Weekender Fisher.png

January 21, 2022

a6eae9b3-a027-43c5-b7d7-2f5971be3b18 image

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

BioNJ is sad to learn of the passing of Dr. Bonita Stanton, the founding dean of the Hackensack Meridian School of Medicine. Dr. Stanton will be remembered for her extraordinary leadership -- forever transforming the health care and innovation landscape in New Jersey. She will be missed and her legacy will live on.

As New Jersey’s life sciences trade association, BioNJ believes that Patients should have access to the treatments they need when they need them. Unfortunately, we remain concerned with policy proposals that could limit Patients’ access to desperately needed medicines and therapies…proposals such as “value” assessments that rely on cost considerations to assess coverage of a particular treatment or restricted Medicaid formularies rather than the overall value to the Patient and the health care system.


BioNJ is dedicated to working collaboratively with our elected leaders to develop policy proposals that will deliver meaningful savings to Patients as well as protect the medical innovation that is helping people lead longer, healthier lives.


We invite you to join our efforts. Receive valuable resources, keep up to date on the latest happenings in Trenton and Washington and see how you can be engaged in this effort by clicking here to receive BioNJ’s bi-weekly Public Policy Update. Together we can make a difference. Thank you.


Click here for BioNJ’s latest whitepaper on the “Facts & Myths of Prescription Drug Affordability Boards”. 

Meanwhile, we hope you will take a moment to review the BIO report on "Best Practices in Bioscience Economic Development". The report which can be accessed here provides a state-by-state comparison of incentives and support to the life sciences innovation ecosystem and we are proud to report that New Jersey’s leadership on this front is on full display. Thank you to our friends at the New Jersey Economic Development Authority for their efforts in making sure that New Jersey’s many programs are highlighted.  

Because Patients Can't Wait®,

The BioNJ Team

Welcome New Members

Learn more at www.BioNJ.org/Membership

cup hello.png

Upcoming BioNJ Events


BioNJ’s 12th Annual BioPartnering Virtual Conference

Register Today!

May 9-13, 2022

BioNJ’s 29th Annual Dinner Meeting and Innovation Celebration

Register Today!

June 9, 2022

Putting Patients First:

The Value of Medical Innovation

068caf30-e35d-41c9-8186-cde2cfb3a81d image

New Report Outlines Best Practices in Bioscience Economic Development Initiatives

The Biotechnology Innovation Organization (BIO), in partnership with the Council of State Bioscience Associations (CSBA), released a new report on bioscience economic development best practices, “Driving the Bioscience Economy Forward During the COVID-19 Pandemic: Best Practices in State and Regional Economic Development Initiatives.” Now in its sixth edition, the report, which reviewed public policy strategies and programs in all 50 states, highlights new and innovative initiatives that enhance the future of the bioscience industry. In addition to several evaluations of specific state and policy examples, the report identified seven national trends for state bioscience growth in 2021:

  • States are building career pathways for future biosciences talent.
  • States and regions are implementing an overall supportive regulatory climate to ensure predictable and stable regulatory treatment of biosciences firms.
  • States and regions are focusing on developing their agricultural, industrial, and environmental bioscience sectors in addition to their biomedical and health sectors.
  • Physical infrastructure and facilities remain a priority.
  • Universities and other research centers’ technology transfer efforts are better understood by public agencies.
  • Proximity to academic innovation is a driving influence.
  • Increased focus on biomanufacturing is the future.

Pharmacy Outlook: Stephen Ubl, PhRMA

Throughout 2021, lawmakers engaged in a robust debate over ways to lower the cost of prescription drugs. Our industry was at the center of this debate, fighting for reforms that would lower costs at the pharmacy while preserving patient access to life-saving medicines and future innovation. Unfortunately, Congress refused to take a holistic approach that would address the real affordability challenges patients experience, which means there is still a lot of work ahead to ensure every patient can access and afford the medicines they need. Improving patient affordability issues requires an accurate diagnosis of the problem. For instance, net prices for brand medicines have increased under the rate of inflation for the past five years, and in 2020 they actually declined 2.9%, on average.

New Study Finds More Than Half of Brand Medicine Spending Goes to the Supply Chain and Others

More than half of total spending on brand medicines went to the supply chain, middlemen and other stakeholders in 2020 according to a new analysis from the Berkeley Research Group (BRG). These new findings help illuminate the problems that exist throughout the health care system and why holistic, patient-centered solutions are needed to make medicines more affordable for patients. The analysis looks at all spending on brand medicines at the pharmacy or paid on a claim to a health care provider.

Private Sector’s Critical Role in Biomedical Innovation

A Fact Sheet Created by BIO

There is a misguided perception that NIH funding, not private market investment, is largely responsible for the creation and approval of new therapies. A new study by Vital Transformation tests that hypothesis by tracking more than 20,000 patents linked to NIH grant over a 20-year period, identifying those associated with clinical trials and approved medicines, and quantifying the public and private investments made for those investigational and approved medicines.

Terry Wilcox: AARP has a Conflict of Interest on Drug Pricing Legislation. That Could Hurt the Seniors it Protects

AARP is the nation’s biggest and most influential advocacy group for seniors. It has about 38 million members – more than 11% of the U.S. population. From lobbying for better conditions in nursing homes to getting travel discounts for members, the organization has done much to help retired people over the years. When it comes to one of AARP’s signature products, though, it may not always be putting its members first. The problem is that the organization is dependent on revenue from insurance companies. And while sometimes the interests of insurance companies and seniors align, at times they don’t.

