Banner-Header_NEW LOGO.jpg

September 10, 2021

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

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


We are excited to announce BioNJ's new Value of Medical Innovation Blog. In our first edition, Alliance for Patient Access (AfPA) Executive Director Josie Cooper explains how the Institute for Clinical and Economic Review (ICER) undermines the critical relationship between patients and their providers with its “one-size-fits-all” approach to drug value assessment. 

Health care providers work closely with their patients to deliver optimal, personalized care. Unfortunately, a variety of factors threaten to undermine that important relationship. One growing threat is the Institute for Clinical and Economic Review, a health economics organization whose work minimizes the patient and physician perspective and undermines shared decision-making.  


“In its evaluations, ICER often omits key elements of value. These include the impact of diseases on caregivers and children, or health disparities. ICER also repeatedly fails to incorporate a disease’s effect on overall quality of life.” 


In the piece, Josie outlines three things we should know about ICER, including: 

  • ICER’s Approach Undercuts Patient-Centered Care 
  • ICER Ignores Patients’ and Providers’ Values 
  • State Legislatures Are Taking Action 

Click here to read the Blog. To learn more about ICER and its threat to Patient access and the future of medical innovation, please visit BioNJ's toolkit at

Because Patients Can' Wait®,

The BioNJ Team


Upcoming BioNJ Events


Scientific & Legal Briefing: Working Together to Meet the Challenges Posed by the Continuing Pandemic

Register Today!

September 13, 2021

Clinical Development Briefing

Mark Your Calendar!

September 23, 2021

Manufacturing Briefing: Pandemic-Induced Innovation & Adaptation

Register Today!

September 29, 2021

C-Suite Summit: Transitioning to the "Next Norm" 

Register Today!

October 15, 2021

IT/Cyber Security Briefing

Mark Your Calendar!

November 17, 2021

Membership Webinar

Mark Your Calendar!

November 18, 2021

Inspiring Women in STEM Conference 

Mark Your Calendar!

December 3, 2021

Patient Advocacy Summit

Mark Your Calendar!

December 9, 2021

BioNJ_Guest Blog_Banner_3.png

Putting Patients First:

The Value of Medical Innovation


More than 230 Bristol Myers Squibb Employees Pedal Across the U.S. to Advance Cancer Research in Seventh Annual Coast 2 Coast 4 Cancer Ride

Princeton-based BioNJ Member Bristol Myers Squibb employee Mark DeLong is joining more than 230 of his colleagues in Coast 2 Coast 4 Cancer, an epic ~3,000-mile cycling event on two unique routes (~6,000 miles total) to raise funds for the V Foundation for Cancer Research. Like many of the riders, DeLong has been personally affected by cancer – first when he lost his 16-year-old son Peter to Ewing’s sarcoma, and years later when he was diagnosed with an aggressive form of prostate cancer himself. The ride begins today from Cannon Beach, Ore., and concludes on October 1 in Long Branch, N.J.

Patients and Innovators Lose if the Government Pursues ‘March-in’

The Biden Administration this summer issued an executive order that seems to endorse the use of “march-in” – when the government seizes patent rights from an innovator to let competitors use that patented invention – in an effort to address medicine affordability. This policy could have a grave impact on the pipeline of new treatments and cures, while ignoring the reality that today more than 90% of prescriptions for drugs are filled with generics – up from 19% 35 years ago thanks to our competitive system that includes intellectual property (IP) protections, including patents.

NJ Company News


FDA Grants Soligenix Orphan Drug Designation for the Treatment of T-cell Lymphoma

Princeton-based BioNJ Member Soligenix, Inc. announced that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient hypericin for the treatment of T-cell lymphoma, extending the target population beyond cutaneous T-cell lymphoma (CTCL) as previously granted. "The FDA's decision to grant and expand our hypericin orphan drug designation beyond CTCL signifies an important step for Soligenix as we continue to advance the program toward NDA filing in the first half of 2022," stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix.

