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December 10, 2021

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Welcome to the latest edition of the BioLines Weekender...

Things on the policy front have been heating up with the New Jersey Legislature’s post-election “lame duck” session continuing through mid-January.

In particular, BioNJ continues to urge lawmakers in New Jersey to oppose A-2418/S-1066 which would threaten Patients, health equity and the very innovations that so many Patients rely on. Prescription Drug Affordability Boards provide little in terms of savings to consumers and impede the investment needed by small and emerging biopharmaceutical companies working to discover tomorrow’s cures. Recently, BioNJ released a white paper, Prescription Drug Affordability Boards: Myths vs. Facts on Drug Supply Chain,” that corrects the record on several common myths about Prescription Drug Affordability Boards (PDAB) and explains their harmful impact.

Click here for a copy of BioNJ's white paper.

BioNJ remains committed to working with New Jersey policymakers to implement solutions that ensure Patients have meaningful access to their medicines, reduce health care costs and support innovation necessary for future cures and treatments. Please join us in our opposition of A-2418/S-1066 and instead support policies and solutions that ensure access to care while controlling health care costs in a way that promotes innovation in New Jersey and beyond. Click here to learn more.

Together we can make a difference. Thank you.

Because Patients Can't Wait®,

The BioNJ Team

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Upcoming BioNJ Events


BioNJ’s 29th Annual Dinner Meeting and Innovation Celebration

Save the Date!

February 2, 2022

BioNJ’s 12th Annual BioPartnering Virtual Conference

Save the Date!

May 9-13, 2022

Putting Patients First:

The Value of Medical Innovation

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Insurance Design Barriers Can Impact Patient Adherence and Can Lead to Poor Health Outcomes

According to our inaugural Patient Experience Survey (PES), insurance design can jeopardize patients’ health due to access barriers to medicines. Here are three things you should know. 1) High out-of-pocket costs can prevent patients from accessing the medicines they need. 2) Non-adherence is most prevalent among the sickest and most vulnerable patients. 3) Non-adherence often leads to poor health outcomes and increased health care costs. 

A Price Control by Any Other Name Would Still Put Patients at Risk and Threaten Innovation

Some policymakers in DC are laser focused on giving the government the power to “negotiate” in Medicare. What they aren’t saying is that this isn’t negotiation at all. They essentially just want the government to dictate medicine prices. The latest drug pricing plan in the Build Back Better Act, Speaker Pelosi’s proposal (commonly known as H.R. 3), proposals that would tie medicine prices in Medicare to prices paid by the Department of Veterans Affairs – all are attempts at implementing a price control approach where the government has unprecedented, sweeping authority to set prices for your medicines. Each of these so-called negotiation proposals, no matter what name is used, would have the same problem: negative consequences for patients.

New Analysis Confirms Government Price Setting Leads to Reduction in R&D Investment and Delayed Access to Medicines

A new analysis adds to a growing body of research showing that government price setting has a devastating impact on biopharmaceutical research and development and places an additional barrier between patients and innovative medicines. The analysis – conducted by Vital Transformation confirms that government intervention that forces medicine prices artificially low threatens access to medicines and discourages investment in drug development. The new analysis looked at the impact of government price setting on the European biopharmaceutical ecosystem and concluded that government price control policies correlate to less R&D and, consequently, less access to medicines.

What is Missing in the Current Drug Pricing Plan

A recent congressional forum looked at the role pharmacy benefit managers (PBMs) play in determining what patients pay out of pocket for prescription medicines. The forum provided an important reminder of how these middlemen operate in an opaque system that often leaves patients paying far more than they should for medicines. And it’s also a reminder of what’s missing from the current drug pricing bill that passed in the House last week: PBMs and the health plans they work for are receiving a greater share of spending on prescription medicines. Drug companies set list prices for medicines and then negotiate rebates and discounts with PBMs to help ensure patients have access to them. In 2020, brand drug companies provided $187 billion in total discounts, rebates and other price concessions.

New Data Show Insurers and PBMs Increase Barriers to Care

New data show insurers and middlemen known as pharmacy benefit managers (PBMs) are making it harder for patients to get the medicines they need. Patients increasingly face access restrictions to their medicines. Insurers and PBMs use what’s known as utilization management restrictions as a strategy to reduce their spending on medicines, but they can have an adverse impact on patient access. These insurance tactics include prior authorization and fail first requirements (also known as step therapy) and often prevent or delay patients from accessing the medicines they need. A recent analysis by Avalere Health looked at commercial insurers’ use of utilization management for single-source brand medicines across 12 therapeutic areas and found that from 2014 to 2020, these types of restrictions increased across all 12 therapeutic areas, which included cancer, depression, rheumatoid arthritis and diabetes.

Build Back Better Will Crush Rare Disease Innovation

The Rare Access Action Project (RAAP) released a study entitled, Build Back Better Act (BBBA) May Not Build a Future of Innovation. The study explores the Medicare Part D provisions of the House passed BBBA to understand the impact on rare disease products and ultimately on rare disease patients. The study found that under the BBBA, rare products would face an increase in Medicare Part D costs of between 519% - 1423%. Such increases would be devastating, particularly for smaller, emerging rare disease companies without resources to absorb those new costs, which will lead to the decline of innovation in rare disease therapies. According to the study, "a 20% manufacturer liability in the catastrophic phase would likely change the path of innovation.

Issue Brief: The Impact of HR 5376 on Antiviral Innovation and Patient Health

This Issue Brief reviews the evidence-base to assess the impact of HR 5376 on innovation into antivirals and patient health. A large academic literature estimates the effect of future drug revenues on R&D spending and finds that on average that a 1 percent reduction in revenue leads to a 1.5 percent reduction in R&D activity. We find that HR5376 will reduce revenues by 15 percent through 2039 and therefore that the evidence base predicts that R&D spending on antivirals will fall about 23.1 percent, amounting to $165 billion. We find that this cut in R&D activity leads to 21 to 43 fewer new antivirals, dependent on methodologies used to estimate new drugs from R&D spending. This drop in new antiviral drugs is predicted to generate a loss of 82.4 million life years, about 7.7 times as large as the life years lost from COVID-19 in the U.S. to date.

BioNJ in the News


Council of State Bioscience Associations Elects New Board Leadership

The Council of State Bioscience Associations (CSBA) announced the election of new board members to its Board of Directors for the next two-year term (2022-2023). CSBA is pleased to announce the following leaders and members of the board of directors for the 2022-2023 term: Maria Thacker, Board Chair & President & CEO, Georgia Bio; Kelvyn Cullimore, Board Member President & CEO, BioUtah; Michael Fleming, Board Member President, Delaware Bio; Laura Gunter, Board Member President, NCBIO; Sonia Hall, Board Member President & CEO, BioKansas; Debbie Hart, Past Chair & President & CEO, BioNJ; and Lisa Bozinovic, CSBI Representative Executive Director, Oregon Bio. “It has been my honor to serve as the CSBA Board Chair over these last two years,” said Debbie Hart, Past Chair, CSBA and President & CEO, BioNJ. “Our state associations have faced immense challenges on the policy arena as well as an unprecedented global pandemic. I am proud of what we have collectively accomplished in helping to stave off grave policy proposals, offering unique educational opportunities, and supporting our Members, all despite operating remotely in a time of immense change for our country."

NJ Company News


Celularity Announces FDA Clearance of Investigational New Drug Application (IND) for Natural Killer Cell Therapy CYNK-101 in First-line Advanced Her2/neu Positive Gastric and Gastroesophageal Junction Cancer

Florham Park-based BioNJ Member Celularity announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the use of CYNK-101 in combination with standard chemotherapy, trastuzumab and pembrolizumab in patients with first-line locally advanced unresectable or metastatic HER2/neu positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. CYNK-101 is an investigational genetically engineered natural killer (NK) cell therapy designed to enhance antibody-dependent cellular cytotoxicity (ADCC) with approved and novel antibody therapeutics. The Phase 1/2a open-label, non-randomized clinical trial is designed to evaluate the safety and preliminary efficacy of the combination treatment strategy.