BioNJ News


Verve Group Consulting Announces Sponsorship of BioNJ’s 2022 IT/Cybersecurity Awareness Newsletter Series Bedminster-based BioNJ Member Verve Group Consulting will sponsor BioNJ’s 2022 IT/Cybersecurity Awareness Newsletter Series. “We are delighted to expand our relationship with BioNJ,” said Larry Samilow, Co-Founder and Managing Director of Verve Group Consulting. “Verve Group Consulting is proud to be a founding member of BioNJ’s IT/Cybersecurity Awareness Committee dedicated to raising awareness and educating our community about the cyber threats facing New Jersey’s life sciences ecosystem. “BioNJ’s IT/Cybersecurity Awareness Newsletter Series is a great way for the community to share tactics and tools on how to protect their organizations from cybersecurity attacks and data-related breaches,” Samilow added. 

NJ Company News


Apprentice.io Scores $100M Funding for Augmented Reality Tech that Helped Drug Plants Work Through COVID-Time

Augmenting reality for pharma manufacturers has brought Jersey City-based BioNJ Member Apprentice.io lots of investment – a Series A round of $8 million in September of 2018, followed by a Series B boost of $24 million during the first eight months of the pandemic. Now comes an influx of $100 million in a Series C financing round as Apprentice.io aims to help manufacturers fortify their supply chains against threats from the spread of the omicron variant. The timing was right for the arrival of Apprentice.io and its augmented reality technology, which has helped drug makers work through the pandemic. To date, it has helped facilitate manufacturing of 370 million vaccine doses.

Novartis and Molecular Partners Report Positive Topline Data from Phase 2 Study for Ensovibep (MP0420), a Darpin Antiviral Therapeutic for COVID-19

East Hanover-based BioNJ Member Novartis and Molecular Partners announced that Part A of the EMPATHY clinical trial that compared single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate vs. placebo to treat COVID-19, met the primary endpoint of viral load reduction over eight days. The two secondary endpoints also showed clinically meaningful benefit over placebo – (1) composite endpoint of hospitalization and/or Emergency Room (ER) visits or death, and (2) time to sustained clinical recovery. Novartis confirms it will now exercise its option to in-license ensovibep from Molecular Partners and, following exercise of the option, will seek expedited access globally, first via the FDA’s EUA process.

Rafael Pharmaceuticals Announces Successful Completion of Dose Escalation With No Dose-Limiting Toxicity (DLT) in First Cohort of APOLLO 613 Phase 1/2 Clinical Trial of CPI-613® (Devimistat) in Patients With Relapsed Clear Cell Sarcoma

Cranbury-based BioNJ Member Rafael Pharmaceuticals announced the completion of the first cohort of dose escalation with no dose-limiting toxicity (DLT) in the APOLLO 613 Phase 1/2 clinical trial of CPI-613® (devimistat) in combination with hydroxychloroquine in patients with relapsed clear cell sarcoma. Rafael is also launching additional sites for the trial at Seattle Children’s and Atrium Health Wake Forest Baptist. Existing sites already enrolling patients include City of Hope in Duarte, California, Cleveland Clinic Children’s, University of Michigan’s Rogel Cancer Center and Vanderbilt University Medical Center. “The success of our first cohort of dose escalation increases our optimism that devimistat may help address the gaps for efficacious treatment methods for relapsed clear cell sarcoma,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals.

Otsuka and Lundbeck Announce FDA Approval of Supplemental New Drug Application for REXULTI® (brexpiprazole) to Treat Schizophrenia in Pediatric Patients Ages 13-17

Princeton-based BioNJ Member Otsuka and H. Lundbeck A/S announce the U.S. Food and Drug Administration has approved the supplemental new drug application of REXULTI® (brexpiprazole) for the treatment of schizophrenia in pediatric patients 13 to 17 years of age. The FDA previously granted Priority Review for the sNDA, a designation for a drug application that, if approved, would represent a significant improvement in the safety and/or effectiveness of the treatment, diagnosis, or prevention of a serious medical condition. REXULTI was approved in the U.S. in 2015 for the treatment of schizophrenia in adults and for adjunctive treatment of major depressive disorder in adults.

Agile Therapeutics and Afaxys Partner to Expand Access to Twirla® (Levonorgestrel and Ethinyl Estradiol) Transdermal System

Princeton-based BioNJ Member Agile Therapeutics announced a new alliance with Afaxys Pharma, LLC to promote Twirla® (levonorgestrel and ethinyl estradiol) transdermal system. Every year, more than 31 million Americans rely on community and public health centers to get essential care. This agreement expands access of Twirla in the U.S. family planning community and for the patients who rely on healthcare in this setting. As a trusted expert in community and public health, Afaxys is a leading provider of innovative contraceptive options, which will now include Twirla, an effective, low-dose contraceptive option in a non-daily, non-invasive patch.

PTC Therapeutics Announces Launch of 2022 Global Talent Pipeline Program

South Plainfield-based BioNJ Member PTC Therapeutics announced the launch of the company's 2022 Talent Pipeline Program, a one-year, global initiative designed to provide recent college graduates with high-quality, real-world opportunities at work. Fellow selection process, manager support and on-the-job activities are aligned with PTC's goal to attract, develop and retain the best and brightest talent. The 2022 Talent Pipeline Program will include approximately 30 Fellows for a one-year program of work experience with a stipend. Some positions will require that participants to live near PTC's research or manufacturing sites in New Jersey and California, and other positions will be remote. 

