Welcome New Members

• 325
• EpiBone, Inc.
• Lumanity
• Med-Con Technologies
• Syridex Bio

 Learn more at www.BioNJ.org/Membership.

Biden’s Fantasyland Medicare Plan Would Mean Even More American Life Years Lost

President Joe Biden announced a plan to keep Medicare solvent by relying on even more aggressive price negotiations with the pharmaceutical industry than Congress has already agreed to. The president claims it’ll result in $200 billion in savings. That’s quite a claim considering the nonpartisan Congressional Budget Office has said such negotiations “would have a negligible effect on federal spending.” Talk about playing poker with money you don’t have. The reality is these negotiations’ main consequence will be the U.S. healthcare system falling further down the slippery slope of federally mandated price controls, restricting patient choice and destroying the research-and-development system that makes America the world leader in medical innovation.

WTAS: Inflation Reduction Act Already Impacting R&D Decisions

The Inflation Reduction Act’s (IRA’s) drug price setting provisions, as predicted, are already impacting biopharmaceutical research & development (R&D) decisions. Whether you are looking at estimates of how many fewer medicines or indications will be developed, or noting shifts away from areas of unmet patient need because the law is signaling those innovations are not valued, the IRA’s price setting provisions are a loss for patients everywhere. While companies will be differentially impacted depending on their specific product portfolios, most project that over time, the IRA’s drug price setting provisions will have significant ripple effects across the R&D ecosystem, impacting companies large and small. 

Physicians Say Prior Authorization Rules Harm Patients, AMA Survey Finds, as CMS Works Toward New Policy

Prior authorization requirements have long been criticized for putting additional administrative requirements on physicians and even leading to burnout. The AMA survey found physicians believe the rules are also impacting health outcomes, and comes as the CMS works to finalize a new rule on the policies. While insurers have said the policies reflect evidence-based medicine, physicians disagree and said they feel a lack of transparency in the payer approval process and that their clinical authority and expertise is diminished, according to the AMA report. Almost 90% of respondents said the rules had a negative impact on patient clinical outcomes, the survey, which included responses from 1,000 physicians collected, found.

PhRMA Submits Comments to OSTP on Enhancing Clinical Trial Diversity

The White House’s Office of Science and Technology Policy (OSTP) recently solicited stakeholder feedback on the clinical research infrastructure for emergency clinical trials, for which PhRMA submitted comments. PhRMA shares OSTP’s recognition of the importance of having a clinical trial infrastructure that supports sites that are ready to respond to emergency situations like COVID-19. We also agree that one goal of such an infrastructure should be to support the expansion of clinical research into underserved communities by increasing diversity among both trial participants and clinical trial investigators. The COVID-19 pandemic raised the public’s consciousness about gaps in the clinical trial infrastructure and about barriers that many underrepresented communities may face when it comes to participating in a clinical trial.

What We’ve Learned from Three Years of Fighting COVID-19

Three years ago, amidst an unprecedented public health crisis, biopharmaceutical industry made a commitment to fight COVID-19. Leveraging decades of research and investments in emerging technologies and scientific expertise, we dedicated ourselves to finding medical solutions to prevent, diagnose and treat those impacted by the coronavirus. Working around the clock, biopharmaceutical researchers conducted hundreds of clinical trials to identify potential treatments and vaccines and bolstered investments into new technologies to speed the manufacturing of safe and effective medicines. Biopharmaceutical manufacturers also partnered with community groups and local governments to spread awareness about the safety and effectiveness of COVID-19 vaccines and increase access. 

Biden's Victory Lap on Drug Prices is Premature

Since President Joe Biden’s State of the Union address – and his recent trip to the Suncoast – one thing has become clear: members of both sides of the aisle believe protecting Medicare and lowering seniors’ health care costs are critical goals. That’s why Biden and his team have traveled around the country to tout his policy accomplishments, including the drug pricing provisions of the Inflation Reduction Act, which he is seeking to build on with his proposed budget. When my neighbors ask me if this law will help them, the best I can say is this: “It depends.”

