Middlemen are Often Standing Between Patients and Their Medicines

Insurance companies use pharmacy benefit managers (PBMs) to decide if medicines get covered and what people pay. Just three PBMs control 80% of the prescription drug market, and last year, they denied coverage to more than 1,150 medicines. When people are sick, they should be fighting their illness, not the middlemen.

Inflation Reduction Act’s Medicare Drug Price Negotiation Program is Unconstitutional

When it comes to the Inflation Reduction Act’s heavy-handed new authority on drug pricing, there’s one immutable fact to remember and repeat as a mantra: “Price controls equal choice controls.” The predictable outcome of pharmaceutical price controls is the significant disincentivization of the research-and-development system that makes America the world leader in medical innovation. At the heart of the debate is whether we are going to improve our health care system using smart and evolving free-market principles or go down the sound-bite-laden path of government negotiation (today) and rationing care (tomorrow).

Lilly Teams Up With the American Diabetes Association and Adam Duvall to Launch "Tap the Cap"

BioNJ Member Eli Lilly and Company is teaming up with the American Diabetes Association® (ADA) and Adam Duvall, American professional baseball player, to launch a nationwide effort to increase awareness of insulin affordability solutions for all people living with diabetes. Lilly's Tap the Cap campaign underscores how easy it is for people with diabetes to tap Lilly's monthly out-of-pocket insulin cap and access $35 insulin. Lilly will also give back to the diabetes community through contributions to local ADA summer camps. Lilly is also joined by Adam Duvall, who was diagnosed with type 1 diabetes in 2012 and is sharing his story of managing diabetes as a professional athlete. Since his diagnosis, Duvall has become an advocate for the importance of diabetes education and navigating life with the disease.

Novartis Premieres Powerful New Docuseries at Tribeca Festival to Shine a Light on Debilitating Skin Disease

East Hanover-based BioNJ Member Novartis announced the launch of a new docuseries, "The Beacons: Illuminating HS Stories," which will premiere during the 2023 Tribeca Festival in New York in recognition of Hidradenitis Suppurativa (HS) Awareness Week. The docuseries, co-produced with and hosted by HS advocate, journalist and filmmaker Jasmine IVANNA Espy, highlights the experiences of people from multiple countries living with HS. The six-part series follows Jasmine as she talks about her own experiences and has intimate discussions with five other "Beacons" of light for this underserved community – Selina and Jeremy (United States), Marion (France), Kim (United Kingdom) and Latoya (Canada). Each advocate offers a unique glimpse into life with HS, the importance of self-advocacy and the challenges of balancing symptom management with daily activities, relationships, personal passions and work.

India’s Enzene Biosciences to Open a $50M Bio-Manufacturing Plant in Hopewell

Enzene Biosciences, Ltd., a global biotech company based in Pune, India, will open a state-of-the-art biopharmaceutical manufacturing plant on the Princeton West Innovation Campus in Hopewell. Operations in the new facility, the company’s first location outside of India, are expected to begin in June 2024. As part of Enzene’s expansion plans, the company will initially hire 50 employees and grow to 300 employees at its New Jersey facility. “We are thrilled that Enzene Biosciences has chosen Princeton as the location for its new biomanufacturing facility – Enzene’s only U.S. site,” said Debbie Hart, BioNJ president and CEO. “With its extensive drug development know-how and experience, Enzene will be a valuable addition to New Jersey’s robust life sciences ecosystem – bringing innovative medicines to Patients around the world.”

Tech Trends: Woman-led SciMar ONE’s Drug Development Offering Evolves

For Donna and Mike Conroy, co-founders of SciMar ONE, the opportunities available to them in New Jersey to speed up their start-up’s progress have been game-changing — due to programs sponsored by the New Jersey Economic Development Authority; BioNJ and the Merck Digital Sciences Studio, at New Jersey Institute of Technology’s New Jersey Innovation Institute. The co-founders participated in BioNJ’s BioPartnering Conference, held in April at the Palace at Somerset Park in Somerset. There, they connected with investors for half-hour meetings, and Conroy was able to participate in a pitch competition, where she was asked to give a two-minute elevator pitch. 

