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June 3, 2022

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

Core to BioNJ's mission to help our Members help Patients is BioNJ's Value of Medical Innovation Campaign. The goal of the campaign is to educate and engage with legislators, advocates and our community on the value of medical innovation as well as policy threats to Patients, innovation and health care equity. From health care affordability to misconceptions about PBMs and PDABs and, of course ICER, there is still lots of work to be done. 

With this in mind, BioNJ recently released the latest instalment in our Guest Blog Series: Expert Perspectives on Patient Access, ICER and Innovation. Click here to read "CMS Coverage Determination for Alzheimer's Treatment Is a Lesson on Patent Access," written by Sue Peschin, President & CEO, Alliance for Aging Research.

Meanwhile, with hearings and debate at both the State and federal level examining practices by Pharmacy Benefit Managers (PBMs), BioNJ President and CEO Debbie Hart’s op-ed, "The True Driver for High Cost of Medicines," published last week in the Asbury Park Press provides timely insight into the role that PBMs play. Click here to read. 

BioNJ is proud of the endless work being done by our Members and the full industry...bringing new groundbreaking treatments and cures to Patients everywhere. Please join BioNJ in our efforts to advocate for policies and solutions that help Patients access the medicines they need and promote a thriving life sciences industry in New Jersey and beyond. Click here to learn more.

Hope to see you at the Annual Dinner Meeting and Innovation Celebration on June 9!

Thank you.

Because Patients Can't Wait®,

The BioNJ Team

Upcoming BioNJ Events


BioNJ’s 29th Annual Dinner Meeting and Innovation Celebration

Register Today!

June 9, 2022

BioNJ’s IT/Cybersecurity Briefing

Register Today!

June 21, 2022

A Model for Moving from Medical Breakthrough to Blockbuster

Register Today!

June 22, 2022

Putting Patients First:

The Value of Medical Innovation


Podcast: Drug Prices: A Dysfunctional Market Limits Patient Access

A convoluted, confusing and opaque system for pricing drugs has evolved that distorts the market and often limits patient access to the drugs they need to survive. In this episode of BIO's podcast, three experts explain how the system works — or doesn’t — and the consequences of a dysfunctional pricing system. 

BioNJ Company News


BioNJ Op-Ed Published in Asbury Park Press: The True Driver for High Cost of Medicines

America's thriving life sciences industry has enabled new and innovative drugs to come to market, promising a better quality of life for people in New Jersey and around the world. Recent conversations in Washington, and even in the New Jersey State Legislature, have continued to focus on the "high prices" of many of these drugs — often blaming the biopharmaceutical manufacturers. While policymakers rightly focus their attention on the rising high out-of-pocket costs of drugs, they ignore the true culprits... industry middlemen. While it may make for an easy talking point, the innovative biopharmaceutical manufacturers leading the way to breakthroughs on treatments for devastating diseases like cancer and Alzheimer's are not the cause of out-of-pocket price increases for prescriptions — and the data backs this up.

NJ Company News


FDA Approves Label Extension for Evrysdi® for Infants With Spinal Muscular Atrophy Under 2 Months Old

South Plainfield-based BioNJ Member PTC Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include infants under 2 months old with spinal muscular atrophy (SMA). The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that pre-symptomatic babies treated with Evrysdi achieved key milestones, such as sitting and standing, with half walking after 12 months of treatment. All infants were alive at 12 months without permanent ventilation. Evrysdi is designed to treat SMA by increasing and sustaining the production of the SMN protein, which is found throughout the body and is critical for maintaining healthy motor neurons and movement.

Phathom Pharmaceuticals Announces FDA Acceptance for Filing of Vonoprazan NDA for the Treatment of Erosive Esophagitis

Florham Park-based BioNJ Member Phathom Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for vonoprazan as a treatment for adults for the healing of all grades of erosive esophagitis (EE) and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn. Vonoprazan is a novel, orally administered investigational potassium-competitive acid blocker (PCAB) from a new class of acid suppressant agents and under development for the treatment of erosive esophagitis and non-erosive gastroesophageal reflux disease (NERD). This NDA is supported by the positive data previously announced from Phathom’s pivotal Phase 3 PHALCON-EE trial, a randomized, double-blind, multicenter trial that enrolled 1,027 patients with EE in the U.S. and Europe and compared vonoprazan to lansoprazole, a proton pump inhibitor (PPI), in the healing and maintenance of healing of EE and heartburn symptom relief. 

Key Binding Characteristics of Dusquetide to Important Intracellular Protein Identified

Princeton-based BioNJ Member Soligenix announced a publication describing the binding of its Innate Defense Regulator (IDR), dusquetide, to the p62 protein. Dusquetide has demonstrated anti-infective, anti-tumor and anti-inflammatory actions in multiple animal models by modulating the body's own innate immune system. Dusquetide previously demonstrated significant benefits in reducing the duration of severe oral mucositis (SOM) in a Phase 2 clinical trial and reduction in SOM rates in the per protocol population in a Phase 3 study. In addition to the reduction of SOM, an acceleration in the clearance of tumor response and an increase in overall survival were also observed in the Phase 2 clinical study as an ancillary benefit to treating oral mucositis in patients receiving chemo-radiation for their head and neck cancer (HNC).

Soligenix Receives U.S. Patent Allowance for its Thermostabilized Vaccine Platform

Princeton-based BioNJ Member Soligenix announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the patent application titled "Compositions and Methods of Manufacturing Trivalent Filovirus Vaccines." The allowed claims are directed to unique, proprietary compositions and methods directed to combinations of glycoprotein antigens with nanoemulsion adjuvants comprising sucrose fatty acid esters prior to lyophilization. The described vaccine platform has previously been successfully applied to filovirus vaccines (as mono-, bi- and tri-valent candidates for Zaireebolavirus, Sudan ebolavirus and Marburg marburgvirus) as well as a SARS-CoV-2 vaccine. The candidate filovirus vaccines have been previously shown to protect non-human primates (NHPs) from subsequent infection and represent the only recombinant subunit vaccines that have demonstrated efficacy against Zaire ebolavirus and other filoviruses in NHPs.

Y-mAbs Announces FDA Acceptance of Biologics License Application for OMBLASTYS® (omburtamab) for the Treatment of Neuroblastoma for Priority Review

Nutley-based BioNJ Member Y-mAbs Therapeutics, Inc. announced that the Biologics License Application for OMBLASTYS® (omburtamab) for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma has been accepted for priority review by the U.S. Food and Drug Administration. “We believe that the FDA’s acceptance of our OMBLASTYS® BLA for priority review is a significant achievement for Y-mAbs and a crucial step forward as we anticipate that OMBLASTYS, if approved by the FDA, can address a significant unmet medical need for children with CNS/leptomeningeal metastasis from high-risk neuroblastoma, where no standard therapy currently exists, potentially adding a second rare disease product to our commercial portfolio and without any significant further investment in our existing commercial infrastructure,” stated Thomas Gad, Founder, President and Interim CEO. 