ADMA Biologics Receives FDA Approval for VanRx Aseptic Fill-Finish Machine and Related Operations

Ramsey-based BioNJ Member ADMA Biologics, Inc. announced that the U.S. Food and Drug Administration (“FDA”) has granted approval for the company’s in-house aseptic fill-finish machine, the VanRx SA25 (“VanRx”). “The FDA approval of the VanRx marks the successful completion of ADMA’s multi-year supply chain enhancement initiative, firmly establishing ADMA as the only American domiciled end-to-end producer of specialty plasma-derived biologic drugs. This announcement is expected to have transformative financial and strategic implications for ADMA as the company now joins an elite group of U.S.-based drug manufacturers with comprehensive in-house control of its critical manufacturing functions,” said Adam Grossman, President and CEO of ADMA.

BioAegis Therapeutics Announces Publication of a Compassionate Use Case Study of a Critical COVID-19 Patient

North Brunswick-based BioNJ Member BioAegis Therapeutics Inc. announced that a case study, Recombinant Human Plasma Gelsolin (rhu-pGSN) in a Patient Hospitalized with Critical COVID-19 Pneumonia, was published in Clinical Infection in Practice. This compassionate-use case paper is intended to introduce clinicians to BioAegis’ novel host-based therapeutic, rhu-pGSN, under development for critical COVID-19 pneumonia as well as for other serious infectious and noninfectious diseases. 

PTC Therapeutics Recognizes 2021 STRIVE Awards Recipients for Initiatives Supporting Duchenne Patient Community

South Plainfield-based BioNJ Member PTC Therapeutics, Inc. announced the three recipients who will receive funding through the company's STRIVE Awards program. The global STRIVE Awards program provides grants to non-profit organizations serving the Duchenne muscular dystrophy community. 2021 marks the seventh year of the STRIVE Awards program, and the highest number of applications in the program's history with 58 applications from organizations around the world. This year's grant funding will support initiatives to establish a Duchenne-specific residential model aimed to support independent living, to structure a clinic with needed equipment and furniture for the provision of care, and to develop a suite of resources to support people with Duchenne to transition to adulthood.

Amarin Reports Overview of Latest Clinical Research Evaluating Vascepa®/Vazkepa (Icosapent Ethyl) and Eicosapentaenoic Acid (Epa) Presented at Esc Congress 2021, Organized by the European Society of Cardiology

Bridgewater-based BioNJ Member Amarin Corporation plc reported an overview of new data relating to VASCEPA®/VAZKEPA (icosapent ethyl). “As we approach the European launch of VAZKEPA, it is particularly important that such clinical and scientific findings are reported. Collectively, these data are building a body of clinical evidence that elucidate and evolve our understanding of the potential mechanisms of action and supporting role of the therapy in alleviating the burden of the worldwide public health crisis caused by cardiovascular disease,” said Karim Mikhail, Amarin’s President and CEO.

Vyant Bio to Present at the H.C. Wainwright 23rd Annual Global Conference

Cherry Hill-based BioNJ Member Vyant Bio, Inc. is rapidly identifying small and large molecule therapeutics to treat central nervous system (“CNS”) and oncology-related diseases. The company announced that it will be presenting at the H.C. Wainwright 23rd Annual Global Conference. During the presentation, Vyant Bio’s Chief Executive Officer, Jay Roberts, will highlight the company's recent merger, integration with StemoniX, Inc. and the resulting transformational business strategy, noteworthy collaborations and partnerships, and the broader going-forward corporate vision. The presentation will be webcast and an archived recording will be made available in Investors’ section of the Vyant Bio website.

Evotec Announces Bristol Myers Squibb Opt-in of EVT8683 as the First Program from iPSC-Based Neurodegeneration Collaboration

Princeton-based BioNJ Member Evotec announced that Princeton-based BioNJ Member Bristol Myers Squibb Company has exercised its option to enter into an exclusive global license for EVT8683 which comes from a broader neurodegeneration collaboration. EVT8683 is a small molecule targeting a key cellular stress response that holds great promise in various neurodegenerative indications and is ready to enter clinical development. The program originated from a phenotypic screening approach based on Evotec's leading iPSC platform and reached IND filing within only 5 years. Under an option agreement with Celgene (which is now a Bristol Myers Squibb company), Bristol Myers Squibb has rights to additional programs in neurodegenerative diseases.