PTC Therapeutics Shares Positive Interim Data from PIVOT-HD Clinical Trial in Huntington's Disease Patients

South Plainfield-based BioNJ Member PTC Therapeutics, Inc. shared interim data from the 12-week portion of the PIVOT-HD Phase 2 study of PTC518 in Huntington's disease (HD) patients. The study demonstrated dose-dependent lowering of Huntingtin (HTT) protein levels in peripheral blood cells, reaching a mean 30% reduction in mutant HTT levels at the 10mg dose level. In addition, PTC518 exposure in the cerebrospinal fluid (CSF) was consistent with or higher than plasma unbound drug levels. PTC518 treatment was also demonstrated to be well tolerated, with no treatment-related serious adverse events, no reports of peripheral neuropathy or dose-limiting toxicities. Furthermore, there were no CSF neurofilament light chain protein (NfL) treatment-related spikes, with an overall trend towards lowering of CSF NfL levels following 12 weeks of PTC518 treatment.

Genmab Showcases Data from Comprehensive Epcoritamab Development Program in Patients Across B-Cell Lymphomas at European Hematology Association (EHA) Annual Meeting 2023

Princeton-based BioNJ Member Genmab announced data from its ongoing phase 1/2 EPCORE™ NHL-2 trial investigating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in combination with rituximab-lenalidomide (R2) showed an overall response rate (ORR) of 98 percent and complete metabolic response (CMR) of 87 percent in response evaluable patients (n=104) with relapsed or refractory (R/R) follicular lymphoma (FL). Additional findings from the study observed consistent ORR and CMR across high-risk subgroups, including a 98 percent ORR and a 75 percent CMR in patients whose disease progressed within 24 months (POD24, n=40), a 95 percent ORR and 75.7 percent CMR in patients who were double refractory (refractory to both an anti-CD20 and an alkylating agent, n=37), a 100 percent ORR and 83.8 percent CMR in patients who were primary refractory (no response or relapse within six months after first-line treatment, n=37), and a 96 percent ORR and 80.9 percent CMR in patients refractory to prior anti-CD20 treatment (n=47). 

Celldex Therapeutics Presents Positive Data from Barzolvolimab Chronic Urticaria Program at EAACI 2023

Hampton-based BioNJ Member Celldex Therapeutics, Inc. presented updated data from the company’s Phase 1b multi-dose clinical trial in chronic spontaneous urticaria (CSU) and new data from the Phase 1b single-dose cholinergic cohort included in the chronic inducible urticaria (CIndU). Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival of mast cells. Data continue to support that mast cell depletion by barzolvolimab, as demonstrated by tryptase suppression, parallels symptom improvement. "We are extremely pleased with these further results which once again demonstrated strong clinical activity, rapid onset and sustained durability with a well-tolerated safety profile, including in patients who had previously taken omalizumab," said Anthony S. Marucci, President and CEO of Celldex Therapeutics. 

Hepion Pharmaceuticals Announces Passing of Key Safety Milestone in Phase 2b ‘ASCEND-NASH’ Trial of Rencofilstat

Edison-based BioNJ Member Hepion Pharmaceuticals, Inc. announced that the Data and Safety Monitoring Board has met to review the current data for the ASCEND-NASH Phase 2b trial and has issued a “study may proceed without modification” clearance. This, the first planned DSMB meeting, occurred on schedule, and all labs, EKGs, adverse events and protocol deviations were reviewed, focusing on any potential safety signals from the placebo-controlled trial. Hepion is on track to complete enrollment in ASCEND-NASH in the first quarter of 2024, and the initial subjects are now approaching the later stages of the 12-month trial. ASCEND-NASH is a Phase 2b, randomized, multi-center, double-blinded study to evaluate the safety and efficacy of rencofilstat in 336 subjects dosed for 12 months. 

Acadia Pharmaceuticals Announces Phase 3 Development Candidate ACP-101 (intranasal carbetocin) for Prader-Willi Syndrome

Princeton-based BioNJ Member Acadia Pharmaceuticals Inc. announced the addition of a new Phase 3 development candidate to its rare disease portfolio, ACP-101 (intranasal carbetocin), for the treatment of hyperphagia (a false and unrelenting state of starvation) in Prader-Willi syndrome (PWS). Acadia acquired worldwide rights to develop and commercialize ACP-101 with the acquisition of Levo Therapeutics in June 2022. Prior to Acadia’s acquisition, Levo conducted a Phase 3 multi-center, randomized, double-blind, 8-week placebo-controlled study evaluating two doses of ACP-101, 3.2 mg and 9.6 mg, versus placebo three times daily with an even randomization (1:1:1). Top-line results showed that ACP-101 was safe and well-tolerated and demonstrated nominally statistically significant efficacy at the 3.2 mg dose.

