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October 7, 2022

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

Calling all BioNJ Members!

Join us next Wednesday, October 12, for BioNJ's Member Café -- 'open' exclusively to BioNJ Members. Taking place virtually, BioNJ's Member Café offers Members an interactive environment to engage with old friends and build new relationships. In addition to networking with fellow BioNJ Members, you'll enjoy updates on upcoming events, cost-saving business solutions and industry news. Click here to register for FREE. 

Plus, we are now accepting nominations for the 2023 Dr. Sol J. Barer Award for Vision, Innovation and Leadership. Named for Dr. Sol J. Barer, former BioNJ Chair, former Chair & CEO of Celgene Corporation and Board Chair for Teva Pharmaceutical Industries, the 2023 Dr. Sol J. Barer Award will be presented by Dr. Barer at BioNJ's 30th Annual Dinner Meeting and Innovation Celebration on Thursday, February 2, 2023, at the Hilton East Brunswick.


The Award recognizes outstanding biopharma industry business leaders who have made significant contributions to his or her own organization as well as to the growth and prosperity of the industry in New Jersey and beyond. Click here to submit your nomination by Friday, October 28. 


Meanwhile, BioNJ's C-Suite Summit, "A New Era in Life Sciences" is less than two weeks away! Check out our all-star roster of speakers by clicking here. And, plan to join us on Tuesday, October 18, at the Bridgewater Marriott for this important conversation on how the industry might evolve in coming years and how we can best prepare for (and shape) the next paradigm in life sciences. Visit for more information on this and all of BioNJ's upcoming events. Thank you.

Because Patients Can't Wait®,

The BioNJ Team

Upcoming BioNJ Events


BioNJ's Member Café

Register Today!

October 12, 2022

BioNJ's C-Suite Summit

Register Today!

October 18, 2022

BioNJ's IT/Cybersecurity Breakfast Briefing

Register Today!

October 27, 2022

BioNJ's Inspiring Women in STEM Conference

Save the Date!

December 2, 2022

BioNJ's Patient Advocacy Summit

Attendance is exclusive to Patient Advocacy Groups and R&D company Patient advocacy and government affairs professionals.

Register Today!

December 13, 2022

Putting Patients First:

The Value of Medical Innovation


Partnerships Are Driving Global COVID-19 Treatment Access

Through the constant efforts of U.S. innovators and their global partners, COVID-19 treatments have continued to be distributed to patients around the world — changing the pandemic’s treatment landscape and the trajectory of the virus’ impact. This is in no small part due to the more than 140 collaborations for COVID-19 treatments that have been signed since the start of the pandemic, as reported to PhRMA by global data provider Airfinity. Many collaboration agreements occur through the Medicines Patent Pool (MPP), a United Nations-backed organization that promotes medicine access through voluntary licensing and patent pooling. This showcases how intellectual property (IP) not only incentivizes investment in innovation, but also facilitates collaboration to increase distribution of treatments to patients in low- and middle-income countries throughout the world. 

NIH’s Impact on FDA Approvals is Statistically Zero, With Vital Transformation's Grumpy Old Men

In this podcast, Vital Transformation’s Grumpy Old Men (Harry Bowen, Joseph Hammang, and Duane Schulthess) discuss their recently published peer review study. The study, “The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals” investigates 8,000 NIH-funded patents invented from over 23,000 NIH grants to determine how much an NIH-funded discovery impacts the creation of new drugs approved by the FDA to treat patients. Additionally, the Grumpy Old Men discuss the many profound implications of the recently approved Medicare price control provisions in the Inflation Reduction Act, the World Trade Organization’s decision to exercise IP ‘TRIPS’ waivers on the core intellectual property of the mRNA technologies used by Pfizer and Moderna in the COVID-19 vaccines, and the continued attack on IP with the hypothetical use of ‘march-in rights’ for NIH-derived patents in commercially available medicines.

BioNJ in the News


BioNJ Launches Initiative to Facilitate Equity in Clinical Trials

MBA Business Plan Case Competition to Engage Next Gen

BioNJ announced the launch of its Health Equity in Clinical Trials Initiative, which the organization says is part of a commitment to its vision of Health Equity for All. According to the statewide life sciences trade association, the effort will define concrete issues, identify long-term interventions, support companies to improve equity and access in their clinical trials strategies, benchmark best practices and shape policy. “Health equity in clinical trials is critical to deepening the understanding of the safety and efficacy of medicines in under-represented populations, expanding access to medical innovation for these populations, and increasing dialogue among the biopharma industry, communities and health systems,” said Amadou Diarra, senior vice president, Global Policy, Advocacy & Government Affairs for Bristol Myers Squibb; BioNJ board member; and chair of the Health Equity in Clinical Trials Initiative. “The life sciences sector plays a major role in addressing equity of care, and BMS is dedicated to ensuring that no patient is left behind. We are a proud supporter of BioNJ’s Health Equity in Clinical Trials Initiative.”