Gilead Leases 96,000 sq. ft., Eyes New Corporate Hub at Parsippany’s ‘Latitude’ Campus

Biopharmaceutical giant Gilead Sciences has leased nearly 100,000 square feet at a Parsippany office campus, with plans to open a highly anticipated East Coast hub by early next year. The company said it will occupy two floors for a total of 96,300 square feet at 369 Interpace Parkway, part of the Latitude complex just south of Interstate 80. Gilead plans to open the new space in the first quarter of 2023. It’s also slated to make significant operational and capital investments “to ensure the site reflects Gilead’s corporate standards of a modernized and inclusive workspace” for its employees in the New Jersey area.

European Medicines Agency Grants Orphan Drug Designation to Cornerstone Pharmaceuticals’ CPI-613® (Devimistat) for Treatment of Patients With Advanced Unresectable Biliary Tract Cancer

Cranbury-based BioNJ Member Cornerstone Pharmaceuticals announced that the European Medicines Agency (EMA) has granted orphan drug designation to CPI-613® (devimistat) for the treatment of advanced unresectable biliary tract cancer. Also known as cholangiocarcinoma, biliary tract cancer is an extremely rare and hard to treat cancer, affecting just over 2,000 people in the UK annually with incidents steadily increasing every year. This orphan drug designation is the fourth granted for devimistat by the EMA, following existing designations for Burkitt’s lymphoma, pancreatic cancer and acute myeloid leukemia (AML). The Food and Drug Administration (FDA) has granted orphan drug designation for devimistat in seven indications in the United States, including in biliary tract cancer.

Advaxis to Present Updated Clinical and Immunogenicity Data from Ongoing Phase 1/2 Trial of ADXS-503 in Metastatic Non-Small-Cell Lung Cancer (NSCLC) and Study Design of ADXS-504 Trial in Early Prostate Cancer at the American Society of Clinical Oncology

Princeton-based BioNJ Member Advaxis announced the publication of updated results from the clinical trial of the lead asset from its ADXS-HOT off-the-shelf, cancer-type specific, immunotherapy program. These results from the clinical study ADXS-503-101 evaluating the ADXS-503 construct, which is designed to target certain cancers’ commonly occurring hotspot mutations and other tumor-associated antigens, will be presented at the ASCO Annual Meeting along with the trial design of the study of the second construct from the ADXS-HOT program, ADXS-504. The goals of this Phase 1/2 open-label trial are to evaluate safety, tolerability, antitumor activity and immune-correlative data of ADXS-503 administered in combination with KEYTRUDA® in patients with metastatic NSCLC.

Starton Therapeutics Announces Approval to Proceed With Final Dose Escalation in Phase 1 Clinical Study Evaluating STAR-LLD

Paramus-based BioNJ Member Starton Therapeutics announced that the Independent Data Monitoring Committee reviewed the totality of the safety data from the first two cohorts and recommended advancement to the third- and final dose escalation, where subjects will receive the highest infusion strength of STAR-LLD. The ongoing Phase 1 STAR-LLD clinical trial is evaluating continuous delivery lenalidomide in healthy subjects. Eight subjects in the first two cohorts received 24 hours of STAR-LLD continuous lenalidomide, and a single oral dose of lenalidomide after a 24-hour washout period. The company previously announced that the upcoming Phase 1b/2 clinical study in multiple myeloma is on track to begin enrollment in Q4 2022 at three already identified sites in the European Union. 

CHMP Recommends Approval of Lilly and Incyte's OLUMIANT® (baricitinib) as the First and Only Centrally-Authorized Treatment for Adults With Severe Alopecia Areata (AA)

Bridgewater-based BioNJ Member Eli Lilly and Company and Incyte announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for OLUMIANT® (baricitinib) for the treatment of adults with severe alopecia areata (AA). This opinion marks the first step toward European regulatory approval of OLUMIANT for patients with severe AA, and it is now referred to the European Commission for final action. If approved, OLUMIANT would be the first centrally authorized oral treatment and first JAK inhibitor for patients with severe AA in the European Union. The European Commission's decision is expected in the next one to two months. 

Fifty Percent of Patients With Ulcerative Colitis Treated With Mirikizumab Achieved Clinical Remission at One Year in Lilly's Pivotal Phase 3 Study

In Bridgewater-based BioNJ Member Eli Lilly and Company’s pivotal, Phase 3 LUCENT-2 study, patients with ulcerative colitis (UC) who responded to mirikizumab at 12 weeks achieved and maintained statistically superior and clinically meaningful improvements at one year compared to placebo across the primary endpoint of clinical remission and all key secondary endpoints, including bowel urgency severity, using a novel, patient-reported outcome measure. If approved, mirikizumab would become the first and only anti-IL23p19 treatment for people with UC. Mirikizumab was superior to placebo on clinical, symptomatic, endoscopic and histologic endpoints regardless of previous failure to TNF inhibitors, tofacitinib or other biologics. Among patients who had responded to 12-week induction treatment with mirikizumab, one-half of patients receiving mirikizumab maintenance treatment (49.9%, n=182/365) achieved clinical remission at one year compared to one-fourth of patients on placebo (25.1%, n=45/179, p<0.001). 

Gamida Cell Completes Rolling Biologics License Application Submission to the FDA for Omidubicel

BioNJ Member Gamida Cell Ltd. announced completion of the rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for omidubicel for the treatment of patients with blood cancers in need of an allogenic hematopoietic stem cell transplant. The omidubicel BLA is supported by the statistically significant results from Gamida Cell’s pivotal Phase 3 study, the results of which were published in Blood, the official journal of the American Society of Hematology. For the study’s primary endpoint, the median time to neutrophil engraftment in patients with hematologic malignancies undergoing allogeneic bone marrow transplant receiving omidubicel compared to standard umbilical cord blood (UCB), the median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p < 0.001).

