What’s Really Happening When it Comes to Prescription Drug Costs

New data show how robust competition continues to keep national spending on life-saving medicines in check, even as new innovative treatments reach patients. According to the latest report by the health care data analytics experts at IQVIA: Net prices for brand medicines increased by an average of just 1.0% in 2021, below the rate of inflation for the fifth year in a row. Looking ahead, brand medicine net prices for brand medicines are expected to remain flat or decline through 2026. Rebates, discounts, and other payments from manufacturers reduced the list price of brand medicines by 49% on average in 2021. 

U.S. Food and Drug Administration Approves Camzyos™ (mavacamten) for the Treatment of Adults With Symptomatic New York Heart Association Class II-III Obstructive Hypertrophic Cardiomyopathy (HCM) to Improve Functional Capacity and Symptoms

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Camzyos™ (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms. Camzyos is the first and only FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of obstructive HCM. “This is a first-in-class medicine specifically for patients living with symptomatic obstructive HCM,” said Milind Desai, M.D., Director of the Hypertrophic Cardiomyopathy Center and Director of Clinical Operations in Cleveland Clinic’s Heart Vascular & Thoracic Institute. 

SCYNEXIS Presents Data Analyses Showing Ibrexafungerp’s Potential to Fight Invasive Candidiasis and Candidemia, Including Infections Caused by Candida Auris, During the 32nd Annual European Congress of Clinical Microbiology & Infectious Diseases

Jersey City-based BioNJ Member SCYNEXIS announced several poster presentations highlighting details from interim analyses of data from its ongoing Phase 3 FURI and CARES studies investigating the potential of ibrexafungerp as a treatment for invasive candidiasis (IC) and candidemia, including infections caused by Candida auris (C. auris). “We are excited to share these latest data with the medical community as we advance our hospital clinical programs in invasive candidiasis, including candidemia,” said David Angulo, M.D. Chief Medical Officer of SCYNEXIS. “There is great unmet need for additional therapies to fight these infections, which can be quite serious, especially if the pathogen is resistant to current therapies, as can be the case with C. auris. We are proud to be a part of this important research.”

SCYNEXIS Announces Closing of $45 Million Public Offering of Common Stock, Pre-Funded Warrants and Warrants

Jersey City-based BioNJ Member SCYNEXIS announced the closing of its previously announced underwritten public offering of common stock, pre-funded warrants and warrants. The shares and warrants were sold at a public offering price of $3.00 per share and accompanying warrants, and the pre-funded warrants were sold at a public offering price of $2.999 per pre-funded warrant and accompanying warrants. The total gross offering proceeds to SCYNEXIS from this offering were $45.0 million, before deducting the underwriting discount and other estimated offering expenses and excluding the exercise of any pre-funded warrants or warrants. All of the shares of common stock, pre-funded warrants and warrants were offered by SCYNEXIS.

Starton Therapeutics Doses First Subjects in Phase 1 Clinical Trial of STAR-LLD Continuous Delivery Lenalidomide

Paramus-based BioNJ Member Starton Therapeutics announced that it has dosed the first subjects in a first-in-human Phase 1 STAR-LLD clinical trial of its investigational continuous delivery lenalidomide, in healthy subjects. The STAR-LLD Phase 1 trial is being conducted in Groningen, the Netherlands and will enroll 16 healthy human subjects. The objective of the study is to assess and compare the pharmacokinetics of a 24-hour continuous subcutaneous infusion of lenalidomide versus lenalidomide oral capsules at three escalating infusion rates and reference oral doses. The study seeks to validate the safety required for selecting the dose for the upcoming Phase 1b/2 clinical study in multiple myeloma.

Caladrius Biosciences and Cend Therapeutics Announce Definitive Merger Agreement

Basking Ridge-based BioNJ Member Caladrius Biosciences and Cend Therapeutics announced that the companies have entered into a definitive merger agreement under which Cend will merge with a wholly owned subsidiary of Caladrius in an all-stock approximate “merger of equals” transaction unanimously approved by the Boards of Directors of each company. Following closing, the combined company will be renamed Lisata Therapeutics, Inc. (“Lisata”) and will trade on the Nasdaq under the ticker symbol “LSTA”. Following the closing of the merger, Lisata is expected to advance CEND-1 as its lead product candidate in a variety of difficult to treat solid tumor applications, including pancreatic ductal adenocarcinoma (PDAC), where the product is being evaluated in ongoing Phase 1 and Phase 2 clinical studies with Cend and its partner in China, Qilu Pharmaceutical. 

Lilly's Tirzepatide Delivered up to 22.5% Weight Loss in Adults With Obesity or Overweight in SURMOUNT-1

Tirzepatide achieved superior weight loss compared to placebo at 72 weeks of treatment in topline results from Bridgewater-based BioNJ Member Eli Lilly and Company's SURMOUNT-1 clinical trial, with participants losing up to 22.5% (52 lb. or 24 kg) of their body weight for the efficacy estimand. This study enrolled 2,539 participants and was the first phase 3 global registration trial evaluating the efficacy and safety of tirzepatide in adults with obesity, or overweight with at least one comorbidity, who do not have diabetes. Tirzepatide met both co-primary endpoints of superior mean percent change in body weight from baseline and greater percentage of participants achieving body weight reductions of at least 5% compared to placebo for both estimands. The study also achieved all key secondary endpoints at 72 weeks.

