BIO Comments on NIST Proposal to Use March-In Rights for Price Controls

Contention over the Bayh-Dole march-in rights provision is in the news again. The National Institute of Standards and Technology (NIST) proposes using the process as a “back door” for drug price controls. In comments on NIST’s Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, the Biotechnology Innovation Organization (BIO) states that the clause cannot be used for price controls. The Bayh-Dole Act “created a uniform patent policy among the many federal agencies funding research.” The Act connected universities, industry and government to open and expand the pipeline of innovation. It has been considered a landmark piece of legislation — and a huge success. 

‘March-in’ rights: Why Biden’s Changes Contradict the Point of the Bayh-Dole Act

The unintended consequences of President Biden’s proposal to dictate prices would destroy the US’ thriving tech transfer framework — and in industries far beyond pharmaceuticals, explain former USPTO Directors Andrei Iancu and David Kappos. It's a striking show of unity. Nine former senior officials from the US Department of Commerce spanning more than 20 years and five administrations — both Democratic and Republican — have joined forces to write to President Joe Biden. In a letter, the signatories urge Biden to withdraw his administration's proposed framework for exercising ‘march-in rights’ under the Bayh-Dole Act.

Pill Penalty Provisions Will Have a Chilling Effect on the Prescription Ecosystem

Small-molecule medicines have an outsized impact on patient health. Small molecules

account for more than 90% of all prescriptions and two thirds of new drug approvals yearly. Often taken orally rather than requiring a shot or infusion in doctors' offices and hospitals, they offer patients and caregivers improved convenience and ease of use. These pills, tablets, capsules and creams treat important health conditions such as heart disease, depression and other mental illnesses, neurological conditions and many cancers. Exciting new research is also testing ways for small molecules to modify gene expressions, proteins and viral infectivity and treat other conditions previously thought to be “undruggable.”

BioNJ President & CEO Debbie Hart Honored on the 2024 NJBIZ Power 100 List

The NJBIZ Power 100 is an annual list that recognizes New Jersey's most important business leaders. The 2024 list honors people who have gained public attention for their professional accomplishments and public service. The list also recognizes people who have contributed to the advancement of the public interest through their work and/or community. Congratulations to BioNJ President and CEO Debbie Hart for being name to the 2024 NJBIZ Power 100.

Investment Reports: Insights from Debbie Hart, President & CEO BioNJ

Building on our long and strong pharmaceutical heritage and a commitment by industry and government to continue to invest in key areas and to grow and innovate, New Jersey is in a strategic position to capitalize on its strong foundation to expand and to deliver needed innovations for Patients. Investments made by the State, the New Jersey Economic Development Authority, and the New Jersey Commission on Science, Innovation and Technology, especially in early stage companies, are laying the groundwork for future success. Our strategic vision includes nurturing emerging sectors like cell and gene therapy and ensuring a robust talent pipeline. We anticipate these efforts will be rewarded, ensuring New Jersey's position as a leader in this important sector.

BioAegis Therapeutics Unveils Upcoming Clinical Study of Gelsolin, an Immune Regulator, as a Treatment for Patients with Acute Respiratory Distress Syndrome (ARDS)

North Brunswick-based BioNJ Member BioAegis Therapeutics announced site recruitment for BTI-203, a Phase 2 study of recombinant human gelsolin (rhu-pGSN) for the treatment of Acute Respiratory Distress Syndrome (ARDS) (NCT05947955). The study, A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Recombinant Human Plasma Gelsolin With Standard of Care for Moderate-to-Severe ARDS Due to Pneumonia or Other Infections is being conducted under a contract with BARDA’s Division of Research, Innovation, and Ventures (DRIVe), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.

U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Epcoritamab (EPKINLY®) for Difficult-to-Treat Relapsed or Refractory Follicular Lymphoma

Princeton-based BioNJ Member Genmab A/S and BioNJ Member AbbVie announced the U.S. Food and Drug Administration (FDA) granted Priority Review for the supplemental Biologics License Application (sBLA) for epcoritamab-bysp, a T-cell engaging bispecific antibody administered subcutaneously, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The FDA grants Priority Review to investigational therapies that, if approved, may offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2024.

Legend Biotech Announces Positive CHMP Opinion for CARVYKTI® (ciltacabtagene autoloader) for the Treatment of Patients With Relapsed and Lenalidomide Refractory Multiple Myeloma in Earlier Lines of Therapy

Somerset-based BioNJ Member Legend Biotech Corporation announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expansion of the CARVYKTI® label to include adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide. The Type II variation application was submitted to the EMA by Janssen-Cilag International N.V., an affiliate of Janssen Biotech, Inc., Legend Biotech’s collaborator for the development and commercialization of CARVYKTI®. The positive opinion from the CHMP will now be reviewed by the European Commission which renders the final decision on approval.

Matinas BioPharma Provides Positive Outcomes Update on the MAT2203 Compassionate/Expanded Use Access Program, Including Multiple Patients With Complete Clinical Resolution

Bedminster-based BioNJ Member Matinas BioPharma provided an update from its ongoing Compassionate/Expanded Use Access Program with MAT2203, the company’s proprietary, LNC-delivered oral formulation of the broad-spectrum antifungal drug amphotericin B. To date, 19 patients have been enrolled in the Program at prestigious healthcare institutions. The majority of enrolled patients are post-transplant or are undergoing treatment for underlying malignancies. The infections being treated with MAT2203 include a variety of micro-organisms (including Aspergillus, Mucorales species, Candidiasis, Fusarium and suspected Coccidioides) occurring at multiple sites of infection, including brain, bladder/colon, bone, lung, sinus and skin. Most patients were receiving AmBisome prior to enrollment but developed treatment-limiting nephrotoxicity and most also required treatment for either azole-resistant organisms or had clinically failed azole therapy and had no other treatment options.

