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Learn more at www.BioNJ.org/Membership.

A Podcast: EU Cost Effectiveness Models Threaten Vulnerable U.S. Patients

The Quality Adjusted Life Year, or QALY, was invented at the UK’s University of York by Prof Alan Williams in the 1970s. Some currently engaged in the bitter trench warfare of America’s drug pricing debate think it’s high time for another British invasion, and the US should fully embrace the UK’s use of QALYs. In this Vital Health Podcast, we have a discussion with William Smith, a Senior Fellow at the Pioneer Institute, about his recently published book, “Rationing Medicine: Threats from European Cost-Effectiveness Models to America’s Seniors and other Vulnerable Populations.” William makes a strong case that the use of QALY for cost-effectiveness assessments within Medicare and Medicaid would violate several key provisions of the Americans with Disabilities Act.

Four Ways That America’s Biopharmaceutical Industry Supports Jobs and Fuels Economic Growth

May is World Trade Month — an opportunity to remind the Biden Administration of the importance of international trade. America’s biopharmaceutical industry, and the hundreds of thousands of Americans that it employs, depends on an open and rules-based global trading system to ensure that innovative medicines can be developed, manufactured and distributed to health systems and patients worldwide. Continue reading for examples of how the industry and its robust participation in global trade contribute to the U.S. economy and American workers.

Setting the Record Straight on Accelerated Approval

The U.S. Food and Drug Administration’s (FDA) accelerated approval program has served as a critical lifeline for patients with serious and life-threatening conditions. The program was originally established at the urging of patient advocates during the height of the HIV/AIDS epidemic, in which patients waited years for the FDA to review and approve new treatments. From its inception three decades ago, the pathway’s purpose has always been to get medicines to patients most in need, especially those who lack any viable treatment options. Without accelerated approval, patients in need would have fewer or no treatment options.

Drug Price Caps in Inflation Reduction Act Exacerbating Shortages, Gottlieb Says

Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb said that drug price caps in the Inflation Reduction Act are exacerbating drug shortages. “The features under the Inflation Reduction Act will exacerbate this problem, because it’ll prevent these generic manufacturers from being able to take price increases,” Gottlieb, who now serves on the board of Pfizer, told CBS’ “Face the Nation.” “For example, if they enter a market for the first time, or they spend a lot of money upgrading a facility to be compliant with state-of-the-art regulations, they’re not gonna be able to take a price increase to recoup some of those costs,” he added. “So, it’s going to come out of their own pocket.”

New Resource Underscores the Importance of Small Molecule Medicines

A small molecule medicine is what most people think of when they imagine a medicine. These medicines typically come in the form of a tablet or capsule and are usually taken by mouth. These medicines play essential roles in the treatment of different diseases and are indispensable in providing patients, caregivers and health care providers with the tools necessary to achieve improved health outcomes. Despite the important advantages small molecule medicines offer in the treatment of many illnesses, government price setting provisions in the recently passed Inflation Reduction Act (IRA) could result in fewer of these medicines being developed for patients.  

4 Key Facts on Medicine Prices and Spending

Policymakers on Capitol Hill continue to discuss the cost of lifesaving medicines and how to make them more affordable for Americans. It’s an important discussion that the biopharmaceutical industry believes we need to have. A new treatment or cure can’t improve a patient’s life if they can’t get it. As the conversation continues in Congress, IQVIA is out with a new and timely report on medicine prices and spending.

The Regulatory Landscape: Measuring Inflation Reduction Act (IRA) Implications

The regulatory environment is a key element in keeping the U.S. the undisputed life sciences innovation leader globally. Over the years, legislation and regulations from Washington, DC, contributed to initiating and sustaining that leading position. Yet, industry leaders worry that recent policies will inhibit big pharma and biotech’s ability to innovate. Indeed, as put by BioNJ President and CEO Debbie Hart: “A central pillar of the nation’s hospitable environment for the life sciences ecosystem has been its strong, predictable and reliable intellectual property framework. Biomedical innovation is risky, as approximately nine out of 10 therapeutic candidates from biotechs never come to fruition.”

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Global Business Reports Launches USA Life Sciences 2023 Report Featuring an Interview With BioNJ President & CEO Debbie Hart

After having provided a lightning-quick response to the COVID-19 pandemic, the industry gathered the lessons learned and sought a sense of normalcy to continue developing necessary drugs for patients worldwide. Yet, the geopolitical, macroeconomic and regulatory environments all come with their set of challenges, forcing executives into increasingly complex decisions when defining their strategies. The above has not deterred an industry that is known for its innovation, and resilience, but mostly for the strength of its science. For pharma and biopharma firms, the focus will now be on embracing digitalization, navigating a changing regulatory and financial landscape and tackling health inequalities.