NJ Company News


CARVYKTI™ (ciltacabtagene autoleucel) Receives Approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

Somerset-based BioNJ Member Legend Biotech Corporation announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved CARVYKTI™ (ciltacabtagene autoleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adults with relapsed or refractory multiple myeloma, limited to cases meeting both of the following conditions: Patients have no history of CAR-positive T cell infusion therapy targeting BCMA, Patients who have received three or more lines of therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, and in whom multiple myeloma has not responded to or has relapsed following the most recent therapy. CARVYKTI™ features two BCMA-targeting single domain antibodies, is specifically developed for each individual patient and is administered as a single infusion.

U.S. FDA Approves FGFR Inhibitor, Futibatinib for the Treatment of Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma

Taiho Pharmaceutical Co., Ltd. announced that its U.S. subsidiary, BioNJ Member Taiho Oncology, Inc., with a site in Princeton, has been granted U.S. Food and Drug Administration (FDA) approval of futibatinib (Development code: TAS-120, U.S, Product Name: LYTGOBI®, Form: Tablets) for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. The indication is approved under accelerated approval based on overall response rate and duration of response in the FOENIX-CCA2 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Dupixent® (dupilumab) Approved by FDA as the First and Only Treatment Indicated for Prurigo Nodularis

Bridgewater-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adult patients with prurigo nodularis. With this approval, Dupixent becomes the first and only medicine specifically indicated to treat prurigo nodularis in the U.S. Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and its impact on quality of life is one of the highest among inflammatory skin diseases. The FDA evaluated the Dupixent application for prurigo nodularis under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

Oncologic Drugs Advisory Committee to Review Zejula Overall Survival Data from the NOVA Phase III Trial in Recurrent Ovarian Cancer

Warren-based BioNJ Member GSK announced that the U.S. Food and Drug Administration will convene a meeting of the Oncologic Drugs Advisory Committee to discuss overall survival data from the ENGOT-OV16/NOVA Ohase III clinical trial. NOVA is a randomized, double-blind, placebo-controlled Phase III trial of Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor for the maintenance treatment of women with platinum-sensitive recurrent ovarian cancer. The Phase III NOVA trial met the primary endpoint of progression-free survival in both the gBRCAm and non-gBRCAm cohorts, demonstrating a statistically significant and clinically meaningful treatment effect of Zejula in this patient population, regardless of biomarker status. These PFS results served as the primary basis for the U.S. FDA approval for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. 

GSK and Spero Therapeutics Announce Exclusive License Agreement for Tebipenem HBr, a Late-Stage Antibiotic that may Treat Complicated Urinary Tract Infections

Warren-based BioNJ Member GSK and Spero Therapeutics, Inc. announced they have entered into an exclusive license agreement for tebipenem pivoxil hydrobromide (tebipenem HBr), a late-stage antibiotic being developed by Spero, as the first oral carbapenem antibiotic to potentially treat complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain bacteria. Luke Miels, Chief Commercial Officer, GSK, said: “There is a high unmet medical need for a novel oral antibiotic as an alternative to intravenous hospital therapy for drug-resistant complicated urinary tract infections. Tebipenem HBr complements GSK’s infectious disease strategy and is consistent with our commitment to find value-enhancing opportunities to build a strong late-stage portfolio.”

GSK and Microsoft, in Collaboration With the Centre for Health and Disease Studies, Launch Disease Surveillance Project in Nepal

Warren-based BioNJ Member GSK and Microsoft, in an innovative collaboration with the Centre for Health and Disease Studies (CHDS) Nepal, announced the start of a disease surveillance project in Nepal. The pilot project, which will leverage Microsoft’s Premonition systems and GSK’s expertise in health and disease, will investigate how AI and robotics can support local community response to vector-borne diseases and climate change. It’s anticipated the project will help develop new monitoring strategies to detect and manage disease threats early, especially in underserved communities where outbreaks may be detected too late. The project is also expected to demonstrate autonomous monitoring and robotic sampling of dangerous species in remote environments. If successful, the ambition is to engage new partners and expand to other countries.

Lilly Receives U.S. FDA Fast Track Designation for Tirzepatide for the Treatment of Adults With Obesity, or Overweight With weight-Related Comorbidities

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of tirzepatide for the treatment of adults with obesity, or overweight with weight-related comorbidities. The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. Based on discussions with the FDA, Lilly plans to initiate a rolling submission of a new drug application (NDA) for tirzepatide in adults with obesity or overweight this year, which when complete, will be based primarily on results from two Phase 3 clinical trials: SURMOUNT-1, which is complete, and SURMOUNT-2, which is expected to complete by the end of April 2023. 

Ferring Receives Positive Vote from U.S. FDA Advisory Committee for RBX2660

BioNJ Member Ferring Pharmaceuticals, with a site in Parsippany, announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) issued a positive vote for RBX2660, an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrence of C. difficile infection (CDI) after antibiotic treatment. VRBPAC voted 13 to 4 that the data were adequate to support the effectiveness of RBX2660 to reduce the recurrence of CDI in adults 18 years of age and older following antibiotic treatment for recurrent CDI. The Committee also voted 12 to 4 with 1 abstention that the data were adequate to support the safety of RBX2660 when administered to adults 18 years of age and older following antibiotic treatment for recurrent CDI. 