BeiGene Announces New Efficacy Analysis Comparing BRUKINSA® vs Acalabrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia

Hopewell-based BioNJ Member BeiGene announced a new matching adjusted indirect comparison (MAIC) of the efficacy of BRUKINSA® (zanubrutinib) versus acalabrutinib in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) based on data from the Phase 3 ALPINE and Phase 3 ASCEND trials. The analysis suggests a progression-free survival and complete response advantage for BRUKINSA versus acalabrutinib, as well as potentially improved overall survival. In this MAIC, individual patient-level data from ALPINE was matched against the aggregate data from ASCEND. An unanchored MAIC was used due to the lack of a common comparator arm between the ALPINE and ASCEND trials. Given the differences in the timing of the studies, with respect to the onset of the COVID-19 pandemic, the analysis adjusted for the impact of COVID-19 in the ALPINE study.

BeiGene’s Biologics License Application for TEVIMBRA® (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA

Hopewell-based BioNJ Member BeiGene announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for TEVIMBRA® (tislelizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. The FDA’s action date on the BLA is expected in December 2024. “There is an urgent need for new treatment options for gastric cancer, which is often diagnosed at the advanced or metastatic stage,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “In clinical trials, TEVIMBRA has demonstrated its potential to improve survival for patients with gastric and gastroesophageal junction cancer.”

BeiGene Receives Positive CHMP Opinion for Tislelizumab as Treatment for Non-Small Cell Lung Cancer

Hopewell-based BioNJ Member BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications: “Through three Phase 3 clinical trials enrolling nearly 1,500 patients across the world including in the European Union, tislelizumab has been shown to be an effective therapy for patients with treatment-naïve and treatment-resistant NSCLC,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “Today's positive CHMP opinion brings us one step closer to providing an important treatment option to patients in Europe with lung cancer, which is among the most common cancers and a leading cause of cancer death in the region.”

Cell Therapy Company Tevogen Bio Holdings Inc. Prepares to Launch Crucial Genetic Predisposition Study in Preparation to Investigate the Potential of TVGN 489 to Address Critical Unmet Need for Long COVID Treatment

Prior to launching the Long COVID clinical trial, Warren-based BioNJ Member Tevogen seeks to address whether Long COVID occurs more commonly with certain HLA types and less commonly with others, or whether Long COVID occurs randomly in the population regardless of HLA. This effort will help Tevogen generate CTL products recognizing the HLA types that are most commonly associated with Long COVID, if a relationship between Long COVID and HLA type is identified, with the goal of allowing a Long COVID treatment trial to be designed and completed expeditiously. “Generating this information will provide important insights into the immunologic factors that contribute to Long COVID development and will greatly facilitate the treatment trial we expect to follow,” said Shannon Rudolph, Clinical Scientist at Tevogen.

Celldex Therapeutics Presents Positive 12 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria

Hampton-based BioNJ Member, Celldex Therapeutics, Inc. announced positive 12-week results from the company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease. The studies will continue dosing patients until week 52. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival. CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes. Treatment options for patients with CSU are limited and there are no approved therapies for patients who are not adequately controlled by omalizumab. 

Sibeprenlimab Receives U.S. FDA Breakthrough Therapy Designation for the Treatment of Immunoglobulin A Nephropathy

Princeton-Based BioNJ Member Otsuka Pharmaceutical Development & Commercialization, Inc., and Visterra, Inc. announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the investigational drug sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgAN; Berger’s disease). Sibeprenlimab is a humanized monoclonal antibody that blocks the action of the B-cell growth factor, APRIL (an acronym for a proliferation-inducing ligand), which plays a key role in the development and progression of IgAN. Otsuka and Visterra announced positive results of the Phase 2 ENVISION trial (NCT04287985) for IgAN. The trial results were also published in The New England Journal of Medicine. Immunoglobulin A nephropathy is the most common form of primary glomerulonephritis worldwide and is the most common cause of kidney failure in young adults.

Kyowa Kirin Announces Launch of PHOZEVEL® Tablets for Improvement of Hyperphosphatemia in Chronic Kidney Disease Patients on Dialysis in Japan

BioNJ Member Kyowa Kirin Co., Ltd., with a site in Princeton, announced that PHOZEVEL® Tablets, was launched in Japan for the improvement of hyperphosphatemia in chronic kidney disease patients on dialysis. Tenapanor hydrochloride, discovered and developed by Ardelyx in the United States, is a first in-class phosphate absorption inhibitor. Kyowa Kirin entered into an exclusive license agreement with Ardelyx for the development and commercialization rights for cardiorenal diseases in Japan, including hyperphosphatemia. Kyowa Kirin received approval for manufacturing and marketing PHOZEVEL® Tablets in September 2023, and will now launch PHOZEVEL® Tablets in Japan. PHOZEVEL® Tablets has a novel mechanism of action, distinct from conventional hyperphosphatemia treatment agents, that blocks phosphate absorption through the paracellular pathway by inhibiting the sodium hydrogen exchanger 3 (NHE3) on intestinal epithelial cells in the gut.

Chromocell Therapeutics Corp. and Benuvia Operations, LLC Announce Strategic Partnership to Advance Healthcare Solutions

New Brunswick-based BioNJ Member Chromocell Therapeutics Corporation and Benuvia Operations, LLC announced Chromocell’s first Development and License Agreement. Under the Agreement, Chromocell licensed sublingual formulation of a Diclofenac spray for the treatment of acute pain, a Rizatriptan intranasal spray formulation and an Ondansetron sublingual spray formulation, diversifying our pipeline of non-opioid pain treatment therapies, while adding therapeutic options for related conditions. This collaboration leverages the unique strengths of both organizations to enhance patient outcomes and address unmet medical needs. Under the terms of the agreement, Chromocell expects to develop clinical programs of one or more of the licensed products within 18 months. During 2024, Chromocell intends to complete the development and business plans for each of the three compounds with the expectation that development would commence following the completion of the review by the FDA.

