You Won’t Fix What You Don’t Value: Two Reasons Why Traditional Cost-Effective Analyses Can Perpetuate Health Inequities

A new report from Partnership for Health Analytic Research or PHAR describes how value assessments that use traditional cost-effectiveness analyses can overlook important health disparities and risk perpetuating health inequities. These analyses, also known as CEAs, frequently are the basis for value assessments such as those performed by the Institute for Clinical and Economic Review (ICER) and other assessment organizations to evaluate the value of medicines and other tests and treatments. But using traditional cost-effectiveness analyses in coverage decisions can hinder progress toward an equitable U.S. health care system by failing to account for important differences among different patient groups. Supporting a more affordable, sustainable health care system for all patients is essential. So is making sure the tools we use to do this reduce health disparities rather than reinforce them.

Patients Support State Action Requiring PBMs and Insurers to Share Savings and Cap Costs for Medicines

Patient concerns over ever-increasing costs are growing, especially when it comes to their health care. Morning Consult recently conducted a 50-state poll of 20,000 Americans on behalf of PhRMA to get to the root of affordability challenges, and to learn more about what real people believe policymakers should do to tackle these problems. 88% of American adults across all 50 states agree that policymakers should prioritize lowering their out-of-pocket health care costs. When it comes to bringing actual solutions to the table, 77% of those surveyed favor requiring health insurance companies and pharmacy benefit managers (PBMs) to share the savings they receive directly with patients at the pharmacy counter. Insurance companies and their PBMs often require patients to pay either the full list price of their medicine or set patient cost-sharing based off the full list price of the medicine. Policies at the state level to address this could save some patients nearly $1,000 annually on their medicines.

PODCAST: Accelerated Approval Study Release a Vital Pathway for Patients

This podcast discusses the results of Vital Transformation's latest research study outlining the impact of proposed changes to the Accelerated Approval pathway, and what this would mean for patients with rare conditions. The study quantifies the impact of the Accelerated Approval pathway in bringing new therapies for unmet needs to market, and the vital role played by small innovative biotech firms in that process. As well, with the use of the U.S. Government's 'march-in rights' for NIH funded research being discussed as an option to influence pricing and patient access, this podcast also touches on the relative role that private and public R&D serves in the creation of needed new therapies via groundbreaking intellectual property. The podcast features contributions by Nick Shipley, the Executive Vice President of BIO; John Murphy, BIO's Chief Policy Officer & Deputy Counsel; and Joseph Hammang Ph.D., Vital Transformation's U.S. Business Director.

Tech Trends: Entrepreneur and Investor Harvey Homan Gives Advice at Princeton Event

When an experienced entrepreneur like Harvey Homan starts a new company, people take notice. In August, he started a new company, MetasTx, based in Basking Ridge, which has the potential to change the way men are treated for prostate cancer in its advanced stages. “We have created what we believe will be a paradigm-shifting approach to prostate cancer. MTX 101 is our lead compound,” said Homan. This compound has a small molecule that has been shown in mice to specifically target cells that metastasize and migrate to the lungs, brains and other areas of the body. It also inhibits the growth of these cancer cells. Homan presented MetasTx at BioNJ’s 12th Annual BioPartnering Virtual Conference, where he hoped to develop invaluable relationships.

Soligenix Announces Successful Protection Using a Bivalent Thermostabilized Filovirus Vaccine

Princeton-based BioNJ Member Soligenix announced 100% protection of non-human primates (NHPs) against lethal Marburg marburgvirus (MARV) challenge using a bivalent, thermostabilized vaccine formulated in a single vial, reconstituted only with sterile water immediately prior to use. This follows the previous successful demonstration of 100% protection against lethal Sudan ebolavirus (SUDV) challenge. This important milestone is part of an ongoing collaboration with the University of Hawaiʻi at Mānoa (UHM), demonstrating the successful presentation of one or more antigen(s) within the same formulation while maintaining full potency and thermostability. It further demonstrates the broad applicability of the heat stable vaccine platform, and its potential role in the US Administration's initiative for pandemic preparedness. 

Soligenix Receives FDA IND Clearance for Phase 2 Clinical Trial of Synthetic Hypericin in the Treatment of Psoriasis

Princeton-based BioNJ Member Soligenix announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 2a clinical trial titled, "Phase 2 Study Evaluating SGX302 in the Treatment of Mild-to-Moderate Psoriasis." Under this IND, the Phase 2a clinical trial of SGX302 will be a randomized, double-blind, placebo-controlled study that will enroll up to 32 patients age 18 years or older with mild to moderate, stable psoriasis covering 2 to 30% of their body. Patients will receive placebo or SGX302 (randomized 1:1) as a twice weekly treatment for up to 18 weeks. Each treatment will consist of the application of SGX302 followed approximately 24 hours later with visible light activation.

SCYNEXIS Announces Initiation of New Phase 3b Study (VANQUISH) to Evaluate Oral Ibrexafungerp as a Treatment for Complicated Vulvovaginal Candidiasis (VVC) in Patients Who Failed to Respond to Treatment With Fluconazole

Jersey City-based BioNJ Member SCYNEXIS announced the initiation and first patient enrolled in a new Phase 3b, open-label, multicenter study (VANQUISH) to evaluate the efficacy, safety and tolerability of oral ibrexafungerp as a treatment for complicated vulvovaginal candidiasis (VVC) in patients who have failed treatment with fluconazole, based on mycological and clinical outcomes. The VANQUISH study will enroll approximately 150 difficult-to-treat complicated VVC patients who will receive 600 mg of oral ibrexafungerp for one, three or seven consecutive days determined by their underlying complicating condition including immunocompromised state. Of the 14 patients in the Phase 3 open-label, single-arm FURI study (NCT03059992) with refractory or relapsed cases of VVC treated with ibrexafungerp, 10 (71.4%) had successful clinical outcomes as judged by an independent Data Review Committee.

Celldex Announces First Patient Dosed in Phase 2 Study of Barzolvolimab in Patients With Chronic Spontaneous Urticaria

Hampton-based BioNJ Member Celldex Therapeutics announced that the first patient has been dosed in a Phase 2 clinical study of barzolvolimab for the treatment of chronic spontaneous urticaria (CSU). Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes. The activation of the mast cells in the skin results in episodes of itchy hives, swelling and inflammation of the skin that can go on for years or even decades.