Bristol Myers Squibb Research at ESMO 2021 Demonstrates Clinical Benefits of Immunotherapies in Multiple Hard-to-Treat Advanced or Metastatic Cancers and Reinforces the Benefit of Opdivo in Earlier-Stage Cancers

Princeton-based BioNJ Member Bristol Myers Squibb Company announced that data reinforcing the potential of immunotherapies to impact clinical outcomes for patients. Research demonstrating the durable, long-term benefits of Opdivo plus Yervoy in advanced or metastatic cancers, growing evidence supporting the use of Opdivo in earlier-stage cancers, and results for combinations with novel agents such as the investigational LAG-3 blocking antibody relatlimab. “Since immune checkpoint inhibitors were introduced more than a decade ago, they have played a transformational role in treating cancers with high unmet need, and most importantly, helping people with cancer live longer,” said Samit Hirawat, M.D., Executive Vice President, Chief Medical Officer, Global Drug Development, Bristol Myers Squibb.

UK’s MHRA Grants Marketing Authorisation for Pfizer’s CIBINQO® (abrocitinib) for Adults and Adolescents With Moderate to Severe Atopic Dermatitis

BioNJ Member Pfizer Inc., with offices in Peapack, announced announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Great Britain marketing authorization for CIBINQO® (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents aged 12 years and over, who are candidates for systemic therapy. Abrocitinib is licensed in Great Britain in recommended doses of 100mg and 200mg. This is the first marketing authorization worldwide for this treatment. Last year, abrocitinib received a Promising Innovative Medicine (PIM) designation from the MHRA.

Myovant Sciences and Pfizer Announce FDA Acceptance of Supplemental New Drug Application for MYFEMBREE® for the Management of Moderate to Severe Pain Associated With Endometriosis

BioNJ Member Pfizer Inc., with offices in Peapack, and Myovant Sciences announced that the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis. The FDA set a target action date of May 6, 2022 for this sNDA under the Prescription Drug User Fee Act (PDUFA). The sNDA submission in endometriosis is supported by results from the Phase 3 SPIRIT program, which included two multinational, replicate pivotal clinical studies (SPIRIT 1 and SPIRIT 2) in over 1,200 women with pain associated with endometriosis for 24 weeks, and an open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2 through one year.

Pfizer Announces Start of Phase 3 Clinical Trial in Adults for Its Investigational Vaccine Against Respiratory Syncytial Virus (RSV)

BioNJ Member Pfizer Inc., with offices in Peapack, announced the initiation of RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease), a Phase 3 clinical trial evaluating the efficacy, immunogenicity, and safety of a single dose of its respiratory syncytial virus (RSV) bivalent prefusion F subunit investigational vaccine candidate (RSVpreF) in adults ages 60 years or older. The Phase 3 RENOIR trial of RSVpreF is a global, randomized, double-blind, placebo-controlled study that expects to enroll approximately 30,000 participants 60 years and older. The primary objectives of the study will assess safety and efficacy for the prevention of moderate to severe lower respiratory tract illness (msLRTI-RSV) during the first RSV season.

Positive Top-Line Results from Pfizer’s Phase 3 JADE DARE Trial Comparing the Efficacy of Abrocitinib and Dupilumab for Moderate to Severe Atopic Dermatitis

BioNJ Member Pfizer Inc., with offices in Peapack, announced that JADE DARE (B7451050), a 26-week, randomized, double-blind, double-dummy, active-controlled, multi-center Phase 3 study, met its co-primary and key secondary efficacy endpoints. The study showed that abrocitinib was statistically superior compared to dupilumab in each evaluated efficacy measure and had a safety profile consistent with previous studies. The head-to-head study was designed to directly compare the efficacy of abrocitinib 200mg versus dupilumab 300mg, in adult participants on background topical therapy with moderate to severe atopic dermatitis (AD). Abrocitinib 200mg was administered by once-daily oral tablet and dupilumab was administered by subcutaneous injection every other week following a 600mg induction dose.

Janssen Announces U.S. FDA Approval of INVEGA HAFYERA™ (6-month paliperidone palmitate), First and Only Twice-Yearly Treatment for Adults With Schizophrenia

Titusville-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic INVEGA HAFYERA™ (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults. Before transitioning to INVEGA HAFYERA™, patients must be adequately treated with INVEGA SUSTENNA® (1-month paliperidone palmitate) for at least four months, or INVEGA TRINZA® (3-month paliperidone palmitate) for at least one 3-month injection cycle.

