and CEO Debbie Hart reports that the Garden State is one of the top two states in the nation for the most facilities manufacturing FDA-approved products (50% of new FDA approvals in the US last year) and is the No. 1 state for life sciences manufacturing employees.

New Jersey Continues to Lead the Way in Life Sciences Innovation

As featured in NJBIZ

New Jersey’s life sciences and biopharma heritage is widely known – and one glance around the State shows constant examples of the continued momentum of the sector. In May, BioNJ held its 14th Annual BioPartnering Conference – for the first time at Liberty Science Center in Jersey City, which will serve as the home for the highly anticipated SciTech Scity. “The mission of the BioPartnering Conference is to cultivate the ecosystem and foster partnerships that propel medical innovation forward. The energy throughout the day – as new opportunities and business endeavors were discussed – was absolutely palpable. More than 600 participants turned out for the event, which brought together entrepreneurs, life sciences executives, investors, academic collaborators and others for plenary sessions, partnering meetings, exhibits, company pitch presentations, one-on-one sessions at the Industry Connections Desk and networking," said BioNJ President and CEO Debbie Hart.

EPKINLY® (epcoritamab-bysp) Approved by U.S. FDA for Patients With Relapsed or Refractory (R/R) Follicular Lymphoma (FL)

Princeton-based BioNJ Member Genmab announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY® (epcoritamab-bysp) for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. With this approval, EPKINLY is the first and only T-cell engaging bispecific antibody administered subcutaneously approved in the U.S. to treat this patient population. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial(s). FL is the second most common form of non-Hodgkin’s lymphoma (NHL), accounting for 20-30 percent of all NHL cases. About 15,000 people develop FL each year in the U.S.

Epcoritamab (TEPKINLY®) Receives Positive CHMP Opinion for the Treatment of Adults With Relapsed/ Refractory Follicular Lymphoma

Princeton-based BioNJ Member Genmab announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of conditional marketing authorization of epcoritamab (TEPKINLY®), a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The CHMP opinion is supported by overall and complete response data from the Phase 1/2 EPCORE® NHL-1 clinical trial in 128 patients with R/R FL treated with epcoritamab after two or more lines of systemic therapy. The study included patients who were refractory to both anti-CD20 monoclonal antibody therapy and an alkylating agent, patients who were refractory to last prior treatment, and patients whose disease progressed within two years of first systemic therapy. 

Lilly's Kisunla™ (donanemab-azbt) Approved by the FDA for the Treatment of Early Symptomatic Alzheimer's Disease

The U.S. Food and Drug Administration (FDA) approved Kisunla™ (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion), BioNJ Member Eli Lilly and Company's (with a site in Branchburg) Alzheimer's treatment for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment (MCI) as well as people with the mild dementia stage of AD, with confirmed amyloid pathology. Once-monthly Kisunla is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions. In the TRAILBLAZER-ALZ 2 Phase 3 study, people who were the least advanced in the disease experienced the strongest results with Kisunla.

Lilly to Acquire Morphic to Improve Outcomes for Patients With Inflammatory Bowel Disease

BioNJ Member Eli Lilly and Company, with a site in Branchburg, and Morphic Holding, Inc. announced a definitive agreement for Lilly to acquire Morphic, a biopharmaceutical company developing oral integrin therapies for treatment of serious chronic diseases. Morphic's lead program is a selective oral small molecule inhibitor of α4β7 integrin for the treatment of inflammatory bowel disease (IBD) that has the potential to improve outcomes and expand treatment options for patients. This molecule (known as MORF-057) is being evaluated in two Phase 2 studies in ulcerative colitis and one Phase 2 study in Crohn's disease. Additionally, Morphic is developing a preclinical pipeline of other molecules for the treatment of autoimmune diseases, pulmonary hypertensive diseases, fibrotic diseases and cancer.

Expanded HyBryte™ Treatment Demonstrating Positive Outcomes in Early Stage Cutaneous T-Cell Lymphoma

Princeton-based BioNJ Member Soligenix announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ treatment for up to 12 months in patients with early stage cutaneous T-cell lymphoma (CTCL). To date six patients have been enrolled and treated with HyBryte™ over a time period ranging up to 44 weeks. Patients have responded positively to HyBryte™ therapy with 75% (3 of the 4 subjects who have completed at least 12 weeks of therapy) already achieving "Treatment Success", as predefined in the study's protocol as ≥50% improvement in their cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score compared to Baseline. Of the three Treatment Successes, two were achieved within the first 12 weeks of treatment and the third within 18 weeks.