Soligenix Announces Successful Protection Using a Bivalent Thermostabilized Filovirus Vaccine

Princeton-based BioNJ Member Soligenix announced 100% protection of non-human primates (NHPs) against lethal Sudanebolavirus (SUDV) challenge using a bivalent, thermostabilized vaccine formulated in a single vial, reconstituted only with water immediately prior to use. This milestone is part of an ongoing collaboration with the University of Hawaiʻi at Mānoa, demonstrating the successful presentation of one or more antigen(s) within the same formulation while maintaining full potency and thermostability. It further demonstrates the broad applicability of the vaccine platform, and its potential role in the U.S. government's initiative for pandemic preparedness.

Evrysdi® Distinguished by Two Prestigious Awards for Outstanding Innovation in Drug Discovery

South Plainfield-based BioNJ Member PTC Therapeutics announced that Evrysdi® (risdiplam) has received multiple awards that recognize it as one of the most innovative therapies of 2021 and for its life-saving impact. The British Pharmacological Society has chosen Evrysdi as the 2022 Drug Discovery of the Year award. In addition, Evrysdi was awarded the 2021 Drug Discovery Prize by the Society for Medicines Research. Evrysdi was selected from a list of 150 innovative medicines for the British Pharmacological Society's Drug Discovery of the Year award. Evrysdi was discovered through PTC's innovative alternative splicing platform.

Adare Pharma Solutions Acquires Frontida BioPharm to Expand Leading CDMO Offerings

Lawrenceville-based BioNJ Member Adare Pharma Solutions announced the acquisition of Frontida BioPharm, a vertically integrated CDMO focused on oral formulations. The acquisition reinforces Adare’s commitment to transform drug delivery by providing world class solutions from product development through commercial scale manufacturing and packaging. Adare’s portfolio of offerings for its customers will expand to include new capabilities such as high potency compound handling and packaging services. The combination of the two organizations will further establish Adare as a leader in the development and manufacturing of life saving medications in complex dosage forms. 

Taiho Pharmaceutical Exercises Option for an Exclusive License to Arcus Biosciences’ Anti-TIGIT Program in Japan and Certain Territories in Asia

Princeton-based BioNJ Member Taiho Pharmaceutical and Arcus Biosciences announced that Taiho optioned its exercise for anti-TIGIT antibodies domvanalimab (development code: AB154) and AB308 from Arcus Biosciences, in Japan and certain other territories in Asia (excluding China). This option exercise is based on an option and license agreement between Taiho and Arcus contracted in September 2017. Taiho has already obtained exclusive rights to etrumadenant (AB928), an adenosine A2a/A2b receptor antagonist, and zimberelimab (AB122), an anti-PD-1 monoclonal antibody. This is the third option exercise to an Arcus program.

MEI Pharma and Kyowa Kirin Announce Data from the Ongoing Global Phase 2 TIDAL Study Evaluating Zandelisib as a Single Agent in Patients With Relapsed or Refractory Follicular Lymphoma

West Windsor-based BioNJ Member Kyowa Kirin and MEI Pharma announced that the pivotal Phase 2 TIDAL study evaluating zandelisib as a single agent for follicular lymphoma (FL) patients who received at least two prior systemic therapies demonstrated a 70.3% objective response rate (ORR) as determined by Independent Review Committee (IRC) assessment in the primary efficacy population (n=91). In addition, 35.2% of patients achieved a complete response. The data are currently insufficiently mature to accurately estimate duration of response (DOR). In line with previously reported data from the Phase 1B study, zandelisib was generally well tolerated.

Sanofi to Acquire Origimm Biotechnology in First Move to Treat Acne With Vaccine-Based Immunotherapy

Bridgewater-based BioNJ Member Sanofi announced it entered into an agreement to acquire Origimm Biotechnology GmbH, an Austrian privately owned biotechnology company specializing in the discovery of virulent skin microbiome components and antigens from bacteria causing skin disease, such as acne. With this acquisition, Sanofi continues executing its global Play to Win strategy, pursuing growth opportunities and building an industry-leading vaccines pipeline. The transaction will add ORI-001 to Sanofi’s early stage pipeline. ORI-001 is a therapeutic vaccine candidate for acne vulgaris based on recombinant proteins, which entered preliminary clinical studies in Q3 2021.

Celldex Announces First Patient Dosed in Phase 1 Study of CDX-0159 in Prurigo Nodularis

Hampton-based BioNJ Member Celldex Therapeutics announced that the first patient has been dosed in a Phase 1 study of CDX-0159 for the treatment of prurigo nodularis (PN). CDX-0159 is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. The randomized, double-blind, placebo-controlled, Phase 1 study is evaluating CDX-0159 in patients with prurigo nodularis. Approximately 40 patients will be enrolled across 4 parallel groups and treated for 8 weeks (1.5 mg/kg dose every 4 weeks, 3.0 mg/kg single dose followed by placebo 4 weeks later, 4.5 mg/kg single dose followed by placebo four weeks later and placebo dose every 4 weeks) with 10 patients in each group.

Helsinn Group and BridgeBio Pharma Announce Strategic Collaboration to Co-Develop and Co-Commercialize BridgeBio’s Novel GPX4 Inhibitor in Multiple Cancer Tumor Types

Iselin-based BioNJ Member Helsinn and BridgeBio Pharma announced they have entered into a strategic collaboration to co–develop and co-commercialize a potentially first-in-class inhibitor designed to target glutathione peroxidase 4 (GPX4) with the hope of providing an effective new therapy for patients with difficult-to-treat tumors. The joint collaboration for BridgeBio’s GPX4 inhibitor was established as part of a new non-exclusive collaboration framework between BridgeBio and Helsinn that allows the companies to propose co-development and co-commercialization opportunities for preclinical precision oncology programs. Under the terms of the non-exclusive agreement, BridgeBio and Helsinn will have the option to collaborate on preclinical oncology programs that are identified from time to time by either party. 

Hovione Announces New Pharma Campus Expansion in New Jersey

East Windsor-based BioNJ Member Hovione announced that it is adding a 31,000 sq. ft. building next to its current facility in East Windsor, laying the foundations for a state-of-the-art Hovione Campus. This investment will bring additional commercial spray drying capacity online by 2023. The expansion will allow the company to respond to the needs of customers who favor U.S.-based manufacturing through their development cycles all the way to commercial. “Hovione has set the goal of becoming the leading company provider of innovative and integrated solutions for the global pharmaceutical industry by 2028. Given its dimension and above all, the extremely high regulatory requirements, the U.S. market is fundamental for the company and this investment represents a key step in our expansion strategy” says Filipe Tomás, General Manager at Hovione in New Jersey. 

Biogen and Sage Therapeutics Announce Positive, One-Year Zuranolone 50 mg Data in the Ongoing Open-Label SHORELINE Study in Patients With MDD

Princeton-based BioNJ Member Biogen and Sage Therapeutics announced 12-month data for the cohort of patients (n=199), who received zuranolone 50 mg once nightly for 14-days as their initial dose in the ongoing Phase 3 open-label SHORELINE Study and had the opportunity to be followed for 12-months. The SHORELINE Study, part of the LANDSCAPE clinical program, was designed to naturalistically follow adult patients with major depressive disorder (MDD) and evaluate the safety and tolerability of zuranolone as well as the need for repeat dosing for up to one year. For the primary endpoint of safety and tolerability, the data analyzed to date show zuranolone was generally well-tolerated, with no new safety findings or trends identified in the long-term safety data available regardless of the number of courses of zuranolone a patient received. 

