Enjoy this recorded webinar brought to

you by the IT/Cybersecurity Committee,

"De-risking Cybersecurity for Emerging

Life Sciences Companies."

Unanswered Questions and Unintended Consequences of State Prescription Drug Affordability Boards

Since 2019, states have enacted prescription drug affordability boards (PDAB) with the asserted intention of lowering drug spending and improving affordability for patients. Variability across states and uncertainty surrounding the implementation of PDAB processes raise questions about the downstream consequences of state governments setting maximum reimbursement rates for drugs purchased in their state. The policy relevance of these questions is heightened as more states debate PDAB legislation, ongoing litigation challenges aspects of PDAB constitutionality, and states with PDABs begin ill-defined affordability review processes and rulemaking that seek to cap drug prices by limiting reimbursement for specified drugs across state-run and/or state-regulated health plans.

The Inflation Reduction Act’s Medicare Impact: Beware This Faustian Deal

The Biden administration is moving forward with a process that represents a sea change in how Medicare pays for drugs. In August 2023, the Centers for Medicare & Medicaid Services (CMS) kicked off a process in which ten medicines will go through a “negotiation” process presumably designed to lower the nation’s medicine bill. As a Preventive Cardiologist, I’m increasingly worried that these new provisions will leave a mark on seniors, and not the kind that was intended. And soon, every American will feel its effects...My first concern stems from my front-row seat to the drug development process. I know that innovation in pharmaceuticals comes from the combined efforts of scientists and pharmaceutical companies, and I’ve seen enough clinical trials to know that drug development is neither cheap nor easy. In fact, for every 10,000 compounds screened by scientists, only one makes it to FDA approval.

Op-Ed: Health Care Middlemen Don’t Benefit NJ Patients or Pharmacists

By Debbie Hart and Brian Oliveira

As featured in NJ Spotlight News

New Jersey is home to nearly 850 independent community pharmacies, which together employ over 10,000 professionals. Some 88.9% of the U.S. population lives within five miles of a community pharmacy, making local pharmacy professionals a critical source of information about patients’ health care. But these vital community institutions are becoming less and less common — in 2023, there were over 300 net closures of independent pharmacies across the country. At the same time, patients in the Garden State continue to face barriers to the medications they need to manage complex and chronic conditions.

Life Sciences Regulatory Environment in the U.S.

As featured in Global Business Reports

Ironically, incentives towards biologics provided in the IRA come at a time when the scientific potential for small molecules has never been higher: 34 of the 55 novel drugs approved by the FDA in 2023 were small molecules. The IRA however states that small molecule drugs become eligible for price negotiations four years earlier than biologics, potentially resulting in missed opportunities for significant sales revenue. Debbie Hart, president and CEO of BioNJ, explained the challenge: “One troubling aspect is the differential treatment between small and large molecules, with small molecule patent life reduced to 9 years compared to the 13-year timeframe for large molecules. The reduction from 13 to 9 years is discouraging investment in small molecule therapeutic development. Estimates from Vital Transformation suggest that numerous drugs currently available would not have reached the market under IRA policies, and as many as 139 therapies may not be developed over the next decade due to these regulations.”

Interim PIVOT-HD Results Demonstrate Evidence of Favorable CNS Biomarker and Clinical Effects at Month 12 in Huntington's Disease Patients

Warren-based BioNJ Member PTC Therapeutics, Inc shared interim results from the Phase 2 PIVOT-HD study of PTC518 in Huntington's disease (HD) patients. At Month 12, PTC518 treatment resulted in dose-dependent lowering of mutant huntingtin (mHTT) protein in the blood and cerebrospinal fluid (CSF) in the interim cohort of patients. In addition, favorable trends were demonstrated on several relevant HD clinical assessments including Total Motor Score (TMS) and Composite Unified Huntington's Disease Rating Scale (cUHDRS). Furthermore, following 12 months of treatment, PTC518 continues to be safe and well tolerated. At Month 12, durability of dose-dependent mHTT lowering in the blood was demonstrated with lowering of 22% and 43% for 5mg and 10mg dose levels, respectively.

Amicus Therapeutics Opens Global HQ in Princeton

Amicus Therapeutics cut the ribbon on a new global headquarters in Princeton. Founded by John Crowley in the early 2000s, Amicus is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases. Mr. Crowley launched the company after his children’s, Megan and Patrick, diagnosis with Pompe disease, a severe neuromuscular disorder. Amicus has two approved therapies for Fabry disease and Pompe disease, along with a portfolio of preclinical programs in rare disease. The ribbon cutting marked a major next milestone for Amicus. The company was originally based in Cranbury and then, briefly, in Philadelphia – before selecting Princeton as its global headquarters. There, the site will house more than 150 of its employees.

Soligenix Announces Positive Clinical Results from a Comparative Study Evaluating HyBryte™ Against Valchlor® in the Treatment of Cutaneous T-Cell Lymphoma

Princeton-based BioNJ Member Soligenix, Inc. announced positive clinical results from a comparability study evaluating HyBryte™ (synthetic hypericin) versus Valchlor® (mechlorethamine gel) in the treatment of cutaneous T-cell lymphoma (CTCL). The open-label study (protocol HPN-CTCL-04) enrolled 10 patients (5 patients per group) with treatment success defined as a ≥50% improvement in a patient's cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score after 12 weeks of topical treatment compared to Baseline. The study revealed that HyBryte™ treatment resulted in 60% of patients achieving a 50% or better improvement in their mCAILS score versus 20% of Valchlor® patients, with HyBryte™ having a more favorable safety profile. All subjects were enrolled by Brian Poligone, M.D., Ph.D., at the Rochester Skin Lymphoma Medical Group, Fairport, NY.

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) at the European Hematology Association 2024 Hybrid Congress. The presentation fe data from arm D of SEQUOIA evaluating BRUKINSA in combination with venetoclax in treatment-naïve (TN) patients with high-risk chronic lymphocytic leukemia (CLL) and/or small lymphocytic lymphoma (SLL) with del(17p) and/or TP53 mutation. 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.