BioNJ’s Pavita Howe Honored on NJBIZ’s 2023 People to Watch in Finance List

The NJBIZ Power lists recognize the most influential business leaders in the State. Many of those folks have spent their entire careers building businesses, ascending the ranks of corporate management, training new generations or in some other way making New Jersey a better place to live, work and do business. Ms. Howe was appointed in December as Vice President, Innovation & Entrepreneurship at BioNJ. She brings more than 20 years of experience in business development, marketing, strategy, program management, new product launches, business planning and building ecosystems at startups, academic institutions and large organizations. Previously, Ms. Howe served as Director of Entrepreneurship Partnerships at Rutgers University, where she was involved with growing the schools’ entrepreneurial ecosystem, bringing visibility to start-ups affiliated with RU, and connecting them to resources.

EPKINLY™ (epcoritamab-bysp) Approved by U.S. Food and Drug Administration as the First and Only Bispecific Antibody to Treat Adults with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)

Princeton-based BioNJ Member Genmab announced that the U.S. Food and Drug Administration has approved EPKINLY™ (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B‑cell lymphoma, after two or more lines of systemic therapy. EPKINLY was approved under accelerated approval based on response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial(s). EPKINLY is being co-developed and co-commercialized by Genmab and AbbVie as part of the companies’ oncology collaboration.

Hepion Pharmaceuticals’ Phase 2 ‘ALTITUDE-NASH’ Trial Achieves Primary and Secondary Endpoints, Including Improvement in Liver Function and Multiple NASH Biomarkers

Edison-based BioNJ Member Hepion Pharmaceuticals Inc. announced positive topline results from its recently completed Phase 2 ALTITUDE-NASH clinical trial. ALTITUDE-NASH met its primary endpoint by demonstrating improved physiologic liver function and was well tolerated after four months of treatment in subjects with stage 3 or greater fibrosis based on the AGILE 3+ criteria. All additional secondary endpoints were also met, including reductions in the liver injury biomarkers, alanine and aspartate transaminases (“ALT” and “AST”); and multiple fibrosis-associated biomarkers, including ProC3 (procollagen 3 C-terminal peptide), PIIINP (procollagen 3 N-terminal peptide), TIMP1 (tissue inhibitor of metalloproteinase-1), hyaluronic acid, and enhanced liver fibrosis (“ELF”) scores (composite of PIIINP, TIMP1 and hyaluronic acid). 

U.S. FDA Approves RINVOQ® (upadacitinib) as a Once-Daily Pill for 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 has approved RINVOQ® (upadacitinib) for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers. This is the seventh FDA approval for RINVOQ across rheumatology, dermatology, and gastroenterology, where it is now indicated in both ulcerative colitis and Crohn's disease. "AbbVie recognizes the need for more treatment options for Crohn's disease that can help address both rapid relief of symptoms along with the visible reduction of intestinal lining damage," said Thomas Hudson, M.D., Senior Vice President, Research and Development and Chief Scientific Officer, AbbVie. "We're pleased that RINVOQ may provide this relief and is now available to treat Crohn's disease."

SKINVIVE™ by JUVÉDERM® Receives U.S. FDA Approval

BioNJ Member AbbVie, with a site in Madison, and Allergan Aesthetics announced the U.S. FDA approval of SKINVIVE™ by JUVÉDERM® to improve skin smoothness of the cheeks in adults over the age of 21. SKINVIVE™ by JUVÉDERM® is the first and only hyaluronic acid (HA) intradermal microdroplet injection for skin smoothness available in the U.S. with results lasting through six months with optimal treatment. "SKINVIVE™ by JUVÉDERM® is a category-creating HA product that leaves skin looking healthier, more glowing, and more hydrated," said Carrie Strom, President, Global Allergan Aesthetics and Senior Vice President, AbbVie. "This unique product is a result of our vast experience in HA science and complements our current collection of HA products, with the JUVÉDERM® Collection of Fillers and SkinMedica® topicals."

New England Journal of Medicine Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Upadacitinib (RINVOQ®) in Crohn's Disease

BioNJ Member AbbVie, with a site in Madison, announced the New England Journal of Medicine published results from the pivotal Phase 3 clinical trials – U-EXCEL, U-EXCEED and U-ENDURE – evaluating upadacitinib (RINVOQ®) in adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to conventional therapy or a biologic agent. The publication reports the safety and efficacy results of oral upadacitinib versus placebo in two induction studies (U-EXCEL and U-EXCEED) and one maintenance study (U-ENDURE), evaluating the co-primary endpoints of clinical remission and endoscopic response. Data from this Phase 3 program formed the basis of the company's application for approval by regulatory agencies.

PTC Therapeutics Announces APHENITY Trial Achieved Primary Endpoint with Sepiapterin in PKU Patients

South Plainfield-based BioNJ Member PTC Therapeutics announced that the primary endpoint was achieved in the APHENITY, Phase 3 registration-directed clinical trial of sepiapterin in adult and pediatric patients with phenylketonuria (PKU). "The positive results from the APHENITY trial bring us one step closer to providing a therapy that could deliver meaningful benefit to PKU patients," said Matthew B. Klein, M.D., Chief Executive Officer, PTC Therapeutics. "The Phe reductions observed in the placebo-controlled portion of the study are consistent with, and, in some cases, exceed the magnitude of Phe reductions recorded in the open label portion of the study. We look forward to meeting with regulatory authorities to discuss the path to approval."