PsychoGenics’ High Data Security Standards are Certified by the NIH

Paramus-based BioNJ Member PsychoGenics announced that the National Institutes of Health has completed the assessment of PsychoGenics data/IT security standards and systems and gave official authority to operate as a government contractor. PsychoGenics provides services to the Preclinical Screening Platform for Pain, under the National Institute of Neurological Disorders and Stroke’s direction, as well as to many third-party clients and collaborators. NIH contractors are required to conform to the standards of data/IT security established by the government, including access control, data recovery, auditing and risk assessment, according to the content of the information produced, stored and transmitted.

Celularity Receives Fast Track Designation from U.S. FDA for its NK Cell Therapy CYNK-101 in Development for the First-Line Treatment of Advanced HER2/neu Positive Gastric and Gastroesophageal Junction Cancers

Florham Park-based BioNJ Member Celularity announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, CYNK-101, which is being developed in combination with standard chemotherapy, trastuzumab and pembrolizumab in patients in first-line locally advanced unresectable or metastatic HER2/neu positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. CYNK-101 is an investigational genetically modified NK cell therapy designed to synergize with approved antibody therapeutics through enhanced antibody-dependent cellular cytotoxicity (ADCC).

Helsinn Launches Fully Integrated Targeted Therapy (FITT) Strategy and Announces Leadership and Structural Changes

Iselin-based BioNJ Member Helsinn Group announced the launch of its Fully Integrated Targeted Therapy (FITT) Strategy and Board and management changes. Helsinn’s FITT strategy will focus on developing a differentiated pipeline of highly innovative oncology assets addressing unmet needs, transforming Helsinn from a leading cancer supportive care company to a fully integrated targeted therapy company. In addition to this, as previously announced, Helsinn has also entered into a non-exclusive framework agreement with BridgeBio Pharma, Inc. (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, to identify and potentially co-develop and co-commercialize preclinical precision oncology therapies.

Hillstream BioPharma Announces Pricing of Initial Public Offering

Bridgewater-based BioNJ Member Hillstream BioPharma announced the pricing of its initial public offering of 3,750,000 shares of the company’s common stock at a public offering price of $4.00 per share for aggregate gross proceeds of $15,000,000 prior to deducting underwriting discounts, commissions and other offering expenses. In addition, the company has granted the underwriters a 45-day option to purchase up to an additional 562,500 shares of common stock at the public offering price less discounts and commissions, to cover over-allotments. The net proceeds from the initial public offering will be used to advance the company’s product candidate HSB-1216 through pre-clinical activities, completion of Phase 1 studies and manufacturing, to advance the Company’s product candidate HSB-888 through pre-clinical activities and IND submission, as well as for general corporate and working capital purposes.

Celsion Corporation Announces Pricing of $30 Million Registered Direct Offerings of Convertible Redeemable Preferred Stock

Lawrenceville-based BioNJ Member Celsion Corporation announced that it has entered into a securities purchase agreement with certain institutional investors to purchase 50,000 shares of Series A convertible redeemable preferred stock and 50,000 shares of Series B convertible redeemable preferred stock. Each share of Series A and Series B preferred stock has a purchase price of $285, representing an original issue discount of 5% of the $300 stated value of each share. Each share of Series A preferred stock is convertible into shares of Celsion's common stock at an initial conversion price of $0.91 per share.

GSK and Vir Biotechnology Announce United States Government Agreement to Purchase Additional Supply of Sotrovimab, Authorised for the Early Treatment of COVID-19

Warren-based BioNJ Member GlaxoSmithKline and Vir Biotechnology announced that the U.S. Government will purchase an additional 600,000 doses of sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19, enabling further nationwide access to sotrovimab for patients. The additional 600,000 doses will be delivered throughout the first quarter of 2022. This agreement is an amendment to earlier commitments announced with the US Government. Including the commitments announced, GSK and Vir have received binding agreements for the sale of approximately 1.7 million doses of sotrovimab worldwide. Sotrovimab, which was granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) in May 2021, is an investigational single-dose intravenous (IV) infusion SARS-CoV-2 monoclonal antibody. 

Fosun Pharma and Insilico Medicine Announce a Strategic, AI-driven Drug Discovery and Development Collaboration to Jointly Advance Multiple Targets

Princeton-based BioNJ Member Fosun Pharmaceutical and Insilico Medicine entered into a collaboration agreement to advance the discovery and development of drugs targeting a number of different targets globally through the use of AI technology. This strategic collaboration includes an AI-driven drug discovery research and development (R&D) collaboration on four biological targets, as well as the co-development of Insilico’s QPCTL program. Insilico will receive a total upfront payment of $13 million for the R&D collaboration projects and the co-development of the QPCTL program, potential milestone-based payments, and share commercialization profits from the QPCTL program. In addition, Fosun Pharma will make an equity investment in Insilico.

FDA Acceptance of New Drug Application for Oral Edaravone Formulation for the Treatment of ALS

Jersey City-based BioNJ Member Mitsubishi Tanabe Pharma announced the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for an investigational oral formulation of edaravone (MT-1186) for the treatment of amyotrophic lateral sclerosis (ALS) by Mitsubishi Tanabe Pharma Development America, Inc. (MTDA) which is MTPCʼs research and development subsidiary in the US. MT-1186 is an oral suspension formulation that contains the same active ingredient as edaravone for intravenous infusion (U.S. product name: Radicava®, Japanese product name: Radicut® Injection 30 mg and Radicut® Bag for I.V. Infusion 30 mg) for ALS treatment. 