Lilly's Tirzepatide Reduced Obstructive Sleep Apnea (OSA) Severity, With Up to 51.5% of Participants Meeting the Criteria for Disease Resolution

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced detailed results from the SURMOUNT-OSA phase 3 clinical trials evaluating tirzepatide injection (10 mg or 15 mg) for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity, with and without positive airway pressure (PAP) therapy. In both studies, tirzepatide achieved all primary and key secondary endpoints for both the efficacyⁱ and treatment-regimeniⁱ estimands and demonstrated a mean reduction of up to 62.8% on the apnea-hypopnea index (AHI), or about 30 fewer events restricting or blocking a person's airflow per hour of sleep, compared to placebo. In a key secondary endpoint, the efficacy estimand showed that 43.0% (Study 1) and 51.5% (Study 2) of participants treated with tirzepatide at the highest dose met the criteria for disease resolution.

Lilly's Tirzepatide was Superior to Placebo for MASH Resolution, and More Than Half of Patients Achieved Improvement in Fibrosis at 52 Weeks

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced detailed results from SYNERGY-NASH, a Phase 2 study of 190 patients, with or without type 2 diabetes, to evaluate the investigational use of tirzepatide in adults with biopsy-proven metabolic dysfunction-associated steatohepatitis (MASH) with stage 2 or 3 fibrosis. The efficacy estimand showed 51.8%, 62.8% and 73.3% of participants taking 5 mg, 10 mg and 15 mg, respectively, achieved an absence of MASH with no worsening of fibrosis on liver histology compared to 13.2% of participants on placebo at 52 weeks of treatment, meeting the study's primary endpoint. The data was published in The New England Journal of Medicine (NEJM).

Bristol Myers Squibb Announces U.S. FDA Accelerated Approval of KRAZATI® (adagrasib) in Combination With Cetuximab for Adult Patients With Previously Treated KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer (CRC)

Princeton-based BioNJ Member Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for KRAZATI ® (adagrasib) in combination with cetuximab as a targeted treatment option for adult patients with KRASG12C -mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) results. Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial. The approval is based on results from cohorts of the Phase 1/2 KRYSTAL-1 open-label study which evaluated KRAZATI (600 mg tablets administered orally twice daily) in combination with cetuximab in 94 patients with heavily pretreated CRC harboring a KRASG12C mutation.

European Medicines Agency Validates Bristol Myers Squibb’s Application for Subcutaneous Nivolumab

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated the extension application to introduce a new route of administration (subcutaneous use) for Opdivo ® (nivolumab) that includes a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial) across multiple previously approved adult solid tumor indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab combination therapy, or in combination with chemotherapy or cabozantinib, based on the results from the Phase 3 CheckMate -67T study. Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure.

Evotec Announces Progress in Neuroscience Collaboration With Bristol Myers Squibb

Princeton-based BioNJ Member Evotec announced that the company has reached important scientific progress within its neuroscience collaboration with BioNJ Member Bristol Myers Squibb triggering a research payment of US$ 20 m to Evotec. A target-based program progresses into late pre-clinical development, further contributing to the fast-growing and promising pipeline of discovery to clinical-stage programs in neurodegeneration that the partnership has generated. Evotec and Bristol Myers Squibb entered their strategic neuroscience collaboration in December 2016 to identify disease-modifying treatments for a broad range of neurodegenerative diseases. Currently approved drugs mainly offer short-term management of the patients' symptoms and there is a significant unmet medical need for therapeutic modalities that slow down or prevent disease progression.

FDA Accepts Eisai’s Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease

Nutley-based Eisai and BioNJ Member Biogen Inc. announced that that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: LEQEMBI®) intravenous (IV) maintenance dosing. A Prescription Drug User Fee Act (PDUFA) action date is set for January 25, 2025. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD). As part of the proposed monthly IV maintenance regimen, the patients who have completed the biweekly IV initiation phase, exact period under discussion with the FDA, would receive a monthly IV dose that maintains effective drug concentration to sustain the clearance of highly toxic protofibrils which can continue to cause neuronal injury.

Eisai Continues Contract for FY2024 Dementia Examination Project by Tokyo Bunkyo City

Nutley-based BioNJ Member Eisai Co., Ltd. announced that the company has achieved the pre-set performance indicators in FY2023 for the dementia examination project in Bunkyo City, Tokyo, which the company has been commissioned to conduct in order to raise awareness of dementia and promote early detection, and will continue the commission for this project in FY2024. The dementia examination project has been implemented since FY2021 as a priority policy of Bunkyo City, and Eisai has been commissioned for the project since its launch, providing NouKNOW and operational support for their public examinations. In FY2022, a Pay For Success (PFS) contract was introduced and targets were established for the outcome indicators of number of NouKNOW checks performed and number of participants in lifestyle improvement programs.

Tevogen Bio Confirms Ongoing Efficacy of TVGN 489, Its Investigational Allogeneic Off-the-Shelf Immunotherapy, Against Dominant FLiRT Strains of SARS-CoV-2

Warren-based BioNJ Member Tevogen announced TVGN 489, its investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes (CTLs) immunotherapy for treatment of COVID-19 in high-risk patients and Long COVID, retains activity against the currently dominant and highly mutated FLiRT strains of SARS-CoV-2 based on a review of this variant’s protein sequences. Named FLiRT to reflect amino acid changes occurring in the spike protein, these Omicron subvariants are descendent from JN.1, the previously dominant strain in the US. TVGN 489 contains Cytotoxic T lymphocytes that recognize multiple SARS-CoV-2 proteins, or peptides. TVGN 489’s peptide targets have been preserved in all previously studied COVID strains. Continuing surveillance by Tevogen Bio of SARS-CoV-2 variants show that 95% of these CTLs remain active against FLiRT variants, including KP.2, the current dominant strain.