Pfizer Completes Acquisition of Global Blood Therapeutics

BioNJ Member Pfizer Inc., with a site in Peapack, announced the completion of its acquisition of Global Blood Therapeutics, Inc. (GBT), a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities starting with sickle cell disease (SCD). The acquisition reinforces Pfizer’s commitment to SCD, building on a 30-year legacy in the rare hematology space. GBT brings a portfolio and pipeline that has the potential to address the full spectrum of critical needs for this underserved community. GBT discovered and developed Oxbryta® (voxelotor), a first-in-class medicine that directly targets the root cause of SCD. In addition, GBT’s promising pipeline of preclinical and clinical investigational assets focused in SCD includes GBT021601 (GBT601) and inclaclumab.

Pfizer Announces Positive Topline Results from Phase 3 TALAPRO-2 Trial

BioNJ Member Pfizer Inc., with a site in Peapack, announced positive topline results from the Phase 3 TALAPRO-2 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide) compared to placebo plus XTANDI in men with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations. The study met its primary endpoint with a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared with placebo plus XTANDI. The results of the primary endpoint exceeded the pre-specified hazard ratio of 0.696. Results showed a trend toward improved overall survival, a key secondary endpoint, at the time of the analysis, but these data are not yet mature.

Pfizer Completes Acquisition of Biohaven Pharmaceuticals

BioNJ Member Pfizer Inc., with a site in Peapack, announced the completion of its acquisition of Biohaven Pharmaceutical Holding Company Ltd., the maker of NURTEC® ODT (rimegepant), an innovative migraine therapy approved for both acute treatment and prevention of episodic migraine in adults. The acquisition brings to Pfizer a portfolio of promising calcitonin gene-related peptide (CGRP) receptor antagonists including Rimegepant, Zavegepant and a portfolio of pre-clinical CGRP assets.

Pfizer and Sangamo Therapeutics Announce Phase 3 Trial of Investigational Gene Therapy for Hemophilia A has Re-Opened Recruitment

BioNJ Member Pfizer, with a site in Peapack, and Sangamo Therapeutics announced that the Phase 3 AFFINE study evaluating giroctocogene fitelparvovec, an investigational gene therapy for patients with moderately severe to severe hemophilia A, has re-opened recruitment. Trial sites have resumed enrollment and dosing. All trial sites are anticipated to be active by the end of 2022 and a pivotal readout is expected in the first half of 2024. The Phase 3 AFFINE (NCT04370054) study is an open-label, multicenter, single arm study to evaluate the efficacy and safety of a single infusion of giroctocogene fitelparvovec in more than 60 adult (ages 18-64 years) male participants with moderately severe to severe hemophilia A. 

Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age

BioNJ Member Pfizer, with a site in Peapack, and BioNTech announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age. The request for Emergency Use Authorization of the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group is supported by safety and immunogenicity data from the companies’ bivalent Omicron BA.1-adapted vaccine, non-clinical and manufacturing data from the companies’ 10-µg bivalent Omicron BA.4/BA.5-adapted vaccine, and pre-clinical data from the companies’ Omicron BA.4/BA.5-adapted vaccine in their decision. 

Merck’s KEYTRUDA® (pembrolizumab) Receives Four New Approvals in Japan, Including in High-Risk Early Stage Triple-Negative Breast Cancer (TNBC)

Kenilworth-based BioNJ Member Merck & Co. announced that KEYTRUDA, Merck’s anti-PD-1 therapy, received four new approvals from Japan’s Ministry of Health, Labor and Welfare (MHLW). “Based on compelling data from our clinical trial program, KEYTRUDA has become an important treatment option in Japan and now has 23 approved uses across 13 different types of cancer,” said Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. “These four new approvals provide certain patients with advanced or recurrent cervical cancer, high-risk early stage triple-negative breast cancer, renal cell carcinoma and completely resected stage IIB and IIC melanoma the opportunity to be treated with KEYTRUDA.” 

Johnson & Johnson Announces Kenvue as the Name for Planned New Consumer Health Company

New Brunswick-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson took another step forward in establishing two independent, market-leading companies with the announcement of Kenvue as the name for the planned New Consumer Health Company. The new corporate brand comes to life through a compelling purpose, and a timeless visual brand. Kenvue (pronounced ken·view), is inspired by two powerful ideas: “ken” – meaning knowledge, an English word primarily used in Scotland, and “vue,” referencing sight. With rich knowledge of human needs and deep consumer insights, Kenvue will deliver meaningful, personal health solutions. Kenvue’s purpose, Realize the Extraordinary Power of Everyday Care, will guide the company’s actions and long-term aspirations, from strategy to talent philosophy, and more.