Risankizumab (SKYRIZI®) Met Primary and Key Secondary Endpoints in 52-Week Phase 3 Maintenance Study in Ulcerative Colitis Patients

BioNJ Member AbbVie, with a site in Madison, announced positive top-line results from COMMAND, its Phase 3 maintenance study, showing risankizumab (SKYRIZI®, 180 mg or 360 mg subcutaneous [SC]) achieved the primary endpoint of clinical remission (per Adapted Mayo Score) at week 52, as well as key secondary endpoints in adult patients with moderately to severely active ulcerative colitis. In the COMMAND maintenance study, patients from the Phase 2b/3 INSPIRE study who responded to induction treatment were re-randomized to receive risankizumab 180 mg SC, 360 mg SC or withdrawal from risankizumab treatment (risankizumab intravenous [IV] induction-only control group). Approximately 75% of patients previously failed at least one advanced therapy (biologics, JAK inhibitors and/or S1P receptor modulators) for ulcerative colitis.

AbbVie's VENCLYXTO®/VENCLEXTA® (venetoclax) Continues to Show Sustained Progression-Free Survival (PFS) in Chronic Lymphocytic Leukemia (CLL) Patients

BioNJ Member AbbVie, with a site in Madison, announced new findings demonstrating sustained long-term safety and efficacy of VENCLYXTO®/ VENCLEXTA® (venetoclax)-based combination therapies in patients with previously untreated CLL with co-existing conditions, as well as R/R CLL. "Results from the CLL14 and MURANO studies demonstrate the long-term benefits of fixed-duration venetoclax combinations for patients living with CLL," said Mariana Cota Stirner, M.D., Ph.D., Vice President, Hematology, AbbVie. "These results underscore our commitment to transform how blood cancers are treated today and show that venetoclax can give patients lasting results with time off treatment." New six-year follow-up results from the Phase 3 CLL14 study showcase updated outcomes in previously untreated patients with CLL and co-existing conditions. 

5 Reasons Why Sanofi is Committed to New Jersey

Stefan Roehr, Head of North America Supply Chain, Distribution and Logistics at BioNJ Member Sanofi, acknowledges that the company could have moved anywhere when it decided to leave its longtime headquarters in Bridgewater. But leaving New Jersey, the company’s North American flagship since 1971, was not in the plans, he said. Mr. Roehr offered five reasons why New Jersey still is the right fit for Sanofi.: 1) Sanofi’s history here, 2) The college connection, 3) The changing face of bio, 4) The DC to Boston corridor, and 5) The commitment of the State.

FDA Advisory Committee Unanimously Recommends Nirsevimab as First Immunization Against RSV Disease for All Infants

Bridgewater-based BioNJ Member Sanofi announced that the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously 21 to 0 that Sanofi and AstraZeneca’s nirsevimab has a favorable benefit risk profile for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. The Committee also voted 19 to 2 in support of nirsevimab’s favorable benefit risk profile for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. If approved, nirsevimab would be the first immunization specifically designed to protect all infants through their first RSV season, including those born healthy at term or preterm, or with specific health conditions that make them vulnerable to RSV disease. 

Sanofi “All In” on Artificial Intelligence and Data Science to Speed Breakthroughs for Patients

Bridgewater-based BioNJ Member Sanofi takes the next step in its company-wide digital transformation and rolls-out plai at scale. plai, Sanofi’s industry-leading app developed with artificial intelligence (AI) platform company Aily Labs, delivers real-time, reactive data interactions and gives an unprecedented 360° view across all Sanofi activities. The app aggregates available company internal data across functions and harnesses the power of AI to provide timely insights and personalized “what if” scenarios to support thousands of Sanofi teams decision makers to take informed decisions in a simple and modern digital user experience. plai is an essential enabler in the company-wide digital transformation and data democratisation journey. AI-powered tools help Sanofi teams make better and faster data-driven decisions, hence boosting productivity across the value chain: from research to clinical operations to manufacturing and supply to business analysis.

Pfizer’s TALZENNA® in Combination With XTANDI® Receives U.S. FDA Approval

BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Food and Drug Administration (FDA) has approved TALZENNA (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI (enzalutamide), for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). This approval is based on the statistically significant and clinically meaningful radiographic progression-free survival (rPFS) data from the Phase 3 TALAPRO-2 trial, which demonstrated a 55% reduction in the risk of disease progression or death in patients with mCRPC with prospectively identified HRR gene mutations (ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C) treated with TALZENNA plus XTANDI vs placebo plus XTANDI (HR 0.45; 95% CI, 0.33–0.61; p<0.0001).