Gamida Cell Announces Opening to Enrollment of Company-Sponsored Phase 1/2 Study of NK Cell Therapy Candidate GDA-201

BioNJ Member Gamida Cell Ltd. announced the activation of the initial clinical sites to screen and enroll patients in the company-sponsored Phase 1/2 study evaluating a cryopreserved formulation of GDA-201, a readily available cell therapy candidate for the treatment of follicular and diffuse large B cell lymphomas (NCT05296525). On April 26, 2022, Gamida had announced that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application and removed the clinical hold for a cryopreserved formulation of GDA-201. GDA-201 leverages Gamida Cell’s proprietary NAM technology platform to expand the number and functionality of NK cells to direct tumor cell killing properties and antibody-dependent cellular cytotoxicity (ADCC). In an investigator-sponsored Phase 1/2 study in patients with relapsed or refractory lymphoma, treatment with the fresh formulation of GDA-201 with rituximab demonstrated significant clinical activity.

European Commission Approves KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Neoadjuvant Treatment, Then Continued as Adjuvant Monotherapy After Surgery for Locally Advanced or Early Stage Triple-Negative Breast Cancer at High Risk of Recurrence

Kenilworth-based BioNJ Member Merck & Co. announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced or early stage triple-negative breast cancer (TNBC) at high risk of recurrence. The approval is based on results from the pivotal Phase 3 KEYNOTE-522 trial, in which KEYTRUDA in combination with chemotherapy before surgery and continued as a single agent after surgery prolonged event-free survival (EFS), reducing the risk of EFS events or death by 37% (HR=0.63 [95% CI, 0.48-0.82]; p=0.00031) compared to neoadjuvant chemotherapy alone in this patient population. 

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adult and Adolescent (≥12 Years of Age) Patients With Stage IIB or IIC Melanoma Following Complete Resection

Kenilworth-based BioNJ Member Merck & Co. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection. Additionally, the CHMP recommended expanding the indications for KEYTRUDA in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients aged 12 years and older. The positive opinion was granted based on results from the Phase 3 KEYNOTE-716 trial. 

Novartis Announces Partnership With the American Society of Hematology to Fight Sickle Cell Disease in Sub-Saharan Africa

East Hanover-based BioNJ Member Novartis announced a partnership with the American Society of Hematology (ASH) to provide six additional African nations with technology that is already being used in Ghana to document and share the diagnosis of babies with sickle cell disease. Early diagnosis is key to managing the disease and ensuring better health outcomes to improve the quality of life for people living with SCD. The partnership with ASH will not only deliver better tools to track a baby’s diagnosis, but also support greater knowledge on treatment and care, including through publications on research findings, professional education and dissemination to policy makers and other audiences.

Novartis Cosentyx® (Secukinumab) Receives Positive CHMP Opinion for Expanded Use in Childhood Arthritic Conditions

East Hanover-based BioNJ Member Novartis announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx® (secukinumab), used alone or in combination with methotrexate, in the juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. ERA and JPsA are progressive, debilitating autoimmune diseases. ERA is characterized by joint swelling and pain where tendons and ligaments attach to bone and may present with lower back pain or tenderness at the palpation of the hips.

FDA Approves Novartis Kymriah® CAR-T Cell Therapy for Adult Patients With Relapsed or Refractory Follicular Lymphoma

East Hanover-based BioNJ Member Novartis announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Kymriah® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. In accordance with the Accelerated Approval Program, continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Kymriah is now FDA approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings. The approval is based on data from the Phase II ELARA trial, a single-arm, open-label trial, in which 90 patients were evaluated for efficacy with a median follow-up of approximately 17 months. 

Sandoz Announces New Global ‘Act4Biosimilars’ Initiative, to Improve Patient Access and Increase Adoption by at Least 30% in 30+ Countries by 2030

Princeton-based BioNJ Member Sandoz, a Novartis division, announced the launch of a new global initiative called ‘Act4Biosimilars’ to help address health inequity and inequality worldwide. Act4Biosimilars aims to increase patient access to advanced medicines by facilitating greater approvability, accessibility, acceptability and affordability (the 4 A’s) of biosimilars. The initiative is supported by a multidisciplinary Steering Committee of patient advocacy leaders, healthcare professionals, biosimilar experts and industry leaders from around the world, with a mission to increase global adoption of biosimilar medicines by at least 30% in 30+ countries by 2030. outlines the 12 goals that have been identified under the 4As by the Steering Committee to achieve the mission. These include ensuring equitable pricing, involving patients in treatment decisions and streamlining biosimilar development. 

Late-Breaking Data at EULAR 2022 Demonstrate Deucravacitinib Significantly Improved Disease Activity in Phase 2 PAISLEY Study in Systemic Lupus Erythematosus

Princeton-based BioNJ Member Bristol Myers Squibb announced positive results from the Phase 2 PAISLEY study evaluating deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, compared to placebo in patients with moderate to severe systemic lupus erythematosus (SLE). The study met the primary endpoint of achieving SLE Responder Index-4 (SRI(4)) responses, a composite endpoint used in SLE clinical trials to assess disease activity, at Week 32. A significantly greater proportion of patients on deucravacitinib 3 mg twice daily (BID) and 6 mg BID achieved SRI(4) at 32 weeks versus placebo (deucravacitinib 3 mg BID: 58.2%, P=0.0006; deucravacitinib 6 mg BID: 49.5%, P=0.0210; placebo: 34.4%). While the 12 mg once daily (QD) group had numerically higher SRI(4) responses relative to placebo at 32 weeks, the results did not reach statistical significance on multiplicity adjustment. 

Bristol Myers Squibb and Immatics Expand Strategic Alliance to Develop Gamma Delta Allogeneic Cell Therapy Programs

Princeton-based BioNJ Member Bristol Myers Squibb and Immatics N.V., a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, announced that they have expanded their strategic alliance to pursue the development of multiple allogeneic off-the-shelf TCR-T and/or CAR-T programs. Under this collaboration, Bristol Myers Squibb and Immatics will develop two programs owned by Bristol Myers Squibb and both companies have an option to develop up to four additional programs each. The programs will utilize Immatics’ proprietary gamma delta T cell-derived, allogeneic Adoptive Cell Therapy (ACT) platform, called ACTallo®, and a suite of next-generation technologies developed by Bristol Myers Squibb.

Data from Phase 2 PILOT Study of Bristol Myers Squibb’s CAR T cell Therapy Breyanzi Show Substantial Durable Responses in Patients With Refractory or Relapsed Large B-cell Lymphoma After First-Line Therapy

Princeton-based BioNJ Member Bristol Myers Squibb announced results from the primary analysis of PILOT, a multicenter, Phase 2 study evaluating Breyanzi (lisocabtagene maraleucel) in adults with refractory or relapsed large B-cell lymphoma (LBCL) after first-line therapy who were not deemed candidates for high-dose chemotherapy and hematopoietic stem cell transplant (HSCT). The PILOT study is the only company-sponsored trial to evaluate a CAR T cell therapy as a second-line treatment for patients with relapsed or refractory LBCL who are not considered candidates for stem cell transplant. The PILOT study enrolled a broad patient population of adults with refractory or relapsed LBCL after first-line treatment who were not considered candidates for transplant based on age, performance status and/or organ function and comorbidities, and regardless of time to relapse following first-line treatment.