Janssen Announces Late-Breaking Data from Two Gene Therapy Programs at the American Academy of Ophthalmology 2022 Annual Meeting

New Brunswick-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the primary results from the Phase 1/2 study evaluating the investigational gene therapy botaretigene sparoparvovec (formerly AAV-RPGR) in patients with the inherited retinal disease X-linked retinitis pigmentosa (XLRP) associated with the retinitis pigmentosa GTPase regulator (RPGR) gene. Treatment with botaretigene sparoparvovec was found to have an acceptable safety profile, and efficacy assessments in this proof-of-concept study demonstrated encouraging improvements in retinal sensitivity, visual function and functional vision. XLRP is a rare condition estimated to impact one in 40,000 people globally. People with XLRP have progressive vision loss, starting in childhood with night blindness.

Teva Launches Honestly HD Website to Provide People Living With Huntington’s Disease (HD) Information, Inspiration and Resources on HD Chorea

Parsipanny-based BioNJ Member, Teva Pharmaceuticals announced the launch of the Honestly HD website, which aims to provide information, inspiration and resources to help people understand what to expect with Huntington’s Disease (HD) chorea – one of the most visible and treatable symptoms of HD – and, how to talk to their doctor about preserving independence. In addition to the newly launched site, a Twitter channel, @HonestlyHD, has launched to further support the HD community and expand the resources already available through the Honestly HD Facebook community, which provides a virtual space for sharing personal stories and resources.

Gilead Joins First-of-its-Kind Public-Private Initiative to Improve Management of Viral Hepatitis in Vietnam and the Philippines

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced a new public-private initiative with the Partnership for Health Advancement in Vietnam (HAIVN), a collaboration between Brigham and Women’s Hospital, Harvard Medical School and Beth Israel Deaconess Medical Center. This multi-year initiative will have a phased approach to help address barriers that limit viral hepatitis diagnosis and care at primary healthcare facilities in Vietnam and the Philippines, two countries with high burdens of hepatitis B and C. The focus of the program will be on person-centered approaches in training non-specialist community-based healthcare providers in prevention and management of viral hepatitis, incorporating education, screening, diagnosis and linkage to care for hepatitis B and C into routine patient visits for at-risk populations. 

Enalare Awarded $50.3M Grant to Develop Drug-Overdose Treatment

Princeton-based BioNJ Member Enalare Therapeutics Inc. received a contract for up to $50.3 million from the Biomedical Advanced Research and Development Authority (BARDA) – part of the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response – to further develop a drug-overdose treatment. Enalare Therapeutics announced the award specifying it would support research of lead compound ENA-001, a one-of-a-kind new chemical entity (NCE) that’s designed to use the body’s own ventilation control system to influence breathing. The award is granted in stages and will fund pre-clinical toxicology, human clinical studies, drug and device manufacturing, and regulatory file submission for a formulation of ENA-001 suitable for community use. 

Lecanemab Confirmatory Phase 3 Clarity As Study Met Primary Endpoint, Showing Highly Statistically Significant Reduction of Clinical Decline in Large Global Clinical Study of 1,795 Participants With Early Alzheimer’s Disease

BioNJ Member Biogen Inc. and Eisai Co., Ltd., with a site in Woodcliff Lake, announced positive topline results from Eisai’s large global Phase 3 confirmatory Clarity AD clinical trial of lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. Lecanemab met the primary endpoint (CDR-SB: Clinical Dementia Rating-Sum of Boxes) and all key secondary endpoints with highly statistically significant results. Eisai will discuss this data with regulatory authorities in the U.S., Japan and Europe with the aim to file for traditional approval in the US and for marketing authorization applications in Japan and Europe by the end of Eisai’s FY2022, which ends March 31, 2023. 

Y-mAbs Announces Regulatory Filing for DANYELZA® (naxitamab-gqgk) in Brazil

Y-mAbs Therapeutics, Inc., with a site in Nutley, announced that Adium Pharma has submitted a regulatory filing for DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma to the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária. “We are very pleased with the regulatory capabilities of our partner Adium resulting in submission of DANYELZA® for consideration of potential approval in Brazil. We believe this submission marks another important milestone in our aim to make DANYELZA globally available and address an unmet medical need for families in Brazil,” said Thomas Gad, President, and Interim CEO. “If approved by Anvisa, we look forward to working closely with Adium on the production and logistic planning for DANYELZA to help ensure timely availability to patients in Brazil.”

LEO Pharma Receives Positive CHMP Opinion of Adtralza ® (tralokinumab) for the Treatment of Adolescents With Moderate-to-Severe Atopic Dermatitis

LEO Pharma, with a site in Madison, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending to extend the approval of Adtralza® (tralokinumab) in the European Union (EU) to include adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. The recommended dose for adolescent patients is an initial dose of 600 mg followed by 300 mg administered every other week, which is the same dosing as for adult patients. Adtralza, a high-affinity human monoclonal antibody, is approved for the treatment of adults with moderate-to-severe AD in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. 