EmphyCorp Rx N115 Nonsteroidal Nasal Spray Expanded Phase III Clinical Trial Results Showed a 73% Reduction in Coughing and Clinically Significant Improved Lung Function in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Flemington-based BioNJ Member EmphyCorp Inc. announced the completion of an expanded Phase III clinical trial with its patented Rx N115 non-steroidal nasal spray demonstrating an extraordinary 73% reduction of coughing in patients with Idiopathic Pulmonary Fibrosis (IPF). This was a double-blinded randomized placebo-controlled Phase 3 clinical trial for coughing and improved lung function. The results were listed on www.ClinicalTrials.Gov under Cellular Sciences. Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive lung disorder associated with excessive tissue remodeling, scarring and fibrosis, which makes the lungs unable to effectively transport oxygen into the bloodstream resulting in decreased forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) values, decreased SaO2 and a decrease in nitric oxide associated with nasal inflammation that causes congestion and coughing.

Legend Biotech Announces Positive Overall Survival Results of Landmark Phase 3 CARTITUDE-4 Trial in Multiple Myeloma

Somerset-based BioNJ Member Legend Biotech Corporation announced positive overall survival results from CARTITUDE-4, an ongoing, global randomized, open-label Phase 3 study evaluating the efficacy and safety of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD). In the pre-specified second interim analysis of the trial, CARVYKTI® demonstrated statistically significant and clinically meaningful improvement in overall survival (OS). Safety results were consistent with the established safety profile of CARVYKTI®, and no new safety signals were identified.

Boehringer Ingelheim’s Survodutide Shows Breakthrough Improvement in Liver Fibrosis With no Worsening of MASH in 64.5% of Patients With F2 and F3 Fibrosis

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, announced breakthrough results from a survodutide Phase II trial sub-analysis that demonstrate up to 64.5% of adults with fibrosis stages F2 and F3 (moderate to advanced scarring) achieved an improvement in fibrosis without worsening of metabolic dysfunction-associated steatohepatitis (MASH), versus 25.9% with placebo after 48 weeks of treatment [response difference: 38.6% (95% CI 18.1% - 59.1%), p=0.0005]. F2 and F3 patient populations are at increased risk of developing liver-related complications. The secondary endpoint shows that up to 52.3% of adults treated with survodutide (BI 456906) achieved a significant improvement in liver scarring (fibrosis) stages F1, F2 and F3 (mild to moderate or advanced scarring), versus 25.8% with placebo after 48 weeks of treatment [response difference: 26.5% (95% CI 8.37% – 44.66%), p<0.01].

Pfizer Advances Development of Once-Daily Formulation of Oral GLP-1 Receptor Agonist Danuglipron

BioNJ Member Pfizer, with a site in Peapack, announced that based on results from the ongoing pharmacokinetic study (NCT06153758), the company has selected its preferred once-daily modified release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist. Pfizer plans to conduct dose optimization studies in the second half of 2024 evaluating multiple doses of the preferred modified release formulation to inform the registration enabling studies. The ongoing open-label, randomized study is evaluating the pharmacokinetics and safety of immediate- and modified release formulations of danuglipron administered orally in healthy adults 18 years or older. To date, study results have demonstrated a pharmacokinetic profile supportive of once-daily dosing. with a safety profile consistent with prior danuglipron studies including no liver enzyme elevations observed in more than 1,400 study participants.

Gilead’s Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention

BioNJ Member Gilead Sciences, with a site in Morris Plains, announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1 trial indicating that the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women. PURPOSE 1 met its key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV). Based on these results, the independent Data Monitoring Committee (DMC) recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants.

Brazil and Thailand Become First Malaria-Endemic Countries to Launch New Single-Dose Radical Cure Medicine to Prevent the Relapse of Plasmodium Vivax Malaria

Warren-based BioNJ Member GSK and Medicines for Malaria Venture announced that the first single-dose medicine for the prevention of relapse of Plasmodium vivax (P. vivax) malaria – tafenoquine, co-administered with chloroquine for radical cure, has now been launched in both Thailand and Brazil, in support of malaria elimination efforts. P. vivax is the dominant malaria parasite in most countries outside of sub-Saharan Africa. It is characterized by clinical relapses, with patients repeatedly falling sick unless the latent liver-stage infection is treated. This takes a considerable physical, economic and social toll on patients and communities, perpetuating cycles of poverty. In some cases, relapses can lead to severe malaria and death. Relapses also increase the disease burden and the potential for onward transmission, ultimately impeding global efforts to eliminate malaria.