New Tezepelumab Data Show 86% Reduction in Exacerbations in Patients With Severe Asthma And Comorbid Nasal Polyps

Berkeley Heights-based BioNJ Member Amgen announced new data from the pivotal NAVIGATOR Phase 3 trial demonstrating that tezepelumab reduced exacerbations and improved lung function and nasal symptoms in patients with severe, uncontrolled asthma and comorbid nasal polyps. Tezepelumab is a potential first-in-class treatment that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine, and has the potential to treat a broad population of patients with severe asthma. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca.

Clinical Trial of Investigational Epcoritamab (DuoBody®-CD3xCD20) in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL) Published in The Lancet

Madison-based BioNJ Member AbbVie BioNJ Member Genmab A/S announced The Lancet published the results of the dose escalation part of the Phase 1/2 EPCORE™ NHL-1 first-in-human (FIH) dose escalation and cohort expansion clinical trial evaluating safety and preliminary efficacy of the investigational therapy epcoritamab (DuoBody®-CD3xCD20) in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma (B-NHL). Epcoritamab is being co-developed by Genmab and AbbVie. The FIH trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive, or refractory CD20+ mature B-NHL, including diffuse large B-cell Lymphoma (DLBCL) and follicular lymphoma (FL), to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).

FDA Grants Jardiance® Breakthrough Therapy Designation for Heart Failure With Preserved Ejection Fraction

Bridgewater-based BioNJ Member Eli Lilly announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Jardiance® (empagliflozin) as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF). The decision is based on results from the landmark EMPEROR-Preserved phase III trial, in which Jardiance demonstrated a 21% relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction compared with placebo. The benefit was independent of ejection fraction or diabetes status. 

Eli Lilly Japan and Daiichi Sankyo Enter a Collaborative Agreement to Commercialize Lasmiditan Succinate in Japan for the Acute Treatment of Migraines

Bridgewater-based BioNJ Member Eli Lilly and Basking Ridge-based Daiichi Sankyo Company have concluded an agreement on commercialization collaboration in Japan for the 5-HT1F receptor agonist lasmiditan succinate, for which Eli Lilly Japan has submitted a new drug application for the treatment of migraines. Under the terms of the agreement, Eli Lilly Japan will hold authorization for marketing lasmiditan succinate, similar to the humanized anti-CGRP monoclonal antibody Emgality® (generic name: galcanezumab (genetic recombination)) to which a sales agreement has already been concluded between the two companies, and Daiichi Sankyo will take charge of its distribution and sales after marketing approval.

Dupixent® (Dupilumab) Pivotal Trial Meets All Primary and Secondary Endpoints Becoming First Biologic Medicine to Significantly Reduce Signs and Symptoms of Moderate-to-Severe Atopic Dermatitis in Children as Young as 6 Months

Bridgewater-based BioNJ Member Sanofi announced a pivotal Phase 3 trial evaluating Dupixent® (dupilumab) for the treatment of children aged 6 months to 5 years with moderate-to-severe atopic dermatitis, a chronic type 2 inflammatory disease, met its primary and all secondary endpoints. The data shows adding Dupixent to standard of care topical corticosteroids (TCS) significantly reduced overall disease severity and improved skin clearance, itch, and health-related quality of life measures at 16 weeks compared to TCS alone. Dupixent is the first biologic medicine to show positive results in this young population and remains the only approved biologic medicine in patients 6 years and older with uncontrolled moderate-to-severe atopic dermatitis.

Landmark Trial Demonstrates Jardiance® (Empagliflozin) is the First Therapy to Show Statistically Significant Improvement in Heart Failure Outcomes in Adults With Preserved Ejection Fraction

Bridgewater-based BioNJ Member Sanofi announced full results from the landmark EMPEROR-Preserved Phase III trial demonstrated that Jardiance® (empagliflozin) showed an impressive 21% relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction (HFpEF) compared with placebo. The benefit was independent of ejection fraction or diabetes status, establishing Jardiance as the first and only treatment to significantly improve outcomes for the full spectrum of heart failure patients. The results were published in The New England Journal of Medicine.