Nevakar Injectables Receives U.S. FDA Approval of Ready-to-Use Ephedrine Injection in a Prefilled Syringe

Bridgewater-based BioNJ Member Nevakar Injectables announced that the U.S. Food and Drug Administration (“FDA”) has approved its ready-to-use Ephedrine Sulfate Injection (“Ephedrine”) in a prefilled syringe (“PFS”). This product is an ephedrine formulation prediluted to a 5mg/mL concentration and supplied in a ready-to use 5mL PFS. It will be marketed and sold in the U.S. by the Par Sterile Products (“Par”) business of Endo International plc (“Endo”). Ephedrine is a widely used injectable vasopressor agent indicated for the treatment of clinically important hypotension occurring during surgery. Last month, Nevakar announced the launch of its ready-to-use ephedrine prediluted vial. With the added approval of the ephedrine prefilled syringe, Nevakar and Endo aim to offer a portfolio of ephedrine products to health care professionals treating patients in the surgical setting.

Nevakar Injectables Sells Six Development-Stage, Ready-to-Use Injectable Product Candidates to Endo Ventures Limited

Bridgewater-based BioNJ Member Nevakar announced that it has entered into an asset sale agreement with Endo Ventures Limited, a subsidiary of Endo International plc (“Endo”), for the sale of six of its differentiated, sterile injectable product candidates, which are currently in various stages of early development. Under the terms of the agreement, Nevakar transferred all rights and responsibilities for these product candidates to Endo in exchange for an upfront payment of $35 million. In 2018, under an exclusive licensing agreement, Nevakar licensed five sterile injectable products to Endo that are in various stages of development and commercialization.

Legend Biotech Achieves Milestone Under Collaboration Agreement With Janssen Biotech, Inc. for BCMA CAR-T

Somerset-based BioNJ Member Legend Biotech announced the achievement of a $50 million milestone under its collaboration agreement with Janssen Biotech, Inc. for ciltacabtagene autoleucel (cilta-cel), now marketed in the United States under the brand name CARVYKTI^TM. Cilta-cel is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy. Legend Biotech entered into the agreement with Janssen to develop, manufacture and commercialize cilta-cel for the treatment of multiple myeloma. Under the agreement, Legend Biotech received an upfront payment of $350 million and is entitled to receive additional payments upon achievement of landmarks for development, production performance, regulatory and sales. 

Phathom Pharmaceuticals Announces FDA Approval of VOQUEZNA™ TRIPLE PAK™ (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA™ DUAL PAK™ (vonoprazan, amoxicillin) for the Treatment of H. pylori Infection in Adults

Florham Park-based Phathom Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approved both VOQUEZNA™ TRIPLE PAK™ (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA™ DUAL PAK™ (vonoprazan tablets, amoxicillin capsules), for the treatment of Helicobacter pylori (H. pylori) infection in adults. VOQUEZNA treatment regimens contain antibiotics conveniently packaged with vonoprazan, a novel potassium-competitive acid blocker (PCAB) and the first innovative acid suppressant from a new drug class approved in the U.S. in over 30 years. The two New Drug Applications for these products were given priority review designation by the FDA and previously granted as qualified infectious disease products (QIDP). Helicobacter pylori is a bacterial pathogen estimated to affect nearly 115 million people in the U.S., and over the last few decades, eradication rates have dropped to below 80%.

Agile Therapeutics Announces Findings of First-Year Post-Marketing Pharmacovigilance in ACOG Poster Presentation

Princeton-based BioNJ Member Agile Therapeutics, Inc. publicly released the findings of its first year of post-marketing pharmacovigilance safety surveillance for Twirla® (levonorgestrel and ethinyl estradiol) transdermal system (LNG/EE TDS). The contraceptive transdermal delivery system was approved by the U.S. Food and Drug Administration (“FDA”) in February 2020 as a method of contraception for use in women of reproductive potential with a body mass index (BMI) < 30 kg/m2. Approval of LNG/EE TDS was based on the SECURE study, which demonstrated safety in a large diverse group of women in a clinical trial setting. The current assessment provides an update of LNG/EE TDS safety based on real-world post-marketing adverse event reporting.

Gamida Cell Announces FDA Clearance of IND and Removal of Clinical Hold for NK Cell Therapy Candidate GDA-201

BioNJ Member Gamida Cell Ltd. announced that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application and removed the clinical hold for a cryopreserved formulation of GDA-201. GDA-201 is an off-the-shelf cell therapy candidate for the treatment of patients with follicular and diffuse large B cell lymphomas. Gamida Cell expects to initiate a company-sponsored Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022. GDA-201 leverages Gamida Cell’s proprietary NAM technology platform to expand the number and functionality of NK cells to direct tumor cell killing properties and antibody-dependent cellular cytotoxicity (ADCC). In an investigator-sponsored Phase 1/2 study in patients with relapsed or refractory lymphoma, treatment with the fresh formulation of GDA-201 with rituximab demonstrated significant clinical activity.

