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April 7, 2023

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

The process involved in bringing a medical treatment, product, or device from the research stage into the hands of Patients, including the process of drug pricing, is a complex one that involves a range of policies and stakeholders across the healthcare system.


To help our community navigate the drug development and drug pricing environment, we have developed the inaugural BioNJ Drug Pricing Dictionary to serve as an at-a-glance resource for these complex conversations.


The BioNJ Drug Pricing Dictionary includes definitions and helpful information about:


  • Treatment Types
  • Government Programs & Agencies
  • Drug Pricing Policy
  • Health Insurance
  • The Institute for Clinical & Economic Review (ICER)


This new resource underscores the importance of foundational priorities in the drug development and drug pricing environment, such as health equity, medical innovation and Patient access.


Current policies that claim to lower costs threaten future R&D which is essential to bringing additional treatments and new cures to the Patient communities in need. The BioNJ Drug Pricing Dictionary will help Patients, advocates, policymakers and stakeholders across the healthcare spectrum in critical conversations about the importance of Patient access and affordability, and the value of medical innovation in New Jersey and beyond. Please click here for BioNJ's Drug Pricing Dictionary.

Thank you for your continued support.

Because Patients Can't Wait®,

Debbie Hart

President and CEO


BioNJ President and CEO Debbie Hart testified in D.C. last week before the U.S. International Trade Commission in opposition to the potential TRIPS waiver expansion. This issue is of critical importance as the proposed expansion of the TRIPS waiver will have a detrimental impact on innovation and investment in the life sciences, as well as on the economies of both New Jersey and the U.S. BioNJ’s testimony as delivered can be found at ( BIO release:

Welcome New Members

 Learn more at

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Upcoming BioNJ Events


BioNJ's 13th Annual BioPartnering Conference

Register Today!

April 17-21, 2023

BioNJ's HR Conference

Kean University

Save the Date!

June 13, 2023

BioNJ's Manufacturing Briefing

Rutgers University

Save the Date!

September 13, 2023

BioNJ's C-Suite Summit

Bridgewater Marriott

Save the Date!

October 6, 2023

Putting Patients First:

The Value of Medical Innovation


New Report: More Than 400 Medicines in Development for Leading Chronic Conditions Affecting Older Americans

Chronic diseases like Alzheimer’s disease, diabetes and kidney disease disproportionately affect older adults. In the United States, nearly 95% of older adults have at least one chronic condition and almost 80% have two or more. Chronic diseases can often limit an older adult’s ability to work, perform daily activities, cause them to lose their independence and lead to the need for long-term care. Furthermore, the economic burden imposed by chronic conditions is substantial, but this burden is concentrated among older Americans covered under Medicare. In fact, the combined costs of managing chronic diseases account for two-thirds of all health care costs and 93% of Medicare spending.  

Quest Diagnostics, Sesame Workshop Team to Address Health Inequities Among Kids

Quest Diagnostics is teaming up with Sesame Workshop to address health and well-being inequities among young children, particularly in low-income, rural and marginalized communities. Thanks to a grant from the Secaucus-based testing provider, Sesame Workshop is rolling out a series of resources to connect parents and caregivers with providers by promoting whole child well-being, focusing on forming a healthy team and building on families’ strengths. According to Sesame Workshop, the resources are being implemented with national partners, as well: the Council on Black Health, National Alliance for Hispanic Health, National Association of Community Health Centers and The Center for Indigenous Health. In addition to being distributed through the Sesame Street in Communities program, an initiative that supports community providers who serve families.

BioNJ in the News


BIO Opposes Extension of WTO IP Waiver in Federal Hearing

The threat of expanding intellectual property waivers by the World Trade Organization (WTO) dampens investment in research, Biotechnology Innovation Organization’s (BIO) Chief Policy Officer John Murphy testified as U.S. International Trade Commission (USITC) held hearings on a proposal for a new TRIPS waiver. The goal of the hearing was to determine whether the United States should support a proposal to extend the waiver of IP on COVID-19 vaccines to include COVID diagnostics and therapeutics. The U.S. Trade Representative (USTR) agreed to the first IP waiver in June, but before supporting the extension, they requested an investigation from the USITC. As part of its investigation, USITC held two days of hearings. Witnesses included BIO Board member Eddie Sullivan, President and CEO of SAB Biotherapeutics; Kevin Haninger, Vice President, International Policy of PhRMA; Debbie Hart, President and CEO of BioNJ; George Scangos, CEO of Vir Biotechnology; Dennis Purcell, Partner at Aisling Capital; as well as representatives from BIO members Eli Lilly, Gilead Sciences and Merck.

BioNJ President and CEO Debbie Hart Honored on the 2023 NJBIZ Health Care Power 50

The power lists are compiled by the NJBIZ editorial staff based on our reporting throughout the past year with input from experts in a variety of fields and recommendations from our readers. The staff looks for people who have gained public attention – and perhaps acclaim – for their professional accomplishments and public service. Each list identifies individuals who, through their efforts, are helping to make New Jersey a better place to live, work and do business. Honorees have contributed meaningfully to the advancement of the public interest through their work and/or community service. In addition to BioNJ's President and CEO Debbie Hart, congratulations to all of our BioNJ Members on the list, including Kevin Ali, Organon; Thomas Cavalieri, Rowan University; Robert Davis, Merck & Co.; Amadou Diarra, Bristol Myers Squibb; Jacquin Duato, Johnson & Johnson; Matthew Edson, Rowan University; Robert Garrett, Hackensack Meridian Health; Andre Goy, Hackensack Meridian Health; Perry Halkitis, Rutgers School of Public Health; Robert Johnson, Rutgers New Jersey Medical School; Doug Langa, Novo Nordisk; Steve Libutti, Rutgers Cancer Institute of New Jersey; Christine Ann Miller, Melinta; Donald Parker, Hackensack Meridian Health; Stuart Peltz, PTC Therapeutics; David Perlin, Hackensack Meridian; Gary Small, Hackensack University Medical Center; Brian Strom, Rutgers School of Biomedical and Health Sciences; Dennis Wilson, Delta Dental of New Jersey.