Sanofi to Acquire Kadmon to Further Strengthen Growth of Transplant Business

Bridgewater-based BioNJ Member Sanofi has entered into a definitive merger agreement with Kadmon Holdings, Inc., a biopharmaceutical company that discovers, develops, and markets transformative therapies for disease areas of significant unmet medical needs. The acquisition supports Sanofi’s strategy to continue to grow its General Medicines core assets and will immediately add Rezurock™(belumosudil) to its transplant portfolio. Rezurock is a recently FDA-approved, first-in-class treatment for chronic graft-versus-host disease (cGVHD) for adult and pediatric patients 12 years and older who have failed at least two prior lines of systemic therapy.

World-First Agreement Between Novartis and the NHS Enables Broad and Rapid Access to First-in-Class Cholesterol-Lowering Medicine Leqvio® (Inclisiran)

East Hanover-based BioNJ Member Novartis has reached a commercial agreement with the NHS in England as part of a collaboration to pioneer a first-of-its-kind population health management approach to address elevated LDL-C in eligible patients with ASCVD across England. The NHS and Novartis collaboration moves into the implementation phase following the positive final recommendation from the National Institute for Health and Care Excellence (NICE) for use of inclisiran in primary care for the treatment of adult patients within its licensed indication who also have persistently elevated LDL-C levels (2.6 mmol/l or more despite maximum tolerated statins with or without ezetimibe) and a history of certain cardiovascular events.

Novartis Leqvio® (inclisiran) Analyses Show Effective and Sustained LDL-C Reduction in Two Sub-Populations of Patients With ASCVD

East Hanover-based BioNJ Member Novartis announced results from two pooled post hoc analyses of Phase III ORION-9, -10 and -11 trials that showed twice-yearly Leqvio® (inclisiran) provided effective and sustained low-density lipoprotein cholesterol (LDL-C) reduction in two sub-populations of atherosclerotic cardiovascular disease (ASCVD) – established cerebrovascular disease (CeVD) and polyvascular disease (PVD). In the first analysis, patients with established CeVD treated with Leqvio achieved an average 55.2% reduction in LDL-C from baseline to Day 510 compared with placebo (P<.0001).

FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment of Certain Patients With Urothelial Carcinoma (Bladder Cancer)

Kenilworth-based BioNJ Member Merck & Co. announced a label update for KEYTRUDA, Merck’s anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the U.S. The U.S. Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy.

Merck and Ridgeback Biotherapeutics Announce Initiation of Pivotal Phase 3 MOVe-AHEAD Study Evaluating Molnupiravir for Post-Exposure Prophylaxis of COVID-19 Infection

Kenilworth-based BioNJ Member Merck & Co. and Ridgeback Biotherapeutics announced the initiation of the Phase 3 MOVe-AHEAD clinical trial to evaluate molnupiravir, an investigational oral antiviral therapeutic, for the prevention of COVID-19 infection. The global study is enrolling individuals who are at least 18 years of age and reside in the same household as someone with laboratory-confirmed SARS-CoV-2 infection with symptoms. The safety and efficacy of molnupiravir is also currently being evaluated in Part 2 of the ongoing MOVe-OUT trial, which is a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild to moderate COVID-19 and at least one risk factor associated with poor disease outcomes.

Merck’s KEYTRUDA® (pembrolizumab) Approved in China in Combination With Chemotherapy for First-Line Treatment of Patients With Locally Advanced Unresectable or Metastatic Esophageal or Gastroesophageal Junction (GEJ) Carcinoma

Kenilworth-based BioNJ Member Merck & Co. announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has been approved by the National Medical Products Administration (NMPA) in China in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or gastroesophageal junction (GEJ). This new indication was granted approval based on overall survival (OS) findings from the pivotal Phase 3 KEYNOTE-590 trial. KEYTRUDA is now approved for eight indications across five different types of cancer in China.

Teva and MedinCell Announce FDA Acceptance of New Drug Application for TV-46000/mdc-IRM as a Treatment for Patients With Schizophrenia

Parsippany-based BioNJ Member Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. and MedinCell announced that the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia has been accepted by the U.S. Food and Drug Administration (FDA). The acceptance is based on Phase 3 data from two pivotal studies: TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia). 