GSK and CureVac to Restructure Collaboration into New Licensing Agreement

Warren-based BioNJ Member GSK and CureVac N.V. announced they have restructured their existing collaboration into a new licensing agreement, allowing each company to prioritize investment and focus their respective mRNA development activities. Since 2020, GSK and CureVac have worked together to develop mRNA vaccines for infectious diseases. Through this collaboration, GSK and CureVac currently have vaccine candidates for seasonal influenza and COVID-19 in Phase II and avian influenza in phase I clinical development. All candidates are based on CureVac’s proprietary second-generation mRNA backbone. Data generated to date for these candidate vaccines are promising and demonstrate their potential to be best-in-class new vaccines.

Riliprubart One-Year Results from Phase 2 Study Underpin the Potential as a First-in-Class Treatment in Chronic Inflammatory Demyelinating Polyneuropathy

Bridgewater-based BioNJ Member Sanofi’s complement C1s inhibitor, riliprubart, showed encouraging efficacy and safety for participants with chronic inflammatory demyelinating polyneuropathy (CIDP) in the latest findings from an ongoing phase 2 study. In part A results at 24 weeks, riliprubart showed promising disease-controlling benefits, with improving or stable disease, including for participants who experienced failure or inadequate response to SOC treatment and participants with residual disability on SOC. In part B, after an additional 24 weeks of follow-up, riliprubart continued to show promising disease-controlling benefits across all enrolled cohorts. Additional results showed that riliprubart improved participant-reported fatigue and quality-of-life measurements as well as biomarkers associated with CIDP disease progression. 

Dupixent Approved in the EU as the First-Ever Targeted Therapy for Patients With COPD

Bridgewater-based BioNJ Member Sanofi announced that the European Medicines Agency (EMA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. Specifically, the approval covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. The EMA is the first regulatory authority in the world to approve Dupixent for COPD patients. Additional submissions are under review with other regulatory authorities around the world, including in the U.S., China and Japan.

Dupixent Positive Phase 3 Data in Children One to 11 Years of Age With Eosinophilic Esophagitis Published in NEJM

Bridgewater-based BioNJ Member Sanofi announced The New England Journal of Medicine has published results from a positive Phase 3 study of Dupixent (dupilumab) in children aged one to 11 years with eosinophilic esophagitis (EoE). The study showed a greater proportion of those receiving weight-tiered higher dose Dupixent experienced significant improvements in many key disease measures of EoE, compared to placebo at week 16. Data from the study were the basis for the US Food and Drug Administration Priority Review and approval of Dupixent in children aged one to 11 years with EoE weighing at least 15 kg, as well as for the regulatory submission that is currently under review by the European Medicines Agency for this age group.

Frexalimab New Phase 2 Data Showed Reduction of Key Biomarker of Nerve Cell Damage in Relapsing MS

Bridgewater-based BioNJ Member Sanofi announced CD40L monoclonal antibody, frexalimab, reduced a key biomarker associated with multiple sclerosis nerve cell damage in patients with relapsing MS, supporting the rationale for this novel mechanism in MS Phase 3 studies aiming to delay disability progression. New Phase 2 results showed significant reduction in plasma levels of neurofilament light chain (NfL) after one year of treatment, a biomarker of nerve cell damage that is typically elevated in people living with MS. Ninety-seven percent (125/129) of the study participants from the initial 12-week double-blind period entered the open-label extension (OLE) of the Phase 2 study, and 87% (112/129) remained in the study by the 48-week cut-off. 