Chromocell Therapeutics Announces Closing of Initial Public Offering for Gross Proceeds of $6.6 Million

New Brunswick-based BioNJ Member Chromocell Therapeutics Corporation announced the closing of its initial public offering of 1,100,000 shares of its common stock at a public offering price of $6.00 per share. The gross proceeds from the offering to Chromocell, before deducting the underwriting discounts and estimated offering expenses, were approximately $6.6 million. Chromocell’s common stock is listed on the NYSE American LLC under the ticker symbol “CHRO”. The company’s initial clinical focus is to selectively target the sodium ion-channel known as NaV1.7 for the treatment of various types of chronic neuropathic pain and eye pain. The company’s portfolio also includes pre-clinical work on other sodium channel receptor subtypes and the company intends to explore these and other compounds for the treatment of additional pain indications.

Survodutide Phase II Trial Shows 83% of Adults Treated Achieved Groundbreaking Results in Liver Disease due to MASH, With Significant Improvements in Fibrosis

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, announced that up to 83.0% of adults treated with survodutide (BI 456906) achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%) in a Phase II trial [response difference: 64.8% (CI 51.1% - 78.6%), p<0.0001]. The trial met its primary endpoint with survodutide reaching a biopsy-proven improvement in MASH after 48 weeks, without worsening of fibrosis stages F1, F2 and F3 (mild to moderate or advanced scarring). Survodutide also met all secondary endpoints, including a statistically significant improvement in liver fibrosis. Full data will be presented in the coming months. Survodutide has the potential to become a best-in-class treatment for MASH, a liver disease connected with other cardiovascular, renal and metabolic conditions.

Phase 2 Data Published in NEJM Show Potential of Frexalimab as High-Efficacy Therapy in Relapsing MS

Bridgewater-based BioNJ Member Sanofi announced that The New England Journal of Medicine published results from a positive Phase 2 clinical trial demonstrating frexalimab significantly slowed disease activity in people with relapsing multiple sclerosis (MS), corresponding to 89% and 79% reduction in new gadolinium-enhancing (GdE) T1 brain lesions at Week 12 in the high- and low-dose treatment arms compared to placebo, meeting the study’s primary endpoint. Findings also showed both doses of frexalimab provided significant reduction in new or enlarging T2 lesions, a secondary endpoint of the study. Frexalimab is Sanofi’s novel second-generation investigational anti-CD40L antibody that has a unique method of action with the potential to address both acute and chronic neuroinflammation in MS without causing lymphocyte depletion. 

Japan First in the World to Approve Dupixent® for Chronic Spontaneous Urticaria (CSU)

Bridgewater-based BioNJ Member Sanofi announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent® (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not adequately controlled with existing therapy. Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs. CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and persistent itch. CSU is typically treated with histamine (H1) antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria.

Dupixent® sBLA Accepted for FDA Priority Review for Treatment of COPD With Type 2 Inflammation

Bridgewater-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The target action date for the FDA decision is June 27, 2024. Regulatory submissions are also under review in China and the European Union. The sBLA, as well as other submissions around the world, is supported by data from the Phase 3 COPD clinical research program evaluating the efficacy and safety of Dupixent in adults who were current or former smokers with uncontrolled COPD with evidence of type 2 inflammation (screening blood eosinophils >300 cells/microliter). 

Dupixent® Continues Scientific Leadership With Late-Breaking Results Showing Reduced Airway Inflammation and Mucus Plugging in Adults With Uncontrolled Moderate-to-Severe Asthma

Bridgewater-based BioNJ Member Sanofi announced topline results from the VESTIGE Phase 4 clinical trial evaluating the effect of Dupixent® (dupilumab) on airway remodeling parameters through the use of functional respiratory imaging (FRI) in adults with uncontrolled moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid dependent asthma will be presented in collaboration with BioNJ Member Regeneron. The study, the largest of its kind to utilize FRI to evaluate a biologic’s impact on the lungs, found that patients taking Dupixent achieved a significant reduction in airway inflammation, and had numerically greater reductions in mucus plug (mucus buildup in the lungs) scores and numerically greater improvements in airway volume and flow, indicating improvements in their ability to breathe more normally.

Phase 2 Results Demonstrate Rilzabrutinib Rapidly Reduced Itch Severity and Significantly Improved Disease Activity in Adults With Chronic Spontaneous Urticaria

Bridgewater-based BioNJ Member Sanofi announced positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines. Professor Marcus Maurer, M.D., Professor of Dermatology and Allergy, Executive Director of the Institute of Allergology at the Charité Berlin said “People with CSU are living with debilitating symptoms such as intensely itchy recurrent hives, swelling, or both which can have a high impact on their day-to-day lives. These data are promising news for patients that cannot be controlled with standard-of-care antihistamines – the possibility of controlling itch rapidly with an oral medicine would offer an important advancement in the treatment of this disease.”

Peer Support, Flexible Work Arrangements, Salary for a Year: Sanofi Launches Global Program for Employees Affected by Cancer and Critical Illnesses

Bridgewater-based BioNJ Member Sanofi launched ‘Cancer & Work: Acting Together’, a global program to support Sanofi employees whose lives are impacted by cancer and other critical illnesses. This program covers all Sanofi employees in the world if they are diagnosed with cancer or critical illnesses. It provides social, emotional and financial support and secures the job, salary and benefits of any employee for up to twelve months, no matter the role or geographical location. On top of financial support, employees will be able to incorporate further flexible work arrangements to better navigate cancer and work. The program also addresses the emotional wellbeing of Sanofi employees impacted by cancer and other critical illnesses. They will have access to a network of volunteer colleagues trained to help them navigate from initial diagnosis through the treatment journey and return to work.