25 Remarkable Stories: Palpable Electricity

Debbie Hart always picks up the phone when Stuart Peltz calls. As the President and CEO of BioNJ, the life sciences trade association for New Jersey, she has been observing and living through every moment with PTC since the company was founded in 1998, by Stuart, Founding CEO of PTC, and the partnership with BioNJ. BioNJ was started in the early 1990s as a trade association to help support and represent the growing life sciences industry in the state. NJ was – and still is – a great place to be for biotech. The industry grew out of big pharma’s presence in the state. Alongside the robust pool of talent, government support, academic institutions and geographic location, NJ has continued to be a significant hub for the industry.

BioNJ Interviewed in GBR Global Business’ 2023 USA Life Sciences Report

What has BioNJ achieved in the past 12 months? BioNJ has stayed laser-focused on our core mission, to help our members help patients and make sure that New Jersey is a robust life sciences ecosystem where innovation is supported, and patients can access that innovation. New Jersey remains a life sciences powerhouse, leading the way in medical innovation. The State stands out in its breadth of industry with employment concentration in three key industry subsectors – pharmaceuticals; research, testing and medical labs; and bioscience-related distribution – as well as a high concentration in a fourth subsector: medical devices and equipment.

NJ Company News


Insmed Completes Enrollment of Adult Patients in Phase 3 ASPEN Study of Brensocatib in Bronchiectasis

Bridgewater-based BioNJ Member Insmed Incorporated announced that adult patient enrollment is complete as of today in its pivotal ASPEN study of brensocatib. ASPEN is a global, randomized, double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety and tolerability of brensocatib in patients ages 12 to 85 years with non-cystic fibrosis bronchiectasis. More than 1,700 adult patients have been enrolled and randomized (1:1:1) to receive brensocatib 10 mg, brensocatib 25 mg, or placebo once daily for 52 weeks, followed by 4 weeks off treatment. The primary endpoint is the rate of pulmonary exacerbations over the 52-week treatment period. Insmed anticipates reporting topline data from adults in the ASPEN trial in the second quarter of 2024.

Amicus Therapeutics Announces European Commission Approval for Pombiliti™ in Patients With Late-Onset Pompe Disease

BioNJ Member Amicus Therapeutics, with a site in Cranbury, announced that the European Commission (EC) has granted approval for Pombiliti™ (cipaglucosidase alfa), a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease (LOPD). The company has submitted the previously requested analytical testing for miglustat, the enzyme stabilizer component of AT-GAA. The Committee for Medicinal Products for Human Use (CHMP) opinion for miglustat is expected in the second quarter of 2023. The EC based its approval on clinical data from the Phase 3 pivotal study (PROPEL), the only randomized, controlled trial in LOPD to include patients in the high unmet need ERT-experienced population, in addition to ERT-naïve patients. The EC approval of Pombiliti follows the positive opinion previously granted by the Committee for Medicinal Products for Human Use (CHMP).

Soligenix Receives USAN Approval for "Hypericin Sodium" as Nonproprietary Name for Novel Active Ingredient in HyBryte™ and SGX302

Princeton-based BioNJ Member Soligenix announced that the United States Adopted Names (USAN) Council has approved the use of the nonproprietary name of "hypericin sodium" for the novel active ingredient in both HyBryte™ (research name SGX301) for the treatment of cutaneous T-cell lymphoma (CTCL) and SGX302 for the treatment of mild-to-moderate psoriasis. "We are pleased that USAN has approved the proposed name," stated Christopher J. Schaber, Ph.D., President and Chief Executive Officer of Soligenix. "We look forward to continuing to work with the World Health Organization (WHO) to advance the International Nonproprietary Name (INN) hypericin from a proposed INN to a recommended INN, which is expected to occur later this year."

Celularity Announces Agreement With Ad Ports Group for Exclusive Product Distribution

Florham Park-based BioNJ Member Celularity Inc. announced that it has entered into an exclusive distribution agreement with AD Ports Logistics (ADPL), a subsidiary of the Logistics Cluster, AD Ports Group, the leading global facilitator of trade, logistics and industry based in Abu Dhabi. In partnership with CH Trading Group LLC, an international import, export and trading company and the exclusive territories distributor of Celularity’s previously announced Halal-Certified regenerative medicine products within more than 100 countries, ADPL will distribute the Celularity’s biomaterial products in the United Arab Emirates, Qatar, Bahrain, Oman, Kuwait and Egypt. “Today’s announcement highlights a significant milestone in our global expansion strategy and focus on the Middle East and North Africa market,” said Celularity’s CEO, Chairman and Founder, Robert J. Hariri, M.D., Ph.D. 

Chugai Receives Forerunner Designation for Enspryng in Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD) and Autoimmune Encephalitis (AIE)

BioNJ Member Chugai Pharmaceutical Co., Ltd., with a site in Berkeley Heights, announced that its pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody Enspryng® [generic name: satralizumab (genetical recombination)], received forerunner designation for the expected indication for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and autoimmune encephalitis (AIE) from the Ministry of Health, Labour and Welfare (MHLW). “We are very pleased that the MHLW granted Enspryng as an innovative drug candidate for treating MOGAD and AIE with no approved therapies,” said Dr. Osamu Okuda, Chugai’s President and CEO. “We intend to proceed with the ongoing global clinical phase III study of each disease in cooperation with Roche to deliver Enspryng to patients waiting for new therapies as soon as possible.”

AbbVie Advances Upadacitinib (RINVOQ®) to Phase 3 Clinical Trials in Systemic Lupus Erythematosus

BioNJ Member AbbVie, with a site in Madison, announced topline results from a Phase 2 study of upadacitinib (RINVOQ®, 30 mg) given alone or as combination therapy (ABBV-599) with a Bruton's Tyrosine Kinase inhibitor (elsubrutinib, 60 mg), once daily in patients with moderately to severely active systemic lupus erythematosus (SLE). The SLEek study met the primary endpoint of SLE Responder Index (SRI-4) and steroid dose less than or equal to 10 mg prednisone equivalent once per day at week 24 in the upadacitinib 30 mg group. Based on the results, AbbVie is advancing its clinical program of upadacitinib in SLE to Phase 3.