Pfizer’s ABRYSVO™ Receives Recommendation for Use in Older Adults from Advisory Committee on Immunization Practices

BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend ABRYSVO™ [Respiratory Syncytial Virus (RSV) Vaccine], the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for use in adults 60 years of age and older to help protect against lower respiratory tract disease caused by RSV. Specifically, the committee voted that: 1) Adults 65 years of age and older may receive a single dose of RSV vaccine, using shared clinical decision making and 2) Individual adults aged 60-64 years may receive a single dose of RSV vaccine, using shared clinical decision making.

U.S. FDA Approves Jardiance® (empagliflozin) for the Treatment of Type 2 Diabetes in Children 10 Years and Older

BioNJ Member Eli Lilly and Company, with a site in Branchburg, and BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, announced the U.S. Food and Drug Administration (FDA) has approved Jardiance® (empagliflozin) 10 mg and 25 mg tablets to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes. Lennart Jungersten, M.D., Ph.D., Senior Vice President, Medicine & Regulatory Affairs, Boehringer Ingelheim. "This FDA approval, which is based on the efficacy results and safety data from the DINAMO trial, marks an important milestone in helping address a clear unmet need for oral treatment options, in addition to metformin, to lower A1c in this rapidly rising population."

Lilly to Acquire DICE Therapeutics to Advance Innovation in Immunology

BioNJ Member Eli Lilly and Company, with a site in Branchburg, and DICE Therapeutics, Inc. announced a definitive agreement for Lilly to acquire DICE. DICE is a biopharmaceutical company that leverages its proprietary DELSCAPE technology platform to develop novel oral therapeutic candidates, including oral IL-17 inhibitors currently in clinical development, to treat chronic diseases in immunology. “In combination with its novel technology and expertise in drug discovery, DICE's talented workforce and passion for innovation will enhance our efforts to make life better for people living with devastating autoimmune diseases," said Patrik Jonsson, Executive Vice President, President of Lilly Immunology and Lilly USA, Chief Customer Officer. "We welcome DICE colleagues to Lilly and, together, we can tackle the challenges ahead in finding new treatments for patients with significant unmet medical needs."

Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) Delivers Deep and Durable Responses in Relapsed or Refractory Follicular Lymphoma and Mantle Cell Lymphoma in TRANSCEND Clinical Trials Presented at ICML 2023

Princeton-based BioNJ Member Bristol Myers Squibb announced the first disclosure of primary analysis results from two pivotal studies, TRANSCEND FL, an open-label, global, multicenter, Phase 2, single-arm study evaluating Breyanzi (lisocabtagene maraleucel; liso-cel) in patients with relapsed or refractory follicular lymphoma (FL) and the relapsed or refractory mantle cell lymphoma (MCL) cohort of TRANSCEND NHL 001, an open-label, multicenter, Phase 1, single-arm, seamless-design study evaluating Breyanzi. TRANSCEND FL, the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma, including FL, enrolled adults with relapsed or refractory disease treated with Breyanzi in the second-line and third-line plus setting. Patients received treatment with Breyanzi at a target dose of 100 x 106 CAR-positive viable T cells.

KEYTRUDA® (pembrolizumab) Plus Trastuzumab and Chemotherapy Met Primary Endpoint of Progression-Free Survival as First-Line Treatment in Patients With HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Rahway-based BioNJ Member Merck & Co. announced that the Phase 3 KEYNOTE-811 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with trastuzumab and chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) for the first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with trastuzumab and chemotherapy demonstrated a statistically significant improvement in PFS compared to placebo in combination with trastuzumab and chemotherapy in the intention-to-treat (ITT) study population. Based on a pre-specified subgroup analysis by PD-L1 expression, the improvement in PFS observed in the ITT population was limited to patients whose tumors were PD-L1 positive (Combined Positive Score [CPS] ≥1). 

Merck to Present Data for Efinopegdutide (MK-6024), an Investigational GLP-1/Glucagon Receptor Co-agonist, in Patients With Nonalcoholic Fatty Liver Disease (NAFLD) at EASL 2023

Rahway-based BioNJ Member Merck & Co. announced new findings for efinopegdutide (MK-6024), an investigational GLP-1/glucagon receptor co-agonist. Data to be shared includes results from the Phase 2a clinical trial evaluating efinopegdutide in adult patients with nonalcoholic fatty liver disease (NAFLD). Separately, efinopegdutide was recently granted Fast Track Designation from the U.S. Food and Drug Administration (FDA) as a potential treatment for patients with nonalcoholic steatohepatitis (NASH), a more severe form of NAFLD that includes inflammation and damage to the liver. Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fulfill an unmet medical need. Currently, there are no approved therapies for NASH. 