Gamida Cell Announces Results of New Health Economic and Outcome Study Reporting Improved Health Equity and Health Outcomes With Omidubicel at 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings

BioNJ Member Gamida Cell Ltd. announced the results of a new study demonstrating the potential impact of access to omidubicel on health disparities in allogeneic hematopoietic stem cell transplant. The study leveraged a decision-tree model to project allo-HCT access and clinical outcomes in a hypothetical population of 10,000 allo-HCT–eligible patients in the U.S. with hematologic malignancies without an available match-related donor. The study concluded that broad use of omidubicel will extend access for allo-HCT-eligible patients, decrease time to transplant and improve clinical outcomes, notably among racial and ethnic groups with worse status quo outcomes. Projected increases in one-year overall survival ranged (with 20% omidubicel use among allo-HCT–eligible patients) from 2.5% for whites patients to 6.3% for Black patients.

Veklury® (Remdesivir) is First and Only Approved Treatment for Pediatric Patients Under 12 Years of Age With COVID-19

Morris Plains-based BioNJ Member Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Veklury® (remdesivir) for the treatment of pediatric patients who are older than 28 days, weighing at least 3 kg, and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death. This approval follows the recent sNDA approval for Veklury for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19. Under the expanded indication, a three-day Veklury treatment regimen is recommended to help prevent hospitalization in non-hospitalized COVID-19 pediatric patients who are at high risk for COVID-19 disease progression. 

Gilead and Dragonfly Announce Strategic Research Collaboration to Develop Natural Killer Cell Engagers in Oncology and Inflammation

Morris Plains-based BioNJ Member Gilead Sciences and Dragonfly Therapeutics announced a collaboration designed to advance a number of Dragonfly's novel natural killer (NK) cell engager-based immunotherapies for oncology and inflammation indications. NK cell engagers represent a novel mechanism with the potential to address a broad range of cancers, including potential for activity in checkpoint resistant and refractory tumors, as well as other disease areas such as inflammation. Under the agreement, Gilead will receive an exclusive, worldwide license from Dragonfly for the 5T4-targeting investigational immunotherapy program, DF7001. The agreement also grants Gilead options, after the completion of certain preclinical activities, to license exclusive, worldwide rights to develop and commercialize additional NK cell engager programs using the Dragonfly Tri-specific NK Engager (TriNKET™) platform. 

RINVOQ® (upadacitinib) Approved by U.S. FDA as an Oral Treatment for Adults With Active Ankylosing Spondylitis

Madison-based BioNJ Member AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib; 15 mg, once daily) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. The FDA approval in AS is supported by efficacy and safety data from the Phase 3 SELECT-AXIS 2 clinical trial (Study 1) evaluating RINVOQ in patients who had an inadequate response or intolerance to one or two biologic disease-modifying anti-rheumatic drugs (bDMARDs) and the Phase 2/3 SELECT-AXIS 1 clinical trial evaluating RINVOQ in patients who were naïve to bDMARDs and had an inadequate response or intolerance to at least two nonsteroidal anti-inflammatory drugs (NSAIDs).

Helsinn Signs Exclusive License Agreement with Juniper Biologics for Infigratinib (INN) for the Emerging Markets

Iselin-based BioNJ Member Helsinn Therapeutics, Inc. and Juniper Biologics Pte Ltd announced the signing of an exclusive license agreement to develop and commercialise infigratinib (INN) in Australia, New Zealand, Southeast Asia and certain markets in the Middle East and Africa (see full list below) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement. In 2021 infigratinib obtained accelerated approval from the U.S. Food and Drug Administration (FDA) under the brand name “TRUSELTIQ”® for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate

BioNJ Member Pfizer, with offices in Peapack, and Valneva SE reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15. Based on these new results, Valneva and Pfizer plan to proceed with inclusion of pediatric participants in their planned Phase 3 trial. The Phase 2 trial, VLA15-221, is the first clinical study with VLA15 which enrolled a pediatric population (5-17 years old). It compared the immunogenicity and safety of VLA15 after administration of two (at months 0 and 6) or three (at months 0, 2 and 6) primary series doses in groups aged 5-11, 12-17 and 18-65 years. 

Pfizer and BioNTech Submit Application for U.S. Emergency Use Authorization for a COVID-19 Vaccine Booster Dose in Children 5 Through 11 Years of Age

BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as children ages 5 through <12). The submission included data from the Phase 2/3 clinical trial in children ages 5 through 11 years who received a booster dose approximately 6 months after the second dose of the Pfizer-BioNTech COVID-19 Vaccine 10-µg two-dose primary series, which was authorized under EUA for this age group in October 2021. 

Pfizer and Biohaven’s VYDURA® (Rimegepant) Granted First Ever Marketing Authorization by European Commission for Both Acute Treatment of Migraine and Prophylaxis of Episodic Migraine

BioNJ Member Pfizer, with offices in Peapack, and Biohaven Pharmaceutical Holding Company announced that the European Commission (EC) has granted marketing authorization for VYDURA® (rimegepant), a calcitonin gene-related peptide (CGRP) receptor antagonist for both the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month. VYDURA®, an orally disintegrating tablet, is the first medicine approved for both acute and prophylactic treatment of migraine in the European Union (EU). Migraine is a leading cause of disability worldwide with approximately one in ten people living with the condition in Europe alone. 