Amgen Announces Positive Top-Line Results from Otezla® (apremilast) Phase 3 DISCREET Study in Moderate to Severe Genital Psoriasis

Berkeley Heights-based BioNJ Member Amgen announced positive top-line results from the DISCREET trial, a Phase 3, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of Otezla® (apremilast) in adults with moderate to severe genital psoriasis and moderate to severe plaque psoriasis. The study showed that oral Otezla 30 mg twice daily achieved a clinically meaningful and statistically significant improvement, compared with placebo, in the primary endpoint of the modified static Physician's Global Assessment of Genitalia (sPGA-G) response (defined as an sPGA-G score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline) at week 16. 

Upadacitinib (RINVOQ®) Achieved Primary and Key Secondary Endpoints in First Phase 3 Induction Study in Patients With Crohn's Disease

Madison-based BioNJ Member AbbVie announced positive top-line results from U-EXCEED, a Phase 3 induction study, showing upadacitinib (45 mg once daily) achieved both primary endpoints of clinical remission and endoscopic response at week 12. The U-EXCEED study enrolled patients with moderate to severe Crohn's disease who had an inadequate response or were intolerant to biologic therapy, with over 60 percent having previously failed two or more biologics. U-EXCEED is the first of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe Crohn's disease. 

Bristol Myers Squibb Receives European Commission Approval of Zeposia (ozanimod) for Use in Adults With Moderately to Severely Active Ulcerative Colitis

Princeton-based BioNJ Member Bristol Myers Squibb announced the European Commission has granted a Marketing Authorization for Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. Zeposia, an oral medication taken once daily,is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). Zeposia is the first and only oral S1P receptor modulator approved for UC, and represents a new way of treating this chronic immune-mediated disease.

Bristol Myers Squibb’s Applications for Deucravacitinib for the Treatment of Moderate to Severe Plaque Psoriasis Accepted by U.S. Food and Drug Administration and Validated by European Medicines Agency

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 10, 2022. These latest regulatory milestones are in addition to the NDA acceptance by Japan's Ministry of Health, Labour and Welfare for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis. 

U.S. Food and Drug Administration Accepts for Priority Review supplemental Biologics License Application for Reblozyl® (luspatercept-aamt) in Adults With Non-Transfusion Dependent (NTD) Beta Thalassemia

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Reblozyl® (luspatercept-aamt), a first-in-class erythroid maturation agent, for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 27, 2022. In addition, the European Medicines Agency has validated the Type II variation for Reblozyl inNTD beta thalassemia. Reblozyl is being co-developed and co-commercialized with BioNJ Member Merck & Co., Inc., following Merck’s recent acquisition of Acceleron Pharma, Inc. 

New Kisqali® Data Shows Consistent Overall Survival Benefit Across Genomic and Clinical Subtypes of Interest in HR+/HER2- Metastatic Breast Cancer

East Hanover-based BioNJ Member Novartis announced new Kisqali® (ribociclib) data demonstrating a consistent overall survival (OS) benefit with Kisqali plus endocrine therapy (ET) across genomic subtypes of hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (mBC), similarly in the indolent as well as in the aggressive, endocrine therapy (ET)-resistant subtypes. A broad ad hoc exploratory analysis of nearly 1,000 tumor samples showed that Kisqali in combination with ET consistently provided significant OS benefit compared to ET alone across main intrinsic subtypes (Luminal A: n=542; HR=0.75; 95% CI: 0.58-0.96; p=.021; Luminal B: n=278; HR=0.69; 95% CI: 0.50-0.95; p=.023; and HER2-enriched: n=147; HR=0.60; 95% CI: 0.40-0.92; p=.018).

Novartis Announces Positive Results from Year Two of the Phase III Trial of Beovu® in Diabetic Macular Edema

East Hanover-based BioNJ Member Novartis announced the first interpretable results from year two (week 100) of the Phase III KESTREL study. KESTREL assessed the safety and efficacy of Beovu® (brolucizumab) 6 mg in patients with visual impairment due to diabetic macular edema (DME). Results from year two confirmed the visual acuity gains, fluid reduction findings and safety profile from year one, while addressing the burden of frequent treatments for DME patients. Results from year two of KESTREL were consistent with those seen at year one, including maintenance of best-corrected visual acuity (BCVA) and sustained reductions in central subfield thickness (CSFT). Additionally, numerically fewer Beovu patients had intraocular fluid and/or sub-retinal fluid (IRF/SRF) versus patients treated with aflibercept.

Novo Nordisk to Acquire Dicerna Pharmaceuticals Including the RNAi Research Technology Platform

Plainsboro-based BioNJ Member Novo Nordisk announced that it has entered into a definitive agreement to acquire Dicerna Pharmaceuticals. The acquisition of Dicerna’s ribonucleic acid interference (RNAi) platform is a strategic addition to Novo Nordisk’s existing research technology platforms and supports the strategy of using a broad range of technology platforms applicable across all Novo Nordisk’s therapeutic focus areas. Dicerna is a publicly held company focusing on RNAi-based therapeutics. Using its proprietary GalXC™ and GalXC-Plus™ RNAi technologies, Dicerna develops RNAi-based therapies to selectively silence genes that cause or contribute to disease. Dicerna’s RNAi technology platform enables access to intracellular disease targets across hepatic and extrahepatic cell and tissue types. 

Lilly and Regor Therapeutics Group Enter into Strategic Collaboration to Discover and Develop Novel Therapies for Metabolic Disorders

Bridgewater-based BioNJ Member Eli Lilly and Company and Regor Therapeutics Group have entered into a multi-year research collaboration and licensing agreement to discover, develop and commercialize novel therapies for metabolic disorders. Under the terms of the agreement, Lilly will have a license to select Regor intellectual property with an option to extend the license. Lilly will be responsible for clinical development, manufacturing and commercialization worldwide, except for People's Republic of China, Macau, Hong Kong and Taiwan, where Regor will maintain these rights and responsibilities. The agreement will allow each company the opportunity to fully leverage both parties' existing compounds and technologies globally to maximize patient treatment choice.

Emgality® Versus Nurtec® ODT Head-to-Head Migraine Preventive Treatment Study Now Enrolling Patients

Bridgewater-based BioNJ Member Eli Lilly and Company announced that enrollment is now open for the CHALLENGE-MIG clinical trial, the first and only head-to-head trial comparing two anti-calcitonin gene-related peptide (CGRP) medicines for the preventive treatment of episodic migraine in adults. The study is evaluating once-monthly Emgality® (galcanezumab-gnlm) injection compared to Nurtec® ODT (rimegepant), a tablet patients take every other day, on patient-centric measures, including reductions in monthly migraine headache days and quality of life improvement. While Nurtec ODT and Emgality are both medications that target CGRP, because Emgality is a monoclonal antibody (mAb) that binds to CGRP (a protein found in the brain thought to play a key role in migraine), it works differently than gepants like Nurtec ODT, that bind to and block the CGRP receptor.

Lilly's Bamlanivimab With Etesevimab Authorized as the First and only Neutralizing Antibody Therapy for Emergency Use in COVID-19 Patients Under the Age of 12

Bridgewater-based BioNJ Member Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab administered together to include certain high-risk pediatric patients from birth to <12 years old. This expansion allows for bamlanivimab and etesevimab to be administered together in high-risk pediatric patients for the treatment of mild to moderate COVID-19 as well as post-exposure prophylaxis. The expanded authorization is based on safety and efficacy data of pediatric and infant patients in BLAZE-1, a phase 2/3 clinical trial studying bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 and who are at high risk for severe disease progression. 