Teva Presents New Data Supporting Safety, Tolerability and Target Engagement of Anti-TL1A (TEV-‘574) Antibody at the 2024 ECCO Annual Meeting

Parsippany-based BioNJ Member Teva Pharmaceutical announced positive safety, tolerability and pharmacokinetic data for its anti-TL1A (TEV-’574) asset, a potentially best-in-class human IgG1 monoclonal antibody that targets the tumor necrosis factor (TNF)-like ligand 1A (TL1A) and is designed to offer both anti-inflammatory and anti-fibrotic effects. The data show the rapid and sustained suppression of free TL1A, confirming the target engagement of anti-TL1A (TEV-’574), and show a well-tolerated safety profile in patients with asthma, which support continued clinical investigation for moderate-to-severe inflammatory bowel disease (IBD); this includes ulcerative colitis (UC) and Crohn's disease (CD). “These results from the first-in-human trials of anti-TL1A (TEV-’574) are exciting because they show that it effectively engages with the TL1A target, supports its safety profile and is well-tolerated,” said Dr. Eric Hughes, Executive Vice President of Global R&D and Chief Medical Officer, Teva. 

Teva and Alvotech Announce U.S. Approval of SIMLANDI® (adalimumab-ryvk) Injection, the First Interchangeable High-Concentration, Citrate-Free Biosimilar to Humira®

Alvotech and BioNJ Member Teva Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) has approved SIMLANDI (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis. Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States. SIMLANDI is the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA, and will qualify for interchangeable exclusivity for the 40mg/0.4ml injection. 

Gilead Announces Funding Initiative to Support HIV Prevention, Anti-Stigma and Health Equity Efforts for Black Cisgender and Transgender Women and Girls in the U.S.

BioNJ Member Gilead Sciences, with a site in Morris Plains, announced it is providing a total of $12.6 million in grant funding to 19 organizations working to improve the HIV landscape for Black women and girls in the United States. These grants are a part of Gilead’s new Setting the P.A.C.E. (Prevention, Arts and Advocacy, Community, Education) initiative, a three-year commitment toward increasing HIV prevention, anti-stigma and health equity efforts for Black cisgender and Transgender women and girls, who are disproportionately impacted by the HIV epidemic. In 2021, Black women accounted for 53% of new HIV diagnoses among women aged 16 and older in the United States, despite comprising only 14% of the women living in the country. 

Organon Announces HADLIMA™ (adalimumab-bwwd) Has Been Exclusively Selected by the US Department of Veterans Affairs (VA), Replacing HUMIRA on Its National Formulary

Jersey City-based BioNJ Member Organon announced that the U.S. Department of Veterans Affairs (VA) has exclusively selected HADLIMA in replacement of HUMIRA (adalimumab) for the VA National Formulary. HADLIMA is an FDA-approved biosimilar to HUMIRA for the treatment of specific autoimmune or autoinflammatory conditions such as rheumatoid arthritis, Crohn’s disease, hidradenitis suppurativa, and plaque psoriasis. "America’s veterans deserve access to quality medicines at a lower cost. “We are proud to support the more than nine million people enrolled in the VA healthcare system through this collaboration, which is a great example of industry and public sector working together,” said Kevin Ali, Organon CEO. “We applaud the VA for its leadership in championing biosimilars and including all three of Organon’s biosimilars available in the U.S. on its formulary."

FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Treatment for Primary Advanced or Recurrent Endometrial Carcinoma

Rahway-based BioNJ Member Merck & Co. announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel), followed by KEYTRUDA as a single agent for the treatment of patients with primary advanced or recurrent endometrial carcinoma. “If approved, KEYTRUDA would be the first immunotherapy indicated for the frontline treatment of advanced endometrial cancer regardless of mismatch repair status,” said Dr. Gursel Aktan, Vice President, Global Clinical Development, Merck Research Laboratories. “We are committed to working closely with the FDA to bring KEYTRUDA to these patients who are in need of additional treatment options, and we thank our collaborators for their partnership on this study.”

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy as Neoadjuvant Treatment, then Continued as Monotherapy as Adjuvant Treatment, for the Treatment of Resectable NSCLC at High Risk of Recurrence

Rahway-based BioNJ Member Merck & Co. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as a monotherapy as adjuvant treatment, for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults. The recommendation is based on results from the Phase 3 KEYNOTE-671 trial, in which neoadjuvant KEYTRUDA plus chemotherapy followed by adjuvant KEYTRUDA as a single agent after surgical resection demonstrated statistically significant and clinically meaningful improvements in overall survival and event-free survival, the study’s dual primary endpoints, versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in these patients.

GSK Announces Positive Headline Results from EAGLE-1 Phase III Trial for Gepotidacin in Uncomplicated Urogenital Gonorrhoea (GC)

Warren-based BioNJ Member GSK announced positive headline results from the pivotal EAGLE-1 phase III trial for gepotidacin, a potential first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urogenital gonorrhoea in adolescents and adults. The trial met its primary efficacy endpoint, with gepotidacin (oral, two doses of 3,000mg) demonstrating non-inferiority to intramuscular (IM) ceftriaxone (500mg) plus oral azithromycin (1,000mg), a leading combination treatment regimen for gonorrhoea. The result is based on a primary endpoint of microbiological response (success or failure) at the Test-of-Cure (ToC) visit 3-7 days after treatment. The safety and tolerability profile of gepotidacin in the EAGLE-1 Phase III trial was consistent with results seen in gepotidacin Phase I and II trials.

European Commission Approves Pfizer’s VELSIPITY® for Patients with Moderately to Severely Active Ulcerative Colitis

BioNJ Member Pfizer, with a site in Peapack, announced that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent. The marketing authorization for VELSIPITY is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway. This authorization follows the recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2023.

FDA Approves Xolair® (omalizumab) as First and Only Medicine for Children and Adults With One or More Food Allergies

East Hanover-based BioNJ Member Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as "food allergen avoidance"). Xolair should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. Immunoglobulin E (IgE)-mediated food allergies are the most common type and are typically characterized by the rapid onset of symptoms following exposure to certain food allergens. Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies. 