Celldex Therapeutics Presents Positive Preclinical Data from TSLP/SCF Bispecific Antibody Program CDX-622 at IMMUNOLOGY2023™

Hampton-based BioNJ Member Celldex Therapeutics, Inc. announced preclinical data from CDX-622, the company’s bispecific antibody with dual targeting of the alarmin TSLP and stem cell factor (SCF), also known as KIT receptor ligand, developed from its bispecific antibody platform. TSLP and SCF have been shown to contribute to the pathophysiology of various inflammatory, fibrotic and allergic disorders. The preclinical data show CDX-622 potently neutralizes the alarmin TSLP, a potent mediator of inflammation, and blocks SCF/KIT interaction required for mast cell function and survival. CDX-622 was well tolerated and demonstrated a favorable pharmacokinetic profile as well as robust evidence of skin mast cell depletion in preclinical models. The biophysical and functional characteristics of CDX-622 support the initiation of development activities including manufacturing and IND-enabling studies.

Soligenix Announces European Patent Grant for Use of Dusquetide in Oral Mucositis

Princeton-based BioNJ Member Soligenix announced that the European Patent Office has granted a patent entitled "Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis". This granted patent builds on similar intellectual property issued in the United States (U.S.), New Zealand, Japan, Australia and Singapore, as well as many pending patent applications in other jurisdictions worldwide. The granted claims will cover therapeutic uses of dusquetide (active ingredient in SGX942) and related innate defense regulator (IDR) analogs and adds to composition of matter claims for dusquetide and related analogs that have been issued in the U.S. and worldwide. "Soligenix continues to pursue broad patent coverage for its dusquetide technology, first with composition of matter claims followed by therapeutic use claims in oral mucositis," stated Christopher J. Schaber, Ph.D., President and Chief Executive Officer of Soligenix.

Phathom Pharmaceuticals Resubmits Erosive GERD New Drug Application to FDA

Florham Park-based BioNJ Member Phathom Pharmaceuticals, Inc. announced that it has resubmitted its New Drug Application (NDA) for vonoprazan, a novel first-in-class potassium-competitive acid blocker (PCAB), for the treatment of Erosive GERD (gastroesophageal reflux disease), also referred to as erosive esophagitis, to the U.S. Food and Drug Administration (FDA). The NDA resubmission contains three months of stability data for six batches of the reformulated vonoprazan tablets. The three-month data demonstrate that Phathom’s mitigation measures are controlling NVP growth through three months and keeping levels well below the acceptable daily intake limit of 96 ng/day or 2.4 ppm (parts per million) based on the maximum approved daily dose of 40 mg/day. 

Gilead Sciences and Arcus Biosciences Expand Partnership to Include Research Programs in Inflammation

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, and Arcus Biosciences, Inc. announced that the companies have expanded the previously announced research collaboration focused on oncology to include therapies for the treatment of inflammatory diseases. The expanded collaboration builds upon Gilead’s growing presence in inflammatory disease and serves as a step towards broadening Arcus’ capabilities and portfolio beyond oncology and into inflammation. “We are pleased to build upon Gilead’s efforts in inflammation with the expansion of our strategic collaboration with Arcus,” said Flavius Martin, M.D., Executive Vice President, Research, Gilead Sciences. “Arcus is an excellent partner with clear strengths in discovery and development, and we believe this partnership will significantly accelerate our progress in developing transformative new therapies for inflammatory diseases.”

The Max Foundation, BeiGene and the BeiGene Foundation Announce Collaboration to Advance Health Equity by Providing Access to BRUKINSA® for the Treatment of Chronic Lymphocytic Leukemia in Low- and Middle-Income Countries

BioNJ Member BeiGene, with a site in Hopewell, The Max Foundation (Max) and the BeiGene Foundation announced a collaboration to provide access to BRUKINSA (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) in 29 low- and middle-income countries over the next three years. This collaboration advances each organization’s focus on patient access by combining Max’s expertise and infrastructure with a donated product from BeiGene, and a grant from the BeiGene Foundation. The Humanitarian PACT is a collaboration among professional, nonprofit, and commercial organizations that share the commitment of Max to increase global access to treatment, care, and support for people living with cancer. 

Legend Biotech to Demonstrate Progress in Advancing Potential Treatment Options for Patients With Multiple Myeloma at ASCO and EHA Annual Meetings

Somerset-based BioNJ Member Legend Biotech Corporation announced that new and updated data from the CARTITUDE Clinical Development Program evaluating ciltacabtagene autoleucel (cilta-cel) will be presented at the American Society of Clinical Oncology Annual Meeting and the European Hematology Association’s Hybrid Congress. Five-year follow-up data from Legend-2, an investigator-initiated trial that has been assessing a similar CAR construct since 2015, will also be presented at the meetings. CARTITUDE-4 is the first international, randomized, open-label Phase 3 study investigating the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received cilta-cel vs standard-of-care regimens, including pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd), following one to three prior lines of therapy.