U.S. Food and Drug Administration Approves Two Opdivo® (nivolumab)-Based Regimens as First-Line Treatments for Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved both Opdivo® (nivolumab) (injection for intravenous use) in combination with fluoropyrimidine- and platinum-containing chemotherapy and Opdivo® plus Yervoy® (ipilimumab) as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) regardless of PD-L1 status. The approvals are based on the Phase 3 CheckMate -648 trial, which evaluated Opdivo in combination with chemotherapy (n=321) and Opdivo plus Yervoy (n=325) each compared to chemotherapy alone (n=324) and was the largest Phase 3 trial of an immunotherapy in first-line ESCC.

FDA Grants Efanesoctocog Alfa Breakthrough Therapy Designation for Hemophilia A

The United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to efanesoctocog alfa (BIVV001) for the treatment of people with hemophilia A, a rare and life-threatening bleeding disorder, based on data from the pivotal XTEND-1 Phase 3 study. Bridgewater-based BioNJ Member Sanofi and Sobi ® collaborate on the development and commercialization of efanesoctocog alfa. Topline results from the pivotal XTEND-1 Phase 3 study demonstrate efanesoctocog alfa met the primary endpoint, showing a clinically meaningful prevention of bleeds in people with severe hemophilia A over a 52-week period. Importantly, the key secondary endpoint was also met, demonstrating that efanesoctocog alfa was superior to prior prophylactic factor VIII replacement therapy in preventing bleeding events based on an intra-patient comparison. 

Sanofi Grants Regeneron Worldwide Exclusive License Rights to Libtayo® (cemiplimab)

Bridgewater-based BioNJ Member Sanofi restructures its immuno-oncology collaboration with Basking Ridge-based Regeneron Pharmaceuticals, Inc. Under the amended and restated license and collaboration agreement, Regeneron will obtain worldwide exclusive license rights to Libtayo. The Sanofi and Regeneron global immuno-oncology license and collaboration agreement was originally executed in 2015. Prior to today, the companies had split Libtayo’s worldwide operating profits equally and co-commercialized Libtayo in the U.S., with Sanofi solely responsible for commercialization in the rest of the world. Under the terms of the amended and restated immuno-oncology license and collaboration agreement, Sanofi will transfer the rights to develop, commercialize, and manufacture Libtayo entirely to Regeneron, on a worldwide basis, over the course of a defined transition period (to start upon receipt of any required governmental clearances worldwide).

CHMP Recommends Approval of Xenpozyme® (Olipudase Alfa), the First and Only Treatment for ASMD

Bridgewater-based BioNJ Member Sanofi announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Xenpozyme® (olipudase alfa), recommending that this investigational enzyme replacement therapy be approved in the European Union (EU) for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in pediatric and adult patients with ASMD type A/B or ASMD type B. The positive CHMP opinion is based on data from the ASCEND and ASCEND-Peds clinical trials, demonstrating that Xenpozyme showed robust and clinically relevant improvement in lung function (as measured by diffusing capacity of the lung for carbon monoxide, or DLco) and reduced spleen and liver volumes, with a well-tolerated safety profile in adults and children with ASMD.

FDA Approves Dupixent® (Dupilumab) as First Treatment for Adults and Children Aged 12 and Older With Eosinophilic Esophagitis

Bridgewater-based BioNJ Member Sanofi announced U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40 kg. With this approval, Dupixent becomes the first and only medicine specifically indicated to treat EoE in the United States. EoE is a chronic inflammatory disease driven by type 2 inflammation that damages the esophagus and prevents it from working properly. For people with EoE, swallowing even small amounts of food can be a painful and worrisome choking experience. They are often left to contend with the frustration and anxiety of a constantly evolving list of foods to avoid, a poor quality of life and a higher risk of depression.

Biogen and Samsung Bioepis’ BYOOVIZ™ (ranibizumab-nuna) Launches in the United States

BioNJ Member Biogen, Inc. and Samsung Bioepis Co., Ltd. announced that BYOOVIZ™ (ranibizumab-nuna), a biosimilar referencing LUCENTIS® (ranibizumab)i has been launched in the United States. Healthcare provider engagement, promotional activity, collaborations with professional societies and patient advocacy groups have commenced and BYOOVIZ will be commercially available on July 1, 2022, through major distributors across the U.S. The list price will be $1,130 per single use vial to administer 0.5mg via intravitreal injection, which is 40% lower than the current list price of LUCENTIS. The FDA approved BYOOVIZ in September 2021 for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion and myopic choroidal neovascularization. Neovascular (wet) AMD, although less common than dry AMD, is responsible for the majority of the severe vision loss or blindness associated with AMD.

New Data from Two Large Studies Reinforce Effectiveness of Dual Pathway Inhibition (DPI) With XARELTO® (rivaroxaban) Plus Aspirin in Patients With Coronary Artery Disease (CAD) and/or Peripheral Artery Disease (PAD)

New Brunswick-based BioNJ Member Johnson and Johnson announced findings from the XARELTO® (rivaroxaban) Phase 3 COMPASS Long-Term Open Label Extension (LTOLE) study and the XARELTO® in combination with Acetylsalicylic Acid (XATOA) registry have been published in the European Society of Cardiology’s (ESC) European Heart Journal, Cardiovascular Pharmacotherapy. These studies provide further evidence supporting the role of dual pathway inhibition (DPI) with the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in patients with CAD and/or PAD. Patients with CAD and/or PAD are at risk of secondary thrombotic events associated with CV disease including stroke, MI, ischemic limb events and CV-related death. Antiplatelet therapies, such as aspirin, are used to help prevent thrombosis by inhibiting platelet aggregation.