Hepion Pharmaceuticals Receives FDA Orphan Drug Status Designation for Rencofilstat for the Treatment of Hepatocellular Carcinoma

Edison-based BioNJ Member Hepion Pharmaceuticals announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to rencofilstat, a liver-targeting, orally administered, novel cyclophilin inhibitor, for the treatment of HCC. HCC is the most common form of liver cancer, accounting for 85-90% of all cases. NASH, viral hepatitis infection, and alcohol consumption all are major causes of HCC. Worldwide, it is estimated that over 800,000 people died from liver cancer in 2020, second only to lung cancer among all cancer-related deaths. The high mortality is largely due to the fact that only around half of all people who develop HCC (in developed countries) receive the diagnosis early enough to have an opportunity for therapeutic intervention. 

U.S. FDA Approves Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi® for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved Breyanzi® (lisocabtagene maraleucel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant (HSCT) due to comorbidities or age.

Otsuka Pharmaceutical and Lundbeck Announce Positive Results Showing Reduced Agitation in Patients With Alzheimer’s Dementia Treated With Brexpiprazole

BioNJ Member Otsuka Pharmaceutical Co., with a site in Princeton, and H. Lundbeck A/S (Lundbeck) announce positive results of the Phase 3 clinical trial of brexpiprazole in the treatment of agitation in patients with Alzheimer's dementia (NCT03548584). The analysis concluded that there is a statistically significant difference (p=0.0026) in the mean change from baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score between brexpiprazole and placebo. Full study results are not yet available. Further prespecified and exploratory analyses of the data set will be conducted to determine the full potential of brexpiprazole in the treatment of agitation in patients with Alzheimer's dementia. Based on this outcome Otsuka and Lundbeck are planning a regulatory filing to the U. S. Food and Drug Administration (FDA) later in 2022. 

Pfizer Announces Submission of New Drug Application to the U.S. FDA for PAXLOVID™

BioNJ Member Pfizer, with a site in Peapack, announced announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for patients who are at high risk for progression to severe illness from COVID-19. PAXLOVID is currently authorized for emergency use for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. The submission provides the longer-term follow-up data necessary for acceptance and potential approval.

Roivant and Pfizer Unveil Priovant Therapeutics and Ongoing Registrational Studies for Oral Brepocitinib in Dermatomyositis and Lupus

BioNJ Member Pfizer, with a site in Peapack, and Roivant Sciences announced the unveiling of Priovant Therapeutics, dedicated to developing and commercializing novel therapies for autoimmune diseases with the greatest morbidity and mortality. Priovant was established in September 2021 through a transaction between Roivant (Nasdaq: ROIV) and Pfizer (NYSE: PFE), in which Pfizer licensed oral and topical brepocitinib’s global development rights and US and Japan commercial rights to Priovant. Pfizer holds a 25% equity ownership interest in Priovant. Brepocitinib is a potential first-in-class dual inhibitor of TYK2 and JAK1, a novel mechanism of action expected to potentially provide greater efficacy in multiple highly inflammatory autoimmune diseases, as compared to agents that inhibit either TYK2 or JAK1 alone.

Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age

BioNJ Member Pfizer, with a site in Peapack, and BioNTech SE announced the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series for children 6 months through 4 years of age (also referred to as 6 months to less than 5 years of age). The 3-µg dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability, and immunogenicity data. The EUA is based on data from a Phase 2/3 randomized, controlled trial that included 4,526 children 6 months through 4 years of age.

Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15

BioNJ Member Pfizer, with a site in Peapack, and Valneva SE announced that they have entered into an Equity Subscription Agreement and have updated the terms of their Collaboration and License Agreement for Lyme disease vaccine candidate VLA15. As previously announced on April 26, 2022, Pfizer plans to initiate the Phase 3 study of VLA15 in the third quarter of 2022. As part of the Equity Subscription Agreement, Pfizer will invest €90.5 ($95) million in Valneva, representing 8.1% of Valneva’s share capital at a price of €9.49 per share, through a reserved capital increase to further support the strategic Lyme partnership between the two companies. 

Novartis Announces Nature Medicine Publication of Zolgensma Data Demonstrating Age-Appropriate Milestones when Treating Children With SMA Presymptomatically

East Hanover-based BioNJ Member Novartis announced that Nature Medicine published final results from both the two- and three-copy cohorts of the completed Phase 3 SPR1NT trial as separate companion manuscripts, reinforcing the transformational benefit of Zolgensma® (onasemnogene abeparvovec) when used early. These data demonstrate that, whether they have two or three copies of the SMN2 gene, nearly all children with spinal muscular atrophy (SMA) treated presymptomatically with Zolgensma were able to achieve age-appropriate motor milestones, including sitting independently, standing and walking. The data represent a significant contrast to the natural history of SMA, a devastating disease affecting approximately one in 10,000 infants worldwide. 

Novartis Receives European Commission Approval for Tabrecta® for the Treatment of Metex14 Skipping Advanced Non-Small Cell Lung Cancer

East Hanover-based BioNJ Member Novartis announced that the European Commission (EC) approved Tabrecta® (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. The approval follows a positive opinion issued in April by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein. The approval is based on results from the Phase II GEOMETRY mono-1 trial that demonstrated positive overall response rates (ORR) among adult patients with advanced NSCLC whose tumors had alterations leading to METex14 skipping.

Novartis Renews Commitment to Neglected Tropical Disease and Malaria Elimination, Investing USD 250 Million Over Five Years to Research and Develop New Treatments

East Hanover-based BioNJ Member Novartis endorses the Kigali Declaration on neglected tropical diseases (NTDs) and announces a five-year financial commitment of USD 250 million to the fight against NTDs and malaria in conjunction with the Kigali Summit on Malaria and NTDs alongside the 26th Commonwealth Heads of Government (CHOGM) meeting. This summit comes at a pivotal time for world leaders to reaffirm commitments to end neglected tropical diseases and malaria through the adoption of the Kigali Declaration. The declaration aims to mobilize political will and secure commitments to achieve the SDG3 target on NTDs and to deliver the targets set out in the World Health Organization’s Neglected Tropical Disease Roadmap (2021-2030).