New England Journal of Medicine Publishes Phase III Data Showing Xolair® (omalizumab) Significantly Reduced Allergic Reactions Across Multiple Foods in People With Food Allergies

East Hanover-based BioNJ Member Novartis announced data from Stage 1 of the National Institutes of Health (NIH)-sponsored pivotal Phase III OUtMATCH study evaluating the efficacy and safety of Xolair® (omalizumab) in patients allergic to peanuts and at least two other common foods were published in the New England Journal of Medicine (NEJM). The study showed treatment with Xolair increased the amount of peanuts, milk, egg, wheat and tree nuts (cashew, hazelnut and walnut) that it took to cause moderate to severe allergic reactions in multi-food allergic people as young as 1 year. Safety findings were consistent with the known safety profile of Xolair across its approved indications and in previous clinical trials. 

U.S. Food and Drug Administration (FDA) Accepts Supplemental New Drug Application for KRAZATI® (adagrasib) in Combination With Cetuximab as a Targeted Treatment Option for Patients With Previously Treated KRAS G12C-Mutated Locally Advanced or...

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental new drug application (sNDA) for KRAZATI® (adagrasib) in combination with cetuximab for the treatment of patients with previously treated KRAS^G12C-mutated locally advanced or metastatic colorectal cancer (CRC). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024. The submission is based on the results of KRYSTAL-1 study, a multicohort trial which evaluated KRAZATI alone or in combination with other anticancer therapies in patients with advanced solid tumors harboring a KRAS^G12C mutation. The primary endpoint for the registrational cohort was objective response rate. The secondary endpoints for the pooled cohorts included duration of response, progression-free survival, overall survival and safety.

Bristol Myers Squibb Receives Positive CHMP Opinion for Reblozyl ® (luspatercept) for Treatment of Adults With Transfusion-Dependent Anemia due to Low- to Intermediate-Risk Myelodysplastic Syndromes (MDS)

Princeton-based BioNJ Member Bristol Myers Squibb announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Reblozyl ® (luspatercept) as a treatment for adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Upon approval, this would represent the fourth authorized indication for Reblozyl in the EU. The CHMP adopted a positive opinion based on results from the pivotal Phase 3 COMMANDS trial. 

Bristol Myers Squibb Completes Acquisition of RayzeBio, Adding Differentiated Actinium-Based Radiopharmaceutical Platform

Princeton-based BioNJ Member Bristol Myers Squibb announced that it has successfully completed its acquisition of RayzeBio, Inc. With the completion of the acquisition, RayzeBio shares have ceased trading on the NASDAQ Global Market and RayzeBio is now a wholly owned subsidiary of Bristol Myers Squibb. This transaction brings a promising pipeline of RPTs to Bristol Myers Squibb, including RayzeBio’s lead program RYZ101 (225Ac-DOTATATE), which targets somatostatin receptor 2 (SSTR2), over-expressed in GEP-NETs and extensive stage small cell lung cancer (ES-SCLC). A Phase 3 clinical trial is currently enrolling patients to evaluate RYZ101 in patients with SSTR-positive GEP-NETs who have previously been treated with lutetium-177 based somatostatin therapies.

Janssen Receives Positive CHMP Opinion for CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) for Treatment in Earlier Lines of Relapsed and Refractory Multiple Myeloma

New Brunswick-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 recommended the approval of a Type II variation for CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of relapsed and refractory multiple myeloma (RRMM). The recommended indication for cilta-cel is for the treatment of adult patients with RRMM, who have received at least one prior therapy, including an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI), have demonstrated disease progression on the last therapy, and are refractory to lenalidomide. Cilta-cel is the first chimeric antigen receptor T-cell (CAR-T) therapy to receive a positive CHMP opinion for the treatment of this patient population, as early as after first relapse. 

TECVAYLI® (teclistamab-cqyv) Biweekly Dosing Approved by the U.S. FDA for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

New Brunswick-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TECVAYLI® (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained a complete response (CR) or better for a minimum of six months. There is a continued unmet need for patients with multiple myeloma and this approval allows increased flexibility in dosing schedule for appropriate patients with a weight-based regimen. TECVAYLI®, which is administered subcutaneously, was the first bispecific antibody targeting B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 on T-cells to activate an immune response.

Johnson & Johnson Announces Expansion of IMBRUVICA® (ibrutinib) Label in the U.S. to Include Oral Suspension Formulation for Adult Patients in its Approved Indications

New Brunswick-based BioNJ Member Johnson & Johnson, in collaboration with its alliance partner, Pharmacyclics LLC, an AbbVie Company, announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for IMBRUVICA® (ibrutinib) with an oral suspension formulation for adult patients in the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); Waldenström’s macroglobulinemia (WM); and chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. Data show that an estimated five percent of patients treated with a Bruton’s tyrosine kinase inhibitor (BTKi) for CLL or WM have potential difficulty swallowing. The oral suspension formulation of IMBRUVICA® provides a benefit compared to other BTKis, offering flexible administration with more options for patients and providers.

AbbVie and Tentarix Announce Collaboration to Develop Conditionally-Active, Multi-Specific Biologics for Oncology and Immunology

BioNJ Member AbbVie, with a site in Madison, and Tentarix Biotherapeutics announced a multi-year collaboration focused on the discovery and development of conditionally active, multi-specific biologic candidates in oncology and immunology. The collaboration will integrate AbbVie's expertise in oncology and immunology with Tentarix's proprietary Tentacles™ platform. Tentacles™ are multi-functional, conditionally active antibody-based biologics that are designed specifically to activate immune cells that can modulate disease pathways, while potentially mitigating safety concerns associated with non-specific targeting of other immune cells. "Oncology and immunology are two of our key strategic growth areas where we are pursuing novel technologies that aim to deliver transformative therapies, which address unmet patient needs," said Jonathon Sedgwick, Ph.D., Senior Vice President and Global Head of Discovery Research, AbbVie. 