New Data Show Patients Treated With First-in-Class TREMFYA® (guselkumab) Achieve Durable Efficacy Across Joint and Axial Symptoms of Active Psoriatic Arthritis Through Two Years

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced new data from Phase 3 studies demonstrating patients treated with TREMFYA® (guselkumab) achieved consistent, long-term efficacy through two years across the domains of active psoriatic arthritis (PsA) – including joint, skin, enthesitis, dactylitis, spinal pain and disease severity endpoints – irrespective of baseline characteristics. Further analyses showed TREMFYA also provided patients with sustained improvements in measures of health-related quality of life (HRQoL), including fatigue, pain and work productivity. TREMFYA is the first and only fully human selective interleukin (IL)-23 inhibitor therapy approved in the U.S. for adults with moderate to severe plaque psoriasis (PsO) and adults with active psoriatic arthritis.

Janssen Presents Study Results Showing Clinical Efficacy for TREMFYA® (guselkumab) and Long-Term Safety Profile for STELARA® (ustekinumab) for Patients Living With Inflammatory Bowel Disease at Digestive Disease Week®

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced new data from the Phase 2 GALAXI 1 clinical trial of TREMFYA® (guselkumab) in adult patients with moderately to severely active Crohn’s disease (CD), and from three separate long-term pooled analyses of adult patients with ulcerative colitis (UC) and CD treated with STELARA® (ustekinumab). The GALAXI 1 data showed study participants with an inadequate response or intolerance to conventional therapies and/or biologics treated with TREMFYA achieved high levels of clinical-biomarker response (47.5-66.7 percent), endoscopic response (44.3-46 percent), and clinical remission with C-reactive protein (CRP) ≤3 mg/L or fecal calprotectin ≤250 μg/g (39.3-66.7 percent) at 48 weeks across dose groups. TREMFYA is not approved to treat adult patients with CD or UC in the U.S.

European Commission Grants Conditional Approval of CARVYKTI® (Ciltacabtagene Autoleucel), Janssen’s First Cell Therapy, for the Treatment of Patients With Relapsed and Refractory Multiple Myeloma

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) granted conditional marketing authorization of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. In December 2017, Janssen Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialize cilta-cel. Cilta-cel is a chimeric antigen receptor T-cell (CAR-T) therapy featuring two B-cell maturation antigen (BCMA)-targeting single domain antibodies. CAR-T therapy is specifically developed for each individual patient, and it is administered as a single infusion.

The Lancet Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Upadacitinib (RINVOQ®) in Ulcerative Colitis

Madison-based BioNJ Member AbbVie announced The Lancet published results from three pivotal Phase 3 clinical trials – U-ACHIEVE (induction), U-ACCOMPLISH and U-ACHIEVE (maintenance) – evaluating upadacitinib (RINVOQ®) in patients with moderately to severely active ulcerative colitis who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. Data from the three studies formed the basis of the company's application for approval by regulatory agencies. The publication reports the efficacy and safety results of the two induction studies and a maintenance study evaluating clinical remission and endoscopic improvement with oral upadacitinib versus placebo over 8 weeks and 52 weeks, respectively.

CHMP Recommends European Commission Approval of Upadacitinib (RINVOQ®) for the Treatment of Adults With Moderate to Severe Ulcerative Colitis

Madison-based BioNJ Member AbbVie announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (RINVOQ®, 45 mg [induction dose] and 15 mg and 30 mg [maintenance dose]) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. UC is the chronic inflammation of the large intestine, usually beginning in the rectum and lower colon, but may also spread continuously to involve the entire colon, which could lead to a significant burden and disability for patients. Living with UC impacts all aspects of a patient's life, largely due to unpredictable symptoms such as bowel urgency, abdominal pain, rectal bleeding and bowel incontinence.

AbbVie Submits New Drug Application to U.S. FDA for Investigational ABBV-951 (Foscarbidopa/Foslevodopa) for the Treatment of Advanced Parkinson's Disease

Madison-based BioNJ Member AbbVie announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in patients with advanced Parkinson's disease (PD). The submission is based on results from a Phase 3, head-to-head, randomized and controlled clinical trial demonstrating statistically significant improvement in "On" time without troublesome dyskinesia compared to oral immediate-release carbidopa/levodopa (CD/LD). ABBV-951 is designed to provide a first-of-its-kind, 24-hour, continuous subcutaneous delivery of CD/LD. Compared to oral CD/LD, it offers the potential for improvement in motor fluctuations in patients with advanced Parkinson's disease, a progressive and chronic neurological disorder resulting from the loss of dopamine-producing brain cells, which primarily manifests with tremor, muscle rigidity, slowness of movement and difficulty with balance. 

Evotec Adds Cell Therapy Manufacturing Facility With Acquisition of Rigenerand

Princeton-based BioNJ Member Evotec announced the signing of a definitive agreement under which Evotec will acquire 100% of the capital of Rigenerand Srl, a leading cell technology company, for a purchase price of € 23 m. Founded in 2009 as a spin-off of the University of Modena and Reggio Emilia, Rigenerand is a pioneering company in the field of cGMP manufacturing of cell therapies. The acquisition adds a great team of cell therapy cGMP manufacturing experts to Evotec. With their highly specialized team, Rigenerand operates a first-class certified facility that integrates state-of-the-art cGMP production with R&D and QC labs and development labs. The acquisition expands Evotec’s cell therapy platform EVOcells by adding a dedicated, high-quality cGMP manufacturing site. The seamless integration of discovery and development of innovative cures combined with in-house capabilities in GMP manufacturing are mandatory within this field.

GSK to Acquire Clinical-Stage Biopharmaceutical Company Affinivax, Inc.

Warren-based BioNJ Member GlaxoSmithKline announced that it has entered into a definitive agreement to acquire Affinivax, Inc. (Affinivax), a clinical-stage biopharmaceutical company based in Cambridge, Boston, Massachusetts, for a $2.1 billion upfront payment and up to $1.2 billion in potential development milestones. Affinivax is pioneering the development of a novel class of vaccines, the most advanced of which are next-generation pneumococcal vaccines. Pneumococcal disease includes pneumonia, meningitis, bloodstream infections and milder diseases such as sinusitis and otitis media and remains a significant unmet medical need despite the availability of current pneumococcal vaccines. Affinivax has developed the Multiple Antigen Presenting System (MAPS), a novel technology that supports higher valency than conventional conjugation technologies, enabling broader coverage against prevalent pneumococcal serotypes and potentially creating higher immunogenicity than current vaccines. 

Pfizer Launches ‘An Accord for a Healthier World’ to Improve Health Equity for 1.2 Billion People Living in 45 Lower-Income Countries

BioNJ Member Pfizer, with offices in Peapack, launched ‘An Accord for a Healthier World.’ This groundbreaking initiative aims to provide all of Pfizer’s patented, high-quality medicines and vaccines available in the U.S. or the European Union on a not-for-profit basis to 1.2 billion people in 45 lower-income countries. The Accord seeks to greatly reduce the health inequities that exist between many lower-income countries and the rest of the world. The Accord countries include all 27 low-income countries as well as 18 lower-middle-income countries that have transitioned from low to lower-middle-income classification in the last ten years. Pfizer will work with healthcare officials in Rwanda, Ghana, Malawi, Senegal and Uganda to identify early insights and opportunities to ensure all medicines and vaccines can reach those in need.