Nipocalimab Pivotal Phase 3 Trial Demonstrates Longest Sustained Disease Control in FcRn Class

New Brunswick-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced positive results from the nipocalimab Phase 3 Vivacity-MG3 study in patients with generalized myasthenia gravis (gMG). Patients treated with nipocalimab plus standard of care (SOC) achieved superiority over placebo plus SOC as measured by the primary endpoint of improvement in the MG-ADL score from baseline over 24 weeks. The double-blind placebo-controlled study enrolled a broad population of anti-AChR+, anti-MuSK+ and/or anti-LRP4+ patients, which account for approximately 95 percent of the gMG patient population. Patients receiving nipocalimab plus SOC improved by 4.70 points on the MG-ADL, significantly more than the 3.25 point improvement from baseline observed with placebo plus SOC from baseline over Weeks 22, 23 and 24 (P=0.002). 

CARVYKTI® (ciltacabtagene autoleucel) Achieved Statistically Significant and Clinically Meaningful Improvement

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced positive results from a prespecified second interim analysis of the Phase 3 CARTITUDE-4 study evaluating CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) compared to standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) for the treatment of patients with relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy. The interim analysis showed a statistically significant and clinically meaningful improvement in overall survival (OS) for patients treated with CARVYKTI® versus standard therapies. Safety data were consistent with the approved label. CARVYKTI® (cilta-cel) received U.S. Food and Drug Administration approval in February 2022 for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. 

Johnson & Johnson Receives Approval from U.S. FDA and European Commission for SIRTURO® (bedaquiline)

New Brunswick-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued traditional approval for SIRTURO® (bedaquiline) as part of combination therapy in adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid. With the FDA’s approval, label restrictions that were included when the medicine was granted accelerated approval in the U.S. in December 2012 are removed. The European Commission (EC) has also granted full approval of SIRTURO®, converting its Conditional Marketing Authorization to a Standard Marketing Authorization, following a positive opinion in April 2024 from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

Johnson & Johnson Strengthens Pipeline to Lead in Atopic Dermatitis With Acquisition of Yellow Jersey Therapeutics

New Brunswick-based BioNJ Member Johnson & Johnson announced that it has successfully completed the acquisition of Yellow Jersey, a demerged subsidiary of Numab Therapeutics to secure the global rights to NM26, a novel, investigational first-in-class bispecific antibody, in an all-cash transaction of approximately $1.25 billion, as announced on May 28, 2024. NM26, which is ready to enter Phase 2 studies in atopic dermatitis (AD), targets two clinically proven pathways, IL-4R alpha subunit (IL-4Rα) and IL-31, which trigger Th2-mediated skin inflammation and skin itch, respectively. AD is the most common inflammatory skin disease. It causes itching and inflammation which are made worse by scratching. It can lead to increased risk of skin infections, skin pain, difficulty sleeping, anxiety, stress, depression and even an increased risk of suicide.

ReShape Lifesciences® Enters Into Merger Agreement With Vyome Therapeutics and Asset Purchase Agreement With Biorad Medisys

Princeton-based BioNJ Member Vyome Therapeutics, Inc. and ReShape Lifesciences® announced that they have entered into a definitive merger agreement under which ReShape and Vyome will combine in an all-stock transaction. The combined company will focus on advancing the development of its immuno-inflammatory assets and on identifying additional opportunities between the world-class Indian innovation corridor and the U.S. market. Under the terms of the merger agreement, which has been unanimously approved by the boards of directors of both companies, existing ReShape stockholders will own approximately 11.1% of the combined company immediately following the closing of the merger, subject to adjustment based on ReShape’s actual net cash at closing compared to a target net cash amount of $5 million. At the closing of the merger, ReShape will be renamed Vyome Holdings, Inc. and expects to trade under the Nasdaq ticker symbol “HIND.”

BeiGene to Present New Data from SEQUOIA Study Evaluating BRUKINSA® Plus Venetoclax in High-Risk First-Line CLL/SLL at EHA2024

Hopewell-based BioNJ Member BeiGene, Ltd. announced the presentation of new data from the SEQUOIA study of BRUKINSA® (zanubrutinib). The preliminary data demonstrate that in the 65 response-evaluable patients treated with the combination, the overall response rate (ORR) was 100%, and the rate of complete response (CR) plus CR with incomplete hematopoietic recovery (CRi) was 48%. The safety profile of the combination is consistent with that of the treatment components, and no new safety signals were seen. Overall, 66 patients with centrally assessed del(17p) and/or TP53 mutation were enrolled in this arm of the SEQUOIA study. Patients received BRUKINSA at 160 mg twice daily for three months, followed by combination treatment of BRUKINSA at the same dose and venetoclax with a ramp-up dosing to 400 mg once daily for 12 to 24 cycles until progressive disease, unacceptable toxicity or confirmed undetectable minimal residual disease (MRD).