Merck’s Ribbon-Cutting in Rahway: Celebrating the Past — While Planning for Future

The campus itself is beyond impressive: More than 100 buildings and more than 300,000 square feet of Class A research space stretched across more than 200 acres that sits in both Rahway and Linden. It even has its own volunteer fire department. But, what’s far more impressive about Merck’s global headquarters is the impact of the work that Merck has done here — and will continue to do here — moving forward. “I couldn’t be more pleased that now, for the first time in over 50 years, we’re bringing back together all of the different divisions and functions within Merck to one site,” said CEO Rob Davis. “When you think of what it takes to ideate, to innovate, to invent — it takes collaboration, it takes teamwork, it takes all of us focused on what matters most, which is putting the patients at the center of everything we do and delivering with urgency on their behalf.

Novartis to Buy Seattle-Based Clinical Stage Biopharma Company for $3.5B

East Hanover-based BioNJ Member Novartis announced that it entered an agreement to acquire Chinook Therapeutics for nearly $3.5 billion. Under the agreement, Chinook Therapeutics will merge with a newly formed subsidiary of Novartis. This merger will enable Novartis to harness the potential of Chinook’s pipeline, which includes two late-stage assets in clinical development to treat Immunoglobulin A Nephropathy, a progressive, rare kidney disease that mostly affects young adults and currently lacks targeted treatment options. This forward-thinking acquisition showcases Novartis’ dedication to advancing the field of nephrology and underscores its commitment to meeting the unmet medical needs of patients worldwide. Novartis aims to finalize the transaction in the second half of 2023, pending customary closing conditions.

SCYNEXIS Announces Achievement of First Development Milestone of $25 Million Under Exclusive License Agreement With GSK

Jersey City-based BioNJ Member SCYNEXIS, Inc. announced the achievement of a $25 million performance-based development milestone under its exclusive license agreement with GSK for ibrexafungerp. The milestone payment follows a development goal for the Phase 3 MARIO study for ibrexafungerp in invasive candidiasis as SCYNEXIS continues executing ongoing ibrexafungerp trials. More details on the MARIO trial can be found here (NCT05178862). This exclusive license agreement gives GSK rights to commercialize BREXAFEMME (ibrexafungerp tablets) for VVC and RVVC while continuing to develop ibrexafungerp, which is in phase 3 clinical trials for the potential treatment of invasive candidiasis (IC), a life-threatening fungal infection, in all countries except the greater China region and certain other countries already out-licensed by SCYNEXIS to third parties. 

U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices Votes to Recommend Arexvy for the Prevention of RSV Disease in Adults Aged 60 and Older With Shared Clinical Decision Making

Warren-based BioNJ Member GSK announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted in favour of recommending the use of Arexvy (respiratory syncytial virus vaccine, adjuvanted) in adults aged 60 and older using shared clinical decision making. Shared clinical decision making empowers patients in consultation with their healthcare providers to determine whether RSV vaccination is appropriate for them. There are an estimated 55.8 million people aged 65 and older in the U.S. who are at increased risk of RSV, a common, contagious virus that can lead to serious respiratory illness. RSV causes approximately 177,000 hospitalizations and an estimated 14,000 deaths in this age group in the U.S. each year. For adults 60 and older, data suggest an increased risk for severe RSV infection that can lead to hospitalization.

GSK Shares Positive Data for Arexvy, Its Respiratory Syncytial Virus (RSV) Older Adult Vaccine, Indicating Protection Over Two RSV Seasons

Warren-based BioNJ Member GSK announced new data from the AReSVi-006 (Adult Respiratory Syncytial Virus) Phase III trial evaluating the efficacy of a single dose of Arexvy (respiratory syncytial virus vaccine, adjuvanted) against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 60 years and older over multiple RSV seasons and after annual revaccination. The results show that one dose of the vaccine is efficacious against RSV-LRTD and severe LRTD over two full RSV seasons. A similar pattern of vaccine efficacy over two seasons was also observed in adults with underlying comorbidities and in advancing age, reinforcing the impact the vaccine could have on those most at risk of the severe outcomes of RSV.