Subcutaneous Amivantamab Biologics License Application Submitted to U.S. FDA for Patients With EGFR-Mutated Non-Small Cell Lung Cancer

Raritan-based BioNJ Member Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) for all currently approved or submitted indications of intravenous (IV) RYBREVANT® (amivantamab-vmjw) in certain patients with non-small cell lung cancer (NSCLC). Data from the Phase 3 PALOMA-3 study (NCT05388669) showed SC amivantamab had comparable overall response rates to IV administration in patients with NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletion or L858R mutations. SC amivantamab also demonstrated significantly shorter administration time and a five-fold reduction in infusion-related reactions, alongside longer overall survival, progression-free survival and duration of response.

TREMFYA® (guselkumab) Studies Underscore Its Potential to Be the Only IL-23 Inhibitor to Offer Both Subcutaneous and Intravenous Induction

New Brunswick-based BioNJ Member Johnson & Johnson announced positive topline results from the pivotal Phase 3 GRAVITI investigational study of TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adult patients with moderately to severely active Crohn’s disease. The study met both co-primary endpoints, achieving statistically significant and clinically meaningful outcomes for clinical remission at Week 12 as well as endoscopic response at Week 12. All remaining multiplicity-controlled endpoints at Week 12, Week 24 and Week 48 were statistically significant compared to placebo. GRAVITI adds to the robust results demonstrated in GALAXI 2 and GALAXI 3, the first-ever double-blind registrational head-to-head clinical trials to demonstrate superiority versus STELARA® (ustekinumab) in key endoscopic endpoints in Crohn’s disease, which together show the potential of TREMFYA® to become the only IL-23 inhibitor to offer both SC or IV induction options. 

Johnson & Johnson Submits Application to U.S. FDA Seeking Approval of TREMFYA® (guselkumab) for the Treatment of Moderately to Severely Active Crohn’s Disease

New Brunswick-based BioNJ Member Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active Crohn’s disease. This marks the second submission to the FDA for TREMFYA® in inflammatory bowel disease this year following an application in March for moderately to severely active ulcerative colitis. The latest submission includes results from the Phase 3 GALAXI program. The GALAXI 2 and GALAXI 3 studies were the first-ever double-blind registrational head-to-head trials to demonstrate superiority versus ustekinumab in Crohn’s disease. TREMFYA®successfully met the co-primary endpoints for both SC maintenance doses (200 mg every 4 weeks [q4w] and 100 mg every 8 weeks [q8w]) compared to placebo in each individual study and demonstrated superiority to ustekinumab in multiplicity-controlled endoscopic endpoints based on data pooled from both studies.

J&J Completes Acquisition of Proteologix, Inc.

New Brunswick-based BioNJ Member Johnson & Johnson has successfully completed the acquisition of Proteologix, Inc., a privately-held biotechnology company focused on bispecific antibodies for immune-mediated diseases, for $850 million in cash with potential for an additional milestone payment. “We look forward to continuing the development of PX-128 and PX-130 alongside the Proteologix team as they join J&J,” said David Lee, Global Immunology Therapeutic Area Head, Johnson & Johnson Innovative Medicine. “These two bispecific antibodies have the potential to become best in disease therapeutics for people living with moderate to severe atopic dermatitis (AD) and asthma by targeting multiple disease-driving pathways. We are thrilled to start integrating them into our industry leading Immunology portfolio.”

Otsuka and Lundbeck Announce FDA Acceptance of sNDA Filing for Brexpiprazole in Combination With Sertraline for the Treatment of Adults With Post-Traumatic Stress Disorder (PTSD)

Princeton-based BioNJ Member Otsuka Pharmaceutical, Co. Ltd. and H. Lundbeck A/S announce the U.S. Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) is sufficiently complete to permit a substantive review. The sNDA submission is based on data from three randomized clinical trials evaluating the safety and efficacy of brexpiprazole in combination with sertraline in adult patients with PTSD.  The primary endpoint for all three trials was the change from randomization (Week 1) to Week 10 in the Clinician-Administered PTSD Scale (CAPS-5) total score for brexpiprazole and sertraline combination therapy versus sertraline plus placebo in patients diagnosed with PTSD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

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. These are the first data generated from Gilead’s landmark PURPOSE program, which is the most comprehensive and diverse HIV prevention trial program ever conducted.

U.S. FDA Approves CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults

Rahway-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for: 1) Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older; 2) Active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older. CAPVAXIVE is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease (IPD) cases.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Carboplatin and Paclitaxel as Treatment for Adult Patients With Primary Advanced or Recurrent Endometrial Carcinoma

Rahway-based BioNJ Member Merck & Co. announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. This approval marks the third endometrial carcinoma indication and the 40th indication overall for KEYTRUDA in the U.S. The approval is based on data from the Phase 3 NRG-GY018 trial, also known as KEYNOTE-868, in which KEYTRUDA plus carboplatin and paclitaxel followed by KEYTRUDA alone reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.46-0.78]; p<0.0001) in patients whose cancer was mismatch repair proficient (pMMR) and by 70% (HR=0.30 [95% CI, 0.19-0.48]; p<0.0001) in patients whose cancer was mismatch repair deficient (dMMR), compared to placebo with carboplatin and paclitaxel followed by placebo alone.

USDA Approves Merck Animal Health’s NOBIVAC® NXT Canine Flu H3N2 – The First and Only RNA-Particle Technology Vaccine for Canine Influenza

Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Rahway-based BioNJ Member Merck & Co., announced today the U.S. Department of Agriculture (USDA) approval of NOBIVAC® NXT Canine Flu H3N2, a next-level solution to help safeguard dogs against the ongoing threat of canine influenza. The product is expected to be available at veterinary clinics and hospitals nationwide late this summer. Merck Animal Health has a long-standing commitment to discovering and developing innovative preventive medicines that support veterinary healthcare teams and improve the lives of pets. NOBIVAC NXT is a revolutionary, first-of-its-kind vaccine technology for companion animals that leverages RNA-particle technology, allowing for a precise immune response to protect against a wide range of viral and bacterial pathogens.