Nirsevimab Delivers 83% Reduction in RSV Infant Hospitalizations in a Real-World Clinical Trial Setting

Bridgewater-based BioNJ Member Sanofi announced new data from the HARMONIE Phase 3b clinical trial show an 83.21% (95% CI 67.77 to 92.04; P<0.001) reduction in hospitalizations due to RSV-related LRTD in infants under 12 months of age who received a single dose of nirsevimab, compared to infants who received no RSV intervention. The Hospitalized RSV Monoclonal Antibody Prevention (HARMONIE) study is a large, multi-country European interventional clinical trial aiming to determine the efficacy and safety of a single intramuscular dose of nirsevimab, with data collected in a real-world setting during the 2022-2023 RSV season. The trial recruited more than 8,000 infants and took place at nearly 250 sites across France, Germany and the United Kingdom. 

Dupixent® (dupilumab) Late-Breaking Phase 3 COPD Results Presented at ATS and Simultaneously Published in The New England Journal of Medicine

Bridgewater-based BioNJ Member Sanofi announced positive Phase 3 results evaluating the investigational use of Dupixent® (dupilumab) compared to placebo in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation were published in The New England Journal of Medicine (NEJM). COPD is a life-threatening respiratory disease that damages the lungs and causes progressive lung function decline. Symptoms include persistent cough and breathlessness that may not only impair the ability to perform routine daily activities, but can also lead to anxiety, depression and sleep disturbances. The results published in NEJM are from the BOREAS trial, which met the primary and all key secondary endpoints.

Positive Data from two Phase 3 Dupixent® (dupilumab) Trials in Prurigo Nodularis Published in Nature Medicine

Bridgewater-based BioNJ Member Sanofi announced positive results from two Phase 3 Dupixent® (dupilumab) trials in adults with uncontrolled prurigo nodularis have been published in Nature Medicine. These first published Phase 3 results in this disease show Dupixent significantly reduced itch (the primary endpoint) and skin lesions compared to placebo. Dupixent also significantly improved health-related quality of life while reducing measures of skin pain and symptoms of anxiety/depression. Results from the trials were the basis for the U.S. Food and Drug Administration approval of Dupixent in September 2022 and the European Medicines Agency approval of Dupixent in December 2022. Dupixent is the only approved biologic indicated for prurigo nodularis in the U.S. and EU. 

SCYNEXIS Reports Closing of Exclusive License Agreement With GSK for BREXAFEMME® (Ibrexafungerp Tablets)

Jersey City-based BioNJ Member SCYNEXIS, Inc. announced the closing of its previously announced exclusive license agreement with Warren-based BioNJ Member GSK to commercialize the novel antifungal BREXAFEMME® (ibrexafungerp tablets) as a treatment for vulvovaginal candidiasis (VVC) and further develop ibrexafungerp for multiple indications in invasive and life-threatening fungal diseases. Under the terms of the agreement, GSK will make an upfront payment to SCYNEXIS of $90 million, plus additional potential milestone-based payments totaling up to $503 million. GSK will also pay mid-single digit to mid-teen digit tiered royalties on the totality of sales across all indications. Further information regarding the financial terms of the agreement can be found in SCYNEXIS’s SEC filings.

GSK Presents Pivotal Data at ESPID Confirming Effectiveness of its 5-in-1 Meningococcal ABCWY Vaccine Candidate, With Demonstrated Coverage Against a Panel of 110 MenB Strains

Warren-based BioNJ Member GSK presented preliminary positive results from the Phase III trial evaluating the immunological vaccine effectiveness and safety of its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years. The vaccine candidate demonstrated non-inferiority in primary endpoints for five Neisseria meningitidis serogroups (A, B, C, W, and Y) compared to two doses of Bexsero (meningococcal group B vaccine) and one dose of Menveo (meningococcal group A, C, W-135, and Y conjugate vaccine) in 10–25-year-olds. In addition, the vaccine candidate was generally well tolerated, with a safety profile consistent with Bexsero and Menveo. 

Lilly's Peresolimab Phase 2a Rheumatoid Arthritis Trial Published in The New England Journal of Medicine

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced The New England Journal of Medicine published detailed results from 2a study of peresolimab in rheumatoid arthritis (RA), in which peresolimab met the primary endpoint for efficacy and had similar rates of adverse events between peresolimab and placebo arms. This data represents the first clinical evidence that stimulating the endogenous PD-1 inhibitory pathway could be an effective approach to treat rheumatologic disease. The Phase 2a clinical trial (NCT04634253) evaluated the safety and efficacy of peresolimab in adult participants with moderate-to-severe RA who had an inadequate response to prior conventional, biologic or synthetic disease modifying antirheumatic drugs (DMARDs).