Novartis Tafinlar + Mekinist Receives FDA Approval for First Tumor-Agnostic Indication for BRAF V600E Solid Tumors

East Hanover-based BioNJ Member Novartis announced the U.S. Food and Drug Administration (FDA) granted accelerated approval for Tafinlar® (dabrafenib) + Mekinist® (trametinib) for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. Tafinlar + Mekinist is the first and only BRAF/MEK inhibitor to be approved with a tumor-agnostic indication for solid tumors carrying the BRAF V600E mutation, which drives tumor growth in more than 20 different tumor types, and it is the only BRAF/MEK inhibitor approved for use in pediatric patients.

New Novartis Extension Phase Data Show Nearly 80% of RMS Patients Treated With Kesimpta® (Ofatumumab) Had No Evidence of Disease Activity (NEDA-3)

East Hanover-based BioNJ Member Novartis announced new data from the Phase 3 ASCLEPIOS I/II trials and the ALITHIOS open-label extension showing continuous treatment with Kesimpta® (ofatumumab) significantly increased the odds of achieving no evidence of disease activity (NEDA-3) versus switching from teriflunomide. These data show that after four years of treatment, 78.8% of those who continuously received Kesimpta achieved NEDA-3 (defined as having no MS relapses, no disability worsening and no MRI activity) versus only 51.8% of those who switched from teriflunomide to Kesimpta in the extension phase (odds ratio: 3.89; p<0.001). These data build on the previously presented efficacy data from ASCLEPIOS I/II and ALITHIOS showing sustained differences in cumulative relapses, MRI lesion activity and the risk of disability worsening between those who were continuously treated with Kesimpta versus those who switched at a later date.

Cosentyx® (Secukinumab) Receives Expanded Approvals in EU for Use in Childhood Arthritic Conditions

East Hanover-based BioNJ Member Novartis announced the European Commission (EC) has approved 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 two forms of juvenile idiopathic arthritis (JIA) and 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.

Sandoz Application for Proposed Biosimilar Adalimumab’s High Concentration Formulation Accepted by EMA

Princeton-based BioNJ Member Sandoz, a Novartis division, announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz® (adalimumab) for regulatory review. The application includes all indications covered by the reference medicine, including rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, and uveitis. Upon approval, the Hyrimoz (100 mg/mL) citrate-free HCF would offer reduced injection volume and potentially decrease the number of injections required for patients who need 80 mg dosing. Hyrimoz HCF will have the same auto injector as Hyrimoz 50 mg/mL, aiming for an enhanced yet familiar patient experience.

Kyowa Kirin Receives Positive CHMP Opinion for Use of CRYSVITA® (burosumab) for the Treatment of Tumor-Induced Osteomalacia (TIO)

BioNJ Member Kyowa Kirin, with a site in Princeton, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that CRYSVITA® (burosumab) be approved for the treatment of FGF23-related hypophosphataemia in Tumor-Induced Osteomalacia (TIO) associated with phosphaturic mesenchymal tumors (PMTs) that cannot be curatively resected or localized in children and adolescents aged 1 to 17 years and in adults. CRYSVITA is also already licensed for use in the rare disease X-Linked Hypophosphataemia (XLH), for children and adolescents between 1 and 17 years of age with radiographic evidence of bone disease, and in adults. 

Mitsubishi Tanabe Pharma America Announces Long-Term Findings from Post-Marketing Safety Study of RADICAVA® (edaravone)

Jersey City-based BioNJ Member Mitsubishi Tanabe Pharma America, Inc. announced findings from an analysis of post-marketing safety data evaluating RADICAVA^® (edaravone) in a real-world setting during the first three years of availability in the United States (U.S.) for the treatment of amyotrophic lateral sclerosis (ALS). RADICAVA maintained a similar safety profile as seen in clinical trials, with no new safety signals or inconsistencies with the clinical trials identified over the treatment period. RADICAVA was approved by the U.S. Food and Drug Administration (FDA) in May 2017, as an intravenous infusion treatment for ALS. The FDA approval of RADICAVA was supported by multiple trials from its comprehensive clinical development program, including the pivotal, Phase 3 study (MCI186-19) evaluating 137 patients with ALS.

DEI Consulting Firm Ranks Top 75 Companies for Executive Women

A strategic professional services firm dedicated to advancing diversity, equity and inclusion in the workplace has ranked what it considers the top 75 companies for executive women. To be considered, companies had to have a minimum of two women on their boards of directors and at least 500 US employees. Congratulations to BioNJ Members AbbVie (#1) and Johnson & Johnson (#7) for making the top 10 list. 

Chugai Obtains Regulatory Approval for Hemlibra for Additional Indication of Acquired Hemophilia A

Berkeley Heights-based BioNJ Member Chugai Pharmaceutical Co. announced that it obtained regulatory approval from the Ministry of Health, Labour and Welfare for the anti-coagulation factor IXa/X humanized bispecific monoclonal antibody/coagulation factor VIII substitute Hemlibra® [generic name: emicizumab (genetical recombination)] for an additional indication of routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with acquired hemophilia A. Hemlibra received orphan drug designation for this indication in October 2021, and under the priority review process, the additional indication was approved seven months after the application in November 2021. The approval is based on the results of the AGEHA study, a Phase III clinical trial conducted in patients with acquired hemophilia A. 

Anti-CD20 Monoclonal Antibody Rituxan Approved for the Prevention of Recurrence of Neuromyelitis Optica Spectrum Disorder

Berkeley Heights-based BioNJ Member Chugai Pharmaceutical Co. and Zenyaku Kogyo Co. announced that Zenyaku obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW), for an anti-CD20 monoclonal antibody Rituxan® intravenous injection 100 mg and 500 mg [generic name: rituximab (genetical recombination)] for the prevention of recurrence of neuromyelitis optica spectrum disorder (including neuromyelitis optica). Rituxan is an anti-CD20 monoclonal antibody that specifically binds to CD20, a protein expressed on B cells, excluding stem cells and plasma cells. It attacks target B cells using the immune system equipped with the human body, and damages cells. This approval is based on the results of an investigator-initiated phase II/III clinical study (RIN-1 study) which evaluated Rituxan for the reduction of relapse in Japanese patients with neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorder (NMOSD).