“LEQEMBI®” (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in Hong Kong

Nutley-based BioNJ Member Eisai and BioNJ Member Biogen Inc. announced that the Department of Health in Hong Kong has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (generic name: lecanemab) for treatment of Alzheimer’s disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD), the population in which treatment was initiated in clinical trials. LEQEMBI’s approval in Hong Kong is based on the large global Phase 3 Clarity AD study. In the Clarity AD study, LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results. In Hong Kong, 9.3% of people aged 70 years and older were living with dementia, increasing to 32% of those aged 85 years and older. Of whom with dementia, 73.5% were reported to have Alzheimer's disease.

“LEQEMBI®” (Lecanemab) for the Treatment of Alzheimer’s Disease Launched in China

Nutley-based BioNJ Member Eisai and BioNJ Member Biogen Inc. announced that the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” has been launched in China. LEQEMBI received approval in January 2024 as a treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia. China is the third country to launch LEQEMBI following the United States and Japan. LEQEMBI selectively binds to soluble Aβ aggregates (protofibrils), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques in AD, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. LEQEMBI is the world’s first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism.

AbbVie Receives Positive CHMP Opinion for Epcoritamab (TEPKINLY®) for the Treatment of Adults With Relapsed/Refractory Follicular Lymphoma

BioNJ Member AbbVie, with a site in Madison, announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the conditional marketing authorization of epcoritamab (TEPKINLY®), the first and only T-cell engaging bispecific antibody administered subcutaneously (under the skin), as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more prior therapies. The European Commission decision on this indication for epcoritamab is anticipated later this year. FL is typically an indolent (or slow growing) form of non-Hodgkin's lymphoma (NHL) that arises from B-lymphocytes and is the second most common form of NHL accounting for 20-30% of all cases.

Just – Evotec Biologics Expands Tech Partnership for Biosimilars With Sandoz

BioNJ Member Evotec, with a site in Princeton, announced that its biologics segment, Just – Evotec Biologics, Inc., has expanded its strategic partnership with Princeton-based BioNJ Member Sandoz. Just – Evotec Biologics will receive appropriate remuneration following early scientific validation, with further funding tied to achieving development milestones from 2025.This expanded partnership solidifies Just – Evotec Biologics’ commitment to providing long-term commercial supply of biosimilars to Sandoz. Sandoz secures further guarantees relating to long-term supply for patients with a reservation of significant commercial manufacturing capacity. Since May 2023, Just – Evotec Biologics and Sandoz have been engaged in a multi-year technology partnership aimed at the rapid development and manufacturing of biosimilars. Leveraging its data-driven, fully integrated design capability and continuous manufacturing technology platform (J.DESIGN), Just – Evotec Biologics aims to deliver the highest product quality and cost efficiency to its partners. 

FDA Approves Biosimilar Pyzchiva® (ustekinumab-ttwe), to be Commercialized by Sandoz in U.S.

Princeton-based BioNJ Member Sandoz announced that the U.S. Food and Drug Administration (FDA) has approved biosimilar Pyzchiva® (ustekinumab-ttwe) 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection and 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion. Developed by Samsung Bioepis Co., Ltd, it is approved for all indications of its reference medicine and will be commercialized by Sandoz in the U.S. In addition, the FDA provisionally determined that Pyzchiva® would be interchangeable with the reference medicine as it is currently subject to an unexpired period of exclusivity for the first interchangeable biosimilar biological products. Sandoz intends to launch Pyzchiva® in the U.S. in February 2025. Pyzchiva® is expected to be among the first wave of ustekinumab biosimilars to launch in the U.S.

Merck and Orion Announce Mutual Exercise of Option Providing Merck Global Exclusive Rights to Opevesostat, an Investigational CYP11A1 Inhibitor, for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Rahway-based BioNJ Member Merck & Co. and Orion Corporation announced that notice has been provided of the mutual exercise of an option to convert the companies’ ongoing co-development and co-commercialization agreement for opevesostat (MK-5684/ODM-208), an investigational CYP11A1 inhibitor, and other candidates targeting CYP11A1 into an exclusive global license for Merck. “We are pleased with the progress made to date in our collaboration with Orion, including the initiation of two pivotal Phase 3 trials evaluating opevesostat in certain patients with metastatic castration-resistant prostate cancer,” said Dr. Dean Y. Li, President, Merck Research Laboratories. “We will continue to advance the clinical development program for opevesostat with speed and rigor to help address the needs of patients living with prostate cancer.” 