AbbVie and OSE Immunotherapeutics Announce Partnership to Develop a Novel Monoclonal Antibody for the Treatment of Chronic Inflammation

BioNJ Member AbbVie, with a site in Madison, and OSE Immunotherapeutics SA (announced a strategic partnership to develop OSE-230, a monoclonal antibody designed to resolve chronic and severe inflammation, currently in the pre-clinical development stage. OSE-230 is a first-in-class monoclonal antibody designed to activate ChemR23, a G-Protein Coupled Receptor (GPCR) target. Activation of ChemR23 may offer a novel mechanism for the resolution of chronic inflammation, modulating functions of both macrophages and neutrophils. "This collaboration underscores our commitment to expanding our immunology portfolio with the ultimate goal of improving the standard of care for patients living with inflammatory diseases globally," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie.

Novo Nordisk Announces Multi-Target Collaboration With Neomorph to Discover Novel Molecular Glue Degraders for Cardiometabolic and Rare Diseases

Plainsboro-based BioNJ Member Novo Nordisk and Neomorph, Inc. announced it has entered into a collaboration and licensing agreement to discover, develop and commercialize molecular glue degraders. Neomorph is a biotechnology company solving critical problems in human health through the discovery of novel therapeutics against 'undruggable' targets. "Novo Nordisk is expanding its drug discovery efforts and deploying a range of novel technology platforms with the aim of discovering and developing new treatment solutions for people living with serious chronic diseases. We are pleased to enter this research collaboration and eager to start the scientific work on the novel class of molecular glue degraders being pioneered by Neomorph," said Brian Vandahl, Senior Vice President of Global Research Technologies at Novo Nordisk.

Eisai Selected for “Human Capital Leaders 2023” and “Human Capital Management Gold Quality”, Recognized as Company Committed to Excellent Management and Disclosure of Human Capital Initiatives

Nutley-based BioNJ Member Eisai announced that it has been selected for “Human Capital Leaders 2023” and “Human Capital Management Gold Quality” in the “Human Capital Survey 2023” jointly conducted by HR Technology Consortium, HR Research Institute (ProFuture Inc.) and MS&AD InterRisk Research & Consulting, Inc. In the “Human Capital Survey 2023”, 16 highly rated companies were selected for “Human Capital Management Gold Quality”, and 8 companies that were recognized by experts as having made particularly outstanding efforts were selected as “Human Capital Leaders 2023” out of approximately 500 participating companies and organizations. 

Palatin Announces Results of PL9643 Melody-1 Pivotal Phase 3 Clinical Trial in Patients With Dry Eye Disease (DED)

Cranbury-based BioNJ Member Palatin Technologies, Inc. announced results for its PL9643 MELODY-1 pivotal Phase 3 clinical trial evaluating the safety and efficacy of PL9643 versus vehicle in the treatment of dry eye disease (DED). MELODY-1 had two co-primary efficacy endpoints: one clinical symptom (pain) and one clinical sign (conjunctival lissamine green staining), as well as multiple other symptom and sign secondary endpoints of DED. Duration of treatment was 12 weeks with a 4-week run-in period. Analysis of the data indicated that both age and sex needed to be accounted for in the primary statistical analysis, (60% of the subjects were over age 60; 68% of the subjects were female). 

Datopotamab Deruxtecan Biologics License Application Accepted in the U.S. for Patients With Previously Treated Advanced Nonsquamous Non-Small Cell Lung Cancer

Basking Ridge-based Daiichi Sankyo and AstraZeneca’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the U.S. for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca. “Datopotamab deruxtecan has the potential to offer patients with previously treated advanced nonsquamous non-small cell lung cancer an effective and tolerable alternative to conventional chemotherapy,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology R&D, AstraZeneca. “With regulatory discussions ongoing around the world and a parallel submission underway in the U.S. in breast cancer, this is only the beginning of our efforts to make this novel treatment available to patients as quickly as possible.

Shionogi Announces New Phase 3 Data Showing Early Resolution of Many Common COVID-19 Symptoms in JAMA Network Open

Shionogi & Co., Ltd., with a site in Florham Park, announced the first peer-reviewed publication of the Phase 3 portion of its pivotal, double-blind, randomized, placebo-controlled Phase 2/3 study (SCORPIO-SR) in patients with mild to moderate COVID-19 in Japan, South Korea and Vietnam in JAMA Network Open. The trial met its primary and key secondary endpoints, making ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”) the first antiviral agent to show both clinical symptom improvement and antiviral effect in a predominantly vaccinated population with Omicron infection regardless of risk factors. The publication reports that treatment with once-daily ensitrelvir in the primary analysis population led to a statistically significant reduction in the time to resolution of five typical COVID-19 symptoms characteristic of Omicron (runny/stuffy nose, sore throat, cough, feeling hot or feverish, and low energy/tiredness) versus placebo (p=0.04). 

BrainStorm Cell Therapeutics Submits Special Protocol Assessment (SPA) Request to FDA for Phase 3b Trial of NurOwn® in ALS

BrainStorm Cell Therapeutics Inc., with a site in Hackensack, announced that it has submitted a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA) for a Phase 3b study of NurOwn®, its investigational treatment for amyotrophic lateral sclerosis (ALS). The submission follows an in-person meeting that BrainStorm held with the FDA in December 2023. The interactions leading up to this submission have provided guidance on advancing the planned Phase 3b trial. Participating in an SPA program would allow BrainStorm to reach consensus with the FDA on its clinical trial design, including the proposed statistical analysis, before the study is initiated. This would help ensure that the study would be considered adequate to support a future marketing evaluation. 