Lilly will Supply an Additional 150,000 Doses of Bebtelovimab to U.S. Government in Ongoing Effort to Provide COVID-19 Treatment Options

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced a modified purchase agreement with the U.S. government to supply an additional 150,000 doses of bebtelovimab for approximately $275 million. The existing U.S. government supply of bebtelovimab, including the new purchase, is expected to meet present demand through late August 2022. Bebtelovimab continues to maintain neutralization activity against the most common, and fastest growing, Omicron variants (BA.2.12.1 and BA.4/BA.5) in the United States, in addition to all known variants of interest and concern. Delivery of doses will begin immediately and complete no later than August 5, 2022. An option for an additional 350,000 doses to be exercised no later than September 14, 2022 will remain in the agreement.

SKYRIZI® (risankizumab-rzaa) Receives FDA Approval as the First and Only Specific Interleukin-23 (IL-23) to Treat Moderately to Severely Active Crohn's Disease in Adults

BioNJ Member AbbVie, with a site in Madison, announced that the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) as the first and only specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderately to severely active Crohn's disease (CD). In two induction and one maintenance clinical trials, SKYRIZI demonstrated significant improvements in endoscopic response (defined as a decrease of greater than 50% from the baseline Simple Endoscopic Score in CD [SES-CD] or for patients with isolated ileal disease and SES-CD of 4, at least a 2-point reduction from baseline) and clinical remission (defined as a Crohn's Disease Activity Index [CDAI] of less than 150), compared to placebo, as both an induction and maintenance therapy.

AbbVie Submits Supplemental New Drug Application to U.S. FDA for Atogepant (QULIPTA™) to Support Label Expansion for the Preventive Treatment of Migraine

BioNJ Member AbbVie, with a site in Madison, announced that it has submitted a supplemental New Drug Application (sNDA) for atogepant (QULIPTATM) to the U.S. Food and Drug Administration (FDA) to support the preventive treatment of chronic migraine in adults. If approved, atogepant (QULIPTA) would be the first gepant (oral calcitonin gene-related peptide [CGRP] receptor antagonist) approved for the broad indication of the preventive treatment of migraine, including episodic and chronic. The sNDA submission includes data from the pivotal Phase 3 PROGRESS trial in patients with chronic migraine, which supplements the existing data in episodic migraine. The pivotal Phase 3 PROGRESS trial met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period in adults with chronic migraine.

CHMP Recommends Approval of Upadacitinib (RINVOQ®) for the Treatment of Adults With Active Non-Radiographic Axial Spondyloarthritis

BioNJ Member AbbVie, with a site in Madison, announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of upadacitinib (RINVOQ® 15 mg, once daily) for the treatment of active non-radiographic axial spondyloarthritis (nr axSpA) in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which will review it and issue a Commission decision that will be valid in all member states of the European Union (EU), as well as Iceland, Liechtenstein, Northern Ireland and Norway.

GSK Selects Target the Future Grant Recipient in Innovation Challenge Supporting Multiple Myeloma Community 

Warren-based BioNJ Member GSK announced the first recipient of the Target the Future Think Tank Challenge £70,000 (equivalent to approximately $100,000) grant to the HealthTree Foundation, a non-profit organization helping patients learn more about their health and become their own best advocates. Their proposal, the “HealthTree Equity and Diversity for Multiple Myeloma Program,” will improve access, education and support for underserved communities and minority patients. GSK’s grant will help support the HealthTree Foundation as it develops digital delivery tools to distribute information on treatments and trials, facilitate digital communities and expand outreach efforts to support, educate and provide more equitable care to multiple myeloma patients.

GSK Announces £1 Billion R&D Investment Over Ten Years to Get Ahead of Infectious Diseases in Lower-Income Countries

Warren-based BioNJ Member GSK announced an investment of £1bn over ten years to accelerate research and development (R&D) dedicated to infectious diseases that disproportionately impact lower-income countries. This research will focus on new and disruptive vaccines and medicines to prevent and treat malaria, tuberculosis, HIV (through ViiV Healthcare), neglected tropical diseases (NTDs), and anti-microbial resistance (AMR), which continue to have a devastating toll on the most vulnerable, accounting for more than 60% of the disease burden in many lower-income countries. To deliver against established targets, GSK has formed a dedicated, non-commercial Global Health Unit for which success is measured by health impact alone. 

GSK Presents Promising New Data for Bepirovirsen, an Investigational Treatment for Chronic Hepatitis B

Warren-based BioNJ Member GSK announced promising interim results from the B-Clear phase IIb trial showing that bepirovirsen, an investigational antisense oligonucleotide treatment for hepatitis B, reduced levels of hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA after 24 weeks’ treatment in people with chronic hepatitis B (CHB). Current treatment options have limited success in leading to functional cure, where the virus is not eliminated from the body but is at low levels that are undetectable in blood and can be controlled by the immune system without medication. The mainstay of therapy includes nucleoside/nucleotide analogues (NA) which are often taken for life because they suppress but rarely clear the virus.  

Japan’s Ministry of Health, Labour and Welfare Accepts Shingrix Regulatory Submission to Prevent Shingles in at-Risk Adults Aged 18 Years and Older

Warren-based BioNJ Member GSK announced the submission of a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are at increased risk. This includes individuals with immunodeficiency or immunosuppression caused by known disease or therapy. Immunocompromised individuals are at greater risk of shingles and associated complications than immunocompetent individuals. Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine given intramuscularly in two doses, was initially approved in 2018 by the Japanese MHLW to prevent shingles in adults aged 50 years or older.