Mitsubishi Tanabe Pharma Corporation Enters into Exclusive License Agreement With ADC Therapeutics to Develop and Commercialize Loncastuximab Tesirine, Anti-CD19 Antibody Drug Conjugate (“ADC”), for Cancer in Japan

Jersey City-based BioNJ Member Mitsubishi Tanabe Pharma announced that it entered into an exclusive license agreement with ADC Therapeutics SA for the development and commercialization of Loncastuximab tesirine, their first-in-class anti-CD19 antibody drug conjugate. This agreement grants to MTPC exclusive rights to develop and commercialize Loncastuximab tesirine for all hematologic and solid tumor indications in Japan. MTPC has been conducting research and development of some antibody drug conjugate projects for the treatment of cancer at Tanabe Research Laboratories U.S.A., Inc. is very delighted to collaborate on the development of Loncastuximab tesirine with ADCT. 

Evotec Partners With Lilly to Research Metabolic Diseases

Princeton-based BioNJ Member Evotec said that it had entered into a drug discovery collaboration in metabolic diseases with Bridgewater-based BioNJ Member Eli Lilly and Company. The total potential value of the collaboration, which will run for three years, is up to $1 billion. As part of the collaboration, Evotec will explore potential drug candidates for the treatment of diabetes and chronic liver disease. Eli Lilly has the right to select up to five programs developed within the partnership and then assume responsibility for further development and commercialization. Evotec will receive an upfront payment from the U.S. company, the amount of which was not disclosed, and will receive performance-based milestone payments of up to $180 million per program and royalties on any products from the collaboration.

Evotec Expands Neuroscience Collaboration With Bristol Myers Squibb to Include New Targeted Protein Degradation Approach

Princeton-based BioNJ Member Evotec announced that the Company has expanded its neurodegeneration collaboration with Princeton-based BioNJ Member Bristol Myers Squibb with the initiation of discovery and development efforts regarding a new strategy to tackle neurodegenerative diseases including Alzheimer's through a novel approach to targeted protein degradation. Evotec receives payments totaling US$ 15 million from Bristol Myers Squibb. Under the expansion, Bristol Myers Squibb increases its access to a novel targeted protein degradation approach. The focus will be on selected targets that are relevant to a range of neurodegenerative conditions. The neurodegeneration collaboration between Evotec and Bristol Myers Squibb was initiated in December 2016 with the goal of identifying disease-modifying treatments for a broad range of neurodegenerative diseases.

Century Therapeutics and Bristol Myers Squibb Enter into a Strategic Collaboration to Develop iPSC-derived Allogeneic Cell Therapies

Princeton-based BioNJ Member Bristol Myers Squibb and Century Therapeutics announced a research collaboration and license agreement to develop and commercialize up to four induced pluripotent stem cells (“iPSC”) derived, engineered natural killer cell (“iNK”) and / or T cell (“iT”) programs for hematologic malignancies and solid tumors. The first two programs include a program in acute myeloid leukemia and a program in multiple myeloma, which could incorporate either the iNK or a gamma delta iT platform. Bristol Myers Squibb has the option to add two additional programs which can be nominated subject to certain conditions agreed with Century in the agreement.

Second Positive Phase 3 Dupixent® (dupilumab) Trial Confirms Significant Improvements for Patients With Prurigo Nodularis

Bridgewater-based BioNJ Member Sanofi announced a second Phase 3 trial evaluating Dupixent® (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease, met its primary and key secondary endpoints, showing it significantly reduced itch and skin lesions compared to placebo at 24 weeks in this investigational setting. The data confirm the positive results that were previously reported from the Phase 3 PRIME2 trial and will be submitted to regulatory authorities around the world starting in the first half of this year. The impact of prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch.

Advaxis Presents Updated Clinical Data from Ongoing Phase 1/2 Trial of ADXS-503 in NSCLC and Upcoming Milestones

Princeton-based BioNJ Member Advaxis announced updated data from the company’s ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA®. ADXS-503 is the first drug construct from the ADXS-HOT off-the-shelf, cancer-type specific, immunotherapy program which leverages Advaxis’ proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens. The Phase 1/2 clinical trial of ADXS-503 is seeking to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone and in combination with a KEYTRUDA® in approximately 50 patients with NSCLC, in at least five sites across the U.S. 

Merck’s KEYTRUDA® (pembrolizumab) Showed Statistically Significant Improvement in Disease-Free Survival Versus Placebo as Adjuvant Treatment for Patients With Stage IB-IIIA Non-Small Cell Lung Cancer Regardless of PD-L1 Expression

Kenilworth-based BioNJ Member Merck & Co. and the European Organization for Research and Treatment of Cancer and the European Thoracic Oncology Platform announced that the Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS, investigating KEYTRUDA, Merck’s anti-PD-1 therapy, met one of its dual primary endpoints of disease-free survival for the adjuvant treatment of patients with stage IB-IIIA non-small cell lung cancer following surgical resection regardless of PD-L1 expression. Based on an interim analysis review conducted by an independent Data Monitoring Committee, adjuvant treatment with KEYTRUDA resulted in a statistically significant and clinically meaningful improvement in DFS compared with placebo in the all-comer population of patients with stage IB-IIIA NSCLC.

Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Overall Survival (OS) Versus Placebo in Certain Patients With Advanced Hepatocellular Carcinoma (HCC) Previously Treated With Sorafenib

Kenilworth-based BioNJ Member Merck & Co. announced the final results from the Phase 3 KEYNOTE-394 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, plus best supportive care (BSC) in patients in Asia with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. KEYNOTE-394 is the first trial with an anti-PD-1/L1 as a second-line monotherapy treatment to show an improvement in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to placebo plus BSC for these patients. These data add to the body of evidence relating to the use of KEYTRUDA as a monotherapy in second-line HCC post sorafenib.