Late-Breaking Data at the International Headache Society & European Headache Federation Joint Congress 2021 Showed AJOVY® (fremanezumab-vfrm) Injection Reduced More Monthly Migraine Days in a Network Meta-Analysis Study With Atogepant and Rimegepant

Parsippany-based BioNJ Member Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced results from a network meta-analysis examining the efficacy of AJOVY (fremanezumab-vfrm), atogepant and Nurtec® ODT (rimegepant) in the preventive treatment of episodic migraine (EM). AJOVY is the first and only long-acting (defined as efficacy measured over a 12-week period following a 675 mg [225 mg x 3] subcutaneous dose) anti-CGRP subcutaneous injection approved for the preventive treatment of migraine in adults with both quarterly and monthly dosing options.

U.S. FDA Grants BRUKINSA® (Zanubrutinib) Approval in Waldenström’s Macroglobulinemia

Ridgefield Park-based BeiGene, Ltd. announced that BRUKINSA® (zanubrutinib) has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). This marks the second FDA approval for BRUKINSA and its third approval in Waldenström’s macroglobulinemia globally. The approval is based on Phase 3 ASPEN trial comparing BRUKINSA against ibrutinib. The primary efficacy endpoint of the ASPEN trial was very good partial response (VGPR) rate in the overall intention-to-treat (ITT) population as assessed by independent review committee (IRC). 

Eisai and FUJI YAKUHIN Conclude License Agreement Concerning the Development and Distribution of Dotinurad, a Treatment for Hyperuricemia and Gout, in Five ASEAN Countries

Woodcliff Lake-based Eisai Co., Ltd. and FUJI YAKUHIN CO., LTD. announced that they have concluded a license agreement concerning dotinurad (generic name), a treatment for hyperuricemia and gout discovered by FUJI YAKUHIN, for development and distribution in five ASEAN (Association of Southeast Asian Nations) member states: Indonesia, Malaysia, Myanmar, the Philippines and Thailand. This agreement conclusion will lead to an expansion into Southeast Asia of an agreement regarding dotinurad in China concluded by Eisai and FUJI YAKUHIN in February 2020.

ENVISAGE-TAVI AF Data Published in The NEJM Demonstrates Edoxaban’s Noninferiority to VKAs in High-risk AF Patients Following Successful Heart Valve Procedure

Basking Ridge-based Daiichi Sankyo Company, Limited has announced the results from the multinational, randomized, controlled, Phase 3b ENVISAGE-TAVI AF study, comparing the efficacy and safety of edoxaban with vitamin-K-antagonists (VKAs) in patients with atrial fibrillation (AF) having undergone successful transcatheter aortic valve implantation (TAVI). Findings from the trial were published in The New England Journal of Medicine. In ENVISAGE-TAVI AF, 1,426 elderly patients with multiple comorbidities were included and followed for up to three years. The study results suggest that edoxaban is an appropriate treatment option for AF patients with severe aortic stenosis following successful TAVI.

Citius Pharmaceuticals Acquires Drug from Dr. Reddy’s

Cranford-based Citius Pharmaceuticals acquired a license from Dr. Reddy’s Laboratories for its late Phase 3 oncology immunotherapy drug E7777, an improved formulation of previously U.S. Food and Drug Administration-approved ONTAK, created by Eisai Co. Ltd. in 2016. E7777 is a late-stage oncology immunotherapy for the treatment of cutaneous T-cell lymphoma or CTCL, a rare form of non-Hodgkin lymphoma. Dr. Reddy’s of Princeton will receive $40 million upfront upon the closing of the transaction followed by approval milestone payment of up to $40 million related to the cutaneous T-cell lymphoma indication approval, and up to $70 million for additional indication approvals.

Catalent Agrees to $1B Acquisition of Supplements Maker

Catalent, a drug delivery technology company based in Somerset, has agreed to acquire gummies maker Bettera Holdings for $1 billion. The purchase of Bettera continues a string of acquisitions this year by Catalent, including deals to acquire bioproduction company Delphi Genetics and cell therapy manufacturer RheinCell Therapeutics GmbH. The purchase of Bettera will bolster Catalent’s global softgel and oral dose formulation and manufacturing business. “As the leading global innovator of softgel and oral technologies, Catalent has a strong, longstanding presence in the rapidly expanding consumer health and nutraceutical marketplace,” said Dr. Aris Gennadios, President of softgel and oral technologies for Catalent.