Gilead Sciences Announces $3 Million in Grant Funding to Eight Organizations Addressing HIV Disparities in Rural U.S. Communities

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced it is providing a total of $3 million in grant funding to eight organizations to provide services to communities disproportionately impacted by HIV in rural areas in the United States. My Brother’s Keeper, based in Ridgeland, Mississippi, will provide technical assistance and capacity building to the organizations funded through this initiative. These grants are part of Gilead’s ongoing Zeroing In™ program to help end the HIV epidemic by supporting organizations working to improve the overall health and wellness of communities most impacted by the HIV epidemic.

Mitsubishi Tanabe Pharma America Announces Enrollment Completion for Global, Phase 3b Study of RADICAVA ORS® (edaravone) in ALS

Jersey City-based BioNJ Member Mitsubishi Tanabe Pharma America, Inc., announced it has completed enrollment for the global, multi-center, double-blind, Phase 3b study (MT-1186-A02) evaluating the long-term efficacy and safety of two dosing regimens of RADICAVA ORS® (edaravone) in people with amyotrophic lateral sclerosis (ALS) over 48 weeks. This study is the postmarketing commitment following the U.S. Food and Drug Administration (FDA) approval of intravenous (IV) RADICAVA® (edaravone). Topline results of the study are anticipated in 2024. Study MT-1186-A02, which enrolled 384 people with ALS across 80 sites in the U.S., Canada, Europe and Asia, will compare two dosing regimens for RADICAVA ORS over 48 weeks of treatment. 

Phase III RUBY Clinical Trial Demonstrates Potential of Jemperli (dostarlimab-gxly) Plus Chemotherapy to Redefine the Treatment of Primary Advanced or Recurrent Endometrial Cancer Versus Chemotherapy Alone

Warren-based BioNJ Member GSK announced interim results from Part 1 of the RUBY/ENGOT-EN-6-NSGO/GOG3031 Phase III trial investigating Jemperli (dostarlimab-gxly) plus standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab-gxly compared to chemotherapy plus placebo followed by placebo in adult patients with primary advanced or recurrent endometrial cancer. Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK said: “These positive results from the RUBY trial bring us one step closer to addressing the significant unmet needs of endometrial cancer patients and add to the growing body of evidence on dostarlimab-gxly, strengthening our belief in its potential to transform cancer treatment as a backbone immuno-oncology therapy.” 

Two Fitusiran Phase 3 Studies Published in The Lancet and The Lancet Haematology Highlight Potential to Address Unmet Needs Across all Types of Hemophilia

Bridgewater-based BioNJ Member Sanofi announced two studies, published in The Lancet and The Lancet Haematology, evaluating the efficacy and safety of fitusiran, an investigational siRNA therapy for the prophylactic treatment of adults and adolescents with hemophilia A or B, reinforce the potential of this investigational therapy to transform the current standard of care and address unmet needs for all types of hemophilia, regardless of inhibitor status. Both Phase 3 studies compared once-monthly subcutaneous fitusiran prophylaxis (80mg) with on-demand/episodic use of clotting factor concentrates in the ATLAS-A/B study, and on-demand/episodic use of bypassing agents in the ATLAS-INH study. Across both clinical studies, prophylactic treatment with fitusiran reduced annualized bleeding rates by 90% (95% CI [84.1%; 93.6%], P <0.0001) compared to the control arms, showing a statistically significant and clinically meaningful improvement in bleeding episodes when compared to on-demand treatments; and showed improvement in quality of life.

KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Progression-Free Survival Compared to Chemotherapy Alone as First-Line Therapy for Advanced or Recurrent Endometrial Carcinoma, Regardless of Mismatch Repair Status

Rahway-based BioNJ Member Merck & Co. announced results from the Phase 3 NRG GY018 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel) then continued as a single agent every six weeks for up to 14 cycles for the first-line treatment of patients with stage III-IV or recurrent endometrial carcinoma whose cancer was either mismatch repair proficient (pMMR) or mismatch repair deficient (dMMR). Results from the trial showed the KEYTRUDA regimen demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients, regardless of mismatch repair status. These late-breaking data are being published in the New England Journal of Medicine

FDA Converts to Full Approval Indication for KEYTRUDA® (pembrolizumab) for Certain Adult and Pediatric Patients With Advanced Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors

Rahway-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has granted full approval to KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. The conversion from an accelerated to a full (regular) approval is based on results from the Phase 2 KEYNOTE-158, KEYNOTE-164 and KEYNOTE-051 trials and includes data in 504 adult and pediatric patients across more than 30 types of cancer. This marks the first full approval for an immunotherapy based on a predictive biomarker, regardless of solid tumor type. 

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

Rahway-based BioNJ Member Merck & Co. announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. This marks the first time an anti-PD-1 therapy has been approved in combination with an antibody-drug conjugate in the U.S. in these patients. 

Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy

Princeton-based BioNJ Member Bristol Myers Squibb announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. The CHMP adopted a positive opinion based on results from the pivotal Phase 3 TRANSFORM study evaluating Breyanzi as a second-line treatment in adults with relapsed or refractory LBCL compared to the standard of care consisting of salvage chemotherapy followed by high-dose chemotherapy plus hematopoietic stem cell transplant (HSCT).

Neoadjuvant Opdivo (nivolumab) With Chemotherapy Demonstrates Long-Term, Durable Clinical Benefits for Patients With Resectable Non-Small Cell Lung Cancer at Three Years in the CheckMate -816 Trial

Princeton-based BioNJ Member Bristol Myers Squibb announced three-year follow-up results from the Phase 3 CheckMate -816 trial, demonstrating sustained clinical benefits with three cycles of Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (NSCLC). With median follow up of 41.4 months, Opdivo with chemotherapy reduced the risk of disease recurrence, progression or death by 32%, demonstrating a landmark three-year event-free survival (EFS) rate of 57% with Opdivo with chemotherapy compared to 43% with chemotherapy alone (Hazard Ratio [HR], 0.68; 95% Confidence Interval [CI], 0.49 to 0.93). While overall survival (OS) remained immature at this analysis, there was a continued encouraging trend in OS favoring neoadjuvant Opdivo with chemotherapy over chemotherapy alone (HR 0.62; 99.34% CI: 0.36 to 1.05). 