Merck and Ridgeback Announce Supply Agreement With UNICEF for Molnupiravir, an Investigational Oral Antiviral COVID-19 Medicine

Kenilworth-based BioNJ Member Merck & Co. and Ridgeback Therapeutics announced the signing of a long-term supply agreement with the United Nations Children’s Fund (UNICEF) to facilitate broad global access for molnupiravir, an investigational oral antiviral COVID-19 medicine. Under the agreement, Merck will allocate up to 3 million courses of molnupiravir to UNICEF throughout the first half of 2022 for distribution in more than 100 low- and middle-income countries following regulatory authorizations. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics and it has been authorized for use in more than 10 countries, including in the United States, United Kingdom and Japan.

Results From Pivotal Phase 3 KEYNOTE-775/Study 309 Trial of KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Advanced Endometrial Carcinoma Published in the New England Journal of Medicine

Kenilworth-based BioNJ Member Merck & Co. and Eisai announced the publication of results from the Phase 3 KEYNOTE-775/Study 309 trial in the New England Journal of Medicine. The pivotal study evaluated the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, versus chemotherapy (treatment of physician’s choice of doxorubicin or paclitaxel) for patients with advanced endometrial carcinoma following at least one prior platinum-based regimen in any setting. Results showed that the KEYTRUDA plus LENVIMA combination demonstrated statistically significant improvements in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to chemotherapy.

Gilead Announces Clinical Trial Collaborations With Merck to Evaluate Trodelvy® in Combination With KEYTRUDA® in First-Line Metastatic Non-Small Cell Lung Cancer

Morris Plains-based BioNJ Member Gilead Sciences announced it has entered into two clinical trial collaboration and supply agreements with Kenilworth-based BioNJ Member Merck & Co. to evaluate the combination of Gilead’s Trop-2 targeting antibody-drug conjugate Trodelvy® (sacituzumab govitecan-hziy) and Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in first-line metastatic non-small cell lung cancer (NSCLC). As part of the collaboration, Merck will sponsor a global Phase 3 clinical trial of Trodelvy in combination with KEYTRUDA as a first-line treatment for patients with metastatic NSCLC. Additionally, the companies recently established an agreement whereby Gilead will sponsor a Phase 2 signal-seeking study evaluating combinations that include pembrolizumab in first-line NSCLC.

Novo Nordisk Brokers Another Deal in Fight Against Obesity

Plainsboro-based BioNJ Member Novo Nordisk is taking another step to managing America’s longest-running epidemic – obesity. Building on its success last June in obtaining the first drug approval for weight management since 2014, the Danish pharma giant is partnering with a fresher-faced biotech, EraCal Therapeutics, to develop new obesity-related drug targets. Headquartered in Switzerland, EraCal is a four-year-old spinout based on IP licensed from Harvard and the University of Zurich. A student at both universities, Josua Jordi, was researching the feeding behavior in zebrafish as a postdoctoral fellow at Harvard when he discovered dozens of drug compounds that could alter food consumption without affecting other behaviors.

AbbVie Submits Applications for Upadacitinib (RINVOQ®) in Non-Radiographic Axial Spondyloarthritis to U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)

Madison-based BioNJ Member AbbVie announced that it has submitted applications seeking approvals for upadacitinib (RINVOQ®, 15 mg once daily) to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have responded inadequately to nonsteroidal anti-inflammatory drugs. The applications are supported by the Phase 3 SELECT-AXIS 2 (Study 2) clinical trial. In the SELECT-AXIS 2 trial (Study 2), evaluating the efficacy and safety of upadacitinib in adult patients with nr-axSpA, upadacitinib met its primary and most ranked secondary endpoints.

U.S. FDA Approves RINVOQ® (upadacitinib) to Treat Adults and Children 12 Years and Older With Refractory, Moderate to Severe Atopic Dermatitis

Madison-based BioNJ Member AbbVie announced the U.S. Food and Drug Administration has approved RINVOQ® (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended. RINVOQ 15 mg once daily can be initiated in adults and children 12 years of age and older weighing at least 40 kg. In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily.

Pfizer and Beam Enter Exclusive Multi-Target Research Collaboration to Advance Novel In Vivo Base Editing Programs for a Range of Rare Diseases

BioNJ Member Pfizer, with offices in Peapack, and Beam Therapeutics announced an exclusive four-year research collaboration focused on in vivo base editing programs for three targets for rare genetic diseases of the liver, muscle and central nervous system. The base editing programs to be evaluated as part of the collaboration will leverage Beam’s proprietary in vivo delivery technologies, which use messenger RNA (mRNA) and lipid nanoparticles (LNP) to deliver base editors to target organs. Combining these technologies with Pfizer’s proven experience in developing and manufacturing medicines and vaccines, this collaboration seeks to advance potentially transformative therapies for patients living with rare diseases.

Pfizer Enters into Agreement With Acuitas Therapeutics for Lipid Nanoparticle Delivery System for Use in mRNA Vaccines and Therapeutics

BioNJ Member Pfizer, with offices in Peapack, and Acuitas Therapeutics announced they have entered into a Development and Option agreement under which Pfizer will have the option to license, on a non-exclusive basis, Acuitas’ LNP technology for up to 10 targets for vaccine or therapeutic development. Acuitas’ clinically validated LNP technology is used in COMIRNATY®, the Pfizer-BioNTech COVID-19 vaccine. “Acuitas is extremely proud that its LNP technology contributes to the success of COMIRNATY® and is excited to be working with Pfizer to advance new vaccines and therapeutic products,” said Dr. Thomas Madden, President & CEO of Acuitas Therapeutics.