Pfizer and BioNTech Receive Positive CHMP Opinion for Comirnaty® in Children 5 to <12 Years of Age in the European Union

BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine COMIRNATY® in children 5 to under 12 years of age. The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future. If the EC grants the variation regarding a vaccination in this age group, the decision will be immediately applicable to all 27 EU member states. If approved, COMIRNATY will be the first COVID-19 vaccine authorized in the European Union for individuals 5 to under 12 years of age.

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older

BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 16 years of age and older. The booster dose is to be administered at least six months after completion of the primary series and is the same formulation and dosage strength as the doses in the primary series. “Today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our COVID-19 vaccine is a critical milestone as we continue to stay vigilant in addressing the virus,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

Pfizer and Arvinas Announce PROTAC® Protein Degrader ARV-471 Continues to Demonstrate Encouraging Clinical Benefit Rate in Patients With Locally Advanced or Metastatic ER+/HER2- Breast Cancer

BioNJ Member Pfizer, with offices in Peapack, and Arvinas announced an update on Phase 1 dose escalation data of ARV-471, a novel PROTAC® estrogen receptor (ER) degrader, which is being co-developed for the treatment of patients with locally advanced or metastatic ER-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer (ER+/HER2-). “We are excited by these results and believe ARV-471 is a promising ER-targeting investigational medicine,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “It is encouraging to see ARV-471 continuing to show durable efficacy and tolerability in heavily pre-treated patients with ER+ breast cancer who have limited treatment choices.”

AWS Helps Pfizer Accelerate Drug Development and Clinical Manufacturing

Amazon Web Services announced that it is working with BioNJ Member Pfizer, with offices in Peapack, to create innovative, cloud-based solutions with the potential to improve how new medicines are developed, manufactured and distributed for testing in clinical trials. The companies are exploring these advances through their newly created Pfizer Amazon Collaboration Team (PACT) initiative, which applies AWS capabilities in analytics, machine learning, compute, storage, security and cloud data warehousing to Pfizer laboratory, clinical manufacturing and clinical supply chain efforts. 

Preclinical Data Demonstrate Sotrovimab Retains Activity Against Key Omicron Mutations, New SARS-Cov-2 Variant

Warren-based BioNJ Member GlaxoSmithKline and Vir Biotechnology announced an update to bioRxiv, a preprint server, with preclinical data demonstrating that sotrovimab, an investigational monoclonal antibody, retains activity against key mutations of the new Omicron SARS-CoV-2 variant (B.1.1.529), including those found in the binding site of sotrovimab. These data were generated through pseudo-virus testing of specific individual mutations found in Omicron. To date, sotrovimab has demonstrated ongoing activity against all tested variants of concern and interest defined by the World Health Organization (WHO). 

GSK and Medicago Announce Positive Phase 3 Efficacy and Safety Results for Adjuvanted Plant-Based COVID-19 Vaccine Candidate

Warren-based BioNJ Member GlaxoSmithKline and Medicago announce positive efficacy and safety results from the global Phase 3 placebo-controlled efficacy study of Medicago’s plant-based COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant, conducted in over 24,000 subjects (adults 18 years and above) across six countries. Vaccine efficacy was demonstrated in an environment dominated by SARS-CoV-2 variants, unlike most published Phase 3 efficacy trials for currently licensed COVID-19 vaccines that were conducted when only the ancestral virus was circulating, making direct comparisons impossible. The overall vaccine efficacy rate against all variants of SARS-COV-2 was 71% (95% CI: 58.7, 80.0; Per Protocol Analysis: PP). 

Gilead Submits Biologics License Application to U.S. Food and Drug Administration for Bulevirtide, an Investigational Treatment for People Living With Chronic Hepatitis Delta

Morris Plains-based BioNJ Member Gilead Sciences announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for bulevirtide for injection (2 mg), a potential first-in-class antiviral medicine for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease; bulevirtide has been granted Breakthrough Therapy and Orphan Drug designations by the FDA. The BLA submission is supported by data from completed and ongoing Phase 2 studies and the ongoing Phase 3 MYR301 study which supports the safety and efficacy of bulevirtide 2 mg once daily after 24 weeks of therapy. 

Trodelvy® (sacituzumab govitecan) Granted European Commission Marketing Authorization for Treatment of Metastatic Triple-Negative Breast Cancer in Second Line

Morris Plains-based BioNJ Member Gilead Sciences announced that the European Commission (EC) has granted marketing authorization for Trodelvy® (sacituzumab govitecan), a first-in-class Trop-2-directed antibody-drug conjugate, as a monotherapy indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for advanced disease. TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. It is more frequently diagnosed in younger and premenopausal women and is more prevalent in Black and Hispanic women. 

Almost 100 Million Doses of Johnson & Johnson COVID-19 Vaccine to be Donated to Lower Income Countries Through COVAX

New Brunswick-based BioNJ Member Johnson and Johnson welcomes the decision of EU Member States along with Norway and Iceland (Team Europe) to donate almost 100 million doses of its COVID-19 vaccine through the COVAX Facility. As a practical rapid response to the urgent need to scale up equitable access to vaccines, these doses will be utilized to help protect individuals in lower-income countries. Supported by the European Commission, Team Europe are providing these doses under an agreement signed recently by the Government of Belgium (acting on behalf of Team Europe), Gavi, The Vaccine Alliance (GAVI) and Johnson & Johnson. 

Johnson & Johnson Discussions to License its COVID-19 Vaccine to Aspen Reach Advanced Stage

New Brunswick-based BioNJ Member Johnson & Johnson is pleased to reach an advanced stage in its discussions for a potential licensing agreement for its COVID-19 vaccine with Aspen SA Operations (Pty) Ltd, which is based in South Africa. The parties will continue to work toward a definitive agreement that builds on their existing manufacturing collaboration and would enable the first COVID-19 vaccine to be manufactured and sold by an African company, in Africa and for people living in Africa. Currently, COVID-19 vaccination rates are significantly lower across Africa compared to those seen in high-income countries. The license under discussion would enable Aspen, using COVID-19 vaccine drug substance supplied by Johnson & Johnson, to produce Aspen-branded finished vaccine for sale to public sector markets in Africa through transactions with national governments of African Union member states and certain multilateral entities serving Africa including the African Vaccine Acquisition Trust (AVAT), Gavi/COVAX and UNICEF.

World Health Organization Strategic Advisory Group of Experts (SAGE) Interim Recommendation Supports Use of Johnson & Johnson COVID-19 Vaccine as a Booster

New Brunswick-based BioNJ Member Johnson & Johnson announced announced the interim recommendation by the Strategic Advisory Group of Experts on Immunization (SAGE) for the World Health Organization (WHO) supporting the use of the Johnson & Johnson COVID-19 vaccine as a booster shot in persons aged 18 years and above. The WHO recommend the booster shot should be administered two to six months after the primary vaccination. SAGE advises WHO on global vaccine and immunization policies, and its recommendations provide guidance on the use of vaccines supplied through the COVAX Facility, a global risk-sharing mechanism for pooled procurement and equitable distribution of COVID-19 vaccines to all participating countries.

Johnson & Johnson COVID-19 Vaccine Fully Approved by Health Canada to Prevent COVID-19 in Individuals 18 years and Older

Titusville-based the Janssen Pharmaceutical Companies of Johnson & Johnson announced that Health Canada has approved its single-shot COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older. This decision was based on scientific evidence, including initial data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination. “We are delighted by Health Canada’s decision to approve the Johnson & Johnson COVID-19 vaccine based on Phase 3 clinical data that proves the vaccine’s robust safety and efficacy,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. 