Bellerophon Announces FDA Acceptance of Change to Ongoing Phase 3 REBUILD Study of INOpulse® for Treatment of Fibrotic Interstitial Lung Disease

Warren-based Bellerophon Therapeutics, Inc. announced that the U.S. Food and Drug Administration has accepted the company’s proposal to reduce the study size for its ongoing registrational REBUILD Phase 3 trial of INOpulse® for the treatment of fibrotic Interstitial Lung Disease. The new study size of 140 subjects does not impact the trial’s principal objective or endpoints and maintains power of >90% (p-value < 0.01) for the primary endpoint of Moderate to Vigorous Physical Activity (MVPA) based on the effect size observed in Phase 2. Following the evaluation of baseline MVPA characteristics, as measured by actigraphy, compliance to treatment and review of safety data of the randomized subjects in the ongoing Phase 3 REBUILD study, the trial’s independent Data Monitoring Committee supported reducing the target study size from 300 to 140 subjects.

Fosun Pharma and MAIA Pharmaceuticals Jointly Announce the Successful Commercialization of Only FDA Approved 20ml Sodium Phenylacetate and Sodium Benzoate (SPSB) Liquid Product

Princeton-based Shanghai Fosun Pharma (Group) Co., Ltd. announced that the 20 ml, Sodium Phenylacetate and Sodium Benzoate (SPSB) liquid product, which is under an exclusive partnership between Fosun Pharma USA Inc., subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd and MAIA Pharmaceuticals, Inc., a Princeton, NJ-based specialty pharmaceutical company, has been recently launched. Fosun Pharma USA has the exclusive commercial rights of this product in the U.S. market. Based upon market feedback, the usage of 50ml SPSB, as prescribed, predominantly in the pediatric setting, is subject to extensive product wastage which is a huge cost to the healthcare system. SBSP is available in 20 ml and 50 ml vial sizes. 

Shionogi Announces Achievement of the Primary Endpoint for Ensitrelvir Fumaric Acid (S-217622) in the Phase 3 Part of the Phase 2/3 Clinical Trial in Asia

Shionogi & Co., Ltd,, with a site in Florham Park, announced that ensitrelvir fumaric acid, an investigational, 3CL protease inhibitor, administered once daily for five days, being evaluated as an antiviral treatment for COVID-19, achieved the primary endpoint in the Phase 3 part of a Phase 2/3 study conducted in Asia. The emergency approval of ensitrelvir was deliberated in the Pharmaceutical Affairs and Food Sanitation Council meeting, in Japan, and review will continue based on the results of the Phase 3 part of the study. The top-line results of the Phase 3 part have been reported to MHLW and PMDA. 

Shionogi and the Medicines Patent Pool (MPP) Sign License Agreement for COVID-19 Oral Antiviral Treatment Candidate to Increase Access in Low- and Middle-Income Countries

Shionogi & Co., Ltd., with a site in Florham Park, and the Medicines Patent Pool (MPP), announced that they have signed a voluntary license agreement for Shionogi’s antiviral candidate ensitrelvir fumaric acid (S-217622). The agreement will enable MPP to facilitate additional production and distribution of the investigational antiviral, pending regulatory authorization or approval, by granting sublicences to qualified generic manufacturers, with the goal of expanding access to people living in LMICs. Ensitrelvir is being evaluated for the treatment of COVID-19 to be administered as an oral tablet formulation taken once daily for five days. Under the terms of the license agreement between Shionogi and MPP, qualified generic manufacturers that are granted sublicences by MPP will be able to manufacture and supply ensitrelvir to 117 countries. 

BD, CerTest Biotec Announce U.S. Commercial Launch of Monkeypox Assay

Franklin Lakes-based BD, also known as Becton Dickinson and Co, together with CerTest Biotec, announced its newly developed molecular polymerase chain reaction assay for monkeypox virus is now commercially available globally, including in the U.S., for research use-only applications by laboratories. The company is working to submit a clinical test for monkeypox virus for emergency used authorization as soon as possible, based on the guidance recently issued by the FDA. “Even before the U.S. Department of Health and Human Services and Food and Drug Administration declared the ongoing monkeypox outbreak in the United States a public health emergency, we were working with CerTest to quickly develop a molecular assay to help better understand and track the disease,” Nikos Pavlidis, Vice President of Molecular Diagnostics, BD.

EZHARMIA® Approved in Japan as First Dual EZH1 and EZH2 Inhibitor Therapy for Patients With Adult T-Cell Leukemia/Lymphoma

Basking Ridge-based Daiichi Sankyo announced that the Japan Ministry of Health, Labor and Welfare (MHLW) has approved EZHARMIA® (valemetostat tosilate), a first-in-class dual inhibitor of EZH1 and EZH2, for the treatment of patients with relapsed or refractory adult T-cell leukemia/lymphoma (ATL). EZHARMIA previously received Orphan Drug Designation (ODD) from the MHLW for this indication and is now the first dual inhibitor of EZH1 and EZH2 to be approved for treatment of ATL. A rare and aggressive hematologic malignancy that can manifest as either leukemia or lymphoma, ATL occurs with higher frequency in certain regions of Japan and is associated with a five-year overall survival rate of approximately 14%.