Infinity BiologiX Signs for 200K sq. ft. at Piscataway Complex

Infinity BiologiX, a biotechnology company that spun out from Rutgers University, will occupy 200,000 square feet at Middlesex Science Center, located at 30 Knightsbridge Road, in Piscataway. “The addition of IBX, a global leader in biotech, to our impressive list of tenants illustrates how MSC’s robust infrastructure satisfies the needs of life sciences tenants,” Keystone founder and CEO Bill Glazer said. “Given Keystone’s growing reputation in the life sciences community, we are thrilled that IBX opted to put its growth under one roof where it can thrive and continue its important work.”

People in the News


Caladrius Biosciences Announces Appointment of Kristen K. Buck, M.D., as Chief Medical Officer

Basking Ridge-based BioNJ Member Caladrius Biosciences, Inc. announced the appointment of Dr. Kristen K. Buck as the company’s Chief Medical Officer. Dr. Buck joins Caladrius from ICON plc. During her time at ICON, Dr. Buck served as its CMO, where she represented the company’s position on key scientific, ethical, and medical governance matters, provided guidance and oversight to the medical and scientific groups, and led the Drug Development Services group. Prior to that, she was Senior Vice President & Chief of Clinical Development at Optum Insights (part of the United Healthcare Group) where she led the clinical operations and regulatory groups within the Digital Research Network (DRN) clinical trial business.

Rocket Pharmaceuticals Appoints Isabel Carmona, J.D., as Chief Human Resources Officer

Cranbury-based Rocket Pharmaceuticals, Inc. announced the appointment of Isabel Carmona, J.D., as Chief Human Resources Officer and Senior Vice President. Ms. Carmona brings more than 25 years of experience in human resources and organizational leadership including the last 15 years within the life sciences industry. Ms. Carmona will be responsible for all aspects of human resources, including talent acquisition, talent management and organizational development, and will serve as a key part of the leadership team. Prior to joining Rocket, Ms. Carmona was chief human resources officer of Ichnos Sciences. There, she led talent and organizational development during the spin-off, setting up and growing Ichnos Sciences as an independent oncology biotechnology.



Former NJ Bioscience Center – Incubator at North Brunswick Tenants Continue Finding Success Months and Years Post Graduation

The New Jersey Economic Development Authority (NJEDA) congratulated NJ Bioscience Center graduate NJ Biopharmaceuticals, LLC on its recent expansion into a 78,000-square-foot facility in Princeton. The integrated chemistry service provider, which is helping to support companies discovering oncology and immunotherapy treatments, joins a growing list of NJ Bioscience Center graduates finding success months and years after graduation.

NJIT Ranked No. 43 For Undergraduate Entrepreneurial Programs

New Jersey Institute of Technology was ranked among the 50 best schools in the country for undergraduates who want to become entrepreneurs by the Princeton Review. NJIT was ranked No. 43. The rankings are based on a survey by the Princeton Review conducted in partnership with Entrepreneur magazine taken in June-August 2019. As part of their experiential learning, entrepreneurship students are also involved with NJIT’s community small business incubator, VentureLink, the largest in New Jersey. Some go on to establish start-ups there, joining dozens of companies primarily in the biotechnology and telecommunications sectors. VentureLink provides budding entrepreneurs with educational workshops, professional networking, mentoring programs and more.

Rowan University Joins National Innovation Network

Rowan University is among the first in the region to join a new, Princeton University-led innovation network designed to transform scientific discoveries into new commercial ventures. The NSF Innovation Corps (I-Corps) Northeast Hub brings together eight institutions from New Jersey, Delaware and eastern Pennsylvania to develop a diverse and inclusive innovation workforce. The consortium is backed by a $15 million, five-year grant from the National Science Foundation. The hub is one of five in a nationwide NSF-funded network of universities formed to accelerate the economic impact of federally funded research and invest in technologies that improve everyday lives, delivering benefits in health care, energy and the environment, computing, artificial intelligence, robotics, advanced materials and other areas. 