Latest Phase 3 Data for First-in-Class TREMFYA® (guselkumab) Demonstrates Significant and Durable Improvement in Signs and Symptoms of Active Psoriatic Arthritis While Maintaining its Safety Profile in Patients With Inadequate Response to Tumor Necrosis Factor Inhibition (TNFi-IR)

Titusville-based the Janssen Pharmaceutical Companies of Johnson & Johnson announced new TREMFYA® (guselkumab) efficacy and safety data from the Phase 3b COSMOS trial published in Annals of the Rheumatic Diseases (ARD), evaluating this selective interleukin (IL)-23 inhibitor in adults with active psoriatic arthritis (PsA) who demonstrated inadequate efficacy or intolerance to tumor necrosis factor inhibition (TNFi). Results showed significantly higher proportions of patients treated with TREMFYA had improvement in joint signs and symptoms and complete skin clearance versus placebo at week 24 in this documented TNFi-IR patient population, which is often more difficult to treat. Furthermore, improvements in signs and symptoms of PsA were maintained or numerically increased through one year (week 48) among TREMFYA-randomized patients.

Janssen Seeks Approval of IMBRUVICA®(ibrutinib) in a Fixed-Duration Regimen for Patients With Untreated Chronic Lymphocytic Leukaemia (CLL)

Titusville-based the Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new treatment option for IMBRUVICA® (ibrutinib) as a fixed-duration combination with venetoclax (I+V) for adult patients with previously untreated chronic lymphocytic leukaemia (CLL). The submission is supported by positive data from the pivotal Phase 3 GLOW study (NCT03462719) which investigated the efficacy and safety of first-line fixed-duration I+V versus chlorambucil plus obinutuzumab in elderly or unfit patients with CLL, and the Phase 2 CAPTIVATE study (PCYC-1142) which evaluated I+V in previously untreated CLL patients 70 years or younger, including patients with high-risk disease.

Merck and Ridgeback Statement on Positive FDA Advisory Committee Vote for Investigational Oral Antiviral Molnupiravir for Treatment of Mild to Moderate COVID-19 in High-Risk Adults

Kenilworth-based BioNJ Member Merck & Co. and Ridgeback Biotherapeutics provided the following statement at the conclusion of the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) regarding the Emergency Use Authorization (EUA) application for molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, for the treatment of mild to moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19 and/or hospitalization. The Advisory Committee voted 13-10 that the known and potential benefits of molnupiravir outweigh its known and potential risks for the treatment of mild to moderate COVID-19 in high-risk adult patients who are within five days of symptom onset. 

Merck Completes $11B Acceleron Pharma acquisition

Kenilworth-based BioNJ Member Merck & Co. announced that it completed its $11.5 billion acquisition of Acceleron Pharma Inc. “This is an important and strategic opportunity for our company to continue growing our cardiovascular portfolio and pipeline, that builds on our long and proud legacy in cardiovascular disease and further bolsters our business development strategy,” said Merck President and CEO Rob Davis. “Fueled by Acceleron’s groundbreaking research, we are excited to explore the opportunities and possibilities ahead to reach even more patients by addressing this critical health need.” The deal was announced in September. 

FDA Accepts Regulatory Submission of Supplemental New Drug Application for LYNPARZA® (olaparib) as Adjuvant Treatment in BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer and Grants Priority Review

Kenilworth-based BioNJ Member Merck & Co. and AstraZeneca announced that a supplemental New Drug Application (sNDA) for LYNPARZA has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of patients with BRCA-mutated (BRCAm), human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery. The sNDA was based on results from the Phase 3 OlympiA trial. These results showed LYNPARZA demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrence, second cancers or death by 42% versus placebo (HR=0.58 [99.5% CI, 0.41-0.82]; p<0.0001).

U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for Use in Infants and Children

Kenilworth-based BioNJ Member Merck & Co. announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental Biologics License Application (sBLA) for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age. The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment or prevention of a serious condition. The sBLA is supported by results from Phase 2 and Phase 3 clinical studies in pediatric populations including infants, children and adolescents. 

Merck’s KEYTRUDA® (pembrolizumab) Approved in Japan in Combination With Chemotherapy for First-Line Treatment of Patients With Radically Unresectable, Advanced or Recurrent Esophageal Carcinoma

Kenilworth-based BioNJ Member Merck & Co. announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has been approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for the first-line treatment of patients with radically unresectable, advanced or recurrent esophageal carcinoma in combination with chemotherapy (5-fluorouracil [5-FU] plus cisplatin) based on data from the Phase 3 KEYNOTE-590 trial. In the KEYNOTE-590 trial, KEYTRUDA in combination with chemotherapy (5-FU plus cisplatin) demonstrated statistically significant improvements in overall survival and progression-free survival versus chemotherapy alone (5-FU plus cisplatin) in chemotherapy-naïve patients with radically unresectable, advanced or recurrent esophageal squamous cell carcinoma or esophageal adenocarcinoma or adenocarcinoma of the esophagogastric junction (Siewert type 1), regardless of histology or PD-L1 expression status.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adult and Pediatric (≥12 Years of Age) Patients With Stage IIB or IIC Melanoma Following Complete Resection

Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection. Additionally, the FDA expanded the indication for KEYTRUDA as adjuvant treatment for stage III melanoma following complete resection to include pediatric patients (12 years and older). The approval in stage IIB and IIC melanoma is based on data from the first interim analysis of the Phase 3 KEYNOTE-716 trial, in which KEYTRUDA showed a statistically significant improvement in recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 35% (HR=0.65 [95% CI, 0.46-0.92]; p=0.0132) compared to placebo. 

European Commission Approves KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) as First-Line Treatment for Adult Patients With Advanced Renal Cell Carcinoma

Kenilworth-based BioNJ Member Merck & Co. and Eisai announced that the European Commission has approved the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA (KISPLYX® in the European Union [EU] for the treatment of advanced renal cell carcinoma [RCC]), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the first-line treatment of adult patients with advanced RCC. The approval for advanced RCC is based on results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements versus sunitinib in the efficacy outcome measures of progression-free survival (PFS), reducing the risk of disease progression or death by 61% (HR=0.39 [95% CI, 0.32-0.49]; p<0.0001) with a median PFS of 23.9 months versus 9.2 months for sunitinib, and overall survival (OS), reducing the risk of death by 34% (HR=0.66 [95% CI, 0.49-0.88]; p=0.0049) versus sunitinib. 

European Commission Approves LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) for Patients With Certain Types of Endometrial Carcinoma

Kenilworth-based BioNJ Member Merck & Co. and Eisai announced that the European Commission has approved the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck, for the treatment of advanced or recurrent endometrial carcinoma in adults 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. This marks the first combination of tyrosine kinase inhibitor with immunotherapy approved in Europe for these patients with advanced or recurrent endometrial carcinoma. 

Eisai and FCNT Enter into Business Alliance Aiming to Support People Living With Dementia and to Prevent Dementia

Woodcliff Lake-based Eisai Co. and FCNT LIMITED announced that both companies have entered into a business alliance agreement aiming to support people living with dementia and to prevent dementia, through developing solutions for maintaining brain performance. Both companies will construct an ecosystem with the aim of supporting people living with and preventing dementia (“Dementia Ecosystem”), with integrating Eisai's wealth of experience and knowledge including drug creation and disease awareness activities as well as Eisai's solution measures such as digital technology, in the area of dementia, and FCNT’s products such as smartphones designed to offer outstanding usability for the elderly as well as FCNT’s services including “Raku Raku Community” on SNS targeting such smartphone users. 

ADMA Biologics Provides Update on Global Intellectual Property Portfolio

Ramsey-based ADMA Biologics, Inc. announced that the European Patent Office (EPO) has issued European Patent No. 3375789, to the Company. This patent relates to the treatment and prevention of S. pneumonia infections, and in particular, to standardized hyperimmune globulins containing elevated antibody titers for a plurality of S. pneumoniae serotypes. This EPO granted patent complements ADMA’s existing U.S. Pat. Nos. 10,259,865 and 11,084,870.