Sanofi-GSK First to Report a Successful Efficacy Study Against Omicron With COVID-19 Beta-Containing Vaccine

Bridgewater-based BioNJ Member Sanofi and Warren-based BioNJ Member GSK announce positive data from their vaccine trial which evaluated an adjuvanted bivalent D614 and Beta (B.1.351) vaccine candidate. Sanofi-GSK’s vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial in an environment of high Omicron variant circulation. The vaccine candidate showed a favorable safety and tolerability profile. Earlier this month Sanofi reported positive data from two trials conducted with its new next-generation COVID-19 booster vaccine candidate modelled on the Beta variant antigen and including GSK’s pandemic adjuvant. The data supporting this next-generation booster vaccine will be submitted to regulatory authorities and indicate the potential of Sanofi-GSK’s next-generation Beta-based booster to be a relevant response to public health needs.

Nexviadyme® (avalglucosidase alfa) Approved by European Commission as a Potential New Standard of Care for the Treatment of Pompe Disease

Bridgewater-based BioNJ Member Sanofi announced the European Commission has granted marketing authorization for Nexviadyme® (avalglucosidase alfa), an enzyme replacement therapy (ERT) for the long-term treatment of both late-onset and infantile-onset Pompe disease, a rare, progressive and debilitating muscle disorder. Nexviadyme is the first and only newly approved medicine for Pompe disease in Europe since 2006, when the European Commission authorized the marketing of alglucosidase alfa, branded Myozyme®. Nexviadyme is approved in multiple markets around the world for the treatment of certain people living with Pompe disease, including the European Union, the United States, Japan, Canada, Switzerland, Australia, Brazil, Taiwan and the United Arab Emirates. 

Xenpozyme® (olipudase alfa) Approved by European Commission as First and Only Treatment for ASMD

Bridgewater-based BioNJ Member Sanofi announced the European Commission (EC) has approved Xenpozyme® (olipudase alfa) as the first and only enzyme replacement therapy for the treatment of non-Central Nervous System (CNS) manifestations of Acid Sphingomyelinase Deficiency (ASMD) in pediatric and adult patients with ASMD type A/B or ASMD type B. The approval is based on positive data from the ASCEND and ASCEND-Peds clinical trials, in which Xenpozyme showed substantial and clinically relevant improvement in lung function (as measured by diffusing capacity of the lung for carbon monoxide, or DLco) and reduction of spleen and liver volumes, with a well-tolerated safety profile. Given the urgent unmet medical needs of the ASMD community, the European Medicines Agency (EMA) granted Xenpozyme PRIority MEdicines (PRIME) designation. 

Investigational Lenacapavir Receives Positive CHMP Opinion for People With Multi-Drug Resistant HIV

BioNJ Member Gilead Sciences, with a site in Morris Plains, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for investigational lenacapavir for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. The CHMP positive opinion is a scientific recommendation to the European Commission (EC) to grant marketing authorization in Europe and will be reviewed by the EC, which has the authority to authorize medicines in the 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein.

Janssen Receives Positive CHMP Opinion for IMBRUVICA®(ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL)

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of a new treatment option with IMBRUVICA® (ibrutinib) in an oral fixed-duration combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukaemia (CLL). Outcomes for patients with CLL have improved in the last decade with the advent of oral therapies that target the underlying disease biology. This provides the opportunity to combine these novel treatments for an effective and convenient approach that results in deep responses with time-limited therapy.

Merck Announces the Launch of the Merck Digital Sciences Studio to Help Healthcare Start-Ups Quickly Bring their Innovations to Market

Kenilworth-based BioNJ Member Merck & Co. announced the launch of the Merck Digital Sciences Studio (MDSS) to enable the generation of innovative technologies for drug discovery and development. MDSS will support early-stage biomedical start-ups with direct investment, access to powerful Azure Cloud computing and opportunities to pilot their technologies in collaboration with discovery and clinical scientists at Merck. Merck welcomes applications for 12 spots for the first MDSS cohort. Start-ups developing artificial intelligence (AI) and machine learning (ML) applications will be prioritized. The MDSS is a collaboration between Merck and the New Jersey Innovation Institute (NJII), a New Jersey Institute of Technology corporation, with investments from the Merck Global Health Innovation Fund, Northpond Ventures and McKesson Ventures. 

Results from Phase 3 PROpel Trial of LYNPARZA® (olaparib) Plus Abiraterone in First-Line Metastatic Castration-Resistant Prostate Cancer Published in NEJM Evidence

Kenilworth-based BioNJ Member Merck & Co. announced that the results from the Phase 3 PROpel trial have been published in NEJM Evidence. Results from the trial showed that LYNPARZA in combination with abiraterone plus prednisone significantly improved radiographic progression-free survival (rPFS) versus abiraterone plus prednisone, a standard of care, as first-line treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) with or without homologous recombination repair (HRR) gene mutations. Globally, prostate cancer is the second most common cancer in patients assigned male at birth, with an estimated 1.4 million patients diagnosed worldwide in 2020. Approximately 10-20% of patients with advanced prostate cancer are estimated to develop CRPC within five years, and at least 84% of these patients may develop metastases at the time of CRPC diagnosis.

Merck Presents Positive Results from Phase 1/2 Study Evaluating V116, the Company’s Investigational Pneumococcal Conjugate Vaccine for Adults

Kenilworth-based BioNJ Member Merck & Co. announced the presentation of positive results from the Phase 1/2 study, V116-001, evaluating the safety, tolerability and immunogenicity of V116, the company’s investigational 21-valent pneumococcal conjugate vaccine (PCV), in pneumococcal vaccine-naïve adults 18-49 years of age (Phase 1) and 50 years of age and older (Phase 2). In both populations, V116 met the primary immunogenicity objectives and was well-tolerated with an overall safety profile generally comparable to PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) across age groups. In the Phase 2 part of the study, V116 demonstrated non-inferior immune responses to PNEUMOVAX 23 for all shared serotypes, and superior immune responses for the serotypes included in V116 but not included in PNEUMOVAX 23, based on study-defined criteria.