Positive Top-Line Results of Pfizer’s Phase 3 Study Exploring Coadministration of PREVNAR 20™ With Pfizer-BioNTech COVID-19 Vaccine in Older Adults Released

BioNJ Member Pfizer, with offices in Peapack, announced positive top-line results from a Phase 3 study describing the safety and immunogenicity of PREVNAR 20™ (Pneumococcal 20-valent Conjugate Vaccine) in 570 adults in the United States 65 years of age or older when administered at the same time as the Pfizer-BioNTech COVID-19 Vaccine or when each vaccine was given with placebo. Responses elicited by PREVNAR 20 for all 20 serotypes were similar whether given with a dose of the Pfizer-BioNTech COVID-19 Vaccine or with placebo. Responses to a booster dose of the Pfizer-BioNTech COVID-19 Vaccine were also similar when given with PREVNAR 20 or given with placebo.

Pfizer Shares In Vitro Efficacy of Novel COVID-19 Oral Treatment Against Omicron Variant

BioNJ Member Pfizer, with offices in Peapack, shared results from multiple studies demonstrating that the in vitro efficacy of nirmatrelvir, the active main protease (Mpro) inhibitor of PAXLOVID™ tablets and ritonavir tablets), is maintained against the SARS-CoV-2 variant Omicron. Taken together, these in vitro studies suggest that PAXLOVID has the potential to maintain plasma concentrations many-fold times higher than the amount required to prevent Omicron from replicating in cells. In the first of these in vitro studies conducted by Pfizer, nirmatrelvir was tested against the Mpro – an enzyme that the coronavirus needs to replicate – from several SARS-CoV-2 variants of concern (VoCs), including Omicron, in a biochemical assay. 

U.S. FDA Approves Pfizer’s CIBINQO® (abrocitinib) for Adults With Moderate-to-Severe Atopic Dermatitis

BioNJ Member Pfizer, with offices in Peapack, announced that the United States (U.S.) Food and Drug Administration (FDA) approved CIBINQO® (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. CIBINQO is approved at the recommended doses of 100 mg and 200 mg, with the 200 mg dose being recommended for patients who are not responding to the 100 mg dose. 

Johnson & Johnson Medical Devices Companies Announces Strategic Partnership With Microsoft to Further Enable its Digital Surgery Solutions

New Brunswick-based The Johnson & Johnson Medical Devices Companies announced that it will collaborate with Microsoft to further enable and expand JJMDC’s secure and compliant digital surgery ecosystem. The Microsoft Cloud will help JJMDC realize its vision of driving innovation that advances skills, improves workflow, and enhances surgical decision making for a better overall customer experience and improved patient and economic outcomes. JJMDC’s innovative medical technology exists across an ecosystem that includes next generation robotics, world-class instrumentation, advanced imaging and visualization, data and analytics, artificial intelligence, machine learning and digital solutions. 

China NMPA Approves Tislelizumab as Second- or Third-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Ridgefield Park-based BeiGene announced that the China National Medical Products Administration has approved BeiGene’s anti-PD-1 antibody tislelizumab as a second- or third-line treatment for patients with locally advanced or metastatic non-small cell lung cancer. A supplemental biologics license application for tislelizumab in this indication was previously accepted for review by the China NMPA in March 2021. The approval of tislelizumab was supported by clinical results from a randomized, open-label, global Phase 3 trial RATIONALE 303 comparing tislelizumab to docetaxel in the second- or third-line setting in patients with locally advanced or metastatic NSCLC who have progressed on prior platinum-based chemotherapy.

FDA Accepts for Review LIBTAYO® (CEMIPLIMAB-RWLC) in Combination With Chemotherapy for First-Line Treatment of Advanced NSCLC

Basking Ridge-based Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) in combination with chemotherapy as first-line treatment in advanced non-small cell lung cancer (NSCLC). The target action date for the FDA decision is September 19, 2022. The sBLA is supported by results from a randomized, multicenter Phase 3 trial that investigated Libtayo in combination with a physician's choice of platinum-doublet chemotherapy (Libtayo combination), compared to platinum-doublet chemotherapy alone. Enrolled patients (n=466) had locally advanced or metastatic NSCLC, irrespective of PD-L1 expression level or tumor histology, and with no ALK, EGFR or ROS1 aberrations.

Regeneron and Ultragenyx Collaborate to Commercialize Evkeeza® (Evinacumab) Outside the United States

Basking Ridge-based Regeneron Pharmaceuticals and Ultragenyx Pharmaceutical announced a license and collaboration agreement for Ultragenyx to clinically develop, commercialize and distribute Evkeeza® (evinacumab) in countries outside of the U.S. This includes the European Economic Area, where Evkeeza was approved in June 2021 as a first-in-class therapy for use together with diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies to treat adults and adolescents aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). Regeneron discovered and developed Evkeeza and launched the medicine in the U.S. in February 2021 when it was approved by the FDA.

Ascendis Pharma A/S Receives European Approval for TransCon™ hGH for Pediatric Growth Hormone Deficiency

Princeton-based Ascendis Pharma A/S announced that the European Commission (EC) has granted marketing authorization for Lonapegsomatropin Ascendis Pharma (developed under the name TransCon hGH) as a once-weekly subcutaneous injection for the treatment of children and adolescents ages 3 to 18 years with growth failure due to insufficient secretion of endogenous growth hormone (also known as growth hormone deficiency, or GHD). TransCon hGH is a prodrug of somatropin that provides sustained release of unmodified somatropin (hGH) at predictable therapeutic levels in the body. The EC approval is based on clinical results submitted in the Marketing Authorisation Application (MAA), including data from the company’s Phase 3 heiGHt, fliGHt and enliGHten Trials, which collectively treated more than 300 pediatric patients diagnosed with GHD, as well as data from a non-clinical safety program.