Cellusion and Miniaris Regenerative Medicine, a Member of Showa Denko Materials, Enter into a Business Alliance to Manufacture the CLS001 for Corneal Endothelial Cell Regenerative Therapy

Allendale-based Cellusion Inc. and Miniaris Regenerative Medicine, LLC, announced a letter of intent for the formulation of CLS001 for corneal endothelial cell regenerative therapy in the United States. Under the LOI, Cellusion and Miniaris, Cellusion’s leading program, will develop the manufacturing process of CLS001, a new regenerative medicine product for bullous keratopathy treatment. The team in Miniaris will demonstrate process optimization to meet FDA requirements. “We are very enthusiastic to have the partnership with Miniaris, a well-established regenerative medicine partner with over 20 years experiences including the predecessor companies, Progenitor Cell Therapy and Hitachi Chemical, and one of the leading CDMOs in the U.S. since the dawn of the field,” said Shin Hatou, M.D. Ph.D., CEO of Cellusion. 

Cellectar Awarded $2M Grant for Brain Tumor Drug Study

The National Institutes of Health’s National Cancer Institute awarded a $1.98 million grant to Florham Park-based Cellectar Biosciences Inc. for its work on a pediatric brain tumor treatment. The biopharmaceutical company said the funds will be used to expand its ongoing Phase 1 pediatric study of iopofosine I 131 in children and adolescents with inoperable relapsed or refractory high-grade gliomas.According to a Sept. 22 statement, lopofosine is a small-molecule Phospholipid Drug Conjugate designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells. The two-part study will first determine the safety, tolerability and initial efficacy of iopofosine; the second part is designed to identify the most effective dose and dosing regimen. 

ZyVersa Therapeutics and Larkspur Health Acquisition Corp. Announce Business Combination, Interim Financing and PIPE Investment Update

Bridgewater-based ZyVersa Therapeutics, Inc., and Larkspur Health Acquisition Corp. announced that Larkspur has refiled with the U.S. Securities and Exchange Commission their proxy/registration statement on Form S-4 in connection with the business combination agreement between Larkspur and ZyVersa previously announced on July 20, 2022. Larkspur and ZyVersa are also pleased to announce commitments of approximately $8.5 million, exceeding the previously announced $7.0 million, contingent financing that provides for the purchase of Convertible Preferred Stock of Larkspur. ZyVersa has also announced an additional closing of an interim finance round of approximately $1.5 million from an offering of Series A Convertible Preferred Stock of ZyVersa that will convert into ZyVersa common stock in connection with the Transaction. 

People in the News


Warren-based Biotechnology Company Tevogen Bio, CEO Nominated for 2023 Nobel Peace Prize

Warren-based BioNJ Member Tevogen Bio and its founder and CEO, Dr. Ryan Saadi, have been nominated for the 2023 Nobel Peace Prize by Curtis Patton, professor emeritus, Yale School of Public Health, Yale University. Dr. Patton, who was one of Dr. Saadi’s professors at Yale, said he nominated Tevogen and Dr. Saadi because of the truly amazing work the company does, and for Dr. Saadi’s brilliance and qualities as a human being. An accomplished graduate of Harvard Business School Executive Education Program, Yale School of Medicine and Dhaka Medical College, Dr. Saadi has dedicated his life to various healthcare matters within both the private sector as well as public.

Celularity Appoints Adrian Kilcoyne, M.D., M.P.H., M.B.A., as Chief Medical Officer

Florham Park-based BioNJ Member Celularity Inc. announced that Adrian Kilcoyne, M.D., M.P.H., M.B.A., has been appointed Executive Vice President, Chief Medical Officer and Head of Global Medical Affairs, Patient Safety and Patient Affairs. Dr. Kilcoyne brings over 15 years of clinical experience to Celularity, having previously served in R&D, medical affairs, and commercialization roles, primarily focused on oncology. He has a track record of advancing early stage clinical programs through commercialization and will provide senior leadership to advance Celularity’s clinical pipeline toward U.S. Food and Drug Administration (FDA) approval. Most recently, Dr. Kilcoyne served as the Chief Medical Officer of Humanigen.

Iain Mackay, Chief Financial Officer, to Retire from GSK, Julie Brown Appointed as Successor

Warren-based BioNJ Member GSK announced that Iain Mackay, Chief Financial Officer, has decided to retire from GSK. The Board has selected Ms. Julie Brown, currently Chief Operating and Financial Officer, Burberry Group plc, as successor to Mr. Mackay. Ms Brown is a highly respected CFO with extensive experience in the biopharma and medtech sectors, having previously worked at AstraZeneca plc and Smith & Nephew plc; and as a Non-Executive Director and Audit Chair of Roche Holding AG. Ms. Brown will join GSK in April 2023 and will work with Mr. Mackay to transition responsibilities, taking responsibility as CFO and as an Executive Director of GSK on May 1, 2023.