Bristol Myers Squibb Receives European Commission Approval of Sotyktu (deucravacitinib), a Once-Daily Oral Treatment for Adults With Moderate-to-Severe Plaque Psoriasis

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission has approved Sotyktu (deucravacitinib), a first-in-class, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy, representing a new way of treating this chronic immune-mediated disease. The approval was based on results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which demonstrated superior efficacy of once-daily Sotyktu compared to placebo and twice-daily Otezla® (apremilast) at both 16 and 24 weeks, with responses maintained through 52 weeks. Additional data from the POETYK PSO long-term extension trial (LTE) also supported approval. The POETYK study program demonstrated a consistent safety profile in patients through three years of continuous treatment. 

Evotec and Bristol Myers Squibb Extend and Expand Strategic Neurodegeneration Partnership

Princeton-based BioNJ Member Evotec announced that the company has extended and expanded its strategic neurodegeneration partnership with BioNJ Member Bristol Myers Squibb originally signed in 2016. The initial partnership proved highly productive in generating a promising pipeline of discovery to clinical-stage programs. Based on this success, Bristol Myers Squibb and Evotec extend and expand this partnership for an additional 8 years with the goal to further broaden and deepen the strategic alliance. Evotec and Bristol Myers Squibb (formerly “Celgene”) initiated the collaboration in 2016 to identify disease-modifying treatments for a broad range of neurodegenerative diseases. Currently approved drugs only offer short-term management of patients’ symptoms and there is a significant unmet medical need for therapies that slow down or reverse disease progression in the field of neurodegenerative diseases.

Bristol Myers Squibb Research Hitches Second Ride to Space Station

Princeton-based BioNJ Member Bristol Myers Squibb recently sent a second biotherapeutics experiment from its New Jersey research laboratories to the International Space Station where microgravity conditions that support tiny protein crystallization may bring big changes to cancer drugs. For patients requiring time-consuming intravenous (IV) infusions, such as people living with cancer, reformulating a therapeutic drug could mean the difference between traveling to a hospital or clinic for lengthy treatments or going to their local doctor for a quick injection. The BMS biotherapeutics experiment, one of 15 ISS National Lab-sponsored payloads on SpaceX CRS-27 resupply mission two weeks ago, will leverage the near-zero gravity conditions at the space station to improve crystallization of biologic medicines (protein-based therapeutics derived from living cells).

New RYBREVANT® (amivantamab-vmjw) Data Showed Long-Term Clinical Response and Safety in Patients With Advanced Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations Who Have Failed Prior Platinum-Based Chemotherapy

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced new long-term data from the CHRYSALIS study evaluating RYBREVANT® (amivantamab-vmjw) in patients with advanced non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease progressed on prior platinum-based chemotherapy. In the analysis of the CHRYSALIS study, investigators assessed the efficacy and safety of RYBREVANT® in patients (n=114) with NSCLC and EGFR exon 20 insertion mutations, who had progressed on prior platinum-based chemotherapy, and were treated at the approved Phase 2 dose of 1050 mg (1400 mg for a patient weight of at least 80 kg). The primary endpoint was overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). 

Otsuka and Lundbeck Published Study Results Showing Aripiprazole 2-Month, Ready-to-Use, Long-Acting Injectable is as Well-Tolerated, and Provides Similar Plasma Levels as Aripiprazole 1-Month for Treatment of Schizophrenia and Bipolar I Disorder

Princeton-based BioNJ Member Otsuka Pharmaceutical Co., Ltd and H. Lundbeck A/S published results from research demonstrating that an investigational long-acting injectable, aripiprazole 2-month, ready-to-use 960 mg, offers comparable tolerability, safety and therapeutic plasma levels as aripiprazole 1-month, ready-to-use 400 mg, currently approved in adult patients for the treatment of schizophrenia or the maintenance treatment of bipolar I disorder (BP-I). The research is published in CNS Drugs. The 32-week randomized trial evaluated the safety, tolerability and pharmacokinetic profile of aripiprazole 2-month compared to aripiprazole 1-month, among 266 eligible patients. Results showed aripiprazole 2-month is a well-tolerated maintenance treatment for schizophrenia and BP-I and maintains consistent therapeutic plasma levels for at least two months as compared to aripiprazole 1-month plasma levels following repeated monthly dosing. 

Novo Nordisk to Lower U.S. Prices of Several Pre-Filled Insulin Pens and Vials up to 75% for People Living With Diabetes in January 2024

Plainsboro-based BioNJ Member Novo Nordisk announced it is lowering the U.S. list prices of several insulin products by up to 75% for people living with type 1 and type 2 diabetes. Products include both pre-filled pens and vials of basal (long-acting), bolus (short-acting) and pre-mix insulins, specifically Levemir®, Novolin®, NovoLog® and NovoLog® Mix 70/30. Novo Nordisk is also reducing the list price of unbranded biologics to match the lowered price of each respective branded insulin. These changes will go into effect on January 1, 2024. “We have been working to develop a sustainable path forward that balances patient affordability, market dynamics, and evolving policy changes,” said Steve Albers, senior vice president, Market Access & Public Affairs at Novo Nordisk, Inc. “Novo Nordisk remains committed to ensuring patients living with diabetes can afford our insulins, a responsibility we take seriously.” 

Sandoz Receives Approval by European Commission for Hyrimoz® (adalimumab) High-Concentration Formulation

Princeton-based BioNJ Member Sandoz, a Novartis division, announced that the European Commission (EC) granted marketing authorization in the European Union (EU) for a citrate-free high concentration formulation (HCF; 100 mg/mL) of its biosimilar Hyrimoz® (adalimumab). The approval includes all indications covered by the reference medicine*: rheumatic diseases, Crohn's disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa. “Living with a chronic disease can take a significant toll on a patient’s quality of life. Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz.

Novartis Kisqali® Phase III NATALEE Trial Meets Primary Endpoint at Interim Analysis Demonstrating Clinically Meaningful Benefit in Broad Population of Patients With Early Breast Cancer

East Hanover-based BioNJ Member Novartis announced positive topline results from an interim analysis of NATALEE, a Phase III trial evaluating Kisqali® (ribociclib) plus endocrine therapy (ET) in a broad population of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) at risk of recurrence. The Independent Data Monitoring Committee recommended stopping the trial early as the primary endpoint of invasive disease-free survival (iDFS) has been met. Kisqali plus ET significantly reduced the risk of disease recurrence, compared to standard adjuvant ET alone, with consistent benefit in patients with stage II and stage III EBC regardless of nodal involvement.