Glenmark Specialty S.A. (Switzerland) Receives NDA Approval by the United States Food and Drug Administration (FDA) for Ryaltris™ Nasal Spray for the Treatment of Symptoms of Seasonal Allergic Rhinitis in Adults and Pediatric Patients 12 Years of Age and Older

Mahwah-based Glenmark Pharmaceuticals announced that its fully owned subsidiary Glenmark Specialty S.A. received FDA approval on its New Drug Application (NDA) for Ryaltris™, an innovative, fixed- dose (metered), prescription, combination drug product nasal spray for the treatment of symptoms of Seasonal Allergic Rhinitis in adults and pediatric patients 12 years of age and older in the United States. Ryaltris™ will be marketed and distributed in the United States (US) by Hikma Specialty U.S.A., Inc., as part of its exclusive licensing agreement with Glenmark Specialty S.A 

ENHERTU® Granted Priority Review in the U.S. for Patients With HER2 Positive Metastatic Breast Cancer Treated With a Prior Anti-HER2-Based Regimen

Basking Ridge-based Daiichi Sankyo and AstraZeneca have received notification of acceptance by the U.S. Food and Drug Administration (FDA) of the supplemental Biologics License Application (sBLA) of ENHERTU® (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients in the U.S. with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2- based regimen. The application has also been granted Priority Review. The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. 

Daiichi Sankyo Sells 8 Cardiovascular Drugs to South Plainfield-Based Pharma Company

Cosette Pharmaceuticals is making a move toward diversification that it hopes will be a launching pad for future portfolio expansion and growth. The South Plainfield-based specialty pharmaceutical company said it purchased the U.S. sales and distribution rights to eight cardiovascular drugs from Basking Ridge-based Daiichi Sankyo. The agreement outlines a 30-month transition period during which Daiichi Sankyo and Cosette Pharmaceuticals will transfer responsibilities for the manufacture, supply and commercialization of these products, including quality assurance, pharmacovigilance and regulatory matters. “This transformative acquisition represents a significant expansion and diversification of Cosette’s portfolio and business,” said Apurva Saraf, Cosette’s CEO and President. 

People in the News


Tony Wood Appointed Chief Scientific Officer Designate, GSK

Warren-based BioNJ Member GlaxoSmithKline plc (GSK) announced the appointment of Tony Wood as Chief Scientific Officer (CSO) designate. Dr. Wood will assume full accountability for Research and Development (R&D) from current CSO, Dr. Hal Barron, on August 1, 2022. Dr. Wood is a highly respected scientist and one of the world’s pre-eminent chemists, with more than 30 years of experience working across diverse disciplines of R&D to deliver innovative medicines. He joined GSK from Pfizer in 2017, as Senior Vice President, Medicinal Science and Technology, and is responsible for all science and technology platforms supporting the discovery, clinical development and delivery of new medicines across GSK.

Lawrenceville Pharma CDMO Announces Appointment of Sellig as CEO

Lawrenceville-based BioNJ Member Adare Pharma Solutions has appointed Tom Sellig as its CEO. Mr. Sellig, a 30-year veteran of the pharmaceutical and life sciences industries, will lead the organization in supporting pharmaceutical companies in the development and manufacturing of transformative medicines that improve patient health and outcomes. Mr. Sellig served as CEO of LabConnect, a leading global provider of central laboratory and support services for the biopharmaceutical industry. Prior to LabConnect, he was Chief Commercial Officer for ConnectiveRx. Before joining ConnectiveRx, Mr. Sellig served as Senior Vice President of Global Sales at Patheon, where he played an integral role in the company’s sale to and integration with Thermo Fisher.



Coriell Institute for Medical Research: A Legacy of Innovation, a Future of Possibility

In Camden, the Coriell Institute for Medical Research is home to world’s most diverse biobank collection. Coriell supports scientific endeavors, large and small alike, through biobanking, laboratory services and independent translational research. The collection of cell line and DNA samples in Coriell’s care constitute one of the most diverse and important repositories in the world. These samples are relied on for genomic research and are used in standards and equipment validation in many laboratories around the world. Coriell also offers its laboratory services to the greater scientific community. This can dramatically cut the investment needed for a growth stage biotech company to get started. 

Rutgers Names Danielle Dick as Inaugural Director of the Rutgers Addiction Research Center

Danielle Dick, an internationally recognized and award-winning expert on genetic and environmental influences on human behavior, has been appointed as the inaugural Director of the Rutgers Addiction Research Center (RuARC) at the Rutgers Brain Health Institute. Dr. Dick also will be a tenured professor in the department of psychiatry at Rutgers Robert Wood Johnson Medical School. Most recently, she was the Distinguished Commonwealth Professor of Psychology and Human and Molecular Genetics at Virginia Commonwealth University in Richmond, where she directed a research institute on behavioral and emotional health. Dr. Dick’s responsibilities will include leveraging the multidisciplinary expertise among scientists and clinicians across Rutgers to advance understanding of, and develop new treatments for, drug addiction.

FluidForm Announces Investment from Hackensack Meridian Health

FluidForm announced an investment from Hackensack Meridian Health and its Bear’s Den innovation program. The investment will enable FluidForm to advance key applications in tissue for drug discovery and surgical repair, including collaboration on preclinical work in 2022. The investment comes amid rapid company growth. FluidForm has recently accomplished several key milestones, including establishing a pilot biofabrication line, receiving grants from both NIH and NSF for foundational work on key programs in collaborating with multiple life sciences companies. This investment in Fluid Form is Hackensack Meridian Health’s sixth through the Bear’s Den, the health network’s successful innovation program, which seeks to drive medical science forward by supporting strategic candidates in biotech and pharma. 