U.S. FDA Approves SKYRIZI® (risankizumab-rzaa) for Ulcerative Colitis, Expanding AbbVie's Portfolio Across Inflammatory Bowel Disease

BioNJ Member AbbVie, with a site in Madison, announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis, making it the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn's disease. SKYRIZI is now approved for four indications across immune-mediated inflammatory diseases. With over 1 million people living with ulcerative colitis, the United States has one of the largest populations affected by this disease and the numbers are continuing to rise. Ulcerative colitis is a form of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining. Patients often experience a range of unpredictable symptoms that impact their daily lives, such as abdominal pain, bloody stool and urgency to use the bathroom.

AbbVie Announces Positive Topline Results from Phase 2 PICCOLO Trial Evaluating Mirvetuximab Soravtansine (ELAHERE®) for High Folate Receptor-Alpha (FRα) Expressing Platinum-Sensitive Ovarian Cancer

BioNJ Member AbbVie, with a site in Madison, announced positive topline results from the Phase 2 PICCOLO trial evaluating investigational mirvetuximab soravtansine (ELAHERE®) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC). The study met its primary endpoint with an objective response rate (ORR) of 51.9% (95%CI 40.4 – 63.3%). In addition, the median duration of response (DOR), a key secondary endpoint, was 8.25 months. "Significant unmet needs remain for patients with platinum sensitive disease, as each subsequent line of therapy in this setting is associated with decreased efficacy and tolerability, which reinforces the need for treatment alternatives for these patients," said Angeles Alvarez Secord, M.D., M.H.Sc., from the Duke Cancer Institute. "The PICCOLO data further support the potential of mirvetuximab soravtansine for platinum-sensitive ovarian cancer patients."

AbbVie Acquires Celsius Therapeutics

BioNJ Member AbbVie, with a site in Madison, announed the acquisition of Celsius Therapeutics, Inc., a privately held biotechnology company pioneering new therapies for patients with inflammatory disease. Celsius' lead investigational asset is CEL383, a potential first-in-class anti-TREM1 antibody that has completed a Phase 1 clinical study for the treatment of IBD. TREM1 has been identified as a key disease driver gene in IBD, where it is expressed on inflammatory monocytes and neutrophils. In these cell types and others, TREM1 is upstream of multiple known inflammatory pathways and acts as an amplifier of inflammation. "Given the potential relevance of TREM1 as a key driver of inflammation and pathology in IBD and other conditions, we are eager to advance the development of CEL383 with a goal of helping more patients with IBD achieve remission," said Kori Wallace, M.D., Ph.D., Vice President, Global Head of Immunology Clinical Development, AbbVie.

AbbVie and FutureGen Announce License Agreement to Develop Next-Generation Therapy for Inflammatory Bowel Disease

BioNJ Member AbbVie, with a site in Madison, and FutureGen Biopharmaceutical announced a license agreement to develop FG-M701, a next generation TL1A antibody for the treatment of IBD currently in preclinical development. FG-M701 is a fully human monoclonal antibody targeting TL1A, a clinically validated target in IBD. FG-M701 is uniquely engineered with potential best-in-class functional characteristics compared to first-generation TL1A antibodies with the goal to drive greater efficacy and less frequent dosing as a therapy for IBD. "The prevalence of IBD continues to increase, and many people living with ulcerative colitis and Crohn's disease do not respond to current therapies," said Jonathon Sedgwick, Ph.D., Senior Vice President and Global Head of Discovery Research, AbbVie.

Sanofi and Biovac Spearhead Polio Vaccine Manufacturing Capabilities in Africa

Bridgewater-based BioNJ Member Sanofi and Biovac announce their local manufacturing partnership to produce inactivated polio vaccines (IPV) in Africa. This agreement is designed to enable regional manufacturing of polio vaccines to serve the potential needs of over 40 African countries. This partnership with Sanofi makes Biovac the first African producer of IPV on and for the African continent and supports the Africa Centers for Disease Control and Prevention’s ambition to have 60 percent of local vaccines produced in Africa by 2040. Sanofi has been a critical partner of the Global Polio Eradication Initiative since 1988 and has supplied the world and UNICEF with more than 1.5 billion doses of IPV through GAVI, the Vaccine Alliance, which aims to vaccinate the populations of more than 70 of the poorest countries on the planet with the aim to eradicate polio.

Sarclisa is First Anti-CD38 to Significantly Improve Progression-Free Survival in Combination With VRd for Newly Diagnosed Transplant-Ineligible Multiple Myeloma in Phase 3

Data from the Bridgewater-based BioNJ Member Sanofi’s IMROZ Phase 3 study demonstrated Sarclisa (isatuximab) in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) followed by Sarclisa-Rd (the IMROZ regimen) significantly reduced the risk of disease progression or death by 40%, compared to VRd followed by Rd in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant. IMROZ is the first global Phase 3 study of an anti-CD38 monoclonal antibody in combination with standard-of-care VRd to significantly improve PFS and show deep responses in this patient population who often have poor prognoses. The use of Sarclisa in combination with VRd in transplant-ineligible NDMM is investigational and has not been fully evaluated by any regulatory authority.

Mitsubishi Tanabe Pharma America Presents New Results of RADICAVA® (edaravone) for People Living With ALS at the European Network to Cure ALS (ENCALS) Meeting 2024

Jersey City-based BioNJ Member Mitsubishi Tanabe Pharma America, Inc. announced results from two studies of RADICAVA® (edaravone) for amyotrophic lateral sclerosis (ALS). Findings from an ongoing real-world study utilizing information in the ALS/MND Natural History Study Consortium (Consortium) database of people living with ALS initiating treatment with RADICAVA suggest an additional survival benefit of 3.2 months with RADICAVA ± riluzole compared to treatment with riluzole alone. Separately, positive results from Study MT-1186-A03 (NCT04577404), a Phase 3 study evaluating the long-term safety of RADICAVA ORS® (edaravone), showed no new safety concerns and that RADICAVA ORS was well-tolerated during the 96-week study period. Restricted mean survival time (RMST) analyses over 50 months suggested a survival benefit for individuals receiving RADICAVA ± riluzole (31.1 months) versus those receiving riluzole only (28.8 months), without adjustment for baseline covariates.