Pfizer to Open First U.S. Sites in Phase 3 Trial of Investigational Gene Therapy for Ambulatory Patients With Duchenne Muscular Dystrophy

BioNJ Member Pfizer, with offices in Peapack, announced plans to open the first U.S. sites in the Phase 3 study evaluating the investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy (DMD). This announcement follows a notification from the U.S. Food and Drug Administration (FDA) that the agency has lifted its clinical hold on the Investigational New Drug (IND) application for fordadistrogene movaparvovec and that Pfizer has addressed the agency’s requests related to the potency assay. The global Phase 3 study, CIFFREO, has been ongoing in 11 countries and was paused to implement a protocol amendment following a fatal serious adverse event that occurred in a Phase 1b study in the non-ambulatory cohort. 

Pfizer Shares Top-Line Results from Phase 2/3 EPIC-PEP Study of PAXLOVID™ for Post-Exposure Prophylactic Use

BioNJ Member Pfizer, with offices in Peapack, shared top-line results from the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study evaluating PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for post-exposure prophylactic use. In this trial, compared to placebo, Pfizer observed risk reductions of 32% and 37% in adults who received PAXLOVID for five and ten days, respectively, to prevent infection. These results, however, were not statistically significant and, as such, the primary endpoint of reducing the risk of confirmed and symptomatic COVID-19 infection in adults who had been exposed to the virus through a household contact was not met. 

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Neoadjuvant Treatment, Then Continued as Adjuvant Monotherapy After Surgery for Locally Advanced, or High-Risk Early Stage Triple-Negative Breast Cancer (TNBC)

Kenilworth-based BioNJ Member Merck & Co. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced, or early stage triple-negative breast cancer (TNBC) at high risk of recurrence. The CHMP’s recommendation was based on results from the pivotal KEYNOTE-522 trial, which was the first Phase 3 study with an immunotherapy to show positive event-free survival (EFS) results in high-risk early stage TNBC.

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy, With or Without Bevacizumab, for Patients With Persistent, Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1 (CPS ≥1)

Kenilworth-based BioNJ Member Merck & Co. announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). This approval is based on results from the Phase 3 KEYNOTE-826 trial, in which KEYTRUDA plus chemotherapy with or without bevacizumab (the KEYTRUDA regimen) demonstrated a statistically significant improvement in overall survival (OS) (HR=0.64 [95% CI, 0.50-0.81]; p=0.0001) and progression-free survival (PFS) (HR=0.62 [95% CI, 0.50-0.77]; p<0.0001) compared to chemotherapy with or without bevacizumab in this patient population. 

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With Microsatellite Instability-High (MSI-H) or Deficient Mismatch Repair (dMMR) Tumors in Five Different Types of Cancer

Kenilworth-based BioNJ Member Merck & Co. announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumors in adults with unresectable or metastatic colorectal cancer after previous fluoropyrimidine-based combination therapy; advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation; unresectable or metastatic gastric, small intestine or biliary cancer, who have disease progression on or following at least one prior therapy. This is the second approval for KEYTRUDA in Europe based on the MSI-H/dMMR biomarker. KEYTRUDA is also approved for the first-line treatment of metastatic MSI-H or dMMR colorectal cancer in adults.

Novartis Receives Positive CHMP Opinion for Tabrecta® for Patients With Metex14 Advanced Non-Small Cell Lung Cancer

East Hanover-based BioNJ Member Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion and recommended granting marketing authorization of Tabrecta® (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. The CHMP opinion is based on results from the Phase II GEOMETRY mono-1 trial that demonstrated positive overall response rates (ORR) among adult patients with advanced NSCLC whose tumors had alterations leading to METex14 skipping.

Novartis Receives European Commission Approval for Jakavi® to be the First Post-Steroid Treatment for Acute and Chronic Graft-Versus-Host Disease

East Hanover-based BioNJ Member Novartis announced the European Commission (EC) has approved Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic GvHD who have inadequate response to corticosteroids or other systemic therapies. The approval of Jakavi follows the positive opinion granted in March by the Committee for Medicinal Products for Human Use of the European Medicines Agency, based on the Phase III REACH2 and REACH3 trials in which Jakavi demonstrated superiority in overall response rate (ORR) compared to best available therapy (BAT). Results of REACH2 showed 62% ORR with Jakavi at Day 28, compared to 39% for BAT; and REACH3 demonstrated a significantly improved ORR at week 24 (50% vs. 26%) with a higher best ORR (76% vs. 60%) vs. BAT, among steroid-refractory/dependent chronic GvHD patients.

Novartis Tislelizumab Plus Chemotherapy Significantly Improved Overall Survival as First-Line Treatment for Advanced Esophageal Cancer in Phase III Study

East Hanover-based BioNJ Member Novartis announced positive topline results from an interim analysis of the Phase III RATIONALE 306 study, which showed anti-PD-1 immune checkpoint inhibitor tislelizumab plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy in patients with previously untreated unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), regardless of PD-L1 expression. Novartis intends to submit these data to regulatory authorities and will collaborate with BeiGene to present them at an upcoming medical meeting. SCC is the most common type of esophageal cancer globally, with an estimated 604,000 new cases and 544,000 deaths from esophageal cancer internationally in 2020.