New Gene Sequencing Technology Comes to Cooper University Health Care

The Department of Pathology at Cooper University Health Care has added the Genexus Integrated Sequencer, a new, fully automated, next-generation rapid gene sequencing technology to its diagnostic resources. Gene sequencing allows physicians and scientists to identify and understand the genetic profiles of many viruses, tumors and other specimens. Cooper is one of a very few health systems in New Jersey that is able to perform next-generation gene sequencing on site. The new technology will enable it to identify COVID-19 variants for those patients tested, which will provide valuable information about the spread of the virus and how it is changing.

MD Anderson Cancer Center at Cooper Receives $9K for Colon Cancer Research

Camden Police Chief Gabriel Rodriguez, representatives from Fraternal Order of Police Lodge 218 and the family of Officer Matthew Sviben visited MD Anderson Cancer Center at Cooper recently to present a check for $9,000 in honor of Officer Sviben. Officer Sviben died in September at the age of 26 after being diagnosed with Stage IV colorectal cancer in January 2020, just days after he graduated from the police academy and joined the Camden County Police Department. Approximately 230 Camden County Police Department officers grew out their mustaches, beards and sideburns during a month-long “No Shave November” observance to raise the funds. 



CSIT Awards $1,075,000 Through Third Round of NJ SBIR/STTR Direct Financial Assistance Program

The New Jersey Commission on Science, Innovation and Technology announced that 37 early stage companies have been awarded a total of $1,075,000 in funding as part of Round 3 of the Direct Financial Assistance component (Phase I&II) of the Small Business Innovation Research and Small Business Technology Transfer Program. The CSIT has awarded a total of $1.9 million to 66 Garden State companies during the program’s three funding rounds. Each of these early stage companies are currently engaged in the federal SBIR and/or STTR programs. The awards will fortify the State’s innovation economy by giving these New Jersey-based businesses the strength and resources they need to be competitive when participating in federal programs.

NJEDA Now Accepting Applications for Aspire Development Tax Credit Program

The New Jersey Economic Development Authority (NJEDA) has began accepting applications for the Aspire program, a place-based economic development program created under the New Jersey Economic Recovery Act of 2020 (ERA). The Aspire program supports mixed-use, transit-oriented development by providing tax credits to commercial and residential real estate development projects that have financing gaps. The Aspire program application, as well as complete rules, eligibility requirements, award sizes and other information, are available at https://www.njeda.com/aspire.

Catalyst Seed R&D Grant Program: Application Deadline Approaching

The New Jersey Commission of Science, Innovation and Technology’s Catalyst Seed R&D Grant Program has a total budget of $1,500,000 for awards. Applicants developing life sciences therapeutics can apply for grants of up to $150,000, all other applicants are eligible to apply for grants of up to $75,000. The goal of the Catalyst Seed R&D Grant Program is to help New Jersey-based early stage innovation-based companies accelerate development of technologies to transform new discoveries from research stage into commercially viable products and services. The grant funds should enable Applicants to make significant progress and have a meaningful impact on their commercialization outcomes.



De-Risking Biotech: Panel Discussion

January 25, 2022

Join the Princeton Innovation Center BioLabs and colleagues at BioLabs@NYU for a panel discussion about how start-ups can work with law firms to enhance success and de-risk endeavors at various stages of a start-up. Panelists will talk the tools and insights that law firms can provide on topics such as partnerships, resources and risk capital. 

Clinical Research Management Collaborative Training Series

January 26, 2022

Interested in Expanding your Knowledge in Clinical and Translational Sciences? The New Jersey Alliance for Clinical and Translational Sciences (NJ ACTS) is inviting you to attend the final session of our three-part training series geared to the advancement of clinical and translational research. This virtual event entitled, "Demystifying Decentralized Clinical Trials in Academic Research Centers" is scheduled to take place on Wednesday, January 26th. All interested are invited to attend!  

2nd Annual Princeton Women Founders Start-Up Showcase

January 27, 2022

Presented by Princeton Entrepreneurship Council, this year’s event will feature six outstanding Princeton founders who represent faculty/postdoc, graduate alumna, and undergraduate alumnae across the Princeton entrepreneurial community. Each will present an overview of their start-up and then answer questions from the audience. At the conclusion of the presentations, each audience member will cast his/her vote for the “best of the best” start-up.

Intro to Design & Manufacturing of Viral Vectors in Gene Therapy

February 14-17, 2022

This online virtual training course will provide a detailed understanding in upstream and downstream processing of viral vectors used in cell and gene therapy. The course will focus on viral vector theory, technical demonstrations of bioreactors, demonstration of chromatography, principles of tangential flow filtration (TFF) and scale-up topics. The course is intended for scientists and engineers from the biopharma industry interested in learning about upstream and downstream processing of viral vectors. Attendees will need to have a basic understanding of cell culture, conventional culture methods and chromatography (affinity, protein capture).

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. To show appreciation for BioNJ Members, BIO is pleased to offer you a $200 registration discount to attend the 2022 BIO International Convention. Request your discount code by February 1, 2022!

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 KMinton@BioNJ.org, or 609-890-3185. Find providers in these categories:


Please contact BioNJ with any questions.

BioNJ@BioNJ.org  | 609-890-3185 | www.BioNJ.org

Follow us on:

Facebook  Twitter  Instagram