Mitsubishi Tanabe Pharma America Celebrates Second Anniversary of RADICAVA ORS® (edaravone) Launch in the U.S.

Jersey City-based BioNJ Member Mitsubishi Tanabe Pharma America, Inc. announced the two-year launch anniversary of RADICAVA ORS® (edaravone) in the U.S. Since its availability in June 2022, RADICAVA ORS has been used to treat over 9,600 people living with amyotrophic lateral sclerosis (ALS). To date, more than 2,400 U.S. healthcare providers (HCPs) have prescribed RADICAVA ORS and/or RADICAVA to one or more of their patients, and 82% of people who started RADICAVA ORS treatment in the 20-month period between June 1, 2022 and March 22, 2024 have continued treatment for three months or more. RADICAVA ORS and RADICAVA are widely distributed by specialty pharmacies across the U.S. and in Puerto Rico.

Teva Announces Launch of Authorized Generic of Victoza® (liraglutide injection 1.8mg), in the United States

Parsippany-based BioNJ Member Teva Pharmaceuticals, Inc. announced the launch of an authorized generic of Victoza®1 (liraglutide injection 1.8mg), in the United States. “By launching an authorized generic for Victoza® (liraglutide injection 1.8mg), we are providing patients with type 2 diabetes another option for this important treatment,” said Ernie Richardsen, SVP, Head of U.S. Commercial Generics at Teva. Generic Victoza® is the first-ever generic GLP-1 and supports increased demand for this category of therapies in the U.S. market. Liraglutide injection is indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus and reduce the risk of cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.

Novo Nordisk A/S: Mim8 Demonstrated Superior Reductions in Annualised Bleeding rate (ABR) Compared to On-demand and Prior Prophylaxis Treatment in People With Haemophilia A

Plainsboro-based BioNJ Member Novo Nordisk announced results from the phase 3 FRONTIER2 trial of 254 adults and adolescents aged 12 years and over with haemophilia A, with and without inhibitors. The trial assessed both once-weekly and once-monthly prophylactic treatment (regular treatment to prevent prolonged and spontaneous bleeding) with the investigational treatment Mim8. “The FRONTIER2 efficacy and safety data is very encouraging,” said Martin Holst Lange, Executive Vice President of Development at Novo Nordisk. “With Mim8, we have the potential of offering a substantial proportion of patients the prospect of zero bleeds and convenient dosing flexibility to fit their lifestyles and needs. We look forward to discussing these data with regulatory authorities.”

Jemperli (dostarlimab) Plus Chemotherapy Application Accepted for Review by the European Medicines Agency to Expand Use to All Patients With Primary Advanced or Recurrent Endometrial Cancer

Warren-based BioNJ Member GSK plc announced the European Medicines Agency (EMA) has accepted its application to expand the use of Jemperli (dostarlimab) in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) to all adult patients with primary advanced or recurrent endometrial cancer. The EMA’s Committee for Medicinal Products for Human Use will begin the formal review process to make a recommendation to the European Commission, with approval expected in H1 2025. Currently, in the EU, Jemperli in combination with carboplatin and paclitaxel is approved for the treatment of adult patients who are candidates for systemic therapy with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).

GSK’s Omjjara (momelotinib) Approved in Japan for Treatment of Myelofibrosis

Warren-based BioNJ Member GSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Omjjara (momelotinib) for the treatment of myelofibrosis. Omjjara is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. The approval is based on data from the pivotal Phase III MOMENTUM and SIMPLIFY-1 trials. This is the fourth major regulatory approval for GSK’s momelotinib in the treatment of myelofibrosis, following approval under the brand name Ojjaara from the US Food and Drug Administration and authorizations under the brand name Omjjara from the European Commission and the Medicines and Healthcare products Regulatory Agency in the UK. Myelofibrosis is a blood cancer that affects approximately 1 in 500,000 people worldwide, with up to 5,000 patients impacted in Japan.

U.S. FDA Approves Expanded Age Indication for GSK’s Arexvy, the First Respiratory Syncytial Virus (RSV) Vaccine for Adults Aged 50-59 at Increased Risk

Warren-based BioNJ Member GSK announced that the U.S. Food and Drug Administration (FDA) has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk. In the US, the vaccine is currently approved for use in adults aged 60 and older and recommended by CDC/ACIP using shared clinical decision-making. A systematic review of studies in the US showed that RSV is estimated to cause 42,000 hospitalisations each year in adults aged 50-64 years old. Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk for severe consequences from an RSV infection compared to those without these conditions.

GSK Accelerates Oligonucleotide Platform and Pipeline Medicines With Acquisition of Elsie Biotechnologies

Warren-based BioNJ Member GSK announced that it has acquired Elsie Biotechnologies, a private biotechnology company dedicated to unlocking the full potential of oligonucleotide therapeutics, for up to $50 million (approximately £39 million). Oligonucleotides have a unique ability to modulate gene expression, making them an attractive modality to address a significant proportion of therapeutic targets that are not amenable to traditional small molecules or biologics. This acquisition allows GSK to integrate Elsie’s oligonucleotide discovery, synthesis, and delivery technologies to enhance GSK’s platform R&D capabilities. This follows a successful research collaboration with Elsie, announced in July 2023, in which GSK was able to explore and validate the technology. Data generated with the Elsie platform, combined with GSK’s expertise in the use of artificial intelligence and machine learning, will support the development of predictive models for future oligonucleotide design.

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].

Kevzara® (sarilumab) Approved by FDA for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, and Bridgewater-based BioNJ Member Sanofi announced that the U.S. Food and Drug Administration has approved Kevzara® (sarilumab) for the treatment of patients weighing 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA), a form of arthritis that impacts multiple joints at a time. “Polyarticular juvenile idiopathic arthritis can be a painful disease for children where multiple joints are impacted by this chronic inflammation,” said George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President and Chief Scientific Officer at Regeneron. "Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment. The approval of Kevzara in polyarticular juvenile idiopathic arthritis provides these vulnerable patients and their families a new FDA-approved treatment option to help navigate this disease.”