Matinas BioPharma Announces Chairman Succession Plan

Bedminster-based BioNJ Member Matinas BioPharma Holdings, Inc. announced its leadership succession plan, with the Board of Directors unanimously appointing current Board Member, Eric J. Ende, to succeed Herbert J. Conrad as Chairman of the Board. Mr. Conrad, the founding Chairman of Matinas will remain on the Board as an independent director of the company. Dr. Ende joined the Company’s Board of Directors in March 2017. Dr. Ende was a Director on Genzyme’s Board from 2010 – 2011 until it was acquired by Sanofi-Aventis for $21B in 2011. Dr. Ende is currently on the Board of Directors of Avadel plc, where he is the Chairman of the Nomination & Corporate Governance Committee and is serving on the Audit Committee. 

Lisata Therapeutics’ Director and Scientific Founder of the CendR Platform™ Technology, Erkki Ruoslahti, M.D., Ph.D., Receives 2022 Albert Lasker Basic Medical Research Award

Basking Ridge-based Lisata Therapeutics, Inc. announced that Erkki Ruoslahti, M.D., Ph.D., the Scientific Founder of the company’s CendR Platform™ technology and a member of the company’s Board of Directors, was a recipient of the 2022 Albert Lasker Basic Medical Research Award. The Albert Lasker Basic Medical Research Award is one of the highly competitive and distinguished international prizes for medical science awarded by the Lasker Foundation. Dr. Ruoslahti, together with Drs. Richard Hynes and Timothy Springer, is being honored for the discovery of integrins and their key role as mediators of cell-cell and cell-matrix interactions in physiology and disease. Dr. Ruoslahti’s most notable scientific contributions are in the field of cell adhesion, where he is credited as one of the discoverers of fibronectin.



Liver Cancer: Excessive Alcohol Use and Other Risks

The liver is one of the most important organs in the body. It removes toxins from the blood and regulates the levels of chemicals. It excretes a product called bile which helps you digest fat. It makes clotting factors and stores sugar that the body uses for energy. Many may associate poor liver health with increased alcohol consumption but does that mean that drinking alcohol causes liver cancer? Mariam F. Eskander, MD, MPH, surgical oncologist at Rutgers Cancer Institute of New Jersey, the state’s leading cancer center only National Cancer Institute (NCI)-designated Comprehensive Cancer Center, together with RWJBarnabas Health, and assistant professor of surgery at Rutgers Robert Wood Johnson Medical School whose clinical expertise includes liver tumors, shares more information on this topic.

Black Women, Breast Cancer and Clinical Trials

For Black women, breast cancer is the most commonly diagnosed cancer and as of 2019 has surpassed lung cancer as the leading cause of cancer death in this population, according to the American Cancer Society. Black women continue to experience disparities in breast cancer diagnosis and treatment, leading to increased mortality of up to 40 percent higher than white women. Researchers are working to improve outcomes for Black women with breast cancer – including through increased participation in clinical trials, which helps find better ways to prevent, diagnose and treat cancer. Coral Omene, M.D., Ph.D., medical oncologist at the Stacy Goldstein Breast Cancer Center and member of the Cancer Health Equity Center of Excellence at Rutgers Cancer Institute of New Jersey, and an assistant professor of medicine at Rutgers Robert Wood Johnson Medical School, shares more on the topic.

Institute for Future Technologies Unveiled by NJIT & Ben-Gurion University

The New Jersey Institute of Technology (NJIT) and Israel’s Ben-Gurion University of the Negev unveiled the home of the Institute for Future Technologies, an international research, education and innovation center in Jersey City. BGU President Daniel Chamovitz comments that with plans spanning study space for exchange students, joint graduate degrees, ideation-stage startups and even combined faculty appointments in fields such as artificial intelligence, civil engineering and cybersecurity, it is difficult to predict how the institute might evolve. “But that’s okay,” he said. NJIT’s Baruch Schieber, Professor of Computer Science and Director of the Institute, agreed that its plans are unconventional, but said they’ve already been fruitful. Faculty at both universities are collaborating and would not have met if not for the partnership, he said. One measure of the Institute’s success will be funding from the National Science Foundation and the joint U.S.-Israel Binational Science Foundation.

Neil Palmisiano, M.D., Appointed as Deputy Director of Phase 1 Therapeutics for Hematologic Malignancies at Rutgers Cancer Institute of New Jersey

Rutgers Cancer Institute of New Jersey, together with RWJBarnabas Health, are welcoming a new leader to its team of internationally recognized physicians and researchers. Neil Palmisiano, M.D., MS, is the new Deputy Director of Phase 1 Therapeutics for Hematologic Malignancies and Co-Medical Director of the Office of Human Research Services at Rutgers Cancer Institute and new System Leader for Leukemia for RWJBarnabas Health. Dr. Palmisiano will be responsible for the coordination of new and novel experimental therapeutics for patients with hematologic malignancies. He will work closely with Sanjay Goel, M.D., MS, Director of the Phase I/Investigational Therapeutics Program at Rutgers Cancer Institute to oversee the activities of the faculty members within that program, supporting clinical trial accruals, contributing to ongoing clinical and translational research and will build the capacity for innovation in research across Phase 1 clinical trials in hematologic malignancies.