U.S. FDA Approves Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Infants and Children

Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) to include children 6 weeks through 17 years of age. VAXNEUVANCE is now indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older. The approval follows the FDA’s Priority Review of Merck’s supplemental application. VAXNEUVANCE is contraindicated for individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

CDC’s ACIP Unanimously Votes to Provisionally Recommend Use of Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) as an Option for Pneumococcal Vaccination in Infants and Children

Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) unanimously voted to include VAXNEUVANCETM (Pneumococcal 15-valent Conjugate Vaccine) as a recommended option for vaccination in infants and children, including routine use in children under 2 years of age. Specifically, the ACIP voted to recommend that VAXNEUVANCE may be used as an option to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for children aged under 19 years according to currently recommended PCV13 dosing and schedules. Additionally, the ACIP unanimously voted to include VAXNEUVANCE in the Vaccines for Children program.

European Commission Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adult and Adolescent Patients (≥12 Years of Age) With Stage IIB or IIC Melanoma Following Complete Resection

Kenilworth-based BioNJ Member Merck & Co. announced that the European Commission (EC) has approved 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 EC approved 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 approval of KEYTRUDA for the adjuvant treatment of patients with resected stage IIB or IIC melanoma was based on results from the Phase 3 KEYNOTE-716 trial, in which KEYTRUDA significantly prolonged recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 39% (HR=0.61 [95% CI, 0.45-0.82]; p=0.00046) compared to placebo in this patient population at a median follow-up of 20.5 months.

LYNPARZA® (olaparib) Receives Positive Opinion from EU CHMP as Adjuvant Treatment for Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer

Kenilworth-based BioNJ Member Merck & Co. and AstraZeneca announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of LYNPARZA for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. The CHMP based its positive opinion on results from the Phase 3 OlympiA trial. In the trial, LYNPARZA demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of invasive disease-free survival (IDFS), reducing the risk of invasive breast cancer recurrences, second cancers or death by 42% (HR=0.58 [99.5% CI, 0.41-0.82]; p<0.0001) versus placebo.  

BeiGene Announces Acceptance of Supplemental Biologics License Application in China for Anti-PD-1 Inhibitor Tislelizumab

Hopewell-based BeiGene announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental biologics license application (sBLA) for the company’s anti-PD-1 inhibitor, tislelizumab, in combination with chemotherapy as a first-line treatment for patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1. The sBLA is supported by data from an interim analysis from the global RATIONALE 305 trial of tislelizumab versus placebo in combination with chemotherapy as a first-line treatment for patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

Lexicon Announces Positive Top-Line Results from Phase 2 Proof-of-Concept Study of LX9211 in Painful Diabetic Neuropathy

Lexicon Pharmaceuticals, with a sit in Basking Ridge, announced top-line results of RELIEF-DPN-1, its Phase 2 proof-of-concept study of LX9211 in painful diabetic neuropathy. LX9211 achieved the primary endpoint of the study, demonstrating a statistically significant reduction in average daily pain score (ADPS) at week 6 compared to placebo in the low dose arm with results that plateaued in the high dose arm. Separation from placebo was seen by week 1 in both dose arms, and the effect was consistent across age, sex, concurrent use of medications for painful diabetic neuropathy and baseline pain score. Patient reported outcomes (global impression of change) were improved in patients treated with LX9211 compared to placebo. Adverse events were more frequent in the LX9211 treatment arms and at the higher dose, with the most common being dizziness, headache and nausea. Nearly all adverse events were reported as mild or moderate. There were no drug-related serious adverse events reported in the study.

Trastuzumab Deruxtecan Supplemental New Drug Application Submitted in Japan for Patients With HER2 Low Metastatic Breast Cancer

Basking Ridge-based Daiichi Sankyo announced that it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for trastuzumab deruxtecan for the treatment of adult patients in Japan with HER2 low unresectable or recurrent breast cancer after prior chemotherapy. The sNDA is based on data from the DESTINY-Breast04 phase 3 trial recently presented at the plenary session of the American Society of Clinical Oncology (#ASCO22) annual meeting and simultaneously published in The New England Journal of Medicine. In DESTINY-Breast04, trastuzumab deruxtecan demonstrated superior and clinically meaningful efficacy in progression-free survival (PFS) and overall survival (OS) in previously treated patients with HER2 low unresectable and/or metastatic breast cancer with hormone receptor (HR) positive or HR negative disease 2 versus standard of care physician’s choice of chemotherapy

Trastuzumab Deruxtecan Recommended for Approval in the EU by CHMP for Patients With HER2 Positive Metastatic Breast Cancer Treated With a Prior Anti-HER2-Based Regimen

Basking Ridge-based Daiichi Sankyo and AstraZeneca announced trastuzumab deruxtecan has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast03 Phase 3 trial, which were published in The New England Journal of Medicine. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU.

Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for Patients With HER2 Low Metastatic Breast Cancer With HR Positive and HR Negative Disease

Basking Ridge-based Daiichi Sankyo announced that the European Medicines Agency (EMA) has validated the Type II Variation application for trastuzumab deruxtecan as monotherapy for the treatment of adult patients with unresectable or metastatic HER2 low (immunohistochemistry (IHC) 1+ or IHC 2+/in-situ hybridization (ISH)-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. Patients with hormone receptor (HR) positive breast cancer must additionally have received or be ineligible for endocrine therapy. Trastuzumab deruxtecan is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

COVID? Flu? RSV? New BD Test Can Check All at Once

Patients wondering whether they have COVID-19, the flu or the respiratory syncytial virus will soon be able to test for all three at the same time, thanks to the new BD MAX Respiratory Viral Panel. The Franklin Lakes medical company announced that the new molecular diagnostic combination test – which checks for SARS-CoV-2, Influenza A + B and Respiratory Syncytial Virus (RSV) – has been CE marked to the IVD directive 98/79/EC, meaning it’s now available in countries that recognize that certification. BD said it plans to submit for Emergency Use Authorization from the U.S. Food and Drug Administration in the coming weeks. The diagnostic uses a single nasal swab or a single nasopharyngeal swab sample to test for any of the three viruses, with results ready in about two hours. BD added that it will help eliminate the need for multiple tests and trips to the doctor and can also speed up the treatment process. 