Bristol Myers Squibb’s Investigational LPA1 Antagonist Reduces the Rate of Lung Function Decline in Patients With Idiopathic Pulmonary Fibrosis

Princeton-based BioNJ Member Bristol Myers Squibb announced results from a Phase 2 study evaluating BMS-986278, a potential first-in-class, oral, lysophosphatidic acid receptor 1 (LPA1) antagonist, in patients with idiopathic pulmonary fibrosis. The study showed twice-daily administration of 60 mg of BMS-986278 over 26 weeks reduced the rate of decline in percent predicted forced vital capacity (ppFVC) by 62% compared to placebo. Pulmonary fibrosis is a devastating, life-threatening illness, with daily symptoms including coughing, labored breathing, and extreme fatigue. In this Phase 2 study, patients were randomized (1:1:1) to placebo, 30 mg or 60 mg BMS-986278 twice-daily for 26 weeks. Two-thirds of patients were on background antifibrotic therapy during the trial. Patients who met prespecified blood pressure reduction criteria were to receive a dose reduction to 10 mg of BMS-986278 or matching placebo twice-daily. 

Novo Nordisk A/S: Oral Semaglutide 50 mg Achieved 15.1% Weight Loss (17.4% if All People Adhered to Treatment) in Adults With Obesity or Overweight in the OASIS 1 Trial

Plainsboro-based BioNJ Member Novo Nordisk announced headline results from OASIS 1, a Phase 3a trial in the global OASIS programme. OASIS 1 is a 68-week, efficacy and safety trial comparing once-daily oral semaglutide 50 mg for weight management to placebo in 667 adults with obesity or overweight with one or more comorbidities. Both treatment arms were in conjunction with lifestyle intervention. The trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss at week 68 with oral semaglutide 50 mg versus placebo. When evaluating the effects of treatment if all people adhered to treatment¹ from a mean baseline body weight of 105.4 kg, people treated with oral semaglutide 50 mg achieved a statistically significant weight loss of 17.4% after 68 weeks compared to a 1.8% reduction with placebo. 

Novo Nordisk and Life Edit Therapeutics Establish Multi-Target Collaboration to Discover and Develop Gene Editing Therapies for Rare and Cardiometabolic Diseases

Plainsboro-based BioNJ Member Novo Nordisk, Life Edit Therapeutics, Inc. and ElevateBio announced a research and development collaboration to discover and develop gene editing therapies against a select set of therapeutic targets. With a focus on advancing base editing capabilities, Novo Nordisk will leverage Life Edit’s suite of gene editing technologies to precisely edit the genome with the aim of developing life-changing therapies for rare genetic disorders as well as more prevalent cardiometabolic diseases. Base editing is a method of gene editing that converts one nucleotide base (a structural component of DNA) into another without cutting both strands of DNA. This is achieved by coupling an enzyme known as a nuclease, modified to cut only one DNA strand, to another enzyme known as a deaminase that edits the target nucleotide base. 

First Phase 3 TREMFYA® (guselkumab) Data in Inflammatory Bowel Disease Show Positive Induction Results Among Patients With Moderately to Severely Active Ulcerative Colitis

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced new efficacy and safety data from the Phase 3 QUASAR Induction Study evaluating the investigational use of TREMFYA® (guselkumab) in adults with moderately to severely active ulcerative colitis (UC) who had an inadequate response or intolerance to conventional and/or advanced therapies. The data show statistically significant and clinically meaningful improvements across symptomatic and histo-endoscopic outcome measures. Safety data were also consistent with the known safety profile of TREMFYA in approved indications.

Boehringer Ingelheim and Zealand Pharma Announce Phase II Trial Showed 14.9% Weight Loss in People Living With Obesity or Overweight

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, and Zealand Pharma A/S announced that patients treated with BI 456906 achieved up to 14.9% weight loss after 46 weeks, using the planned maintenance dose. The Phase II clinical trial evaluating the effect of different doses of the novel glucagon/GLP-1 receptor dual agonist BI 456906 in people living with obesity or overweight without type 2 diabetes (NCT04667377) met its primary endpoint. In 2016, more than 1 billion people worldwide were living with cardio-renal-metabolic (CRM) diseases such as obesity, type 2 diabetes, chronic kidney disease, liver disease, heart failure and cardiovascular disease. Obesity is a major global health challenge, and the worldwide prevalence has more than doubled over the past four decades.

Pfizer’s PAXLOVID™ Receives FDA Approval for Adult Patients at High Risk of Progression to Severe COVID-19

BioNJ Member Pfizer, with a site in Peapack, and BioNJ Member Thermo Fisher Scientific Inc. announced they have entered into a collaboration agreement to help increase local access to next-generation sequencing (NGS)-based testing for lung and breast cancer patients in more than 30 countries across Latin America, Africa, the Middle East and Asia where advanced genomic testing has previously been limited or unavailable. Thermo Fisher will identify local labs that will be using the company's NGS technology and ensure they have the necessary infrastructure, trained staff and quality control measures to meet industry standards for NGS testing services for breast and lung cancer. Pfizer will explore ways to enable affordable patient access for NGS testing for these types of cancer and work to raise healthcare provider awareness regarding the benefits of advanced testing.

FDA Advisory Committee Votes in Support of Approval for Pfizer’s Vaccine Candidate to Help Prevent RSV in Infants Through Maternal Immunization

BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the efficacy and safety of its unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate RSVpreF or PF-06928316. The Committee voted 14 to 0 on effectiveness and 10 to 4 on safety. The vaccine candidate is currently under FDA review for the prevention of medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals.