Helsinn Group and Chugai Pharma Europe Sign a Partnership Agreement Renewal to Commercialize AKYNZEO® in the UK and Ireland

Iselin-based BioNJ Member Helsinn Group and BioNJ Member Chugai Pharmaceutical Co, with a site in Berkeley Heights, announced the signing of the Distribution and License Agreement renewal in the United Kingdom of Great Britain and Northern Ireland, and the Republic of Ireland, for AKYNZEO® (combination of netupitant-palonosetron), for the treatment of chemotherapy-induced nausea and vomiting (CINV) in adult patients. Troy Robinson, Managing Director at Chugai Pharma Europe, said, “We are delighted to have signed this agreement with Helsinn and are proud to continue this collaboration. Our joint efforts with Helsinn will ensure that we continue to support patients in the UK and Ireland throughout their cancer journey, providing access to AKYNZEO®, a valuable supportive care product.”

Cellares Enters into Agreement With Biopharma Kite

BioNJ Member Cellares announced an agreement with Kite to evaluate its automated manufacturing platform, the Cell Shuttle. Earlier this year, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing opened a Smart Factory in Bridgewater. Under the agreement, Kite will assess the Cell Shuttle’s viability as a future manufacturing option using data generated during this proof-of-concept evaluation. Cellares CEO and co-founder Fabian Gerlinghaus said his organization is honored to work with an industry leader like Kite. He noted the company’s work serving patients worldwide with two commercially approved cell therapies. “This agreement with Kite allows the unique capabilities of our Cell Shuttle platform to be potentially utilized by Kite in the future and reinforces Cellares’ position as a cell therapy manufacturer with advanced automated technology,” said Gerlinghaus.

U.S. News Names 8 NJ Companies Among ‘Best’ for Employees

U.S. News & World Report released its second annual Best Companies to Work For list, which highlights publicly traded companies across the U.S. that “best meet employee needs.” The rankings cover 24 industries and are further broken down into four regions. Eight New Jersey-based companies – including one that only recently relocated its headquarters – were named among the best in the nation, while 14 firms made the cut for the Northeast. To determine the results, U.S. News and its expert panel analyzed publicly available employee sentiment as well as factors such as quality of pay and benefits, work-life balance and flexibility, job and company stability, physical and psychological comfort, belongingness and esteem and career opportunities and professional development. Congratulations to these BioNJ Members for making the list: Bristol Myers Squibb, Merck & Co., Organon and PTC Therapeutics

ProBio is Expanding Manufacturing Capabilities in Hopewell, Making State-of-the-Art Facility its North American Hub

ProBio Inc., a contract development and manufacturing organization, announced the expansion of its plasmid DNA and viral vector manufacturing capabilities with the opening of a new state-of-the-art facility in Hopewell. The facility will serve as the hub for North American operations, significantly enhancing ProBio’s capability to support the manufacturing of life-changing cell and gene therapies in North America. Spanning approximately 128,000 square feet, the Hopewell facility encompasses office, laboratory and manufacturing spaces outfitted with the latest equipment and technology for process development and current good manufacturing practice production of plasmid DNA and viral vectors, including adeno-associated virus, lentivirus and retrovirus. This site supports tech transfer, method and analytical development, process development, drug substance, drug product manufacturing for both clinical and commercial-grade plasmid DNA and viral vector-based therapies.

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).

BrainStorm Cell Therapeutics Reaches Alignment With FDA on CMC Aspects of Phase 3b NurOwn® Clinical Trial

BrainStorm Cell Therapeutics Inc., with a site in Hackensack, announced it has reached alignment with the U.S. Food and Drug Administration (FDA) on the Chemistry, Manufacturing, and Controls (CMC) aspects of Brainstorm's Phase 3b clinical trial for NurOwn®, its investigational therapy for amyotrophic lateral sclerosis (ALS). This Type C meeting builds upon the positive momentum established in April 2024, when the FDA granted BrainStorm a Special Protocol Assessment (SPA) agreement for its NurOwn Phase 3b trial. The SPA agreement provided clarity on the design and endpoints of the trial, significantly de-risking the regulatory aspects of the program.

Cranbury Pharmaceuticals Receives FDA Approval for First Generic Version of Emflaza Oral Suspension

Cranbury Pharmaceuticals, a wholly owned subsidiary of Tris Pharma headquartered in Monmouth Junction, announced the U.S. Food and Drug Administration (FDA) approved the Abbreviated New Drug Application (ANDA) for the first generic version of Emflaza® oral suspension (deflazacort) for the treatment of Duchenne muscular dystrophy (DMD). The generic deflazacort oral suspension is now available to patients in the United States. Deflazacort oral suspension is indicated to treat DMD in patients five years of age and older. DMD is a rare genetic disorder characterized by progressive muscle degeneration and weakness. The disease primarily affects boys, with symptom onset in early childhood. DMD occurs in approximately 1 in 5,000 live male births, and it is estimated that about 20,000 children are diagnosed with DMD globally each year.

Lexicon Pharmaceuticals Resubmits Sotagliflozin NDA for Type 1 Diabetes

Lexicon Pharmaceuticals, Inc., with a site in Bridgewater, announced that, following multiple interactions with and recent feedback from the U.S. Food and Drug Administration (FDA), it has resubmitted its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in people with type 1 diabetes and chronic kidney disease (CKD). “We are confident in the benefit/risk profile of sotagliflozin for people with type 1 diabetes and CKD, and our team has been resolute in identifying and pursuing a regulatory path forward,” said Lonnel Coats, Director and CEO. “We are now one step closer to bringing this important potential therapy to market for the many people who suffer from type 1 diabetes and CKD, and who could benefit from an adjunct to insulin therapy for glycemic control.”

Agile Therapeutics Inc. Announces Definitive Merger Agreement With Insud Pharma, S.L.