The New Era of Life Sciences

In this special report, we present the culmination of diligent research: the result of comprehensive interviews with a distinguished cohort of decision-makers who shape the future of the industry. Our interviewees consist of North America's leading CEOs, association leaders and government officials. Amidst the many transformative developments, there is no doubt that the impact of these innovations and policies will be significant, shaping the way we all live our lives. Our interviewees consist of North America’s leading CEOs, association leaders and government officials. Amidst the many transformative developments, there is no doubt that the impact of these innovations and policies will be significant, shaping the way we all live our lives.

Stuart Peltz, Ph.D., Rare Disease Pioneer, to Retire as Chief Executive Officer of PTC Therapeutics

South Plainfield-based BioNJ Member PTC Therapeutics, Inc. Founding Chief Executive Officer Stuart Peltz, Ph.D., announced that he is stepping down after 25 years. Dr. Peltz has led PTC Therapeutics as its CEO since its founding in 1998 and pioneered the field of RNA-directed drug development. Under his leadership, PTC has grown from a research organization with expertise in the control of RNA processes to a publicly traded, integrated, global biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for the treatment of neurological and neuromuscular disorders, metabolic disorders and cancer. Matthew Klein, M.D., M.S., F.A.C.S., current Chief Operating Officer, has been named the company's CEO and will join the Board of Directors.

BeiGene Enters New Phase to Expand U.S. Manufacturing and R&D Footprint in New Jersey

BioNJ Member BeiGene is entering a new phase as it continues to build its U.S. presence. The company announced that the last piece of structural steel has been laid at its Hopewell, NJ campus. This new facility will provide state-of-the-art commercial-stage U.S. biologic pharmaceutical manufacturing, late-stage research and clinical development capabilities that complement the company’s existing capabilities around the world. “The progress we are making in building our flagship U.S. biologics manufacturing and R&D facility at the Princeton West Innovation Campus is especially important to BeiGene as we continue to expand our global business through new approvals, including the FDA’s recent approval of BRUKINSA for adult patients with CLL in the U.S.,” said John V. Oyler, Co-Founder, Chairman and CEO of BeiGene.

Acadia Pharmaceuticals Announces U.S. FDA Approval of DAYBUE™ (trofinetide) for the Treatment of Rett Syndrome in Adult and Pediatric Patients Two Years of Age and Older

Acadia Pharmaceuticals Inc., with offices in Princeton, announced that the U.S. Food and Drug Administration (FDA) has approved DAYBUE™ (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. DAYBUE is the first and only drug approved for the treatment of Rett syndrome. "Today marks an important milestone for the Rett community and Acadia. As the first FDA-approved drug for the treatment of Rett syndrome, DAYBUE now offers the potential to make meaningful differences in the lives of patients and their families who have lacked options to treat the diverse and debilitating array of symptoms caused by Rett syndrome,” said Steve Davis, Acadia’s Chief Executive Officer.

Novartis Tafinlar + Mekinist Approved by FDA for Pediatric Patients With BRAF V600E Low-Grade Glioma, the Most Common Pediatric Brain Cancer

East Hanover-based BioNJ Member Novartis announced the U.S. Food and Drug Administration (FDA) granted approval for Tafinlar® (dabrafenib) + Mekinist® (trametinib) for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. The FDA also approved liquid formulations of Tafinlar and Mekinist, marking the first time a BRAF/MEK inhibitor has been developed in a formulation suitable for patients as young as one year of age. These approvals make Tafinlar + Mekinist the first and only approved combination targeted therapy to treat pediatric patients with BRAF V600E LGG.

Evotec Announces Progress in Strategic Protein Degradation Partnership With Bristol Myers Squibb

Princeton-based BioNJ Member Evotec announced progress within the Company’s strategic partnership with Princeton-based BioNJ Member Bristol Myers Squibb relating to building a molecular glue-based pipeline. Performance-based and program-based achievements trigger payments of in total US$ 75 m to Evotec. Evotec and Bristol Myers Squibb entered their strategic protein degradation partnership in 2018 and expanded it in May of 2022, because of the highly productive initial collaboration generating a promising pipeline. Since the expansion, Evotec has significantly scaled up its activities to develop highly promising compounds from Bristol Myers Squibb’s industry-leading library of cereblon E3 ligase modulators (“CELMoDs™”). The partnership continues to deliver on its goal to build a leading pipeline of novel molecular glue degraders, targeting high-value targets in the field of oncology and beyond. 