Merck Receives Positive EU CHMP Opinion for WINREVAIR™ (sotatercept) in Pulmonary Arterial Hypertension (PAH)

Rahway-based BioNJ Member Merck & Co. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with World Health Organization (WHO) Functional Class (FC) II to III, to improve exercise capacity. WINREVAIR was previously granted Priority Medicines (PRIME) and orphan designation by the EMA for the treatment of PAH. The European Commission (EC) will now review the CHMP recommendation, and the EC’s decision on the marketing authorization application of WINREVAIR in the EU, Iceland, Liechtenstein and Norway is expected in the third quarter of 2024.

Merck Animal Health Completes Acquisition of Elanco’s Aqua Business

Merck Animal Health, part of Rahway-based BioNJ Member Merck & Co., announced it completed the previously announced acquisition of the aqua business of Elanco Animal Health Inc. The completion of this acquisition bolsters Merck Animal Health’s position in the aqua industry with a comprehensive approach to promote fish health, welfare and sustainability in aquaculture, conservation and fisheries. “With the completion of this acquisition, we are well-positioned within the aquaculture industry with a robust and comprehensive portfolio across warm water, cold water, vaccines, anti-parasitic treatments, water supplements and nutrition,” Rick DeLuca, President, Merck Animal Health, said. “We are excited to welcome our new colleagues to Merck Animal Health and we look forward to working together, driven by our common purpose of the Science of Healthier Animals.”

Ipsen’s Iqirvo® Receives U.S. FDA Accelerated Approval as a First-in-Class PPAR Treatment for Primary Biliary Cholangitis

Ipsen, with a site in Basking Ridge, announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo® (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Iqirvo may be prescribed immediately in the U.S. for eligible patients. This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Amarin Partner EddingPharm Receives Regulatory Approval for VASCEPA® (Icosapent Ethyl) in Mainland China for Cardiovascular Risk Reduction (CVRR)

Bridgewater-based Amarin Corporation announced that its commercial partner in Mainland China, EddingPharm (EDDING), has received regulatory approval for VASCEPA® (icosapent ethyl) from China’s National Medical Products Administration (NMPA). NMPA granted approval for VASCEPA to reduce the risk of cardiovascular events as an adjunct to statin therapy in adult patients with elevated and high triglycerides (≥150mg/dL) and established cardiovascular disease or diabetes mellitus with ≥2 other cardiovascular disease risk factors, combined with hypertriglyceridemia. Following approval by NMPA, EDDING is working to include VASCEPA on the National Reimbursement Drug Listing (NRDL) and augment the ongoing commercial launch of VASCEPA in China to include the CVRR indication.

Dr. Reddy’s to Pay $633M for Haleon’s Nicotine Replacement Business

Consumer health care giant Haleon plans to sell its nicotine replacement therapy (NRT) business outside of the U.S. to Princeton-based Dr. Reddy’s Laboratories in a deal worth $633 million. Haleon, a GSK spinoff that has its U.S. headquarters in Warren, said the divestment will allow it to lower debt and focus on growth areas, like non-prescription drugs, vitamins and oral care products. The portfolio consists of brands such as Nicotinell, Nicabate, Habitrol and Thrive available in gum, lozenge and patch forms across over 30 markets. The transaction includes an upfront payment of $579 million. It is expected to close in the fourth quarter. According to the companies, operations will transition to Dr. Reddy’s in a phased approach to ensure successful integration of the business.

Cosette Pharmaceuticals Acquires Sleep Medication Ambien from Sanofi

Bridgewater-based Cosette Pharmaceutical said it acquired sleep medications Ambien and Ambien CR from BioNJ Member Sanofi. The acquisition builds on Cosette’s leading expertise in carving out critical drugs from global pharma companies across Japan, Europe and the U.S. The company’s strategic approach and industry expertise help it make divestiture and product transition seamless, ensuring uninterrupted access to critical medicines for millions of patients. “We are excited at the addition of Ambien to our portfolio,” Apurva Saraf, CEO and President of Cosette, said. “We continue to leverage our demonstrated, best-in-class capabilities in executing complex carve-outs and integrating diverse products. This acquisition not only strengthens our product portfolio, but also reaffirms our commitment to ensuring high-quality products continue to remain available to patients worldwide.”