OncoSec is Encouraged after FDA Meeting to Discuss Proposed Neoadjuvant Melanoma Clinical Program

Ewing-based BioNJ Member OncoSec Medical Incorporated announced a Type C meeting held with the US Food and Drug Administration (FDA). The purpose of the meeting was to discuss the trial design for a planned randomized, open-label Phase 2 clinical trial in patients with high-risk, resectable melanoma to evaluate the neoadjuvant treatment combination of the company's tavokinogene telseplasmid, a plasmid encoding human interleukin 12 (IL-12), administered intratumorally by electroporation (TAVO™-EP) with intravenous KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy. The meeting with the FDA represents an important next step on the company's path to pursue clinical development of TAVO™-EP in combination with anti-PD-1 therapy in the neoadjuvant melanoma setting.

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

Rahway-based BioNJ Member Merck & Co. and Eisai announced data from the final pre-specified overall survival (OS) analysis of the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). After four years of follow-up, KEYTRUDA plus LENVIMA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]). The 24- and 36-month estimated OS rates were 80.4% and 66.4% for KEYTRUDA plus LENVIMA versus 69.6% and 60.2% for sunitinib, respectively.

Merck to Present Extensive New Research Demonstrating Significant Progress in the Treatment of Certain Earlier Stage Cancers and in Advancing Broad Oncology Pipeline at 2023 ASCO Annual Meeting

Rahway-based BioNJ Member Merck & Co. announced that data for four approved medicines and two pipeline candidates in more than 25 types of cancer will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Presentations will feature new or updated findings from Merck’s broad portfolio of cancer medicines: KEYTRUDA, Merck’s anti-PD-1 therapy; LENVIMA; LYNPARZA® (olaparib), in collaboration with AstraZeneca; and WELIREG™ (belzutifan). Additionally, Merck will present data from its broad pipeline, including V940/mRNA-4157, an investigational individualized neoantigen therapy (INT) being developed in collaboration with Moderna, in combination with KEYTRUDA, and MK-2870/SKB264, an anti-TROP2 antibody-drug conjugate (ADC) being developed in collaboration with Kelun-Biotech.

Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease in Great Britain

Nutley-based Eisai Co., Ltd. BioNJ Member Biogen Inc. announced that Eisai has submitted a Marketing Authorization Application (MAA) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain, to the UK Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain. Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP). The MAA is based on the results of the confirmatory Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD and is subject to a validation to determine whether it will be accepted by the MHRA. 

Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer’s Disease

Nutley-based Eisai Co., Ltd. and BioNJ Member Biogen Inc. announced that Health Canada has accepted a New Drug Submission (NDS) for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain. The NDS is based on the results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated the lecanemab treatment showed a reduction of clinical decline in early AD. Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD. 

Eisai Publishes Societal Value of Lecanemab in Japan Using Phase 3 Clarity AD Data in Peer-Reviewed Neurology and Therapy Journal

Nutley-based Eisai Co., Ltd announced the publication of results from a simulation study evaluating the societal value of anti-amyloid-beta (Aβ) protofibril* antibody lecanemab (generic name, U.S. brand name: LEQEMBI™) in individuals living with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia (collectively known as early AD) in the context of the Japanese health care system in the peer-reviewed journal Neurology and Therapy. The paper concluded that lecanemab treatment would improve health and humanistic (quality of life) outcomes and reduce economic burden for individuals with early AD and their caregivers in Japan.

BD Earns FDA 510(k) Clearance for Bacteria-Detecting AI Software

Franklin Lakes-based BD has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its software that can help detect bacterial growth, the medical technology company announced. The new BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) imaging application uses artificial intelligence to automate what BD describes as the “traditionally labor- and time-intensive task of inspecting Petri dishes to determine if there is bacterial growth,” allowing technicians to spend time on higher value analysis. According to the FDA, 510(k) clearance deems a submitted device as safe and effective – or substantially equivalent – as a legally marketed device. 

BD Launches Commercial Sale of Cell-Sorting Technology

Featured in the journal Science and unveiled at last year’s International Society for Advancement of Cytometry CYTO conference, BD’s first-of-its-kind cell-sorting technology has now launched commercially worldwide. The Franklin Lakes medical technology company reiterated that the BD FACSDiscover S8 Cell Sorter features two “breakthrough” technologies that allow researchers to discover detailed information about cells previously unseen in traditional flow cytometry experiments. Joel Sederstrom, Director of flow cytometry core at the Baylor College of Medicine, called the instrument “the next level of expansion in cytometry technologies.” 

VANFLYTA® First FLT3 Inhibitor Approved in Japan for Patients With Newly Diagnosed FLT3-ITD Positive AML

Basking Ridge-based Daiichi Sankyo announced that VANFLYTA® (quizartinib) has been approved in Japan for the treatment of acute myeloid leukemia (AML) that is FLT3-ITD mutation positive. VANFLYTA is now approved to treat patients with newly diagnosed FLT3-ITD positive AML in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy and as maintenance monotherapy, making it the first and only FLT3 inhibitor in Japan approved for newly diagnosed AML treatment. VANFLYTA was first approved in 2019 as a monotherapy in the relapsed/refractory setting. 