Amarin Announces Vascepa® (Icosapent Ethyl) Approved to Reduce Cardiovascular Risk in the Kingdom of Saudi Arabia (KSA)

Bridgewater-based Amarin Corporation plc and its commercialization partner Biologix FZco announced that the Kingdom of Saudi Arabia’s (KSA) Saudi Food and Drug Authority (SFDA) has approved a new indication and label expansion for VASCEPA^® (icosapent ethyl) capsules. VASCEPA is now the first and only drug approved by SFDA as an adjunct to statin therapy in adult patients with elevated triglycerides (TG) levels (≥150 mg/dL) who are at high-risk of cardiovascular (CV) events due to established cardiovascular disease or diabetes mellitus and at least one other risk factor for cardiovascular disease. There is an urgent need to address cardiovascular disease (CVD) in KSA. Over 30 percent of adults (18 years) in KSA are at risk of a CVD event.

Eagle Pharmaceuticals Receives FDA Qualified Infectious Disease Product (QIDP) and Fast-Track Designation for CAL02, Providing Five-Year Exclusivity Extension

Woodcliff Lake-based Eagle Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation under the Generating Antibiotic Incentives Now (GAIN) Act and Fast Track Designation for CAL02, a first-in-class non-biological bacterial virulence neutralizer, anti-infective agent being developed to treat severe community-acquired bacterial pneumonia (SCABP) as an add-on therapy to standard of care. The QIDP designation was created by the GAIN Act implemented in 2012 to encourage the development of treatments for antibiotic-resistant organisms known to cause serious or life-threatening infections. Eagle believes that CAL02 could also be eligible for breakthrough therapy designation.

FDA Advisory Committee Votes Unanimously to Confirm the Clinical Benefit of LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease

Nutley-based Eisai Co., Ltd. and BioNJ Member Biogen Inc. announced that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted unanimously that the data from Eisai’s Phase 3 Clarity AD clinical trial confirms the clinical benefit of LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous use for the treatment of Alzheimer’s disease (AD). Additionally, the committee members confirmed the overall benefit-risk profile of LEQEMBI, the clinical meaningfulness of the data and discussed its use in specific subgroups, including Apolipoprotein E (ApoE) ε4 homozygote patients, patients requiring concomitant treatment with anticoagulant agents and patients with cerebral amyloid angiopathy.

Idorsia Launches QUVIVIQ (daridorexant) in Switzerland – a First-in-Class Treatment for Chronic Insomnia Disorder to Improve both Nighttime Symptoms and Daytime Functioning

Idorsia Ltd., with a site in Cherry Hill, announced that QUVIVIQ™ (daridorexant) is now available to patients in Switzerland for the treatment of adult patients with chronic insomnia characterized by symptoms present for at least three months and considerable impact on daytime functioning. Chronic insomnia is one of the most prevalent sleep disorders in Switzerland, affecting 9.2% of the working-age population, and impacts both physical and mental health. According to a recent report from the RAND Corporation, more than CHF 10 billion is lost from annual GDP in Switzerland due to reduced productivity associated with chronic insomnia. QUVIVIQ is the first dual orexin receptor antagonist (DORA) available in Switzerland for the treatment of chronic insomnia disorder. 

Calliditas Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for Full Approval of TARPEYO[®]

Hoboken-based Calliditas Therapeutics AB announced the submission of a supplemental New Drug Application (“sNDA”) to the U.S. Food and Drug Administration (“FDA”) seeking full approval of TARPEYO® (budesonide) delayed release capsules for the entire study population from the Phase 3 NeflgArd study. TARPEYO is currently approved under accelerated approval to reduce proteinuria in adults with primary IgA nephropathy (“IgAN”) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g. The sNDA submission is based on the full data set from the Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study which assessed the efficacy and safety of TARPEYO (developed under the project name Nefecon®) dosed at 16 mg once daily versus placebo on a background of optimized RASi therapy in adult patients with primary IgAN.

Agile Therapeutics Announces the Availability of Twirla® Through FPA Women’s Health

Princeton-based Agile Therapeutics, Inc. announced that Twirla will become available through FPA Women’s Health. The company expects this increased availability to positively impact growth of demand and factory sales in the non-retail channel, which grew 20% and 15% respectively from the fourth quarter 2022 to first quarter 2023. As California’s leading provider of in-clinic and telehealth women’s healthcare, FPA Women’s Health has 24 locations throughout Los Angeles County and other regions across California. “We are thrilled to be the exclusive patch dispensed within FPA’s California clinics, and we expect to tap into a significant proportion of Twirla’s target population through the FPA network,” says Chief Commercial Officer Amy Welsh, “a connection that was made with the help of our partners at Afaxys.”