Novartis ribociclib (Kisqali®) Only Category 1 Preferred First-Line Treatment Option for HR+/HER2- mBC in Combination With an AI in Updated NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)

East Hanover-based BioNJ Member Novartis announced updates to the NCCN Guidelines® for breast cancer, released in January 2023, recommend ribociclib (Kisqali®) as the only Category 1 preferred CDK4/6 inhibitor (CDK4/6i) for first-line treatment of patients with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer (mBC) when combined with an aromatase inhibitor (AI). This recommendation indicates high levels of clinical evidence and uniform consensus among NCCN on ribociclib (Kisqali) as an appropriate treatment. NCCN Guidelines also continue to recommend ribociclib (Kisqali) plus fulvestrant as a Category 1 preferred regimen for first- and subsequent-line therapies in HR+/HER2- mBC.

GSK and SCYNEXIS Announce an Exclusive Agreement to Commercialise and Further Develop Brexafemme (ibrexafungerp), a Novel, First-in-Class Medicine to Treat Fungal Infection

Warren-based BioNJ Member GSK and Jersey City-based BioNJ Member SCYNEXIS, Inc, announced they have entered into an exclusive license agreement for Brexafemme (ibrexafungerp tablets), a U.S. FDA approved, first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC (RVVC). This exclusive license agreement gives GSK rights to commercialize Brexafemme for VVC and RVVC while continuing to develop ibrexafungerp, which is in Phase III clinical trials for the potential treatment of invasive candidiasis (IC), a life-threatening fungal infection. Infectious diseases and HIV represent around two-thirds of GSK’s pipeline. Brexafemme complements GSK’s first or best-in-class portfolio alongside late-stage antibiotics gepotidacin, potentially the first novel antibiotic for uncomplicated urinary tract infections (uUTI) in over 20 years, and tebipenem, a potential new treatment of complicated urinary tract infections (cUTI).

Phase III RUBY Clinical Trial Demonstrates Potential of Jemperli (dostarlimab-gxly) plus Chemotherapy to Redefine the Treatment of Primary Advanced or Recurrent Endometrial Cancer Versus Chemotherapy Alone

Warren-based BioNJ Member GSK announced interim results from Part 1 of the RUBY/ENGOT-EN-6-NSGO/GOG3031 Phase III trial investigating Jemperli (dostarlimab-gxly) plus standard-of-care chemotherapy (carboplatin-paclitaxel) followed by dostarlimab-gxly compared to chemotherapy plus placebo followed by placebo in adult patients with primary advanced or recurrent endometrial cancer. Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK said: “These positive results from the RUBY trial bring us one step closer to addressing the significant unmet needs of endometrial cancer patients and add to the growing body of evidence on dostarlimab-gxly, strengthening our belief in its potential to transform cancer treatment as a backbone immuno-oncology therapy.” 

FDA Accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI

BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in Fourth-Quarter 2023 for the sNDAs. In the U.S., BRAFTOVI + MEKTOVI is currently approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. BRAFTOVI is also approved, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. 

Libtayo® (cemiplimab) in Combination With Chemotherapy Approved by European Commission for the First-line Treatment of Advanced PD-L1 Positive Non-small Cell Lung Cancer (NSCLC)

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced that the European Commission (EC) approved Libtayo® (cemiplimab) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression. This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation. “Today’s approval considerably expands the number of people in Europe with advanced non-small cell lung cancer who are eligible for Libtayo-based first-line treatment, including those with PD-L1 expression ranges most commonly seen in real-world practice,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology, Regeneron. 

Pacira Announces FDA Acceptance of sNDA for Exparel Nerve Blocks to Produce Regional Analgesia in Lower Extremity Procedures

Pacira BioSciences, Inc., with a site in Parsippany, announced the U.S. Food and Drug Administration (FDA) has accepted the submission of its supplemental new drug application (sNDA) seeking expansion of the EXPAREL label to include both single-dose sciatic nerve block in the popliteal fossa as well as femoral nerve block in the adductor canal. The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is November 13, 2023. The sNDA is supported by two successful Phase 3 studies in which EXPAREL achieved statistically significant and clinically meaningful reductions in postsurgical pain and opioid consumption through 96 hours compared with bupivacaine HCl following lower extremity surgical procedures including bunionectomy and total knee arthroplasty. In both studies EXPAREL was well tolerated with a safety profile consistent with bupivacaine HCl.

Eisai Publishes Long-Term Health Outcomes Using Simulation Model of LECANEMAB Using Phase 3 Clarity AD Data in Peer-Reviewed Neurology and Therapy Journal

Nutley-based Eisai Co., Ltd announced an article about long-term health outcomes of anti-amyloid-beta (Aβ) protofibril antibody lecanemab in people living with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) using simulation modeling was published in the peer-reviewed journal Neurology and Therapy. In this simulation, lecanemab treatment is estimated to potentially slow the rate of disease progression, maintaining treated patients for a longer duration in earlier stages of early AD and improving patients' quality of life. The article compares the long-term clinical outcomes of individuals with early AD and amyloid pathology who received standard of care (SoC) alone (including stable use of acetylcholinesterase inhibitor or memantine) with those who received lecanemab plus SoC (lecanemab+SoC). 

Additional Detailed Analysis from PHASE 2 Study 201 of LECANEMAB Published as Three Papers in Peer-Reviewed Journals

Nutley-based Eisai Co., Ltd and Biogen Inc. announced that three additional detailed analyses from the Phase IIb clinical study (Study 201), evaluating the efficacy and safety of lecanemab for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD), were published in the peer-reviewed journals. Study 201 was a multicenter, double-blind, placebo-controlled, Phase 2b trial conducted in 856 patients with early AD. Its core study evaluated key efficacy assessments, including clinical change on the AD Composite Score (ADCOMS) as the primary endpoint at 12 months and as key secondary endpoints, ADCOMS, Clinical Dementia Rating-Sum-of-Boxes (CDR-SB) and AD Assessment Scale-Cognitive Subscale 14 (ADAS-Cog14) at 18 months.