Daiichi Sankyo Initiates Phase 3 Clinical Trial of Mutant Strain COVID-19 Vaccine (DS-5670) in Japan

Basking Ridge-based Daiichi Sankyo announced that it has administered an mRNA vaccine (DS-5670) against the novel coronavirus infectious disease (COVID-19), which is being developed by Daiichi Sankyo in Japan, to the first subject in a Phase 3 clinical trial of a booster vaccination with an Omicron-adapted bivalent vaccine (booster vaccination trial). This booster vaccination trial is a Phase 3 clinical trial that enrolls approximately 1,400 healthy individuals who have completed the primary and booster series of vaccination with a COVID-19 vaccine approved in Japan and evaluates the efficacy and safety of DS-5670 (Omicron-adapted bivalent vaccine) using a COVID- 19 vaccine (Omicron-adapted bivalent vaccine) approved in Japan as the control.

Integra Dedicates New 14,000 sq. ft. Center of Innovation in Plainsboro

Integra LifeSciences Holdings Corp. hosted a ribbon-cutting ceremony to celebrate the grand opening and dedication of its new center of innovation and learning to Dr. Richard E. Caruso, late founder of the company, in Plainsboro. The new state-of-the-art 14,000-square-foot research & development facility is dedicated to pioneering new advances in treatment pathways and setting new standards of care to restore patient’s lives. Robert T. Davis Jr., EVP and President of Integra’s Tissue Technologies global product division shared, “This new facility reinforces our commitment to deliver cutting-edge regenerative technologies to address unmet clinical needs. In addition, it will be an important site for learning, as we plan to host many educational programs for our customers and colleagues worldwide, which is an important part of our mission.”

Pharmaceutical Company Generichem Locating to Towaco

Pharmaceutical company Generichem has signed a lease for its new corporate office/distribution facility located at 425 Main Road in the Towaco section of Montville Township, Morris County. Generichem has been serving the pharmaceutical and nutritional industries with quality ingredients since 1976. They represent producers of pharmaceutical products, nutritional products, and excipients worldwide, exceeding the highest international standards.

German Biotech Opens U.S. HQ in Princeton

Fennelly Associates has negotiated a lease for 4,093 square feet of office space at 5 Vaughn Drive in Princeton for German biotech ITM Isotope Technologies Munich SE. ITM Isotope Technologies is a privately-owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. “Princeton’s reputation as a hub for biotech and pharmaceutical companies as well as a research and development center is particularly attractive to companies like ITM Isotope Technologies Munich SE,” said Fennelly.

Onyx Reveals First Plans for 2M+ sq. ft. Life Sciences Hub at Former Merck Site

The former Merck campus in Kenilworth will become a hub of life sciences innovation known as the Northeast Science and Technology, or NEST, Center, the latest venture backed by leading real estate investment and property services firm Onyx Equities and equity partner Machine Investment Group. Onyx purchased the state-of-the-art campus in February with an eye on the future of life sciences and biotechnology. Located just 14 miles outside of New York City, NEST will attract the next generation of life sciences and technology leaders to the region. The campus empowers global organizations to tap into New Jersey’s highly educated labor pool. NEST and other significant life sciences projects in New Jersey continue to help it emerge as one of the sector’s new leaders. In fact, Kenvue, Johnson & Johnson’s billion-dollar consumer spinoff, recently selected an Onyx property to house its new global headquarters.

Plans Announced for Phase II of HELIX in New Brunswick

As growth in New Jersey’s life sciences sector accelerates demand for modern lab and innovation space, SJP Properties, in collaboration with New Brunswick Development Corporation, has unveiled plans to develop H-2, the second phase of HELIX Health + Life Science Exchange — the innovation district currently under development on a four-acre site in downtown New Brunswick. HELIX aims to bring together the power of academia and public- and private-sector research under one roof and will provide businesses, universities and researchers with the critical space to work, learn and experiment. HELIX, which will be built in three phases, represents the largest investment in life sciences and medical education in the state of New Jersey’s history.

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

Rutgers University researchers plan to provide serologic antibody testing to help determine the incidence of Long COVID and the effect the condition has on children as part of the National Institutes of Health RECOVER Initiative. The serological testing, which determines the presence and key characteristics of antibodies directed against proteins produced by SARS-CoV-2 — the virus causing COVID-19 — will be performed in the laboratory of Maria Laura Gennaro, professor of medicine and epidemiology at the Public Health Research Institute at Rutgers New Jersey Medical School (NJMS).