Galderma Announces Positive Data From Phase III Trial, Demonstrating Efficacy and Safety of Nemolizumab in Patients With Prurigo Nodularis

Galderma, with a site in Cranbury, announced the Phase III OLYMPIA 2 trial met all primary and key secondary endpoints, showing nemolizumab as monotherapy significantly improved skin lesions and pruritus (itch) compared with placebo in adult patients with moderate to severe prurigo nodularis. The safety profile was consistent with the Phase II trial results. OLYMPIA 2, part of the largest clinical program in prurigo nodularis to date aiming to recruit 540 patients, is a pivotal Phase III clinical trial, evaluating the efficacy, safety, pharmacokinetics and immunogenicity of nemolizumab compared with placebo in adult patients with prurigo nodularis after a 16-week treatment period.

Regeneron and Intellia Present Updated Interim Data from Phase 1 Study of Crispr-Based Ntla-2001 for the Treatment of Transthyretin (Attr) Amyloidosis Demonstrating that Deep Serum TTR Reductions Remained Durable After a Single Dose

Regeneron Pharmaceuticals, with a site in Basking Ridge, and Intellia Therapeutics announced additional positive interim data from an ongoing Phase 1 study of their lead investigational in vivo genome editing candidate, NTLA-2001, which is being developed as a single-dose treatment for transthyretin (ATTR) amyloidosis. The presentation included extended follow-up data from 15 patients with hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN) treated across four single-ascending dose cohorts in Part 1 of the study. Results demonstrated sustained durability of serum transthyretin (TTR) reduction through the last measured timepoint in the ongoing observation. These data support NTLA-2001's continued development as a potential one-time treatment to permanently inactivate the TTR gene and reduce the disease-causing protein.

Dr. Reddy’s to Acquire Injectable Product Portfolio from Eton Pharma for $50M

Princeton-based Dr. Reddy’s Labs acquired a portfolio of branded and generic injectable products from Eton Pharmaceuticals Inc. for approximately $50 million. The portfolio includes the Biorphen (phenylephrine hydrocholoride) Injection and Rezipres (ephedrine hydrochloride) Injection new drug applications, with nine separate combinations of strengths and presentations. “Long before the COVID-19 pandemic, there have been concerns about access to some critical care products for hospitals and health systems. This acquisition provides our North America organization with a foundational footprint to help address products that are not always readily available for patients,” Marc Kikuchi, CEO, North America generics, Dr. Reddy’s, said. “For these and many other reasons, I believe we are well-positioned to integrate the portfolio and grow the business.” 

Phibro Animal Health Corporation and Rejuvenate Bio Announce Agreement to Develop Gene Therapy for Mitral Valve Disease in Canines

Teaneck-based Phibro Animal Health and Rejuvenate Bio, Inc. announced a collaboration for the development and commercialization of a gene therapy for Mitral Valve Disease (MVD) in canines (dogs). The incidence of MVD varies widely but is believed to be present in about 7% of all dogs and can be as high as 80% for some breeds such as Cavalier King Charles Spaniels. Rejuvenate Bio has received support from the American Cavalier King Charles Spaniel Club for this research. MVD is caused by a malfunction of the Mitral Valve which allows blood to flow backward from the heart's lower chamber (ventricle) to the upper chamber (atrium). 

Zoetis Completes Acquisition of Basepaws, Leader in Pet Care Genetics

Parsippany-based Zoetis announced it completed the previously announced acquisition of Basepaws, a privately held pet care genetics company, which provides pet owners with genetic tests, analytics and early health risk assessments that can help manage the health, wellness and quality of care for their pets. “When we first met Basepaws CEO Anna Skaya and the team, we were immediately drawn to their passion for pets and the role that genetic testing and data analytics can have in advancing animal care — a purpose that drives us every day,” Zoetis CEO Kristin Peck said. “The addition of Basepaws will enhance our portfolio in the precision animal health space and inform our future pipeline of pet care innovations.”

PsychoGenics Strengthens Executive Team to Boost CNS Drug Discovery and CRO Capabilities

Paramus-based BioNJ Member PsychoGenics Inc. announced that it has appointed David Bleakman, Ph.D., to President, Drug Discovery and Development, and Thomas Oakley to President, Contract Research Organization and Chief Operating Officer. Dr. Bleakman will lead the Company’s drug discovery team and strategically advance the multiple research programs in development. He is an internationally recognized neuroscientist and expert in drug discovery and development with over 30 years of experience. Mr. Oakley will oversee PsychoGenics’ service business expansion and be responsible for ensuring operational excellence across the company. With over 25 years of strategic and operational experience in the contract research industry, Mr. Oakley most recently served as COO at Inotiv.

Celldex Announces Two New Appointments to its Board of Directors

Hampton-based BioNJ Member Celldex Therapeutics announced that it has appointed Cheryl L. Cohen and Dr. Garry Neil to the company’s Board of Directors. Ms. Cohen has served as President of CLC Consulting, a pharmaceutical and biotechnology consulting firm that specializes in new product start-ups and commercialization. From August 2011 to July 2014, Ms. Cohen served as Chief Commercial Officer of Medivation, Inc., where she built the company’s commercial organization and lead her team to successfully launch the oncology drug, Xtandi®. Dr. Neil has served as Chief Executive Officer at Avalo Therapeutics (formerly Cerecor, Inc.), a publicly held biotechnology company. Prior to that, Dr. Neil was Senior Scientific Adviser and Chief Scientific Officer at Avalo. 

Cyclacel Pharmaceuticals Announces that Kenneth M. Ferguson, Ph.D. was Elected to its Board of Directors

Berkeley Heights-based BioNJ Member Cyclacel Pharmaceuticals announced the election of Kenneth M. Ferguson, Ph.D., to its Board of Directors. Dr. Ferguson’s professional experience includes over 30 years of scientific and drug development experience in the biopharmaceutical industry. Currently, he serves as an Operating Partner at Accelerator Life Science Partners. Previously, he was Chief Scientific Officer of EMulate Therapeutics, where he was responsible for the investigation of magnetic field effects on cell processes to enable novel therapeutic strategies. He previously spent seven years with Omeros Corp, where he last held the position of Chief Development Officer. 