Princeton-based Agile Therapeutics, Inc. announced that it has entered into a definitive merger agreement with Insud Pharma, S.L. a global pharmaceutical group based in Spain with a 45 year track record and a presence in over 50 countries, pursuant to which Insud, through its U.S. subsidiary, Exeltis Project, Inc., will acquire Agile for $1.52 per share in cash net of assumed liabilities and estimated transaction costs for an approximate total enterprise value of $45 million. “We started Agile with the goal of improving women’s health through innovative, clinically differentiated products for women,” said Agile Chairperson and Chief Executive Officer Al Altomari. “We are proud of what we have been able to accomplish with our small, dedicated team: gaining approval of Twirla, the only low dose combined hormonal contraceptive patch, and developing a targeted commercial platform that allowed us to accelerate the growth of Twirla while reducing and managing our operating expenses.”

Lilly Collaborates With OpenAI to Discover Novel Medicines to Treat Drug-Resistant Bacteria

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced a collaboration with OpenAI that will allow Lilly to leverage OpenAI's generative AI to invent novel antimicrobials to treat drug-resistant pathogens. Antimicrobial resistance (AMR) is one of the top public health and development threats across the global health landscape. "Our collaboration with OpenAI represents a groundbreaking step forward in the fight against the growing but overlooked threat of antimicrobial resistance," said Diogo Rau, executive vice president and chief information and digital officer at Lilly. "Generative AI opens a new opportunity to accelerate the discovery of novel antimicrobials and the development of custom, purpose-built technologies in the battle against drug-resistant pathogens. This partnership underscores our commitment to addressing significant health challenges experienced by people around the world."

DePuy Synthes Receives 510(k) FDA Clearance of the VELYS™ Robotic-Assisted Solution for Use in Unicompartmental Knee Arthroplasty Procedures

Johnson & Johnson MedTech announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson, has received 510(k) FDA clearance for the clinical application of the VELYS™ Robotic-Assisted Solution in Unicompartmental Knee Arthroplasty (UKA). The expanded indication builds upon the VELYS Robotic-Assisted Solution platform used in Total Knee Arthroplasty (TKA), which has been cleared for use in 20 markets and utilized in over 55,000 procedures, equipping surgeons with the information needed to help preserve the soft tissue envelope, predict joint stability and work toward returning knee function. The UKA application is designed for both medial and lateral procedures and will enable surgeons to guide precise implant placement without a CT scan.

Johnson & Johnson MedTech Announces the Polyphonic™ Digital Ecosystem for a More Connected Surgical Experience

New Brunswick-based BioNJ Member Johnson & Johnson MedTech unveiled Polyphonic™, the open and secure digital ecosystem for a more connected surgical experience. The ecosystem features software applications that are agnostic to data sources and focused on delivering insights when and where they matter most, with future releases offering an open and secure development platform and marketplace for curated digital solutions. The first release, available now for select hospitals, features Polyphonic Solutions applications for surgical video, telepresence and planning to help surgeons and surgical teams increase collaboration within an integrated, user-focused solution purpose-built for healthcare.

Over $9 Billion in Economic Impact Credited to NJEDA’s North Brunswick Incubator

The New Jersey Economic Development Authority (NJEDA) released findings from the NJ Bioscience Center Incubator (BCI) IMPACT Study, a report seeking to understand and quantify the economic impacts of the incubator and the companies it has hosted and nurtured. The results found that BCI has been a vital resource for New Jersey’s life sciences sector and has had a positive impact on the state’s overall economy in terms of job creation, tax revenue, and total economic output. The Incubator at North Brunswick is part of the 50-acre research park known as the New Jersey Bioscience Center, located on Route 1. The Incubator offers lab space starting at 900 square feet up to 1,300 square feet, conference rooms, loading docks, glass washing, autoclaves, and private offices. The space creates an environment for entrepreneurs to collaborate and develop a natural synergy.

NJIT and Princeton University Earn Top Rating in Money’s 2024 Analysis of the Best Colleges in America

New Jersey Institute of Technology and Princeton University earned top ratings in Money’s 2024 analysis of the Best Colleges in America, released Wednesday. With five stars, NJIT and Princeton tied as the highest-rated university in New Jersey and matched STEM schools like Massachusetts Institute of Technology, Georgia Institute of Technology and California Institute of Technology. With a focus on above-average graduation rates, Money scored colleges in three areas: quality, affordability and future earning potential. These data points take into account important factors like Money’s unique calculation of the net price of a degree, average borrowing rates, median earnings and four “value add” calculations measuring a school’s actual performance against its predicted performance based on its student body.

Princeton Review Ranks NJIT No. 23 in the U.S. for Best Value

New Jersey Institute of Technology’s value proposition has grown in the eyes of The Princeton Review. The university ranks No. 23 nationally among public schools on the review’s list of Top 50 Best Value Colleges for 2024 — up 12 places from last year. At the same time, NJIT remains No. 11 among public schools on the Top 20 Best Career Placement list. Big picture, NJIT is one of just 209 public and private institutions that Princeton Review recognized as Best Value Colleges this year. Those schools emerged from a longer list of 650 that the review considered. It’s the seventh straight year that NJIT has made the cut.

$6.3M Endowed Directorship at Rutgers Cancer Institute Recognizes Visionary Oncology Leader

The Rutgers University board of governors recently approved the establishment of the William Hait Endowed Directorship at Rutgers Cancer Institute, which was made possible by $6.3 million raised in donations. Moving forward, the director of Rutgers Cancer Institute will be known as the William Hait Director. Recognized for his visionary leadership in the field of cancer research and patient care, Dr. William “Bill” Hait is the Executive Vice President, Chief External Innovation and Medical Officer at Johnson & Johnson as well as the founding director of Rutgers Cancer Institute. During his 14-year tenure as director, he earned the institute the prestigious National Cancer Institute designation in 1997 — the first and only in New Jersey. He also led the center to achieve Comprehensive Cancer Center designation from the NCI in 2002, in a record amount of time.