New Lab Space Opens at Hackensack Meridian Center for Discovery and Innovation

Hackensack Meridian Health Research Institute recently cut the ribbon on 20,000 additional square feet of laboratory and office space for the Hackensack Meridian Center for Discovery and Innovation (CDI). This state-of-the-art new space will house nine laboratories and approximately 60 scientists and support staff as part of HMH’s major investment in oncology and immunology. Once completed, the project’s total cost will be approximately $12 million. The newest upgrades bring the total space of the CDI to 128,000 net square feet. CDI, which opened in 2019, is part of the 116-acre Interprofessional Health Sciences Campus, which includes the Hackensack Meridian School of Medicine, located less than 10 miles west of Manhattan on the former site of the global pharmaceutical company Hoffmann-LaRoche in Nutley and Clifton.

Cooper Innovation Center Partners With DigiCARE Realized to Accelerate Early Stage Alzheimer’s Detection Technology for Commercialization

Cooper University Health Care’s Innovation Center and DigiCARE Realized have signed a partnership agreement to test deployment and implementation of an artificial intelligence (AI)-powered technology designed to identify undiagnosed cases of early stage Alzheimer’s disease and related dementias. Researchers and clinicians from Cooper’s Neurological Institute (CNI) will work with DigiCARE Realized’s team to implement this innovative approach to standardize routine brain care and improve patient outcomes. The company’s machine-learning technology is deployed through the hospital’s electronic health records (EHR) system. The AI-technology processes routinely collected data, both structured and unstructured. This technology has demonstrated the ability to review high volumes of patient health records in hours versus what would take clinicians days to review.

Gilead Appoints Cindy Perettie Executive Vice President of Kite

BioNJ Member Gilead Sciences, Inc., building a new site in Parsippany, announced that Cindy Perettie will join the company as Executive Vice President of Kite, a Gilead Company, overseeing the cell therapy business, and will become a member of Gilead’s senior leadership team. Ms. Perettie brings with her extensive experience in oncology and a commitment to improving patient care. Most recently, she was Head of Roche’s Molecular Lab Solutions where she oversaw the PCR (polymerase chain reaction) and Sequencing Business. Prior to that, she was Chief Executive Officer at Foundation Medicine. Before joining Foundation Medicine, Ms. Perettie was Head of Global Oncology Strategy at Roche’s Oncology Unit, where she led one of the largest global oncology portfolios in the industry. 

Lilly ESG Report Highlights Progress Towards Sustainability Goals

Eli Lilly and Company released its latest Environmental, Social and Governance (ESG) report showing progress towards the company's ambitious sustainability goals, which are critical to maintaining a strong and resilient company. Notable sustainability highlights in the report include:

• Reducing greenhouse gas emissions in the company's operations by more than 20% from 2020 to 2022 despite significant business growth over the same timeframe.
• Continuing to improve the diversity of Lilly's workforce with minority group members now serving in a quarter of all management positions in the U.S. – and women serving in nearly half (49%) of all management positions globally.
• Improving access to Lilly insulin in the U.S., including capping out-of-pocket costs at $35 or less per month (effective March 2023) and reducing the list price of Lilly's most prescribed insulins by 70% (effective Q4 2023).1
• Nearly doubling the number of patients reached in resource-limited settings from 7.3 million in 2020 to 13 million in 2022 via the Lilly 30x30 initiative.

Stand Up for Science at BIO 2023

Hosted by BIO International Convention

June 5-8, 2023

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

New Jersey Reception at The Sporting Club: 2023 BIO International

June 5, 2023, 5:00 p.m.-7:00 p.m.

Attending BIO 2023? Come mingle with biotech's best and brightest at New Jersey's BIO International reception. Join us for cocktails and conversation at The Sporting Club in Boston's Seaport District, right across the street from the Boston Convention Center! RSVP at ChooseNJ.com/Reception or email dfigueiredo@choosenj.com.

NJ FoodTech 2023

Hosted by Rutgers Food Innovation Center, Middlesex County and NJEDA

June 28, 2023

Join the Food Innovation Center at Rutgers University, Middlesex County and NJ Economic Development Authority at the first annual NJ FoodTech 2023 Conference. This is a day when food and beverage companies, investors, academics, start-ups, entrepreneurs and food innovation leaders come together to share their insights, discuss opportunities and identify future partners.

ON Helix

Hosted by One Nucleus

July 6, 2023

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

2023 SAPA Healthcare Investment Forum & Roadshow

Hosted by Sino-American Pharmaceutical Professionals Association (SAPA)

July 8, 2023

As a global organization for pharmaceutical professionals, Sino-American Pharmaceutical Professionals Association (SAPA) 6th SAPA Investment Forum & Roadshow is an organizational flagship event, aiming to provide a premium platform for connecting investors and entrepreneurs and offer effective solutions and support to emerging enterprises in the healthcare industry. This in-person only event will include plenary sessions, fireside chats, healthcare innovation roadshow presentations, networking, one-to-one private partnership meetings and other development opportunities. 

Winds of Change: Dealmaking Trends in the Evolving Innovation Economy

Hosted by LES USA & Canada

October 15-18, 2023

Under the theme of Winds of Change: Dealmaking Trends in the Evolving Innovation Economy, our dynamic international IP community will meet in Chicago for two action-packed days of education, outstanding programming and networking, with global deal making opportunities.