BeiGene Closes on Hopewell Property It Will Use to Build New U.S. Manufacturing and R&D Center

Ridgefield Park-based BeiGene announced it has purchased a 42-acre site at the Princeton West Innovation Campus in Hopewell that will house a new state-of-the-art manufacturing campus and clinical research and development center. The company’s intentions were made clear August 3, when it announced its intention to build such a manufacturing campus — and recruit hundreds of highly educated workers with high-paying jobs. The facility is expected to include up to approximately 400,000 square feet of dedicated commercial-stage biologic pharmaceutical manufacturing, including up to 16,000 liters of biologics capacity, along with clinical R&D and office space. Construction of the initial phase is expected to commence in 2022 and be completed in late 2023 or in 2024.

BeiGene Initiates First-in-Human Phase 1 Clinical Trial of Investigational TYK2 Inhibitor BGB-23339

Ridgefield Park-based BeiGene announced that the first patient has been dosed in a Phase 1 clinical trial of BGB-23339, a potent, allosteric investigational tyrosine kinase 2 (TYK2) inhibitor internally developed by BeiGene scientists. TYK2 is a member of the JAK family and functions as a critical mediator in cytokine signaling pathways implicated in multiple immune-mediated disorders, such as psoriasis and inflammatory bowel disease. BGB-23339 is a potent, highly selective, investigational TYK2 inhibitor targeting the regulatory pseudokinase (JH2) domain. The first-in-human Phase 1 trial (NCT05093270) is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of BGB-23339. 

BeiGene Announces Approval of BRUKINSA (zanubrutinib) in the European Union for Treatment of Adults With Waldenström’s Macroglobulinemia

Ridgefield Park-based BeiGene announced that the European Commission (EC) approved BRUKINSA® (zanubrutinib) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy. The approval is applicable to all 27 European Union (EU) member states, plus Iceland and Norway. BeiGene is working to make this new treatment option available to WM patients in the EU as quickly as possible. The EC approval for BRUKINSA follows a positive opinion granted in September by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), based on the results of the ASPEN trial. 

BeiGene and EUSA Pharma Announce NMPA Approval of SYLVANT® (Siltuximab for Injection) in China for Idiopathic Multicentric Castleman Disease

Ridgefield Park-based BeiGene and EUSA Pharma announced that the China National Medical Products Administration (NMPA) has approved SYLVANT® (siltuximab for injection) for the treatment of adult patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpes virus-8 (HHV-8) negative, also known as idiopathic MCD (iMCD). This disease is a rare, life-threatening, and debilitating condition of the lymph nodes and related tissues. Siltuximab is a monoclonal antibody approved in the United States, European Union and other countries and regions around the world. 

FDA Approves Multi-Dose Presentation of Seqirus Bird Flu Vaccine

The Food & Drug Administration approved a multi-dose vial presentation of Audenz, a vaccine made by Summit-based Seqirus for individuals six months and older against bird flu, also known as influenza A or H5N1. Audenz was originally approved by the FDA in February 2020 in prefilled syringe presentation, and the approval of a multi-dose vial presentation marks an “important milestone in the company’s pandemic preparedness efforts in partnership with Biomedical Advanced Research and Development Authority,” the company said. BARDA is a component of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, and under the terms of a public-private partnership established in 2009, Seqirus will position itself to deliver 150 million influenza vaccine doses to the U.S. government to support a flu pandemic response within six months. 

BrainStorm Cell Therapeutics Announces the Presentation of New Analyses from the Phase 3 Trial of NurOwn® in ALS at the 4th Annual ALS ONE Research Symposium

Hackensack-based BrainStorm Cell Therapeutics announced the presentation of new analyses from the Phase 3 trial of NurOwn at the ALS ONE Research Symposium. The presentation showed that although the Phase 3 trial did not reach statistical significance on the primary and secondary endpoints, pre-specified and post hoc analyses leveraging different methods of exploring the heterogeneity of baseline disease in the trial, revealed the potential for a meaningful treatment effect across endpoints when focusing on a subset of participants with less severe disease at baseline. The observed potential treatment effect of NurOwn on ALS disease progression in participants with less severe disease was protected by randomization. 

BrainStorm Cell Therapeutics and Catalent Announce Completion of Technology Transfer for NurOwn® Manufacturing

Hackensack-based BrainStorm Cell Therapeutics and SOMERSET-based Catalent announced that the technology transfer for NurOwn® manufacturing at Catalent's facility has been finalized. NurOwn is BrainStorm's autologous cellular therapy being developed for the treatment of amyotrophic lateral sclerosis (ALS), progressive multiple sclerosis (PMS) and other neurodegenerative diseases. Catalent entered into a partnership with Brainstorm in 2020 to provide CGMP clinical supply of NurOwn, in anticipation of the product candidate's potential regulatory approval. 

Quizartinib Added to Chemotherapy Demonstrates Superior Overall Survival Compared to Chemotherapy Alone in Adult Patients With Newly Diagnosed FLT3-ITD Positive AML

Basking Ridge-based Daiichi Sankyo announced positive topline results from the global pivotal QuANTUM-First Phase 3 trial evaluating quizartinib, a highly potent and selective FLT3 inhibitor, in patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML). QuANTUM-First met its primary endpoint, demonstrating that patients who received quizartinib in combination with standard induction and consolidation chemotherapy and then continued with single agent quizartinib had a statistically significant and clinically meaningful improvement in overall survival (OS) compared to those who received standard treatment alone. The safety of quizartinib was shown to be manageable and consistent with the known safety profile. AML is one of the most common forms of leukemia in adults, representing about one-third of all cases. 

TROPION-Breast01 Phase 3 Trial of Datopotamab Deruxtecan Initiated in Patients With Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

Basking Ridge-based Daiichi Sankyo announced that the first patient was dosed in the global TROPION- Breast01 Phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (Dato-DXd), a TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca, in patients with hormone receptor (HR) positive, human epidermal growth factor 2 receptor (HER2) negative inoperable or metastatic breast cancer previously treated with chemotherapy. Breast cancer is the most common cancer worldwide with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths globally. Approximately 70% of all breast cancers are considered HR positive, HER2 negative.

Daiichi Sankyo Initiates Phase 2 Trial of mRNA Vaccine Against COVID-19 (DS-5670) in Japan

Basking Ridge-based Daiichi Sankyo announced that the first patient has been dosed in a Phase 2 trial in Japan of DS-5670, an mRNA vaccine against the novel coronavirus infectious disease (COVID-19). This Phase 2 trial is being conducted in 80 unvaccinated healthy adults using a batch of DS-5670 from the optimized manufacturing process to evaluate the safety and determine the recommended dose of DS-5670. If successful, a Phase 3 trial of DS-5670 will be initiated within FY2021. Daiichi Sankyo also will continue discussions with the Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) to determine next steps for initiating development of a supplemental (booster) dose of DS-5670 by January 2022. 

EOM Pharmaceuticals, Inc. and Immunocellular Therapeutics, Ltd. Announce Entry into and Close of Definitive Merger Agreement

Montvale-based EOM Pharmaceuticals and ImmunoCellular Therapeutics announced that the companies have entered into and closed on a merger agreement pursuant to which the shareholders of EOM are now the majority shareholders of the combined company. The merger will create a public company that will continue EOM's focus on advancing novel immunomodulatory and retinal disease drug agents to address a range of inflammatory, viral, retinal and other diseases. ImmunoCellular will be renamed EOM Pharmaceuticals Holdings, Inc. EOM Founder, Board Chairman, and Chief Operating Officer Eli Goldberger said, "EOM's merger with ImmunoCellular provides the resources necessary to advance our lead program, EOM613, as a potential treatment for COVID-19, as well as support the development of both EOM613 and EOM147."