Bayer Fund Awards More than $12.1M to Nonprofit Organizations

Bayer Fund, a philanthropic arm of Bayer in the U.S., has provided a total of $4.7 million in grant funding, spanning across 500 organizations, in the second half of 2023. This latest round of grants raised the organization’s total giving to more than $12.1 million for the year across 2,300 charitable and nonprofit organizations supporting Food & Nutrition, Science, Technology, Engineering and Mathematics (STEM) Education and Health & Wellness needs. Bayer Fund’s giving support programs that help solve some of the country’s — and world’s — biggest challenges, including access to Food and Nutrition, STEM Education and Health and Wellness, which is part of Bayer’s mission of ensuring Health for All, Hunger for None.

NJEDA to Create Grant Program to Help Small Business Owners Purchase Commercial Properties

The Board of the New Jersey Economic Development Authority has approved the creation of a pilot program that will help boost small business owners’ liquidity following the purchase of a commercial property. The Main Street Acquisition Support Grant will reimburse applicants for a portion of closing costs after they have purchased an existing New Jersey commercial property from which their small business will operate. The closing must have taken place after the application was open to the public and the grant application date must be no later than one year from date of closing.

RWJBarnabas Signs on With SciTech City

SciTech Scity has added some big partners recently, and announced the largest academic health care system in New Jersey is getting involved, too. RWJBarnabas Health signed on as Hospital Innovation Lead Partner with the Healthcare Innovation Engine at SciTech Scity, the health care system and Liberty Science Center said. It’s the latest high-profile addition at the developing, 30-acre “Science City of Tomorrow.” Previously announced partners include Bristol Myers Squibb, EY, Nokia Bell Labs, Sheba Medical Center in Israel and others. In October, the New Jersey Economic Development Authority committed up to $20 million to the effort. Together, the collective will work to advance the use of digital technologies to spearhead new and more cost-effective methods for delivering care to underserved communities. Additionally, the Healthcare Innovation Engine will promote startups working on health care challenges.

Stockton University’s Biochemistry, Molecular Biology Program 1 of Only 2 in N.J. to Earn ASBMB Accreditation

Stockton University’s Biochemistry and Molecular Biology Program has been recognized as one of the top programs in the country by a national scientific and educational organization. The American Society for Biochemistry and Molecular Biology recently awarded Stockton’s BCMB major with a full, seven-year accreditation — one of only two in New Jersey. Since 2013, the society has granted accreditation to only 101 programs nationwide, ranging from R1 research schools to liberal arts institutions like Stockton. “We are proud of our program and thrilled to earn the full accreditation,” Amanda Norvell, Stockton’s dean of the School of Natural Sciences and Mathematics, said. “Our program provides students with a hands-on education that focuses on experiential learning. BCMB students participate in original research, alongside faculty mentors, with opportunities to present their work at regional and national conferences.”

Sad News: Former Health Care Leader John Lloyd Has Died

John Lloyd, the former Co-CEO of Hackensack Meridian Health, an influential health care thought leader, a veteran and a true gentleman to all who knew him, has died. Mr. Lloyd was instrumental in the 2016 merger of Meridian Health and Hackensack University Health Network — and served as Co-CEO with Bob Garrett during the first two years of the system. Mr. Garrett offered praise for Lloyd — as an executive and as a leader. “John’s legacy lives on in New Jersey and at Hackensack Meridian Health,” he said. “Beyond being a visionary leader, John was a wonderful man, well-known throughout HMH as being someone who truly cared for each and every team member.”

Six from New Jersey Named Among World’s Best Hospitals by Newsweek

Six hospitals from New Jersey have been named among the world’s best by Newsweek, in its World’s Best Hospitals 2024 list. Created by Statista, the World’s Best Hospitals 2024 ranking recognizes the best medical institutions across 30 countries, including the U.S., U.K., Germany, Canada and more. The six hospitals from New Jersey are: No. 47: Morristown Medical Center, Morristown; No. 58: Hackensack University Medical Center, Hackensack; No. 137: Valley Hospital, Ridgewood; No. 174: Overlook Medical Center, Summit; No. 329: Englewood Hospital and Medical Center, Englewood; and No. 411: Monmouth Medical Center, Long Branch. The hospitals recognized on the World’s Best Hospitals 2024 list were selected based on multiple comparability factors, such as standard of living/life expectancy, population size, number of hospitals and data availability.

AbbVie Announces Appointment of Robert A. Michael as Chief Executive Officer

BioNJ Member AbbVie, with a site in Madison, announced that its Board of Directors has unanimously selected Robert A. Michael, AbbVie's current President and Chief Operating Officer, to succeed Richard A. Gonzalez as the company's Chief Executive Officer. Mr. Gonzalez, who has served as CEO since the company's formation in 2013, will retire from the role of CEO and become Executive Chairman of the Board of Directors, effective July 1, 2024. Mr. Michael has 31 years of experience including leadership roles across multiple businesses, including pharmaceuticals, aesthetics, diagnostics, diabetes care and nutrition. He began his career with Abbott as a member of the financial development program and ultimately served as division controller, nutrition supply chain and division controller, molecular diagnostics, among other roles. 

Sanofi’s Board of Directors Proposes the Appointment of Clotilde Delbos, Anne-Françoise Nesmes and John Sundy as Independent Directors

Bridgewater-based BioNJ Member Sanofi announced the Board of Directors has decided to propose, on the occasion of its next General Shareholder Meeting to be held on April 30, 2024, the renewal of the terms of office of Rachel Duan and Lise Kingo and the appointment of Clotilde Delbos, Anne-Françoise Nesmes and John Sundy as independent Directors. Diane Souza, Member of the Audit and Compensation Committees, and Thomas Südhof, Chairman of the Scientific Committee, will leave the Board of Directors at the end of their second terms. The Chairman warmly thanked them for their valued contribution to the Board of Directors and the specialized committees to which they belonged during their terms in office.