NetVation DL Medicine Announces Research Collaboration With Pfizer Inc.

NetVation DL Medicine (“DL Medicine”), a privately held biotechnology company based in Chengdu, China, and focused on the discovery and development of novel drug candidates, announced that it has entered into a two-year research collaboration with BioNJ Member Pfizer, with offices in Peapack. Under the terms of the agreement, DL Medicine will screen and collaborate with Pfizer in producing new chemical entities against preselected targets from multiple therapeutic areas. As part of the collaboration, Pfizer has taken a financial stake in DL Medicine. DL Medicine utilizes resources, funding and emerging technologies from the expanding biotechnology capabilities of the growing life sciences industry in China and employs novel approaches to identify and develop new drug candidates.

Pfizer-BioNTech COVID-19 Vaccine Demonstrates Strong Immune Response, High Efficacy and Favorable Safety in Children 6 Months to Under 5 Years of Age Following Third Dose

BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial evaluating a third 3-µg dose of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months to under 5 years of age. Following a third dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. Vaccine efficacy, a secondary endpoint in this trial, was 80.3% in children 6 months to under 5 years of age. This descriptive analysis was based on 10 symptomatic COVID-19 cases identified from seven days after the third dose and accrued as of April 29, 2022. 

Pfizer Presents ELEVATE Pivotal Findings Demonstrating Etrasimod’s Potentially Best-in-Class Profile in Ulcerative Colitis

BioNJ Member Pfizer, with offices in Peapack, announced detailed results from two pivotal studies that make up the ELEVATE UC Phase 3 registrational program evaluating etrasimod, a once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator for the treatment of moderately-to-severely active ulcerative colitis (UC). Both Phase 3, multi-center, randomized, placebo-controlled trials achieved all primary and key secondary endpoints, with etrasimod demonstrating a safety profile consistent with previous studies. In the 52-week ELEVATE UC 52 study, clinical remission was 27.0% for patients receiving etrasimod compared to 7.4% for patients receiving placebo at week 12 (19.8% differential, P=˂.001) and was 32.1% compared to 6.7% at week 52 (25.4% differential, P=˂.001). 

Pfizer Granted FDA Fast Track Designation for Ervogastat/Clesacostat Combination for the Treatment of Non-Alcoholic Steatohepatitis (NASH)

BioNJ Member Pfizer, with offices in Peapack, announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Pfizer’s investigational combination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis: ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi). Fast Track is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address unmet medical need. The FDA’s decision is informed by the results of Pfizer’s nonclinical studies and a Phase 2a clinical study of ervogastat/clesacostat, which showed that treatment with ervogastat/clesacostat reduced liver fat with a favorable safety and tolerability profile. 

Ministry of Health, Labour and Welfare Grants Orphan Drug Designation in Japan to Mecobalamin Ultrahigh-Dose Formulation With Prospective Indication for Delaying the Progression of Disease and Functional Impairment of Amyotrophic Lateral Sclerosis

Nutley-based Eisai announced that it has received orphan drug designation for ultrahigh-dose mecobalamin, with a prospective indication for delaying the progression of disease and functional impairment of amyotrophic lateral sclerosis (ALS), by the Ministry of Health, Labour and Welfare (MHLW). Based on a favorable clinical results of the JETALS, an investigator-initiated Phase III trial to evaluate efficacy and safety of ultrahigh-dose methylcobalamin in early onset ALS patients, led by a research team with Extraordinary Professor Ryuji Kaji (Principal Investigator), Tokushima University and Professor Yuishin Izumi, the Department of Neurology, Tokushima University Graduate School of Biomedical Sciences, Eisai has initiated preparation on a new drug application (NDA) of ultrahigh-dose mecobalamin for ALS, and plans to submit a NDA during the fiscal year 2023 in Japan.

Daiichi Sankyo Announces Development Progress of mRNA COVID-19 Vaccine (DS-5670) in Japan

Basking Ridge-based Daiichi Sankyo announced the current progress of development of DS-5670, an mRNA vaccine, being evaluated in Japan against the novel coronavirus 

infectious disease (COVID-19) in a Phase 1/2/3 trial to determine the booster effect of an additional dose (booster vaccination trial) and a Phase 2 trial in unvaccinated subjects. The trial is being conducted as a Phase 1/2/3 trial in healthy adult and elderly subjects who received two doses of an mRNA vaccine approved in Japan at least six months before receiving the additional dose of DS- 5670 (third vaccination) in order to evaluate the booster effect of DS-5670. 

GenScript, Fellow NJ Biotech Partner on COVID-19 Antibody Test Distribution

Piscataway-based GenScript announced it reached an agreement with Euroimmun US Inc. to distribute its COVID-19 antibody detection kit in the U.S. and Canada. Financial terms of the agreement were not disclosed. The GenScript cPass SARS-CoV-2 Neutralization Antibody Detection Kit measures a relative concentration of neutralizing antibodies in patients recovering from COVID-19. These tests can help patients determine whether their current vaccinations or boosters provide adequate protection, for example, if they’d like to travel to visit family. If the test results show low neutralizing antibody levels, a health care professional can recommend another booster. The FDA has authorized the kit for emergency use as a serology test to identify an adaptive immune response for patients with recent and prior SARS-CoV-2 infections. 

Lexicon Resubmits New Drug Application for Sotagliflozin for the Treatment of Heart Failure

Basking Ridge-based Lexicon Pharmaceuticals announced that it has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of sotagliflozin for the treatment of heart failure. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. The NDA submission is supported by the results from the Phase 3 SOLOIST-WHF clinical study in patients with type 2 diabetes who had recently been hospitalized for worsening heart failure and the Phase 3 SCORED clinical study in patients with type 2 diabetes, chronic kidney disease and risks for cardiovascular disease. 