Aerie Concludes Exclusive License Agreement With Santen for Rhopressa® and Rocklatan® in Europe and Several Other Regions

Bedminster-based Aerie Pharmaceuticals announced that Aerie and Santen have entered into an exclusive development and commercialization agreement for Rhopressa®/Rhokiinsa® (netarsudil ophthalmic solution) 0.02% and Rocklatan®/Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%. The expanded collaboration includes Europe, Commonwealth of Independent States (CIS) countries, China, India, parts of Latin America and the Oceania countries. Aerie is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, ocular surface diseases and retinal diseases. Rhopressa® and Rocklatan® are approved and being sold in the United States by Aerie. 

BD Acquires Venclose, Inc. to Extend Treatment Innovations in Chronic Venous Disease

Franklin Lakes-based Becton, Dickinson and Company announced it has acquired Venclose, Inc., a provider of solutions for the treatment of chronic venous insufficiency (CVI) — a disease that is the result of malfunctioning valves and can lead to varicose veins. CVI represents a significant and growing therapeutic need within the health care system — impacting up to 40% of women and 17% of men in the United States. Venclose is a leader in CVI treatment through its innovative Radio Frequency (RF) ablation technology platform designed for versatility, efficiency and simplicity. RF ablation is the predominant treatment of CVI and has wide acceptance among physicians. 

BD Announces Intent to Spin Off Diabetes Care Business to Enhance Focus on Innovation and Priority Growth Markets

Franklin Lakes-based Becton, Dickinson and Company announced its board of directors has unanimously authorized management to proceed with a plan to spin off the company's Diabetes Care business as an independent, publicly traded company. "The decision to spin off our Diabetes Care business is part of our active portfolio management and consistent with our BD 2025 strategy to Grow, Simplify and Empower," said Tom Polen, Chairman, CEO and President of BD. "The spinoff will allow BD to strengthen its growth profile, enables a greater investment focus on our other core businesses and high-growth opportunities, and makes a greater impact for our customers and patients."

NJ Bio Expands Its State-of-the-Art Facility in Princeton

Integrated chemistry service provider NJ Bio announced that it expanded its Princeton laboratory and headquarters from 35,000 square feet to approximately 79,000 square feet. This expansion is significant because it will allow the biopharmaceutical company to support the development and good manufacturing practice manufacturing of Antibody Drug Conjugates to meet the growing and urgent demand for clinical assets in this field. NJ Bio is aggressively hiring synthetic organic, bioconjugation and oligonucleotide chemists, as well as analytical and quality assurance/quality control personnel to increase capacity and build up its GMP manufacturing capabilities. 

Alfred Sanzari Enterprises Inks 160K Sq. Ft. Renewal With Nation’s Largest Specialty Laboratory in Elmwood Park

Hackensack-based Alfred Sanzari Enterprises said that BioReference Laboratories signed a long-term lease renewal for approximately 160,000 square feet of industrial space at 481 and 487 Edward H. Ross Drive in Elmwood Park. BioReference is one of the nation’s largest full-service specialty laboratories, servicing approximately 19 million patients annually with a leading position in genetics, women’s health, oncology and urology. The company operates a network of 10 laboratory locations and serves as an industry leader in custom solutions for COVID-19 testing, including point-of-care testing and large-scale screening programs, which have been crucial in the nation’s pandemic response. 

People in the News


Oyster Point Pharma Announces Expansion of Executive Leadership Team to Support Commercialization of Tyrvaya™ (varenicline solution) Nasal Spray for the Signs and Symptoms of Dry Eye Disease

Princeton-based BioNJ Member Oyster Point Pharma announced the promotion of Barry Rosenfeld, JD as General Counsel, and Raegan A. McClain, JD, LLM, CCEP as Chief Compliance offer, both of whom will join the executive leadership team. “Our focus at Oyster Point Pharma is to commercialize TyrvayaTM (varenicline solution) Nasal Spray and rapidly advance our pipeline forward. Barry and Raegan have significant expertise across the legal and compliance functions within the pharmaceutical industry. We look forward to their counsel as we continue to build Oyster Point into a leading company in the eye care space,” said Dr. Jeffrey Nau, President and CEO of Oyster Point Pharma.

Matinas BioPharma Appoints Thomas Hoover, M.B.A. as Chief Business Officer

Bedminster-based BioNJ Member Matinas BioPharma announced the appointment of Thomas Hoover to the newly created position of Chief Business Officer. Mr. Hoover’s role will include business and corporate development, strategic planning, licensing, and alliance management. Mr. Hoover has nearly 20 years of strategic biopharmaceutical experience in business and corporate development roles, as well as new product planning across a wide range of therapeutic categories including CNS, oncology, cell therapy, autoimmune diseases, endocrinology and CV/metabolic. Thomas was most recently Chief Business Officer and Chief Commercial Officer at Millendo Therapeutics. Prior to that role, Mr. Hoover was Vice President of Corporate Development and New Product Planning for Sunovion.

Johnson & Johnson Appoints Senior Leaders to Executive Committee

New Brunswick-based BioNJ Member Johnson & Johnson appointed several senior leaders to the company’s Executive Committee. As previously announced, Alex Gorsky will serve as Executive Chairman of Johnson & Johnson and transition the CEO role to Joaquin Duato. The new Executive Committee appointments are as follows: Vanessa Broadhurst, Company Group Chairman, Global Commercial Strategy Organization, has been appointed Executive Vice President, Global Corporate Affairs; Bill Hait, Global Head of Johnson & Johnson External Innovation, has been appointed Executive Vice President, Chief External Innovation, Medical Safety and Global Public Health Officer; Mathai Mammen, Global Head of Research & Development at the Janssen Pharmaceutical Cos. of Johnson & Johnson, has been appointed Executive Vice President, Pharmaceuticals, R&D; and James “Jim” Swanson, Chief Information Officer, has been appointed Executive Vice President, Chief Information Officer.

18 from New Jersey Included on Newsweek’s America’s Most Responsible Companies 2022 List, With 1 in Top 10

Newsweek Magazine recently announced its third annual Most Responsible Companies for 2022. Newsweek, in partnership with Statista — one of the largest statistics database companies worldwide — evaluated America’s Most Responsible Companies based on the 2,000 largest public companies by revenue in the U.S. The final list recognizes the Top 500 performing companies spanning 14 industries that are making a difference through their environmental, social and corporate governance actions in the nation. Eighteen companies from New Jersey were ranked on the list, with BioNJ Member Merck & Co. in Kenilworth landing in the Top 10 overall. Congratulations to these BioNJ Members for making the list: Amgen, Biogen, Bristol Myers Squibb, Gilead Sciences, Jones Lang LaSalle, Korn Ferry, Merck, Pfizer and Thermo Fisher.

NJBIZ Unveils 2021 Reader Rankings Winners

The results are in for the 2021 NJBIZ Reader Rankings. In more than 50 categories, the Reader Rankings identify the best of New Jersey across a range of businesses and industries as chosen by the State’s business owners, clients and colleagues. Congratulations to these BioNJ Members for making the list: CBRE, Choose New Jersey, Ernst & Young, Hackensack University Medical Center, Insperity, Inc., Johnson & Johnson, Merck & Co., New Jersey Economic Development Authority, New Jersey Institute of Technology, New Jersey State Chamber of Commerce, Princeton Public Affairs Group and Rutgers, the State University of New Jersey.

Rocket Pharmaceuticals Appoints Industry Veteran as Chief Compliance Officer, General Counsel

Cranbury-based Rocket Pharmaceuticals appointed Martin Wilson — who has nearly 20 years of legal, compliance and executive experience and accomplishment within the life sciences industry — as Senior Vice President, Chief Compliance Officer and General Counsel. Mr. Wilson will be responsible for the legal and compliance functions of the of the clinical-stage biotechnology company and serve as a key member of the leadership team. Prior to joining Rocket, Mr. Wilson was General Counsel and Chief Corporate Officer at Ichnos Sciences. Before Ichnos, he served as General Counsel, Chief Compliance Officer, Corporate Secretary and Head of Human Resources at Teligent, and, prior to that, he was Vice President and Assistant General Counsel at Endo Pharmaceuticals following the acquisition of Par Pharmaceuticals.