BeiGene Breaks Ground on New Manufacturing and Clinical R&D Center at the Princeton West Innovation Campus in New Jersey

Beigene announced the groundbreaking of its flagship U.S. manufacturing and clinical R&D center at the Princeton West Innovation Campus in Hopewell, N.J. The initial phase of construction is expected to include approximately 400,000 square feet of dedicated commercial-stage biologic pharmaceutical manufacturing space, with capacity for up to 16,000 liters of biologics formula. BeiGene intends to recruit hundreds of new hires from the area’s attractive talent market to support its continued growth and its commitment to producing life-saving oncology medicines. “The Princeton-Hopewell area is an excellent location for BeiGene and the thriving life science community, with a deep talent pool as we continue to advance our pipeline of innovative cancer medicines and work to diversify our global supply chain,” said John Oyler, Co-Founder, Chairman and CEO of BeiGene.

Global Phase 3 Trial of BeiGene’s PD-1 Inhibitor, Tislelizumab, in Combination With Chemotherapy Meets Primary Endpoint in First-Line Advanced Esophageal Squamous Cell Carcinoma

Hopewell-based Beigene announced the Independent Data Monitoring Committee (IDMC) determined at a pre-planned interim analysis that RATIONALE 306, a global Phase 3 trial of tislelizumab in combination with chemotherapy, had met the study’s primary endpoint of overall survival (OS) in patients with previously untreated advanced or metastatic esophageal squamous cell carcinoma (ESCC). The safety and tolerability profile for tislelizumab in combination with chemotherapy at this interim analysis was consistent with previous trials and no new safety signals were identified. Tislelizumab is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for advanced or metastatic ESCC after prior chemotherapy.

BeiGene Announces the Approval in China of BLINCYTO® (Blinatumomab) for Injection for Pediatric Patients With Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)

Hopewell-based Beigene announced that the China National Medical Products Administration (NMPA) has granted conditional approval of BLINCYTO® (blinatumomab) for injection for the treatment of pediatric patients with relapsed or refractory (R/R) CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). The NMPA granted conditional approval for adult patients in this indication in December 2020. Developed by BioNJ Member Amgen and licensed to BeiGene in China under a strategic collaboration commenced in 2020, this is the second approval for BLINCYTO in China. The pediatric Supplemental Biologic License Application (sBLA) was submitted by BeiGene. BLINCYTO for injection for the treatment of adult patients with R/R CD19-positive B-cell precursor ALL was approved conditionally based on ex-China data and interim analysis results of the Phase 3 clinical trial of adult patients in China (NCT03476239). 

BeiGene Announces BRUKINSA (zanubrutinib) Approval in Uruguay in Mantle Cell Lymphoma, Marginal Zone Lymphoma, and Waldenström’s Macroglobulinemia

Hopewell-based Beigene announced that the BTK inhibitor BRUKINSA (zanubrutinib) has been approved in Uruguay for the treatment of adult patients with previously treated mantle cell lymphoma (MCL), relapsed or refractory marginal zone lymphoma (MZL), and Waldenström’s macroglobulinemia (WM). BeiGene and Adium entered into an exclusive distribution agreement for Adium to commercialize BRUKINSA in Latin America. BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. 

Long-Term Health Outcomes Using Simulation Model of Investigational Lecanemab in Patients With Early Alzheimer’s Disease Published in a Peer-Reviewed Journal, Neurology and Therapy

Nutley-based Eisai announced an article about long-term health outcomes of its investigational anti-amyloid-beta (Aβ) protofibril antibody lecanemab in people living with early Alzheimer’s disease (AD) using simulation modeling was published in a peer reviewed journal Neurology and Therapy. In this simulation, lecanemab treatment is estimated to potentially slow the rate of disease progression, maintaining treated patients for a longer duration in earlier stages of mild cognitive impairment (MCI) due to AD and mild AD (collectively, early AD). The article describes the comparison of the long-term clinical outcomes for the people living with early AD who have amyloid pathology with standard of care (SoC) alone, and with lecanemab with SoC (lecanemab+SoC), using the disease simulation model (AD ACE model) based on the results of a Phase IIb clinical trial (Study 201) evaluating the efficacy and safety of lecanemab. SoC data were estimated from ADNI (Alzheimer's Disease Neuroimaging Initiative) study results. 

BD Forms Sustainable Medical Technology Institute to Reduce the Environmental Impact of its Product Portfolio

Franklin Lakes-based Becton, Dickinson and Company announced the formation of the Sustainable Medical Technology Institute, a model of practice within the organization that will bring together BD researchers and engineers, as well as quality, regulatory, policy and operational expertise, to focus on reducing the environmental impact of the company's product portfolio in three areas, including adopting sustainable product design strategies, developing and deploying sustainable sterilization technologies, and addressing materials of concern (MOC). The Institute will serve as an example of how the company continues to advance the world of health by prioritizing high-quality, safe products for patients, while furthering its environmental, social and governance (ESG) strategy.