AbbVie Announces Late-Breaking Results of Study Evaluating 52-Week Efficacy and Safety of SKYRIZI® (risankizumab) in Plaque Psoriasis Patients With a Prior Suboptimal Response to IL-17 Inhibitor Therapy

BioNJ Member AbbVie, with a site in Princeton, announced new 52-week data from an open-label, single-arm study demonstrating improved plaque psoriasis signs and symptoms among a difficult-to-treat patient population who received SKYRIZI® (risankizumab), an IL-23 inhibitor. These moderate to severe plaque psoriasis patients previously had a suboptimal response to treatment with secukinumab or ixekizumab, both IL-17A inhibitor therapies, for at least six months before switching to risankizumab. Findings from this Phase 3b, open-label single-arm study showed that 56.3% of patients who received risankizumab, without a washout period following a suboptimal response to secukinumab or ixekizumab achieved the week 16 primary endpoint of reduced signs and symptoms of psoriasis (sPGA 0/1).

First Wave BioPharma Announces First Patient Dosed in Phase 2 SPAN Clinical Trial of Enhanced Adrulipase Formulation

BioNJ Member First Wave BioPharma, Inc. announced that the first patient was dosed in the Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). Topline results from the study are anticipated by mid-2023. The Phase 2 multi-center clinical trial is designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving an estimated twelve (12) patients. The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA). Three clinical trial sites in the U.S. will be participating in the trial.

First Wave BioPharma Announces Second Patient Dosed in Phase 2 SPAN Clinical Trial of Enhanced Adrulipase Formulation in Cystic Fibrosis

BioNJ Member First Wave BioPharma, Inc. announced that the second patient was dosed in the Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). The three U.S. clinical trial sites participating in the trial are now actively screening and enrolling patients. The Phase 2 multi-center clinical trial (NCT05719311) is designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving an estimated twelve (12) patients. The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA). 

First Wave BioPharma Announces $4.0 Million Private Placement Priced At-The-Market Under Nasdaq Rules

BioNJ Member First Wave BioPharma, Inc. announced that it has entered into a definitive agreement with a certain institutional investor for the issuance and sale of 1,023,018 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 2,046,036 shares of common stock at an offering price of $3.91 per share (or pre-funded warrant) and accompanying warrant, in a private placement priced at-the-market under Nasdaq rules. The warrants are exercisable immediately upon issuance, have a term of five years and an exercise price of $3.66 per share. The gross proceeds from the offering are expected to be approximately $4.0 million, before deducting the placement agent’s fees and other offering expenses payable by the company. 

Gilead Exercises Option to License Nurix’s IRAK4 Targeted Protein Degrader Development Candidate, NX-0479

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, and Nurix Therapeutics, Inc. announced that Gilead has exercised its option to exclusively license Nurix’s investigational targeted protein degrader molecule NX 0479. This bivalent degrader, designated GS-6791, is the first development candidate resulting from the previously announced Nurix-Gilead collaboration to discover, develop, and commercialize a pipeline of innovative targeted protein degradation therapies. GS-6791 is a potent, selective, oral IRAK4 degrader that targets both the scaffold and kinase functions of the IRAK4 protein kinase to block inflammatory responses downstream of toll-like receptors (TLR) and the pro-inflammatory IL1 cytokine family of receptors (IL1Rs). Degradation of IRAK4 by GS-6791 is hypothesized to have more sustained and deeper inhibition of TLR/IL1Rs signaling as compared to kinase inhibition due to its potential impact on additional signaling nodes. 