Hackensack Meridian School of Medicine Graduates Class of 2024

One hundred and two students from Hackensack Meridian School of Medicine have received their medical degrees – and are now poised to start their medical careers in residencies at top programs across the country. The medical students came from the 2020 cohort of the medical school (75 students) who graduated after four years; and also the 2021 cohort (27 students), who completed their education in three years. Since graduating the inaugural class of 18 doctors in 2021, the school’s classes have grown annually alongside admissions, and this is the first time the graduate total for one class has been over 100. “The Hackensack Meridian School of Medicine was founded upon great ambition and ideals,” said Robert C. Garrett, FACHE, CEO of Hackensack Meridian Health. “Under its able leadership, it is changing the way that doctors are training – and what medicine can ultimately be.”

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.

NJEDA Launches a $35 Million Grant Program to Help Companies Reassign Their New Jersey-Resident Employees to Enhance Their Quality of Life

In an effort to incentivize businesses to reassign New Jersey residents who are working in another state to a New Jersey location, the New Jersey Economic Development Authority board approved the creation of a new program that will provide grants to companies to come back to the Garden State. The $35 million New Jersey Reassigning In-State Employees, or NJ RISE, Program hopes to help firms relocate their New Jersey-resident employees and help redirect tax revenue to New Jersey by ensuring that residents’ income taxes stay in state. The NJ RISE Program is a pilot program that will provide grants to businesses principally located out of state that reassign New Jersey residents currently assigned to work in a state that employs the “convenience of employer” income taxation rule to work in a New Jersey location.

Bristol Myers Squibb Elects Michael R. McMullen to Board of Directors

Princeton-based BioNJ Member Bristol Myers Squibb announced that its Board of Directors has elected independent director Michael R. McMullen to the Board, effective July 1, 2024. Mr. McMullen will serve as a member of the Audit Committee of the Board of Directors. “We are pleased to welcome Mr. Michael McMullen to our Board of Directors,” said Christopher Boerner, Ph.D., board chair and chief executive officer, Bristol Myers Squibb. “Mike's extensive experience in managing large businesses and global operations, combined with his proven track record of delivering excellent shareholder returns, will prove valuable as we continue to strengthen the company’s long-term growth profile, progress our pipeline and prioritize opportunities where we see the highest return for our patients and shareholders.”

Audrey Duval Derveloy Appointed Global Head of Corporate Affairs, Member of Sanofi’s Executive Committee

Audrey Duval Derveloy, a seasoned healthcare industry leader and Sanofi France’s President, has been named Executive Vice President, Global Head of Corporate Affairs. Ms. Duval Derveloy will become a member of Sanofi’s Executive Committee, reporting into CEO Paul Hudson, and will be based in Paris. In her new role, Ms. Duval Derveloy will be responsible for BioNJ Member Sanofi’s stakeholder engagement globally, and oversee the company’s corporate social responsibility strategy, not-for-profit Global Health Unit and Sanofi’s philanthropic arm, Foundation S. Ms. Duval Derveloy retains her role as President, Sanofi France, and will continue supporting and coordinating Sanofi’s representation to its various external stakeholders in this country.

AbbVie Appoints Roxanne S. Austin as Lead Independent Director of the Board of Directors

BioNJ Member AbbVie, with a site in Madison, announced that the independent directors of the board have selected Roxanne S. Austin as Lead Independent Director, effective July 1, 2024. Ms. Austin succeeds Glenn F. Tilton, who has served as lead independent director since 2013. Mr. Tilton will continue to serve on the AbbVie Board as an independent director. Ms. Austin is President of Austin Investment Advisors, a private investment and consulting firm. She chaired the U.S. Mid-market Investment Advisory Committee of EQT Partners from 2017 to 2023. Previously, Ms. Austin also served as the president and chief executive officer of Move Networks, Inc., a provider of Internet television services.

BrainStorm Cell Therapeutics Announces Appointment of Haro Hartounian Ph.D. as Chief Operating Officer

BrainStorm Cell Therapeutics Inc., with a site in Hackensack, announced the appointment of Hartoun Hartounian Ph.D. as its new EVP and COO, effective as of June 24, 2024. Dr. Hartounian brings a distinguished track record with over 32 years of experience in the biopharmaceutical industry, with a focus on cell and gene therapy. His career highlights include founding and leading BioCentriq, a state-of-the-art cell and gene therapy CDMO facility, which was successfully acquired for $73 million in 2022. Dr. Hartounian founded and managed the growth of four biotechnology companies. He has a track record of achieving aggressive goals at large pharmaceutical, contract development and manufacturing organizations, as well as at start-up biotechnology companies.In his new role, Dr. Hartounian will oversee all operational aspects of BrainStorm Cell Therapeutics, including CMC and commercialization. 

3 NJ Health Care Companies Bring on New CEOs

Three New Jersey health care companies kicked off June by welcoming new chief executive officers. Bridgewater-based skin health company Advantice Health announced that longtime Johnson & Johnson Executive Duda Kertesz was appointed CEO. Bringing decades of consumer goods experience to the role, Ms. Kertesz most recently served as President, U.S. Skin Health & Beauty, for New Brunswick-based J&J. Another Bridgewater-headquartered firm, Amarin Corp. announced that Patrick Holt resigned as President and CEO. The pharmaceutical company’s board appointed Aaron Berg to take the reins. Mr. Berg joined Amarin in November 2012. Technology company Health Recovery Solutions also turned to its own executive team for its next CEO. Jason Comer has been with the Hoboken-based firm for seven years, beginning in an advisory capacity and working his way up to his most recent position as President.

Decentralization = Innovation: The Case Against Reinstating Government Management of Federally-Funded Tech

June 27 – Webinar

The Bayh-Dole Coalition will host a webinar to discuss how the Bayh-Dole Act’s decentralization of patent licensing facilitated a technological and economic revolution — and how a recent Biden administration proposal imperils this system. Prior to the Bayh-Dole Act, the government retained any patents resulting from taxpayer-funded research. And it licensed fewer than 5% of them for further research and development. The Bayh-Dole Act gave universities, non-profit research institutions, and startups the ability to retain and license their own patents. Thanks to this decentralization of the licensing process, and the incentives created by the law, roughly 60% of federally funded patents are now licensed for additional development.

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.