CytoSorbents Awarded Preferred Supplier Agreement With One of the Largest Private Hospital Operators in Germany

Monmouth Junction-based CytoSorbents Corp. was recently awarded a new preferred supplier agreement for CytoSorb with the Asklepios Group, one of the largest private hospital operators in Germany. The three-year preferred supplier agreement will make CytoSorb available without restrictions to all of the approximate 170 health care facilities across 14 states throughout Germany that Asklepios operates. This includes Asklepios Klinik St. Georg in Hamburg, Germany, which pioneered the use of CytoSorb to remove antithrombotic drugs during cardiothoracic surgery and is well-known for its seminal publication on CytoSorb use for this application during emergency cardiac surgery in patients at high risk of bleeding.

OncoSec Appoints Dr. Robert Arch as President and Chief Executive Officer

Pennington-based BioNJ Member OncoSec Medical announced the appointment of Robert H. Arch, Ph.D., as President and Chief Executive Officer. Dr. Arch was previously Head of Research at Elpiscience Biopharma, Ltd., and Head of the Liver Disease Department at China Novartis Institutes for BioMedical Research. Dr. Arch’s leadership roles have been focused on shaping strong teams and building diversified R&D pipelines with innovative assets, from ideas to late-stage clinical development programs. His career over 28 years extends from academia to the pharmaceutical industry, including positions at Novartis, Takeda, GlaxoSmithKline and Pfizer. Dr. Arch’s expertise in basic research and drug development includes chronic liver disease, cancer, immuno-oncology, respiratory disease and inflammatory disorders.  

Phathom Pharmaceuticals Appoints Frank Karbe to its Board of Directors

Florham Park-based BioNJ Member Phathom Pharmaceuticals announced the appointment of Frank Karbe to its Board of Directors. Mr. Karbe, who most recently served as President and Chief Financial Officer of Myovant Sciences, Inc., brings over twenty-five years of financial and life sciences expertise to Phathom. As President and Chief Financial Officer of Myovant, Mr. Karbe led the company’s efforts to raise approximately $2 billion in capital and its evolution from a private start-up organization to a publicly listed commercial-stage company with two approved and marketed products. Prior to Myovant, Mr. Karbe served as Executive Vice President and Chief Financial Officer at Exelixis, Inc., where he drove the biopharma company’s transformation from discovery to commercialization.

NJBIZ Announces 2022 Leaders in Law Honorees

NJBIZ is proud to reveal the 2022 Leaders in Law honorees. The honorees were chosen by a panel of independent judges with experience in the justice system. The selections were based on legal professionals — lawyers and general counsels — whose dedication to their occupation and to their communities is outstanding. Congratulations to BioNJ Members Ann Gavzy, Hackensack Meridian Health; Joseph Lubertazzi, McCarter & English LLP; Sherilyn Pastor, McCarter & English LLP; Linda Pissott Reig, Buchanan Ingersoll & Rooney; Kenneth Rosen, Lowenstein Sandler LLP; and Deirdre Wheatley-Liss, Porzio, Bromberg & Newman PC for being named to the list.

32 Women to Be Honored at EWNJ’s ‘Salute to the Policy Makers’ Gala

Thirty-two top female leaders will be honored by Executive Women of New Jersey at the “Salute to the Policy Makers” gala. The gala, being held in commemoration of EWNJ’s 40-year anniversary, will honor the legacy of the organization and celebrate the contributions of high-achieving New Jersey women leaders from the private and the public sectors. Congratulations to these BioNJ Members for making the list: Erin Abreu, Deloitte; Miri Forster, Eisner Advisory Group; Adrienne Gonzales, Bristol Myers Squibb Company; Catie Hall, PwC; Natalya Johnson, Johnson & Johnson; Lisa Presser, Faegre Drinker Biddle & Reath LLP; Ramona Romero, Princeton University; Dr. Oya Tukel, New Jersey Institute of Technology; and Jessica Viotto, PNC Bank.

Governor Phil Murphy, Choose New Jersey and NJCU Sign Memorandums of Understanding With Ireland’s Top Tech Universities and Incubators

Governor Phil Murphy alongside Newark-based BioNJ Member Choose New Jersey President & CEO Wesley Mathews celebrated the signing of three Memorandums of Understanding (MOU) between New Jersey academic and real estate entities with top Irish tech universities and a prominent start-up accelerator. The MOUs aim to create mutually beneficial opportunities and forge collaboration in innovative projects that foster entrepreneurship, business development, career development and international education. New Jersey City University (NJCU) was the only four-year New Jersey higher educational institution as part of these historical discussions and partnerships, as leaders from NJCU’s School of Business and Guarini Institute for International Education and Economic Mobility joined the delegation of Governor Murphy and Choose New Jersey’s Mathews on a trip which will continue to expand NJCU’s international footprint.

Princeton Partners With UNCF and HBCUs to Expand Research and Innovation

In the initial phase, Princeton researchers and researchers from Howard University, Jackson State University (JSU), Prairie View A&M University (PVAMU), Spelman College and the University of Maryland Eastern Shore (UMES) will co-lead research projects. These projects will be funded by Princeton University through its new Princeton Alliance for Collaborative Research and Innovation (PACRI). Teams of Princeton-HBCU researchers are invited to submit proposals by June 30. The initiative’s aim is to fund multiple collaborative projects each year between Princeton and each partnering institution. “Collaboration is a powerful force for new ideas and creativity in research and scholarship,” said Princeton’s Dean for Research Pablo Debenedetti, the Class of 1950 Professor in Engineering and Applied Science and professor of chemical and biological engineering. 