Tevogen Bio Appoints Distinguished Clinician and Former Matheny President and CEO, Dr. Kendell R. Sprott, to Corporate Advisory Board

Warren-based BioNJ Member Tevogen Bio announced that its Board of Directors has appointed Kendell R. Sprott, M.D., J.D., to its Corporate Advisory Board. Most recently, Dr. Sprott served six years as President and CEO at Matheny Medical and Educational Center, which provides care and enhances the quality of life for individuals with special needs and medically complex developmental disabilities. Dr. Sprott, a member of Rutgers New Jersey Medical School for 30 years, has dedicated more than four decades of his life to the pediatric health care practice. The Corporate Advisory Board provides guidance to Tevogen leadership as the company continues to expand its genetically unmodified precision T cell platform technology, which maintains the promise of affordable and convenient cell therapies for large patient populations by overcoming existing barriers of T cell-based therapeutic platforms.

Merck Announces that Chirfi Guindo will Lead Marketing for Merck Human Health

Kenilworth-based BioNJ Member Merck & Co. announced that Chirfi Guindo will lead Human Health Marketing as Chief Marketing Officer for Merck Human Health and will join Merck’s Executive Team. Guindo will report directly to Robert M. Davis, chief executive officer and president, Merck. As chief marketing officer for Human Health, Guindo will be responsible for leading the development and implementation of the company’s long-term strategy for the Human Health portfolio spanning oncology, vaccines, pharmaceutical and pipeline products.

Since 2017, Mr. Guindo has been Executive Vice President and Head of Global Product Strategy and Commercialization at Biogen and served on Biogen’s executive leadership team. 

Wife-and-Husband Team of Rutgers Professors ‘Embraces’ Challenge of Developing Novel Cancer Treatments

A pair of Rutgers professors partnered with a former colleague to form a start-up with the goal of developing novel cancer treatments based on the use of antibody drug conjugates. Wife-and-husband team Renata Pasqualini and Wadih Arap, who are professors and division chiefs at Rutgers Cancer Institute of New Jersey in Rutgers Biomedical and Health Sciences, founded MBrace Therapeutics. The mission of the start-up is to benefit patients with cancer through the discovery of new, targeted treatments. “The company is founded on the research conducted in part by Drs. Pasqualini and Arap to discover and validate new targets and simultaneously identifying an antibody that binds to the target,” Dr. Isan Chen, who serves as CEO of MBrace, stated. “Our goal is to discover and advance novel drugs to offer novel treatment options to cancer patients.”

Rowan University, Community College of Philadelphia Announce Partnership Expanding Access to 4-Year Degrees

A new program-to-program transfer partnership for eligible Community College of Philadelphia graduates is now available through an agreement between Rowan University and the Community College of Philadelphia. To qualify, students must complete an associate degree in the science, technology, engineering and mathematics fields, or other approved majors, and earn admittance into Rowan’s corresponding majors. Rowan President Dr. Ali Houshmand noted that the partnership expands a history of supporting students moving from community colleges in the region to the Glassboro-based university. “Community College of Philadelphia has very high standards, so we know that their students will succeed at Rowan,” Houshmand said. “We have created a variety of pathways for community college graduates to continue on and attain an affordable four-year degree.”

Hackensack Meridian Health Names Chief Data and Analytics Officer

Hackensack Meridian Health welcomed Sameer Sethi as Senior Vice President and Chief Data and Analytics Officer for the network. In his role, Mr. Sethi will help the HMH network continue to transform health care delivery for patients across New Jersey by leading HMH’s data and analytics vision. Mr. Sethi brings a very rich and diverse experience working with health care providers. Over the course of his 14 years in the health care industry, Mr. Sethi has led strategy and execution of various data and analytics transformation projects, with a focus on the use of modern technology and techniques to drive distinctiveness and insight-driven decisions into the DNA of health care organizations.

RWJ University Hospital Appoints Rubinson as Chief Medical Officer

Robert Wood Johnson University Hospital (RWJUH) has named Lewis Rubinson, M.D., Ph.D., FCCP, as its Senior Vice President, Chief Medical Officer and Chief Quality Officer. With more than two decades of C-suite, clinical, academic and government experience, Dr. Rubinson brings expertise in critical care medicine and public health to New Jersey’s largest academic medical center, which is also one of the three state-designated Level I Trauma Centers in New Jersey. He will draw on his experience in academic medicine and government disaster response efforts to advance clinical care and patient outcomes at RWJUH. In his role as CMO, Dr. Rubinson will work with the Medical Staff Executive Committee to engage and lead the nearly 2,000 physicians and advanced practice providers at RWJUH. 

NJ Maternal & Infant Health R&D Grant Program

The Maternal and Infant R&D Grant Program is a $750,000 pilot program. Eligible applicants can apply for vouchers up to $75,000 to support innovation on developing technology, therapeutics, and other solutions to address maternal and infant health challenges in New Jersey. The grant will engage early-stage innovation-based companies in New Jersey and help to accelerate research and development of technologies, transforming new discoveries from research stage into commercially viable products and services.

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. Contact RBromberg@BioNJ.org for the discount code. 

Bio-Manufacturing Innovation Summit

July 7-8, 2022

Driving meaningful innovation, impact and value creation in Bio-Manufacturing and ensuring resilient, adaptable supply chains, efficient re-shoring, on-shoring and cutting edge pharma manufacturing solutions to meet demand and accelerate the development and production of essential novel therapeutics and vaccines, in the U.S. and globally. The Summit will cover: What solutions can technology transfer from the world-leading institutions and most innovative private companies provide? Which partners can provide the expertise to move these innovations to the market? How can industry and private companies reduce costs and accelerate their own programs? How to re-shore on on-shore rapidly and efficiently? What are the intellectual property and regulatory considerations? BioNJ Members receive a 50% discount on admission. Contact RBromberg@BioNJ.org for the discount code. 

MDS-PAS 7th Annual Movement Disorders School for Neurology Residents

October 1, 2022

The Michael J. Fox Foundation, in partnership with the Edmond J. Safra Foundation, provides a free, two-day educational opportunity for neurology residents interested in learning about care, research and careers in Parkinson’s and other movement disorders. The course will take place October 1 and 2 in Northern New Jersey. The deadline to apply is September 5, 2022. Learn more and apply.