Agile Therapeutics Announces New Agreement With VitaCare® Prescription Services to Improve Access to Twirla®

Princeton-based Agile Therapeutics, Inc. announced an agreement with vitaCare Prescription Services, a wholly owned subsidiary of GoodRx, to expand patient access and streamline fulfillment for Twirla (levonorgestrel ethinyl estradiol) transdermal system. VitaCare is a technology and services platform that helps patients navigate key access barriers for branded medications. “The agreement with vitaCare aligns with our strategy to utilize partnerships to efficiently grow Twirla while continuing to responsibly manage our operating expenses,” said Agile Therapeutics’ Chief Commercial Officer Amy Welsh. Agile continues to grow Twirla’s presence on telemedicine platforms, including Twentyeight Health, in addition to existing partners like Pandia Health and Nurx as more women choose telemedicine for their contraceptive needs. Twentyeight Health is a telehealth company providing affordable access and convenience for reproductive and sexual health and recently acquired the platform assets for SimpleHealth.

Acutis Biosciences Unveils State-of-the-Art Facility to Perform Integrated Biomarker and Data Analytics Services

Acutis Biosciences is pleased to announce the opening of its state-of-the-art 60,000-square-foot facility in Monmouth Junction. Acutis Biosciences combines a multi-omics biomarker profiling approach with unparalleled data integration, thereby providing pharmaceutical and biotechnology companies with the tools needed to advance clinical discovery. This unique approach builds on the expertise gained through its standard-of-care business, Acutis Diagnostics, which has processed over three million patient samples over the past seven years with turnaround times that have been consistently at the top of the industry. Acutis Biosciences has developed specialized contract research services to enable biopharmaceutical companies to create value using a holistic approach to "next-generation multi-omics." The company is rolling out the first set of genomic offerings along with immunohistochemistry assays and building out integrated analytics across DNA, RNA, protein and broader multi-omics. 

Bridgewater-Based Pharma Company Accelerates Women’s Health Portfolio With Latest Acquisition

Bridgewater-based Cosette Pharmaceuticals announced it completed its acquisition of Intrarosa from Endoceutics, a subsidiary of Endorecherche Inc. The transaction includes 108 issued and pending patents across the globe with the latest expiring in 2033, including three Orange Book listed patents. “This transformative acquisition further strengthens Cosette’s commitment to women’s health with a patent protected, novel drug formulation. In partnership with MSH Pharma Inc., Cosette will leverage its unique commercial and manufacturing capabilities to ensure continued patient access to Intrarosa. We look forward to expanding Cosette’s global footprint in new territories and with our existing distribution partners,” Apurva Saraf, CEO and President of Cosette, stated.

Cosette Acquires Rights to Women’s Health Medication

Cosette Pharmaceuticals Inc., a Bridgewater company that focuses on women’s health and cardiovascular medicines, announced it completed the acquisition of the global rights to Intrarosa from Endoceutics Inc., a subsidiary of Quebec-based Endorecherche Inc. The deal – terms of which were not disclosed – includes 108 issued and pending patents, including Orange Book listed patents, which are those the U.S. Food and Drug Administration has “approved on the basis of safety and effectiveness under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).” Intrarosa is the only prescription drug providing both estrogen and androgen for the treatment of moderate-to-severe dyspareunia (a common symptom of vulvar and vaginal atrophy [VVA] due to menopause). The drug is available in almost all major markets, including the U.S., U.K., European Union, Canada and Israel.

Rutgers Appoints New Dean to Lead School of Health Professions

Rutgers University announced that Jeffery DiGiovanni, a communications sciences and disorders scholar with extensive higher education experience, has been named Dean of the School of Health Professions (SHP) for Rutgers Biomedical and Health Sciences (RBHS). Mr. DiGiovanni comes to Rutgers having served as the acting Associate Dean of Research for the College of Allied Health Sciences at the University of Cincinnati. He also was a professor and chair of the college’s Department of Communications Sciences and Disorders. Before his tenure at Cincinnati, Mr. DiGiovanni held positions as an associate professor, interim department chair and Chief Clinical Officer at Ohio University’s College of Health Sciences and Professions. He is expected to begin his new leadership role at Rutgers in October.

Bristol Myers Squibb Children’s Hospital Named Top Children’s Hospital in U.S.