Biotech Nonprofit Inks 30K sq. ft. at Jersey City's 95 Greene Street, Moving Lab from Brooklyn

IAVI, a nonprofit scientific research organization that develops vaccines and antibodies for HIV, tuberculosis and emerging infectious diseases, inked a 29,782-square-foot lease at 95 Greene St. in Jersey City. The nonprofit biotech will relocate its Vaccine Design and Development Lab from the Brooklyn Army Terminal to the lab-ready, 350,000-square-foot life sciences building.The IAVI DDL is one of the world’s leading vaccine research and development labs and serves as the preclinical development hub for IAVI’s EID vaccine portfolio. Using the same vaccine vector as a licensed Ebola vaccine, DDL scientists design novel vaccine concepts for priority pathogens including Ebola Sudan, Marburg, Lassa and COVID-19. IAVI’s Lassa vaccine candidate designed by DDL scientists in New York is currently in Phase 2 clinical trials in West Africa.

New Jersey's Largest Biotech Incubator – Labs Available Now!

The Incubator at North Brunswick is one of the more significant incubation facilities in the nation dedicated to life sciences and biotechnology companies – a 46,000 sq. ft. biotech wet lab incubator in a 50-acre research park in North Brunswick in the heart of New Jersey’s “Research Corridor.

2024 Innovation Fund Grants Announced for STEM Education

The New Jersey STEM Strategic Advisory Board (NJSSAB), part of the New Jersey STEM Pathways Network, has announced the recipients of the 2024 Innovation Fund grants.

This year, NJSSAB experienced a substantial increase in Innovation Fund grant applications, nearly 50 in total, reflecting the growing interest and commitment to advancing STEM (“Science, Technology, Engineering and Mathematics”) education across the state. With a record number of proposals received after last year’s inaugural year of the grant, NJSSAB developed a strategic approach to allocate resources effectively, aiming to fully fund as many deserving projects as possible. “We are thrilled to witness such overwhelming enthusiasm for STEM education initiatives in New Jersey,” said Maria Spina, NJSSAB Chair and PSEG Foundation Manager. “The quality and diversity of proposals we received are a testament to the dedication and innovation of educators and organizations across our State.”

NJEDA Innovation Incentive & Funding Office Hours

July 19 at 2 p.m. – Virtual

The Innovation Programs Department now offers Office Hours where companies and professionals can come together to learn more about the various NJEDA programs developed to support the technology and biotechnology startup ecosystem. Companies have the opportunity to learn about the NJEDA programs for early stage life science companies, ranging from matching funds to loan guarantees and tax credits including the following: Angel Investor Tax Credit, Angel Match Program, NJ Entrepreneur Support, NJ Accelerate and Technology Business Tax Certificate Transfer (NOL) Program. Click here to register.

Law Signed Extending On-Site Worker Flexibility for NJEDA Tax Incentives 

The governor has signed legislation, strongly supported by NJBIA, that preserves economic development tax credits for companies that created the jobs they promised but are allowing employees to work remotely some days in hybrid work arrangements. Previously, companies participating in tax incentive programs have had to demonstrate that their workers spend at least 60% of their time on-site or risk losing their tax credits. The law lowers that on-site requirement to 40% for suburban-based employers provided they also make a payment to the New Jersey Economic Development Authority (NJEDA) that is equal to 10% of their maximum annual tax credit. 

The Projected Costs and Economic Impact of Mental Health Inequities in the United States

Article written by BioNJ Member Deloitte

Mental health inequities may not only harm individuals but also hinder economic prosperity. To gain a broader understanding of the costs associated with mental health inequities in the United States, the Deloitte Health Equity Institute and the School of Global Health at Meharry Medical College conducted an equity-focused quantitative analysis. The study examined various types of expenditures related to mental health inequities that have not been explored in detail in other literature, ranging from chronic physical ailments like diabetes and hypertension to productivity-related losses stemming from absenteeism and unemployment.