ADMA Biologics Announces CFO Transition

Ramsey-based BioNJ Member ADMA Biologics, Inc. announced that Brian Lenz, Executive Vice President, Chief Financial Officer & General Manager, ADMA BioCenters will be transitioning from these positions to a consulting role, effective April 1, 2024. “On behalf of ADMA’s Board of Directors and myself, we extend our sincere gratitude to Brian for all of his contributions to ADMA, from working with me in taking the company public over a decade ago, to being an integral team member and partner with the expansion and growth of the business, all the way to corporate profitability. During his tenure, Brian also successfully completed numerous financing transactions and completed the expansion of our ADMA BioCenters business unit,” stated Adam Grossman, President and CEO.

Life Sciences Leader Dave Hickey to Retire from BD

BD (also known as Becton, Dickinson and Co.), announced that Dave Hickey, who became Executive Vice President of the company and President, Life Sciences, in 2021, has informed the Franklin Lakes-based company of his intent to retire, effective July 1. “For over a decade at BD, Dave has demonstrated a strong, strategic and innovative approach, empowering his teams to deliver impactful results through a growth mindset and developing incredible talent and next-gen leaders at BD,” Tom Polen, Chairman, CEO and President of BD, said. “I want to express BD’s sincere gratitude to Dave for his significant contributions to BD, especially during the COVID-19 pandemic, where he led the BD effort to develop numerous rapid and molecular diagnostic tests in record time to support health care providers and patients around the world.”

Integra LifeSciences Announces Leadership Transition Plan as CEO Announces Retirement

Integra LifeSciences Holdings CEO Jan De Witte said he plans to retire by the end of 2024. De Witte joined the Princeton-based medical technology firm in December 2021. De Witte also informed the board that he will wait until a successor has been appointed. Additionally, the company announced that Stuart Essig, Integra’s chairman, has been appointed to the role of Executive Chairman. “We are grateful to Jan for his leadership and commitment to Integra and the role he has played in advancing our portfolio and building upon our legacy of innovation,” Essig said. “Jan’s personal decision to retire from Integra and return to Europe follows a leadership tenure marked by significant contributions to the company, including the evolution of our strategy and an expansion of core capabilities. We appreciate Jan’s commitment to a smooth transition and the execution of our roadmap for 2024 and beyond.”

Broadening Research Participation Through Community Engagement

An article written-by BioNJ Member Deloitte

Systemic change is needed across the U.S. clinical research system to address the lack of diversity among research participants. This effort will require finding new partners. Bringing in new voices. Implementing new policies. Investing in new infrastructure. Providing new incentives. Inventing new business models. And pursuing new research approaches. Moreover, trust must be rebuilt between traditional research institutions and communities. Community Health Centers, which already serve as an essential component of the health care landscape, play a critical role in advancing more equitable and inclusive research. Given their footprint in the community, patient-centered, trusted relationships and diverse patient populations, health centers can enrich the diversity and scope of clinical studies and, ultimately, enhance patient outcomes.

Daiichi Sankyo Recognized With ‘A’ Score for Transparency on Climate Change for the Fourth Consecutive Year

Daiichi Sankyo has been recognized for leadership in corporate transparency and performance on climate change by global environmental non-profit CDP, securing a place on its annual ‘A List’. Based on data reported through CDP’s 2023 Climate Change questionnaire, Daiichi Sankyo is one of a small number of companies that achieved an ‘A’ — out of over 21,000 companies scored.

Bayer's Expert Mondays 2024

Select Mondays in February – December 2024

Calling pre-seed and seed innovators and entrepreneurs in Oncology, Cell & Gene Therapy, Cardiovascular, Immunology, Radiology and Digital Health! Do you have disruptive science but struggle to bring it to life in the entrepreneurial world? Bayer's passion is to enable and support standout healthcare innovation! Take your innovation to new heights and join Bayer´s Expert Mondays 2024, a series of knowledge exchange sessions to supercharge your start-up’s growth. 

Introduction to Advanced Biopharmaceuticals Processing

March 4, 5, 6, 7 and 8 – Rutgers University (New Brunswick, NJ)

This course aims to give the participants an overview of the major biopharma unit operations. Key questions that will be addressed include – What are the underlying physicochemical processes for each unit operation? What are the key features of process design, process analytical technology (PAT), and process development for these unit operations? At the end of the course, the audience will gain a basic understanding of major biopharma unit operations. Case studies will be presented to gain a deeper understanding of these unit operations. Last but not the least, hands on demo of key process steps will be provided, along with review of major operations in a biomanufacturing pilot-plant and bioanalytical lab facility.

NCI Technology Opportunities Webinar: An Adjuvanted Mucosal Subunit Vaccine for Preventing SARS-CoV-2 Transmission and Infection

March 13 – NCI Technology Transfer Center

Register to attend a free NIH webinar. Attendees will learn about a new adjuvanted subunit mucosal COVID-19 vaccine. Study results show this new vaccine prevents SARS-CoV-2 transmission and infection. Most SARS-CoV-2 vaccines focus on delivering immunization through an intramuscular injection. This new technology combines an initial intramuscular injection with subsequent intranasal boost administration of a novel, molecular adjuvant nanoparticle formulation.

Annual Healthcare Symposium

April 18 – Rutgers Business School

The Inflation Reduction Act (IRA) of 2022 brought a tremendous change in the Medicare Part D Prescription Drug benefit operation and coverage. The Academia and the industry has been analyzing the impact of the IRA on the Bio Pharmaceutical R&D, Access to drugs by the elderly population in the USA, impact on drugs approvals, and employment. This will have a spillover effect on the prescription drugs in the private market. The symposium will bring together industry experts, academia and the patients advocacy groups to discuss in front of our students, and faculty, and give them an opportunity to interact with the experts in the form of Q&A session. The symposium is open to all students, faculty, and the industry executives. It is a free event.