Eisai Enters Into Agreement With National Cancer Center to Collaborate on Investigator - Initiated Clinical Research for Anticancer Agent TAZEMETOSTAT Based on “Patient-Proposed Healthcare Services” System

Nutley-based Eisai Co., Ltd announced that it has entered into an agreement with the National Cancer Center to collaborate on investigator-initiated clinical research for the EZH2 inhibitor tazemetostat hydrobromide (generic name, product name “Tazverik® Tablets 200 mg”, “tazemetostat”) based on “Patient-Proposed Healthcare Services” system. This clinical research will be conducted by the National Cancer Center Hospital. The “Patient-Proposed Healthcare Services” system is a system under which medical treatment using unapproved drugs not covered by insurance is applied for to the government based on the patient's request, and is conducted as a clinical trial to confirm safety and efficacy. Eisai will provide tazemetostat free of charge to the National Cancer Center Hospital as the drug to be used in “A clinical trial of Tazemetostat for pediatric and AYA patients with malignant tumors which have no standard of care or and which is refractory to standard of care: Patients-Proposed Healthcare Service” to be conducted by the hospital under this program.

Eisai Presented New Analyses of ARIA and QOL on LECANEMAB in Clarity AD at the AD/PD™ 2023 Annual Meeting

Nutley-based Eisai Co., Ltd with a site in Woodcliff Lakes, and Biogen Inc. announced that Eisai presented new analyses on amyloid-related imaging abnormalities (ARIA) with the use of antiplatelet and anticoagulant medications, isolated ARIA-H, and caregiver burden and health-related quality of life (QOL), from the results of Eisai’s Phase 3 Clarity AD study of lecanemab (generic name, U.S. brand name: LEQEMBI™), an anti-amyloid-β (Aβ) protofibril* antibody. Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer’s disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897). Lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results. 

Cranford Pharma Company, Citius, Advances Spinoff Efforts

Citius Pharmaceuticals located in Cranford announced it is moving forward with is plan to spin off its oncology asset I/ONTAK into a standalone company. Maxim Group LLC will serve as financial adviser to Citius’ wholly owned subsidiary, Citius Acquisition Corp. The Cranford-based late-stage biopharmaceutical company noted that any transactions are subject to the satisfaction of customary conditions, including final approval from the board of directors. I/ONTAK is a “recombinant fusion protein” that combines the “interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments.” It is intended as a treatment for relapsed or refractory cutaneous T-cell lymphoma. The company announced efficacy and safety data from a Phase 3 study for treating CTCL in November.

Proton Therapy’s Pros: ProCure Medical Director Says Cancer-Fighting Technology has Become More Popular … But Not Yet Reached Full Potential

ProCure Proton Therapy Center can’t pretend anymore that the health technology it’s been utilizing for 11 years is a well-kept secret. Dr. Brian Chon, the Somerset-based company’s medical director, said that, in the five years since ROI-NJ profiled the organization’s use of charged particles called protons to combat cancer as an alternative to the conventional X-ray radiation approach, this technology has become much more mainstream. “What you’re now looking at is essentially all top cancer centers, such as (Memorial Sloan Kettering Cancer Center) … have access to proton therapy,” he said. “While not as plentiful as conventional X-ray therapy, it’s really becoming an important tool in the toolbox in the management of cancer.”

ESG Best Practices

Pfizer is Making Continued Progress on its ESG Strategy: 2022 ESG Report

Pfizer strives to be a best-in-class organization built on a strong foundation of Environmental, Social & Governance (ESG) commitments and ambitions. To advance our Purpose in a way that is consistent with our core values, we are committed to action that builds trust and delivers on our commitment to quality and integrity in all we do, so that we can better support the communities that we aim to serve. 2022 was a year in which the company continued to execute on its core strategy and made progress towards its ambitious ESG goals. In 2022, more than 1.3 billion patients were treated with Pfizer’s medicines and vaccines. The company’s global presence and scale help allow it to make a broad patient impact around the world.

Merck Ranked No. 1 in the Pharmaceutical Industry Among Barron’s 100 Most Sustainable U.S. Companies 2023

Rahway-based BioNJ Member Merck & Co. has been named one of Barron’s 100 Most Sustainable U.S. Companies for the third consecutive year, ranking No. 1 in the pharmaceutical industry and advancing 38 spots in the overall rankings from last year — from No. 67 overall in 2022 to No. 29 overall in 2023. “At Merck, we are committed to operating responsibly and moving with urgency to deliver value for patients, society and all of our stakeholders,” said Carmen Villar, Vice President, Social Business Innovation, Merck. Earlier this year, Merck was also recognized as an industry leader among America’s Most JUST Companies by JUST Capital and CNBC, and America’s Most Responsible Companies by Newsweek and Statista.



38K-Square-Foot Roszel Square Life Sciences Facility OKed for ‘Einstein’s Alley’

Plans for a recently approved research facility will offer a new opportunity for life sciences companies in “Einstein’s Alley” in Mercer County. Located within West Windsor’s Roszel Square, a joint venture of Mountain Development Corp. and Gottesman Real Estate Partners announced the forthcoming, 38,000-square-foot research facility. The project is being offered as a build-to-suit, fully customizable property for life sciences firms looking to launch or expand their lab and clinical capabilities. “This is a significant new project that global life sciences companies can take advantage of to enhance and grow their medicine or device research activities and accelerate the pipeline of breakthrough discoveries to meet patient health needs and do so in one of the most recognized and prestigious markets in the world,” said Michael Seeve, President of Mountain Development Corp.

Paladino: HELIX Will Include 42-Story Mixed-Use Building (With 220 Units of Residential)

A 42-story, mixed-use building that will include 37 floors of residential featuring approximately 220 units of housing will be part of the HELIX project in New Brunswick, master developer Chris Paladino said. The building will be the tallest in Middlesex County. Mr. Paladino said the mixed-use tower will help anchor the four-acre site known formally as the New Jersey Health + Life Science Exchange. The inclusion of residential will help make HELIX, the nearly $1 billion, three-tower project that will be a center for translational life sciences research and more, more of a live-work-play destination, he said. HELIX will consist of three towers: H1: Which primarily will house the translational research space, the medical school and the New Jersey Innovation Hub; H2: Which is seeking large corporate life sciences and technology company tenants; and H3: Which will have traditional office space for smaller service providers on the bottom floors, topped by residential.