Red Bank Pharma Firm Appoints SVP of Clinical Development

Red Bank-based Provention Bio appointed Dr. Jan Hillson as Senior Vice President of clinical development. Dr. Hillson bolsters the company’s clinical development leadership group with significant experience in all phases of clinical development across various autoimmune disorders. Dr. Hillson brings over two decades of experience in academic research, patient care, teaching and directing strategy and operations of clinical research and translational medicine programs. She most recently served as Senior Vice President of Clinical Development, at Alpine Immune Sciences. She also served as Senior Vice President of Clinical and Translational Research at ChemoCentryx.

BD Names New SVP of Investor Relations

Franklin Lakes-based Becton, Dickinson and Co. named Francesca DeMartino as Senior Vice President of Investor Relations. In this role, Ms. DeMartino will lead all aspects of communicating progress of the BD2025 strategy to investors and the financial community, including the company’s initiatives that drive shareholder value. She succeeds Kristen Stewart, who has been named Senior Vice President of Enterprise Strategy and Insights for BD. Ms. DeMartino has more than 20 years of combined experience in investor relations, communications and corporate finance, with her most recent position as Vice President of Investor Relations at Medtronic.

BD Names New Chief Scientific Officer

Franklin Lakes-based Becton, Dickinson and Co., named Joseph Smith as its Senior Vice President and Chief Scientific Officer. Mr. Smith has greater than 30 years’ experience in the digital health technology sector and will be primarily responsible for external innovation and BD’s technology roadmap to deliver transformative innovations that align to three irreversible forces driving the future of health care: smart connected care, the transition to new care settings and chronic disease. Mr. Smith joins BD from Digital Health Corp, where he served as President and CEO, responsible for the company’s strategy to invest in or acquire digital health and therapeutic technologies.


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CSIT to Launch New Catalyst Seed R&D Grant Program Dec. 6

The New Jersey Commission on Science, Innovation and Technology (CSIT) announced the creation of a $1.5 million Catalyst Seed Research and Development (R&D) Grant Program to help New Jersey-based start-ups accelerate development of technologies. The funding will help the companies transform new discoveries from the research stage into commercially viable products and services. The Catalyst Seed R&D Grant Program will be open to companies conducting R&D or testing technologies in the following areas that were identified as targeted industries in Governor Phil Murphy’s economic development plan, “The State of Innovation: Building a Stronger and Fairer Economy in New Jersey”. The program will offer two grant components: Grants of up to $150,000 for projects that are developing life sciences therapeutics and grants of up to $75,000 for other innovation projects – non-life sciences therapeutics drug R&D projects and projects that are not eligible for the Clean Tech Seed Grant.



Halm Named Inaugural Vice Chancellor of Population Health at Rutgers

Dr. Ethan Halm, a Professor of Internal Medicine and Population and Data Sciences at University of Texas Southwestern Medical Center, has been named the first Vice Chancellor of Population Health at Rutgers University. In the role, Dr. Halm will oversee initiatives that will examine and offer better solutions to prevent disease, and to manage populations with chronic illnesses such as diabetes and heart disease that cost the United States billions each year in health care costs. Dr. Halm will join Rutgers in January 2022. Dr. Halm’s research focuses on improving cancer screening and chronic disease management, developing clinical prediction models using electronic health records data, understanding patient, provider, system and community factors that influence the quality and outcomes of care, and implementing interventions to foster more evidence-based, patient-centered, equitable and cost-conscious care.

3D Information and Biomedicine: How Artificial Intelligence/Machine Learning will Contribute to Cancer Patient Care and Vaccine Design

Artificial Intelligence/Machine Learning (AI/ML) is the development of computer systems that are able to perform tasks that would normally require human intelligence. AI/ML is used by people every day, for example, while using smart home devices or digital voice assistants. The use of AI/ML is also rapidly growing in biomedical research and health care. In a recent viewpoint paper, investigators at Rutgers Cancer Institute of New Jersey and Rutgers New Jersey Medical School (NJMS) explored how AI/ML will complement existing approaches focused on genome-protein sequence information, including identifying mutations in human tumors.

Rowan University Launches National Search for 10 Sustainability ‘Catalysts’

Rowan University is conducting a national search for 10 new faculty to develop, advance and communicate solutions to humanity’s most pressing existential threats posed by the climate and biodiversity crises. A university-wide Catalysts for Sustainability cohort will lead and collaborate across its colleges, disciplines and communities, driving new initiatives in sustainability research, advocacy and education. The Top 100 public research university is recruiting a diverse pool of researchers with expertise in one or more of the following areas: environmental justice; education and public engagement, including storytelling, public policy and advocacy, discipline-specific sustainability scholarship and sustainability practice.

Atlantic Health-CentraState Partnership Gets Final Regulatory Approval

A unique health care partnership in which Atlantic Health System will become the majority corporate member in CentraState Healthcare System — and CentraState will join the Atlantic Health System network of care — received the final signoff from a New Jersey judge. The ruling, the final regulatory step needed to complete the co-membership transaction, will officially take effect Jan. 1. Officials from both organizations said the partnership will deliver immediate benefits to patients, physicians and caregivers in CentraState’s communities by strengthening its integrated clinical services, physician network and infrastructure through a capital investment of $135 million.

Virtua Health Recruits Renowned Cardiothoracic Surgeon to Lead Cardiovascular Services Line

Virtua Health has a new leader for cardiovascular services. Dr. Chun “Dan” Choi, has been named Vice President of Clinical Operations for the South Jersey health system’s cardiovascular service line. A renowned cardiothoracic and transplant surgeon, Dr. Choi will oversee Virtua Medical Group’s medical and surgical cardiovascular practices and the clinical aspects of the cardiovascular services for Virtua Health. He was previously with the Johns Hopkins University School of Medicine, where he was surgical director of the mechanical circulatory support program and associate program director of the cardiothoracic surgery residency program.

Jefferson Health Names New Chief Quality & Safety Officer

Jefferson Health – New Jersey said it appointed Dr. David May as Vice President and Chief Quality and Safety Officer for the system’s three acute care hospitals and numerous outpatient facilities. At the Cherry Hill-based system, Dr. May will be responsible for overseeing quality, patient safety, infection control, clinical risk management, patient experience and outcomes and managing Jefferson’s leading enterprise safety management system, OnPoint. He joins Jefferson from Shore Medical Center, where he had served as Chief of General Surgery since 2018 and as Chair of its Hospital Quality & Safety Committee since 2014.



Vaccine Information Session with the Governor’s Office and Department of Health

December 16, 2021 at 10:00 a.m.

You are invited to join us for a vaccine information session on Thursday, December 16th at 10:00 am. With much in the news about new variants, third doses, boosters, and the possible approval of a vaccine for children 12 and under, we thought it might be a good time to provide you with an update of the status of vaccines in New Jersey and answer as many questions as possible. Please feel free to share this invitation with others in your community and organization. Registration is required.

BioNJ Member Services Provider Directory


BioNJ recognizes the vital role that our Service Provider Members play in the growth of New Jersey's robust life sciences ecosystem. For this reason, we are delighted to remind our community about BioNJ's Member Service Provider Directory, a categorical listing of BioNJ Members by service sector. By working with fellow BioNJ Member organizations, you are not only supporting our community, but benefiting from a wide variety of high quality organizations. To learn how you can become a Member and be featured on this resource tool, please contact Kim Minton at, or 609-890-3185. Find providers in these categories:


Please contact BioNJ with any questions.  | 609-890-3185 |

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