Funding/Economic Development

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CSIT Makes Additional $1M Available to Small Businesses Involved in Innovation Research and Transfer Technology

The New Jersey Commission on Science, Innovation and Technology is making an additional $1 million of grant funding available to New Jersey-based companies currently involved with — or applying to — the federal Small Business Innovation Research and/or Small Business Technology Transfer. CSIT Chair Debbie Hart said the funding offers additional help to companies at an important time in their development. “Each New Jersey start-up faces unique hurdles as it works toward commercialization, and helping these young companies succeed is a core part of our mission,” she said. “Our SBIR/STTR Direct Financial Assistance Program has a proven track record of supporting startups that are vying for these federal programs by providing funding to support their operations throughout the application process and beyond.” The application period will close Nov. 14, 2022.

NJEDA Expands Innovation Evergreen Tax Credit Funding to $50M

Due to greater than anticipated demand, the New Jersey Economic Development Authority announced an increase in funding for tax credits available through the auction phase of the New Jersey Innovation Evergreen Fund (NJIEF). Because of robust demand, the NJEDA raised the available auction pool from $30 million to $50 million. The organization says the move is a result of established corporate leaders engaging in the State’s innovation economy. The NJIEF is a tool designed to incentivize investment in emerging New Jersey companies while creating mentoring, networking and educational opportunities. This auction is the first of five, which are designed to fuel the investment phase of NJIEF starting later this year.

NJEDA Approves Investment into Innovate Capital Growth Fund to Support Early Stage NJ Companies

The New Jersey Economic Development Authority (NJEDA) announced that its Board has approved investing up to $1 million into Innovate Capital Growth Fund (ICGF) through a limited partnership investment. ICGF marks the NJEDA’s 21st venture fund investment approval to date. ICGF, a Delaware limited partnership, was created last year to provide growth capital, primarily in the form of equity, to minority- and women-owned businesses located substantially in the Mid-Atlantic region. ICGF is expected to invest an additional $2 in New Jersey-based companies for every $1 the NJEDA commits. This would result in a target of $3 million of capital invested into New Jersey companies.



ISG TechXchange: Healthcare & Life Sciences

October 13, 2022

The ISG TechXchange: Healthcare & Life Sciences will explore the evolving healthcare and life science ecosystems. Register today and embrace the digital transformation approaches organizations are taking to succeed in pushing the boundaries of innovation. Put interoperability at the heart of your organization. Utilize emerging innovations to rapidly respond to shifts in patient and payer expectations. Leverage the effects of pandemic-forced advancements to focus on innovation and diversification. Learn more and register here.

Celebrate Princeton Innovation 2022

October 13, 2022

Celebrate Princeton Innovation honors faculty researchers, postdoctoral researchers, graduate students and undergraduates who are making a difference through their discoveries and entrepreneurial spirit. This annual event features faculty innovators and discoveries that have the potential to become everyday innovations that improve life, benefit the planet and grow the economy.

Life Science Funding & Incentives in New Jersey

October 20, 2022

Join Princeton Innovation Center BioLabs on Thursday, October 20, from 5:00–6:30 p.m., to learn about New Jersey’s funding and incentive programs and hear from New Jersey’s life sciences industry leaders who have benefited from these important incentive funding programs. Free and open to the public, but registration is a must and guests must comply with Princeton Innovation Center’s COVID policy for visitors.

The Center for Advanced Human Brain Imaging Research

November 2, 2022

We extend a warm invitation to attend the Center for Advanced Human Brain Imaging Research (CAHBIR) Fall Open House. CAHBIR provides state-of-the-art neuroimaging resources for both academic and industry research in central New Jersey. Come visit our new facility and meet our team of dedicated neuroimaging research specialists. RSVP is appreciated, but not required. If you are interested in the possibility of performing studies at CAHBIR but cannot attend the open house, please feel free to email the Center’s Director, Dr. David Zald.

Genesis 2022

December 7, 2022

The annual Genesis conference has been a pillar of the life science sector for over two decades. Bringing together key opinion leaders, investors and innovators from across the sector to share insight, debate key trends and generate deals. Under a headline theme of “Maximizing Returns from Life Science Innovation”, we expect 2022 to be no different! 

Princeton Chemical & Biological Engineering Graduate Student Symposium Networking Fair

December 9, 2022

The annual Graduate Student Symposium (GSS) is a day-long event organized by the graduate students in the Department of Chemical and Biological Engineering at Princeton University. GSS showcases current graduate student research in the department, ranging from mathematical modeling and simulations to materials science, bioengineering and beyond. At GSS 2022, upper level graduate students in their fourth year and above will be giving oral presentations, and third year students will be presenting posters. If you have questions about GSS 2022, please feel free to reach out to Drew Carson at

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