Cyrus Taraporevala Elected to Pfizer’s Board of Directors

BioNJ Member Pfizer, with a site in Peapack, announced the election of Cyrus Taraporevala to its Board of Directors. Mr. Taraporevala was also appointed to and will join the Audit Committee and Compensation Committee of Pfizer’s Board. Mr. Taraporevala served as President and Chief Executive Officer at State Street Global Advisors from 2017 until his retirement in 2022. Prior to joining State Street, he held numerous leadership roles in asset management, including at Fidelity, BNY Mellon, Legg Mason, and Citigroup. Earlier in his career, Mr. Taraporevala was a partner at McKinsey & Company, based in New York and Copenhagen. He serves on the boards of directors of Shell plc and Bridgepoint Group plc.

AbbVie Announces Appointment of Roopal Thakkar, M.D. as Executive Vice President, Research & Development and Chief Scientific Officer

BioNJ Member AbbVie, with a site in Madison, announced that Roopal Thakkar, M.D. who currently serves as Senior Vice President, Chief Medical Officer, Global Therapeutics has been appointed to the position of Executive Vice President, Research & Development and Chief Scientific Officer. In this position, Dr. Thakkar will lead the company's global R&D organization of more than 14,000 team members across all phases of discovery and development, including therapeutics and aesthetics. "I am excited to assume these new responsibilities for the R&D organization at AbbVie," said Dr. Thakkar. "Our pipeline of more than 90 drug and device programs presents a significant opportunity to ensure AbbVie's growth well into the next decade. I am confident that our outstanding R&D team will continue to deliver critical innovation and it's my privilege to lead this organization as we take on the most challenging health issues for patients."

Y-mAbs Appoints Seasoned Biopharma Executive Peter Pfreundschuh as Chief Financial Officer

BioNJ Member Y-mAbs Therapeutics, Inc., with a site in Nutley, announced the appointment of Peter Pfreundschuh as Chief Financial Officer. Y-mAbs is at a critical inflection point as we continue to gain U.S. commercial traction with DANYELZA® while simultaneously advancing the development of our differentiated Self-Assembly DisAssembly Pretargeted Radioimmunotherapy, or SADA-PRIT, technology platform,” said Mr. Rossi, President and CEO. “With Mr. Pfreundschuh on board as our new U.S.-based Chief Financial Officer, we believe we are in a strong position to make strategic decisions that will serve our mission of improving the lives of patients with cancer and other serious diseases. He brings a wealth of leadership experience across the healthcare sector with deep experience in developing and commercializing novel pharmaceutical products.”

Lexicon Board of Directors Appoints Mike Exton, Ph.D. as New Chief Executive Officer and Director

BioNJ Member Lexicon Pharmaceuticals, Inc., with a site in Bridgewater, announced that the Lexicon Board of Directors has appointed Mike Exton, Ph.D. as CEO and Director of Lexicon. Dr. Exton most recently served as the global cardiometabolic therapeutic head at Novartis. Dr. Exton’s broad experience includes fourteen years with Novartis, most recently leading the global cross functional commercial therapeutic areas of cardiovascular and metabolic disease, with key responsibilities in discovery, development, commercial launch preparation, business development, investor relations and media engagement. Prior to joining Novartis, he was director of business development with Invida Pty Ltd and spent nine years with Eli Lilly Australia, where he held a variety of research, business development and commercial positions.

Boehringer Ingelheim Produces Its Own Green Energy

Boehringer Ingelheim announced that it has inaugurated a biomass power plant at its Ingelheim site. With the new power plant, Boehringer Ingelheim is optimizing its energy supply and protecting the environment at the same time: Around 50,000 tons of CO2 are saved per year. The CO2 emissions of the site's own energy generation are reduced by 70%. In total, the company is investing EUR 205 million in sustainable infrastructure projects in Ingelheim and will be able to cover 95% of its energy requirements at the site from renewable sources in the future.

Bayer's Expert Mondays 2024

Select Mondays in March – December 2024

Calling pre-seed and seed innovators and entrepreneurs in Oncology, Cell & Gene Therapy, Cardiovascular, Immunology, Radiology and Digital Health! Do you have disruptive science but struggle to bring it to life in the entrepreneurial world? Bayer's passion is to enable and support standout healthcare innovation! Take your innovation to new heights and join Bayer´s Expert Mondays 2024, a series of knowledge exchange sessions to supercharge your start-up’s growth.