Princeton Review’s Best Value Colleges 2022 names 5 from N.J.

The Princeton Review published its list of Best Value Colleges for 2022, with Princeton University ranking No. 1 on its list of Top 50 Private Best Value Colleges overall. The College of New Jersey, Drew University, New Jersey Institute of Technology and Stevens Institute of Technology were among the 209 schools honored on the alphabetical list, of which nine are tuition-free. The 2022 list was based on the Review’s survey of more than 650 institutions during the 2020-21 school year and names the public and private colleges that have earned the education services company’s highest Return on Investment rating — a score the company tallies using more than 40 data points. 

NJIT Receives $800K PSEG Grant to Expand STEM Career Pathways

The New Jersey Institute of Technology has received an $800,000 PSEG Foundation grant that will soon expand access to STEM degrees and careers for local Newark residents, first-generation students, and those from historically underrepresented communities in the STEM fields. The five-year grant includes support for new need-based scholarships and research funding for local and underrepresented undergraduate students. It also promises support for vital STEM initiatives and college-prep programs for local elementary, middle school and high school students, offered through the university’s Center for Pre-College Programs (CPCP). CPCP currently offers STEM programs and services to more than 3,000 local elementary and secondary school students each year.

Rutgers Scientists Develop PCR COVID Test That Can Identify Variants

Scientists at Rutgers University have developed a lab test that can identify variants of the virus causing COVID-19. The PCR, or polymerase chain reaction, test is expected to greatly assist health officials in tracking the disease, as well as physicians treating patients infected with the coronavirus. The test utilizes “molecular beacon” technology, seeking out molecules that carry genetic information to make proteins, Rutgers said. The technique was co-invented by Sanjay Tyagi, one of the paper’s authors and a professor of medicine at the Public Health Research Institute of Rutgers New Jersey Medical School. Rutgers scientists hope to share the technology with other labs and testing companies, making variant information readily available.

New Chief of Bone Marrow Transplant and Cellular Therapies Names to New Jersey's Only NCI-Designated Comprehensive Cancer Center

Rutgers Cancer Institute of New Jersey and RWJBarnabas Health have appointed Ira Braunschweig, M.D., as Chief, Section of Transplant and Cell Therapy at Rutgers Cancer Institute, Chief of the Transplant and Cell Therapy Service of the RWJBarnabas Health Oncology Service Line, and Director for Cell Therapy and Bone Marrow Transplantation at Robert Wood Johnson University Hospital, an RWJBarnabas facility. He will also serve as Professor of Medicine at Rutgers Robert Wood Johnson Medical School. He will be joining Rutgers on June 1. The selection comes following an extensive national search. Dr. Braunschweig was most recently Director of the Stem Cell Transplant Program and the clinical program director of Hematologic Malignancies at the Montefiore Einstein Cancer Center. 

Rutgers Protein Data Bank Expands Storage, Research Access With AWS

Part of the Rutgers Institute for Quantitative Biomedicine, the Research Collaboratory for Structural Bioinformatics Protein Data Bank (RCSB PDB) is expanding its storage capabilities. Amazon Web Services’ Open Data Sponsorship Program will provide RCSB PDB with more than 100 terabytes of storage for no-cost delivery of Protein Data Bank information to millions of scientists, educators and students worldwide. The arrangement, which will benefit those working in fundamental biology, biomedicine, bioenerg, and bioengineering and biotechnology. “Open access to Protein Data Bank information is central to accelerating scientific discoveries for the benefit of all humanity,” said Dr. Stephen Burley, Director of the RCSB PDB, Founding Director of Rutgers Institute for Quantitative Biomedicine, University Professor and Henry Rutgers Chair at Rutgers University.

Michael J. Fox Foundation Selects Princeton Co. for Parkinson’s Initiative

Princeton-based WCG announced that The Michael J. Fox Foundation for Parkinson’s Research (MJFF) has chosen it to be the institutional review board (IRB) of record for its Parkinson’s Progression Markers Initiative (PPMI). PPMI is a longitudinal, observational study of participants with and without Parkinson’s disease (PD). It is designed to identify biological markers and clinical changes associated with PD risk, onset, and progression. WCG IRB will review all PPMI research protocols and patient-facing communications, including patient recruitment, retention, and informed consent documents, and in-study instructions. PPMI launched in 2010 to better understand PD and develop tools to advance new treatments. 

Hackensack University Medical Center Offers an Innovative New Screening Option for Patients at High Risk for Pancreatic Cancer

Hackensack University Medical Center launched an innovative surveillance program that screens individuals who are at high-risk for developing pancreatic cancer. The IMMray® PanCan-d Test is the first blood test on the market dedicated to the early detection of familial or hereditary pancreatic ductal adenocarcinoma (PDAC). Patients who are eligible will receive both an imaging test and a novel biomarker test that measures the immune system's response to pancreatic disease in the blood. Unfortunately, studies show only about a quarter of people who qualify for high-risk surveillance actually take advantage of it, but Dr. Ligresti believes this new blood test will be a game changer.