Evkeeza® (Evinacumab) Phase 3 Trial Demonstrates 48% Ldl-C Reduction in Children With Ultra-Rare Form of High Cholesterol

Basking Ridge-based Regeneron Pharmaceuticals announced positive results from a Phase 3 trial evaluating Evkeeza® (evinacumab) in children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH). The trial met its primary endpoint, showing children who added investigational Evkeeza to other lipid-lowering therapies reduced their low-density lipoprotein-cholesterol (LDL-C) by 48% at week 24 on average. Detailed results will form the basis of a regulatory submission to the U.S. Food and Drug Administration (FDA) later this year. Despite treatment with other lipid-lowering therapies, children (n=14) entered the trial with an average LDL-C level of 264 mg/dL, more than twice the target (<130 mg/dL) for pediatric patients with HoFH.

Regeneron Completes Acquisition of Checkmate Pharmaceuticals

Basking Ridge-based Regeneron Pharmaceuticals announced that it has successfully acquired Checkmate Pharmaceuticals, Inc., deepening its commitment to immuno-oncology and adding a new modality to the company's portfolio of potential combination-ready approaches for difficult-to-treat cancers. Checkmate's lead investigational candidate, vidutolimod, is an advanced generation CpG-A oligodeoxynucleotide Toll-like receptor 9 (TLR9) agonist delivered in a virus-like particle (VLP) and has demonstrated clinical responses as a monotherapy in patients with PD-1 refractory melanoma. "As we continue to deepen and expand our efforts in immuno-oncology, the acquisition of Checkmate adds a potentially best-in-class clinical asset, as well as a promising underlying technology platform in the VLP delivery system," said Leonard S. Schleifer, M.D., Ph.D., President and CEO of Regeneron.

Ortho Clinical Diagnostics Agrees to $6B Quidel Acquisition

Quidel Corporation and Raritan-based Ortho Clinical Diagnostics Holdings plc have entered into a definitive agreement in which Quidel will acquire Ortho, one of the world’s largest in vitro diagnostics companies, for $6 billion. “The combination with Ortho will help solidify Quidel as a leader in the diagnostics industry, bringing together innovative, complementary products, solutions, and services that enhance the health and well-being of patients across the globe,” said Douglas Bryant, President and CEO of Quidel, who will serve as Chairman and CEO of the combined company. “Establishing a stronger leadership position, we expect the combined company will emerge as a global player with top-tier R&D capabilities, a more diverse product pipeline and broader geographic footprint.”

Citius Pharmaceuticals, Inc. Announces Intention to Spinoff Late-Stage Oncology Asset, I/ONTAK, into a New Standalone Publicly Traded Company

Cranford-based Citius Pharmaceuticals announced that it intends to split the company's assets into two separate publicly traded entities. Citius plans to form a new company focused on developing and commercializing I/ONTAK, for which a Phase 3 trial was completed in December 2021 and a biologics license application (BLA) is being planned for submission in the second half of 2022. The company's other pipeline assets, including Mino-Lok®, would remain at Citius. Citius would continue to trade on the Nasdaq exchange under its current ticker CTXR. The strategic action is intended to optimize organizational resources and investment capital to support the successful execution of each development program.

People in the News


Insmed Names New Head of Global Commercial Functions

BioNJ Member Insmed announced the appointment of Drayton Wise as Chief Commercial Officer. In addition to his current responsibilities leading the global Arikayce (amikacin liposome inhalation suspension) franchise and U.S. commercial activities, Mr. Wise will assume responsibility for all of Insmed’s global commercial functions. Mr. Wise joined the Bridgewater-based biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases in 2014, holding positions of increasing responsibility in the commercial organization and most recently serving as Senior Vice President, Head of U.S. and General Manager of Arikayce. With Mr. Wise assuming more direct leadership of Insmed’s commercial business, Roger Adsett, Chief Operating Officer, will focus on overseeing Insmed’s overall business operations on a global basis, while continuing to provide valuable commercial insights and strategic perspective for the company.

Sandoz Appoints New Board Representative to Global AMR Industry Alliance

Princeton-based BioNJ Member Sandoz is pleased to announce the appointment of Dr. Boumediene Soufi, Global Head of the Sandoz Antimicrobial Resistance (AMR) program, as its new representative to the Board of the AMR Industry Alliance (AMRIA). The Alliance is a coalition of approximately 100 biotechnology, diagnostic, generic and research-based biopharmaceutical companies and trade associations, formed to drive and measure industry progress towards curbing AMR. Dr. Soufi, who was appointed to lead the Sandoz AMR program earlier this year, assumes the AMRIA role, representing companies in the generics industry section, with immediate effect. Dr. Soufi joined Sandoz in 2015 and has held progressively senior positions focusing on sustainable efficiency, digital innovation and leading the entire end-to end Sandoz anti-infectives portfolio / pipeline. He is a biotechnologist by training, specializing in the field of microbial quantitative proteomics.

GSK Announces Further Appointments to Designate Haleon Board

Warren-based BioNJ Member GlaxoSmithKline announced the appointments of Asmita Dubey, Marie-Anne Aymerich and Bryan Supran to the Designate Haleon Board, the new independent company to be formed following the demerger of the GSK Consumer Healthcare business. These appointments follow the appointment of Sir Dave Lewis as Non-Executive Chair Designate in December 2021 and the appointment of six directors in March 2022 and complete the formation of the Designate Haleon Board. This Board will benefit from an appropriate mix of skills, experience and diversity to support Haleon as a listed company. Haleon is strongly positioned to deliver better everyday health, sustainable above-market growth and attractive returns to shareholders.

Epygenix Therapeutics Appoints Masuoka as Chief Medical Officer

Paramus-based Epygenix Therapeutics announced it appointed Dr. Lorianne Masuoka as its Chief Medical Officer. A highly accomplished clinical development executive with a medical background in neurology, Dr. Masuoka is a board-certified neurologist and brings over 25 years of experience developing high-value pipelines that have resulted in drug approvals and strategic alliances. Prior to joining Epygenix, Dr. Masuoka was Chief Medical Officer at Marinus Pharma, where she led the initiation of Phase 3 trials of ganaxolone, including in children with CDKL5 deficiency disorder and PCDH19 epilepsy. Before that, she served as Chief Medical Officer at In Vivo Therapeutics, Cubist Pharmaceuticals and Nektar Therapeutics.

Shionogi Inc. Shuffles Executive Team, Names New CEO

Shionogi Inc., the U.S. subsidiary of Shionogi & Co. Ltd., announced June 2 that current President and CEO Akira Kato will leave the Florham Park division to lead the parent company in Japan. With his departure, the pharmaceutical company introduced a reorganization of its U.S. executive team, effective July 1. Nate McCutcheon, current chief operating officer, will be promoted to president and CEO. “As I return to Japan to lead Shionogi Pharma Co. Ltd, it was clear Nate McCutcheon was the right choice to take over the company’s helm given his professional experience and leadership abilities,” Kato said in a statement. “Both myself and the leadership in Japan have great confidence in his ability to advance Shionogi’s vision here in the U.S.”