Multiple Sclerosis: What Can Be Done to Slow Its Progression?

With March being Multiple Sclerosis Awareness Month, Dr. Suhayl Dhib-Jalbut, professor and chair of neurology at Rutgers/RWJBarnabas Health, and director of the RWJ Center for MS in New Brunswick, outlines how MS affects the body and what can be done to help slow its progression. Every multiple sclerosis patient is different, but people are typically diagnosed with MS between the ages of 20-40 years old. While the exact cause of MS is unknown, it is known that something triggers the immune system to attack the central nervous system. The resulting damage to myelin, the protective layer insulating wire-like nerve fibers, disrupts signals to and from the brain.

New Jersey Innovation Institute Achieves Centers for Medicare & Medicaid Services Certification for New Jersey Health Information Network

New Jersey Innovation Institute (NJII), a leading provider of innovative and transformative services across the state, announced today that the New Jersey Department of Human Services (NJDHS) Division of Medical Assistance and Health Services (DMAHS) and New Jersey Health Information Network (NJHIN) have been granted Centers for Medicare & Medicaid Services (CMS) Medicaid Enterprise System (MES) certification. A long-standing facilitator of many statewide healthcare initiatives, NJDHS has been a key partner with NJHIN in driving interoperability across New Jersey and ensuring healthy outcomes for more than 2.2 million Medicaid beneficiaries.

Introducing a powerful partnership like no other

Rowan University, a top 100 public research institution, and Virtua Health, South Jersey’s largest health system, are working to advance health care education, research and biomedical engineering. Together, they’ve created the Virtua Health College of Medicine & Life Sciences of Rowan University.

Click here for video

Menendez, Booker Announce Federal Funding for Some NJ College Programs

New Jersey Sens. Bob Menendez and Cory Booker and Kean University’s leaders announced a new round of federal funding heading to the State’s colleges and universities — just over $18 million. Higher education officials recently testified during state budget hearings about a need for more aid to help pay staff salaries, but this money is being set aside for investments in programs like cyber security, STEM research, nursing, medical programs and pre-apprenticeships in advanced manufacturing. Kean University is slated to get more than $4 million out of that pot for projects that will include renovating the university’s research labs along with a new higher-ed program for middle and high school students in the area.

Rutgers Awarded $20M to Lead Consortium Fighting TB

In an effort to coordinate a worldwide effort to stop the most deadly infectious disease from spreading, Rutgers New Jersey Medical School announced it will receive $20 million over five years from the National Institute of Allergy and Infectious Diseases to coordinate research being conducted in eight nations on tuberculosis control and prevention. The research will be done through the TB-RePORT International program that was established in 2012 to accelerate research and development for TB control and prevention. RePORT, or Regional Prospective Observational Research in Tuberculosis, networks exist in and are funded by Brazil, China, India, Indonesia, South Korea, the Philippines and South Africa and will soon include Uganda, bringing together experts in TB research, including clinicians and scientists, from nations hardest hit by TB to collaborate and share information about the disease.

Rutgers Office for Research Executes Exclusive License With Artificial Intelligence Startup Steg.AI

Steg.AI, a start-up based on artificial intelligence technology developed at Rutgers University and founded by Rutgers graduate Eric Wengrowski and School of Engineering professor Kristin Dana, hopes to use its innovative security software to help businesses and organizations protect their media assets and intellectual property. The brainchild of Mr. Wengrowski, the technology developed is information security software that businesses can utilize to protect their media assets and intellectual property. The research conducted by Mr. Wengrowski and Mrs. Dana and their team focused on the ability to transmit information with light in a way that is only visible to a machine or a camera. 

Princeton Cancer Center Receives $2.5M for Geriatric Cancer Research

The Penn Medicine Princeton Cancer Center received a $2.5 million grant from BioNJ Member Bristol Myers Squibb Foundation to help fund a program aimed at improving care for older cancer patients. The goals of the new Geriatric Oncology Program at the cancer center – which is located at Princeton Medical Center in Plainsboro – are to provide a better understanding of geriatric cancer and increase outreach to seniors in central New Jersey. James Demetriades, CEO of Penn Medicine Princeton Health, said 70% of Princeton Cancer Center patients with cancer are 65 or older, and 18% are at least 80 years old. “Every one of those individuals faces unique challenges, and we are committed to working with them to develop care plans that meet their unique needs,” Mr. Demetriades added. 

$3.2 Million Grant Supports Study of New Genetic Testing Approach to Reduce Racial Health Disparities

With the aid of a near $3.2 million National Cancer Institute grant (R01CA277599) recently awarded, investigators from the State’s leading cancer program, Rutgers Cancer Institute of New Jersey, and Georgetown University’s Lombardi Comprehensive Cancer Center, both NCI-designated Comprehensive Cancer Centers, will work to close racial disparity gaps in cancer care delivery by examining a novel approach to genetic testing and care based on community identified needs. Currently, many health care systems and commercial genetic testing laboratories use digital interventions, including videos and chatbots, instead of traditional pre-test genetic counseling sessions with a genetic risk specialist. In this newly funded study, investigators propose use of a community-engaged, culturally tailored and interculturally competent care delivery model that involves community engagement in the development, implementation and evaluation in oncology settings to eliminate racial disparities in genomic health care delivery. 

NJIT Ranks No. 1 in The New York Times College Ranking Tool

The New York Times ranks BioNJ Member New Jersey Institute of Technology located in Newark No. 1 among all public universities nationally when you prioritize high alumni earnings, economic mobility and academic profile. The “Build Your Own College Rankings” tool puts 10 priorities in the hands of students, who can raise or lower them and achieve different results. The other priorities are sticker price, low net price, athletics, racial diversity, campus safety, economic diversity and party scene. NJIT’s results affirm its standing as a nationally ranked university that primes a diverse group of students for rewarding careers that deliver return on investment, particularly in STEM. 