RWJBarnabas Health children’s hospitals were named among the nation’s Best Children’s Hospitals for 2023 – 2024 by U.S. News & World Report. The Bristol Myers Squibb Children’s Hospital (BMSCH) at Robert Wood Johnson University Hospital ranked #34 nationally for orthopedics and ranked #47 for urology. The Urology ranking recognizes a four-hospital practice that is based at The Bristol Myers Squibb Children’s Hospital but that also provides care at three other RWJBarnabas Health hospitals – with Children’s Hospital of New Jersey at Newark Beth Israel Medical Center, McMullen Children’s Center at Cooperman Barnabas Medical Center, and Unterberg Children’s Hospital at Monmouth Medical Center. Additionally, BMSCH was ranked #2 in NJ and #15 in the Mid-Atlantic Region.

CDI Lab Gets $2.6M Grant to Further Efforts to Combat Emerging Infections

A laboratory at the Hackensack Meridian Center for Discovery and Innovation has been awarded a $2.6 million, five-year grant to repurpose drugs to combat non-tuberculous mycobacteria, an emerging family of germs naturally found in soil and water and which can be deadly to those with compromised immune systems and preexisting lung diseases. The grant enables the laboratory of Dr. Thomas Dick, to reengineer tuberculosis drugs to work against NTM like Mycobacterium abscessus, which are TB’s biological cousins. The federal grant, from the National Institutes of Health – National Institute of Allergy and Infectious Diseases, focuses on strategically reengineering rifabutin to overcome NTM resistance. It’s the fourth major grant for the scientist and his lab supporting NTM/TB research since he moved from the National University of Singapore to the U.S. in 2017.

Bernstein Named Interim President at TCNJ

Michael Bernstein, the current provost emeritus at Stony Brook University, has been selected to serve as the interim President at The College of New Jersey. Mr. Bernstein, who will start July 1, has agreed to serve in the position for two years — during the search to find a permanent replacement for retiring President Kathryn Foster. An accomplished educator and administrator, Mr. Bernstein has been an interim president before, serving in that role at Stony Brook from August 2019 through May 2020. During that time, he guided the university through unprecedented challenges posed by the COVID-19 pandemic, including a move to fully remote instruction for a period in 2020.

Bayer Announces Moves to its U.S. Executive Team

Whippany-based Bayer announced changes to its U.S. country leadership team. Dave Tomasi will be the President, Consumer Health North America, effective July 1. Mr. Tomasi replaces Patrick Lockwood-Taylor, President, Bayer U.S., and President, Consumer Health North America, who is leaving the company to accept a role as CEO at a health and wellness company. The Bayer U.S. president will be named in the future. Guru Ramamurthy has been appointed Bayer U.S. Chief Financial Officer, effective July 1, filling an open role on the U.S. country leadership team. Additionally, Asha Hope has joined Bayer as the company’s Vice President and Head, North America Diversity, Equity & Inclusion. 

Life Sciences Start-Ups: Why ESG?

Video developed by BioNJ Member EisnerAmper

ESG, an acronym for environmental, social and governance, has become a competitive advantage for life sciences start-ups, measuring companies’ risks and vulnerabilities to external threats. Ultimately, those companies that effectively integrate ESG to manage them will achieve long-term financial gains.

ON Helix

Hosted by One Nucleus

July 6, 2023

This one-day conference will address key bio innovation trends, from developments in life sciences and technology research to their translation into new diagnostics, prevention tools or treatments. Delegates and Supporters will connect with the One Nucleus network to explore New Horizons for Bio Innovation. BioNJ Members enjoy a 10% discount. Contact RBromberg@BioNJ.org for the discount code.

2023 SAPA Healthcare Investment Forum & Roadshow

Hosted by Sino-American Pharmaceutical Professionals Association (SAPA)

July 8, 2023

As a global organization for pharmaceutical professionals, Sino-American Pharmaceutical Professionals Association (SAPA) 6th SAPA Investment Forum & Roadshow is an organizational flagship event, aiming to provide a premium platform for connecting investors and entrepreneurs and offer effective solutions and support to emerging enterprises in the healthcare industry. This in-person only event will include plenary sessions, fireside chats, healthcare innovation roadshow presentations, networking, one-to-one private partnership meetings and other development opportunities. 

Winds of Change: Dealmaking Trends in the Evolving Innovation Economy

Hosted by LES USA & Canada

October 15-18, 2023

Under the theme of Winds of Change: Dealmaking Trends in the Evolving Innovation Economy, our dynamic international IP community will meet in Chicago for two action-packed days of education, outstanding programming and networking, with global deal making opportunities.