Bayer Promotes Two Within U.S. Operations

Life sciences company Bayer, whose U.S. headquarters is in Whippany, announced two appointments to its U.S. leadership team. Brian Branca, who has been with the company since 2006, was promoted to Bayer U.S. Chief Financial Officer. Mr. Branco most recently served as Vice President and Treasurer for Bayer U.S. Mr. Branca has held numerous financial leadership roles at the company, including serving as Chief Financial Officer for Bayer subsidiary Climate Corp. Bayer also announced Marina Hong has been named Senior Vice President and Head of U.S. Duman Resources. Ms. Hong joined the company in 2021 as Vice President, Human Resources for Bayer Pharmaceuticals Americas. Ms. Hong, who brings more than 20 years of human resources experience to Bayer, will succeed Lisa Massa, who will retire in July.



Princeton to Name New Dorm Hariri Hall After ‘Major Gift’ From Couple

A new dorm scheduled to open on Princeton University’s campus next fall will be named Hariri Hall, thanks to a major gift from Margaret and Robert Hariri. The Hariris made the gift to the school’s Venture Forward campaign to support undergraduate student expansion at Princeton. Hariri Hall, a new dormitory in Yeh College, will welcome students in the fall of 2022. BioNJ Member Robert Hariri is the Founder, Chair and CEO of Celularity Inc., a leading human cellular therapeutics company. He is a pioneer in the use of stem cells to treat life-threatening diseases and has made transformative contributions in the field of tissue engineering.

Rutgers Researchers Will Provide Antibody Testing to Help Study Long COVID in Children

Rutgers will provide antibody testing to help determine the incidence and long-term effects of COVID-19 in children as part of an initiative by the National Institutes of Health. The serological testing, which detects the presence of antibodies directed against proteins produced by SARS-CoV-2 – the virus causing COVID-19 – will be performed in the laboratory of Maria Laura Gennaro, a professor of medicine and epidemiology at the Public Health Research Institute at Rutgers New Jersey Medical School. As part of the national Researching COVID to Enhance Recovery Initiative (RECOVER), Rutgers is leading a consortium called the Collaborative Long-Term Outcomes of COVID-19 in Kids (CLOCK) and is recruiting more than 2,000 participants for the RECOVER initiative. 

Rutgers Pair Creates Monitoring Toolkit to Speed Production of Biologic Drugs

Two Rutgers University engineers specializing in the process of making drugs derived from living organisms created an analytical tool they expect will accelerate the discovery and production of biologic drugs that are often at the cutting edge of biomedical research. In the cover story in Analytical Chemistry, the researchers provide details about what they call an “automated toolkit” — or, more formally, the N-GLYcanyzer — and its potential to rapidly monitor drug quality during production of biologics. While most biologics are tested at the end of the manufacturing process for quality and uniformity, the Rutgers toolkit can monitor biologics as they are being produced and enable the drugs to meet the quality compliance needs of regulatory agencies, such as the U.S. Food and Drug Administration.

New Chief of Bone Marrow Transplant Begins Role at Rutgers Cancer Institute, RWJBarnabas Health

Rutgers Cancer Institute of New Jersey and RWJBarnabas Health announced the recent appointment of Dr. Ira Braunschweig as Chief, Section of Transplant and Cell Therapy, at Rutgers Cancer Institute, Chief of the Transplant and Cell Therapy Service of the RWJBarnabas Health Oncology Service Line and Director for cell therapy and bone marrow transplantation at Robert Wood Johnson University Hospital, an RWJBarnabas facility. Dr. Braunschweig will also serve as professor of medicine at Rutgers Robert Wood Johnson Medical School. Braunschweig will lead the Blood and Marrow Transplant and Cellular Therapies Program at Rutgers Cancer Institute, which offers transplants for patients with acute and chronic leukemias, myelodysplasia, various types of lymphoma, Hodgkin disease, multiple myeloma, amyloidosis and related diseases.

Stevens Institute wins Mission 50’s 1st Hudson County-wide collegiate Entrepreneurship Pitch Competition

Young entrepreneurs from four of Hudson County’s higher education institutions competed for $5,000 — and the chance to turn their idea into a reality — as Mission 50 in Hoboken hosted the finals of its first county-wide Entrepreneurship Pitch Competition. The grand prize was awarded to Stevens Institute of Technology student Arianna Gehan for “Daia,” a diabetes management tool. In the Mission 50 Entrepreneurial Pitch Competition, students developed ideas for a business, product or service and then presented the idea to a panel of business experts, who selected the winning idea. The format is similar to the television show “Shark Tank.”

Atlantic Health Announces Arrival of Chief Clinical Officer

Dr. Suja Mathew, a highly respected physician with decades of experience in clinical leadership and physician development, has been named the Chief Clinical Officer at Atlantic Health System. Working directly with Atlantic Health System’s Chief Medical Officers and quality, research and academic teams, Dr. Mathew will work collaboratively to deliver innovative and high-quality care for patients across the region. Dr. Mathew’s work will strengthen the bonds that connect Atlantic Health System’s entire network of care, empowering every patient to benefit from its systemwide resources. Dr. Mathew will primarily focus on three key areas: optimizing patient access to the full Atlantic Health System network of care, elevating the system’s innovative research and academic programs, and continuing the system’s commitment to the highest-quality care.

Funding/Economic Development


World-Class Team Partners to Fight COVID-19, Viruses of the Future With $65M Grant from NIH

With a mission to discover, optimize and test innovative small molecule antiviral drugs to target coronaviruses, a unique collaborative enterprise of academic and pharmaceutical experts in northern New Jersey and New York City announced they formed a regional drug accelerator to address the urgent need to develop novel antiviral treatments for SARS-CoV-2, its variants, other coronaviruses and pandemic viruses, and as well as future viral threats. Known as the Metropolitan AntiViral Drug Accelerator, the consortium will combine world-class virologists and academic drug finders from Rockefeller University, Columbia University and Memorial Sloan-Kettering Cancer Center in New York City, and the Hackensack Meridian Center for Discovery and Innovation and Rutgers University in New Jersey, along with proven antiviral drug developers Merck, the Tri-Institutional Therapeutics Discovery Institute and Aligos Therapeutics.



BIO 2022 in San Diego

June 13-16, 2022

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

New Jersey Research Cores Partnering Conference

June 29, 2022

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

ON Helix

July 7, 2022

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

BioNJ Member Services Provider Directory

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

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

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