New Chief of Thoracic and Head and Neck Medical Oncology Named to New Jersey’s Only NCI-designated Comprehensive Cancer Center

Expanding its multidisciplinary teams of highly specialized experts uniquely focused on the management of head and neck cancers and cancer of the lung, pleura and mediastinum, Rutgers Cancer Institute of New Jersey and RWJBarnabas Health have welcomed Missak Haigentz, Jr., M.D., as Chief of Thoracic and Head and Neck Medical Oncology and Clinical Director for Oncology Integration. He also has been appointed as a Professor of Medicine at Rutgers Robert Wood Johnson Medical School. He comes from Atlantic Health System, where he served as Medical Director of Hematology and Oncology and section Chief of Hematology and Oncology at Morristown Medical Center.



Stack Family Center for Biopharmaceutical Education and Training (CBET) With a Technical Symposium

September 15, 2021

Join Albany College of Pharmacy and Health Sciences as we celebrate the Grand Opening of the Stack Family Center for Biopharmaceutical Education and Training (CBET) with a technical symposium.

NJEDA to Host Virtual Small Business Resource Workshops to Showcase Available State & Federal Resources

September 13-17, 2021

The New Jersey Economic Development Authority announced that it will host a series of three virtual small business resource workshops to present information on available resources to support the growth of the State’s small businesses. The workshops will be held during National Small Business Week (NSBW) and will connect business owners with the people and information they need to start or grow their businesses with building their long-term resilience in mind as we emerge from the COVID-19 pandemic.

Princeton University Empower Conference

September 23-24, 2021

The new Princeton University Empower conference strives to broaden opportunities for academic entrepreneurs from different historically underrepresented groups. This first conference in the series, Empower 2021, will focus on Black entrepreneurs from throughout academia, bringing together national thought leaders to share actionable knowledge and tools that can help transform university discoveries into companies and ventures that advance societal and economic progress.

Innovation Forum

October 7, 2021 

The Innovation Forum is an annual competition and networking event showcasing Princeton research with commercialization, cultural or societal potential. Participants present their research in a three-minute presentation to the audience and a panel of judges, followed by a two-minute question and answer period. The event consists of two distinct tracks: a track for science and engineering innovations and a track for social sciences and humanities innovations.

Translational Neuroscience Event

October 13, 2021 

Sponsored by the Commission on Science, Innovation and Technology & JLABS, this virtual event will feature two panel sessions to discuss “Advances in the Treatment of Alzheimer's Disease” and “CNS Models and Biomarkers”. 



New Jersey Matches Federal SBIR/STTR Funding for Start-Ups

Have you received a federal Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) program grant? If so, the State of New Jersey has matching funds for you. The New Jersey Commission on Science, Innovation and Technology has just started accepting applications for a $1.25 million round of grant funding through its SBIR/STTR Direct Financial Assistance Program on Monday, August 16. The program provides $25,000 to $50,000 in matching funds to New Jersey-based companies that have received federal SBIR/STTR grants within the last two years. The federal SBIR and STTR programs together provide more than $3 billion each year to small businesses in a variety of technology and life-science areas that propose innovative ideas for meeting specific federal research-and-development (R&D) needs.

NJEDA Celebrates the Success of NJ Accelerate-Supported Morgan Stanley Multicultural Innovation Lab

The New Jersey Economic Development Authority (NJEDA) congratulates start-up companies that recently graduated from the fifth cohort of the Multicultural Innovation Lab (MCIL). The MCIL, Morgan Stanley’s in-house start-up accelerator, promotes financial inclusion and provides access to capital for early stage technology and tech-enabled companies led by women and multicultural entrepreneurs. It was the first accelerator accepted into NJEDA´s NJ Accelerate program in late 2020. NJ Accelerate, which launched in 2020, incentivizes accelerators from around the country to recruit participants in New Jersey. It also incentivizes the start-ups to locate in the Garden State after graduating from approved accelerators. Through NJ Accelerate, the NJEDA matches investment provided by approved accelerators with up to $250,000 in direct loans for startups that locate in New Jersey within six months after graduating from the approved programs.

BioNJ Member Services Provider Directory


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


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

Follow us on:

Facebook  Twitter  Instagram