NJ Innovation Challenge Seeks Disruptive Health Solutions

Hackensack Meridian Health is launching a New Jersey Innovation Challenge to foster innovation and disruptive solutions from New Jersey companies. The goal is to add to the network’s comprehensive strategies to continuously improve the patient experience and patient outcomes throughout the state. “We are challenging companies throughout New Jersey to play a role in helping us transform healthcare,’” said Robert C. Garrett, FACHE, Hackensack Meridian Health CEO. “The best ideas sometimes take fresh approaches from a wide array of perspectives. Our health network prides itself on finding new ways to do even better.” The Challenge seeks to reduce 30-day readmissions for: acute myocardial infarction; chronic obstructive pulmonary disease; heart failure; pneumonia; coronary artery bypass graft (CABG) surgery and elective primary total hip arthroplasty and/or total knee arthroplasty.

Rider Renames Science and Technology Center, After $9M Renovation

A 9,500-square-foot addition that features a number of new labs and innovative spaces has given cause for Rider University to rename its Science and Technology Center. The $9 million renovation project was made possible through the generosity of a $4 million leadership gift from Mike Hennessy of the Class of 1982, who passed away in November unexpectedly. The gift is the largest ever received for the sciences, and the catalyst behind the project. Mike made the gift in honor of his late wife, Patrice “Patti” Shelmet Hennessy, Class of 1982. The original 30,000-square foot science building has more than doubled in size since it was first constructed in 1961, with two previous additions having been completed in 1963 and 1994. Since 1994 the university has been adding onto and upgrading its science complex to meet the demands of a continuously evolving science education.

Cushman & Wakefield Arranges Sale of Life Science R&D Facility in Princeton

Cushman & Wakefield arranged the sale of a 78,922-square-foot life science research and development facility located in Princeton. Located at 350 Carter Road, the asset is a single-story, 78,922-square-foot lab building situated on 19 acres of land. The property features a mix of chemistry and biology labs; nuclear magnetic resonance suites; solvent storage rooms; temperature-controlled rooms; a central glass washroom; nearly 100 fume hoods piped for nitrogen, carbon dioxide, vacuum and compressed air, along with many other features catered to the modern-day life science user. The property is strategically located in New Jersey’s “Einstein Alley,” and is surrounded by a myriad of life sciences and pharma companies. The asset is equidistant from New York City and Philadelphia, both of which are within an hour drive.

NJEDA Opens 2022 Net Operating Loss Program Application

The NJEDA announced that it has opened applications for the 2022 Technology Business Tax Certificate Transfer Program, commonly known as the Net Operating Loss (NOL) Program. Hailed as a lifeline for companies that have yet to reach profitability, the NOL Program enables early stage life sciences businesses in the Garden State to sell a percentage of their New Jersey net operating losses and unused research and development (R&D) tax credits to unrelated profitable corporations for cash. The NJEDA is accepting applications online through June 30, 2022 at http://www.njeda.com/nol.

Nasdaq Breaks Ground on New Facility in Middlesex County

A group of labor leaders, executives and elected officials, including U.S. Rep, Josh Gottheimer, D-5th District, came together in Carteret to celebrate the ceremonial groundbreaking of Nasdaq’s new state-of-the-art cloud infrastructure and data center facility. The project, which will double the size of Nasdaq’s existing facility in Carteret, is expected to create a slew of new jobs. “Today is a day to celebrate Jersey’s economic growth and future successes… there is no better state to do business than New Jersey.” Gottheimer said. “The greater New Jersey area is the financial capital of the entire world. Twenty percent of the nation’s GDP runs through here. The financial sector is not only key our region’s economy; it is literally the engine behind the global economy.”

BIO 2022 in San Diego

June 13-16, 2022

BIO is thrilled to be back in person for the 2022 International Convention happening in San Diego, CA June 13-16, 2022. The Convention theme ‘LIMITLESS’ is BIO's commitment to unlocking possibilities for attendees while paving the path to the future of our industry. The BIO International Convention attracts 15,000+ biotechnology and pharma leaders who come together for one week of intensive networking to discover new opportunities and promising partnerships. BIO brings together a wide spectrum of life sciences and application, including drug discovery, biomanufacturing, genomics, biofuels, nanotechnology and cell therapy. Reach out to RBRomberg@BioNJ.org if you are interested in being part of the New Jersey Pavilion at BIO.

New Jersey Research Cores Partnering Conference

June 29, 2022

The New Jersey Research Cores Partnering Conference will showcase cutting-edge resources and facilities available to innovators at universities and companies across the Garden State. Hosted at Rutgers University, the conference will include sessions on successful collaborations between companies and universities, posters and presentations from Princeton, NJIT, Rowan, Rutgers, Montclair, and Hackensack Meridian Health. Attendees who do not have a Rutgers parking permit are required to register your vehicle here.

ON Helix

July 7, 2022

This one-day conference will address the main bio innovation trends, from the developments in life science and technology research to their translation into new diagnostics, prevention tools or treatments. Don’t miss this opportunity to reconnect with the One Nucleus network and keep up to date with the latest trends in Bio Innovation for Health. BioNJ members receive a 10% discount to attend the conference.