BeiGene Appoints Julius Pryor III as First Global Head of Diversity and Health Equity

BioNJ Member BeiGene, with a site under development in Hopewell, announced the appointment of Julius Pryor III as its first Global Head of Diversity and Health Equity. Mr. Pryor has more than 30 years of experience in Diversity, Equity, Inclusion & Belonging (DEI&B) efforts, having successfully built transformational DEI&B programs for biotechnology companies, as well as global consumer-focused businesses. In this newly created role, he will lead BeiGene’s efforts to elevate the company’s health equity and DEI&B initiatives, ensuring representation is at the forefront in BeiGene’s commitment to colleagues as well as patients, caregivers and other external stakeholders in combating disparities in healthcare. 

Genmab Announces Appointment of Martine van Vugt to Chief Strategy Officer

Princeton-based BioNJ member Genmab announced that Martine van Vugt has been appointed to Chief Strategy Officer and promoted to Executive Vice President. Ms. van Vugt will oversee Corporate Strategy, Corporate Development, Business Development and Licensing and Alliance Management. Ms. van Vugt joined Genmab in 2001 and most recently served as Genmab’s Senior Vice President, Corporate Strategy & Planning. She will continue her role as a member of the Executive Committee with Genmab’s President and Chief Executive Officer Dr. Jan van de Winkel, Chief Development Officer Dr. Judith Klimovsky, Chief Financial Officer Anthony Pagano, Chief Medical Officer Dr. Tahi Ahmadi, Chief Operating Officer Anthony Mancini, Chief Legal Officer Birgitte Stephensen, and Chief People Officer Chris Cozic.

Kamal Named President at Prime Therapeutics

Prime Therapeutics LLC, with a site in Newark, has appointed Mostafa Kamal as President of the organization. Mr. Kamal also serves as CEO of Magellan Rx, a company that was acquired by Prime in December 2022. Ken Paulus, CEO of Prime, will continue in his current position. Mr. Kamal previously held the role of Executive Vice President at Prime with overall responsibility for all of Magellan Rx’s lines of business as well as Prime’s specialty pharmacy solutions and enterprise marketing and communications. In his newly expanded role as President, Mr. Kamal will add Prime’s pharmacy benefit management solutions as well as enterprise operations and technology to his areas of accountability.

BD Promotes Quinn to EVP, General Counsel

BD (Becton, Dickinson and Co.) located in Franklin Lakes announced that Michelle Quinn has been named Executive Vice President and General Counsel. “Michelle exemplifies BD’s core value of doing what is right, and I look forward to her continued strategic guidance as our general counsel,” President Tom Polen said. “Michelle’s deep experience in leading legal functions in a variety of health care companies has and will continue to benefit BD, our associates, the patients we serve and our shareholders through her focus on advancing the company’s business strategies and governance initiatives.” Before joining BD in 2019, Ms. Quinn was Vice President and General Counsel of North America for Sandoz Inc., a division of Novartis. She also served as Vice President and Associate General Counsel at Catalent Pharma Solutions. 

Rocket Pharmaceuticals Announces Leadership Expansion to Support Company on Evolution Towards Commercial Stage

Cranbury-based Rocket Pharmaceuticals on Wednesday said it expanded its leadership team to support its growing and industry-leading pipeline of AAV and LV gene therapy assets and evolution towards commercial stage. Dr. Jonathan Schwartz was appointed Chief Gene Therapy Officer to enhance the company’s focus on strategic application of gene therapy technologies to current and future therapeutic areas. Additionally, Dr. Mark White joined Rocket as Chief Medical Officer following more than 25 years at AstraZeneca where he gained deep expertise in late-stage drug development and commercialization across small and large molecules, vaccines and therapeutic areas including rare diseases.

Thought Leaders

Portfolio Valuation in the Aftermath of the IRA

A strategic guide developed by BioNJ Member Hogan Lovells

Now more than ever, companies must think strategically and be more nimble about attracting investments and/or strategic partnerships, pathways to regulatory approval and product commercialization. Market access has become the single most important factor of commercial success in the U.S. market. What are the pricing and reimbursement activities that pre-commercial life sciences and health care emerging companies should consider, even at a pre-clinical stage? What impacts of the Inflation Reduction Act (IRA) of 2022 should early stage companies be prepared to discuss with investors? Great data are no longer enough, and answering these questions early on is an imperative in advancing your technology toward the market.

Industry Events


Annual Spring Symposium and Healthcare Workshop

Presented by the Rutgers Master of Health Administration Program

April 26, 2023

The interplay between health systems and the life sciences is a critical driver in the discovery

and development of new therapies and cures. This symposium is designed to provide insight into the respective roles of health systems and the life sciences that foster the development of lifesaving and life-enhancing research and solutions. This half-day event will include panel discussions with representatives from select health systems, pharmaceutical and life science companies, and patient advocates. The audience will consist of students, faculty, healthcare executives, industry representatives and the media.

Navigating the Funding Landscape: Insights for Early-Stage Biotechs

Hosted by LES USA & Canada

MAY 18, 2023

Join us for an engaging and timely event on May 18 at the Basking Ridge Country Club. Discover what it takes for early-stage biotechs to secure funding in today's challenging market conditions. This event will shed light on the unique challenges and opportunities facing the industry through in-depth case studies, insightful discussions, and a comprehensive analysis of current funding trends. Don't miss out on this invaluable opportunity to gain a competitive edge in the world of pharma deals. Register now and be a part of the conversation!

Stand Up for Science at BIO 2023 Hosted by BIO International Convention

June 5-8, 2023

Stand up for innovation. Stand up for truth. And stand up for science. It’s time to inspire, honor and recognize the true value of the breakthrough work biotech performs for society. Today. And every day. Well into the future. Join the global power players in the biotech and pharma industry at the world's most influential biotech meeting! Sign up for updates to receive everything you need to know about the BIO International Convention.

ON Helix Hosted by One Nucleus

July 6, 2023

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

Winds of Change: Dealmaking Trends in the Evolving Innovation Economy

Hosted by LES USA & Canada

October 15-18, 2023

Under the theme of Winds of Change: Dealmaking Trends in the Evolving Innovation Economy, our dynamic international IP community will meet in Chicago for two action-packed days of education, outstanding programming, and networking, with global deal making opportunities. The month of May will be here before we know it! Register before May 1, 2023 and save.

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