Sandoz Receives U.S. FDA Approval for Biosimilar Hyrimoz® (adalimumab-adaz) High-concentration Formulation

Princeton-based BioNJ Member Sandoz, a Novartis division, announced that the U.S. Food and Drug Administration (FDA) approved a citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz® (adalimumab-adaz) injection. The adalimumab citrate-free HCF (100 mg/mL) is approved to treat seven indications covered by the reference medicine, Humira® (adalimumab), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis. Sandoz intends to launch the Hyrimoz citrate-free HCF in the US on July 1, 2023. The FDA approval was based on a Phase I pharmacokinetics (PK) bridging study comparing the FDA-approved adalimumab 50 mg/mL to the citrate-free 100 mg/mL (HCF). This study met all of the primary objectives, demonstrating comparable PK and showing similar safety and immunogenicity of the adalimumab 50 mg/mL and adalimumab HCF.

Hovione and Laxxon Medical Establish an Agreement for the cGMP Production of 3D Screen Printed Pharmaceutical Applications

BioNJ Member Hovione, with a site in East Windsor, and Laxxon Medical announced a strategic collaboration to advance the use of 3D screen printing technologies for the pharmaceutical industry. This partnership combines Laxxon´s expertise in 3D screen printing, based on their SPID®-Technology, with Hovione's product & process development, engineering and manufacturing expertise in pharmaceutical applications. The 3D technology displays numerous advantages including the potential to produce unique or customized dosage forms with characteristics that cannot be achieved with conventional dosage forms, the ability to create tablets of any shape and size, the option to easily adjust the number of active substances and individual components in the composition of the tablet and even to set the dosage individually for each patient for personalized medicines.

Evotec Receives US$ 6.6 m Grant for Drug Discovery in Tuberculosis

Princeton-based BioNJ Member Evotec announced that the company has received a US$ 6.6 m grant from The Bill & Melinda Gates Foundation for drug discovery in tuberculosis (“TB”). The grant is the second award from the foundation to Evotec supporting TB drug discovery, and allows the company to progress a portfolio of TB drug discovery projects that have the potential to contribute to a universal, shorter, safer and simpler TB drug regimen. The current regimen for drug-sensitive TB, the most common and easiest-to-treat form of TB, requires that patients take multiple drugs for six or more months under clinical monitoring. Patients with drug-resistant TB face longer and more complex treatment regimens, often with significant side effects. A shorter drug regimen that can treat TB irrespective of pre-existing drug resistance could provide a significant benefit to both patients and health systems.

Dupixent® (dupilumab) Approved by European Commission as First and Only Targeted Medicine for Children as Young as Six Months Old With Severe Atopic Dermatitis

Bridgewater-based BioNJ Member Sanofi announced the European Commission (EC) has approved Dupixent® (dupilumab) in the European Union (EU) to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy. With this approval, Dupixent is the first and only targeted medicine indicated to treat these young children in Europe and the U.S. The approval is based on data from a Phase 3 trial evaluating Dupixent every four weeks (200 mg or 300 mg based on body weight) plus low-potency TCS or TCS alone (placebo) in 162 children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. At 16 weeks, Dupixent improved skin clearance and reduced overall disease severity and itch compared to placebo in the overall enrolled population.

Sanofi to Acquire Provention Bio in $2.9B Deal

Following Bridgewater-based BioNJ Member Sanofi‘s $35 million equity investment last month, the global health care company will acquire Red Bank-based Provention Bio Inc. for $25 per share, representing an equity value of approximately $2.9 billion. “The acquisition of Provention Bio builds on Sanofi’s mission to deliver best- and first-in-class medicines and resonates with our purpose of chasing the miracles of science for the benefit of people,” said Sanofi Executive Vice President, General Medicines, Olivier Charmeil. “By coupling Provention Bio’s transformative innovation with Sanofi’s expertise, we aim to bring life-changing benefits to people at risk of developing Stage 3 type 1 diabetes.”

Sanofi Cuts U.S. List Price of Lantus®, its Most-Prescribed Insulin, by 78% and Caps Out-of-Pocket Lantus Costs at $35 for all Patients With Commercial Insurance

Bridgewater-based BioNJ Member Sanofi announced that it will cut the list price of Lantus (insulin glargine injection) 100 Units/mL, its most widely prescribed insulin in the U.S., by 78 percent. The company also will establish a $35 cap on out-of-pocket costs for Lantus for all patients with commercial insurance, underscoring its longstanding commitment to offer affordable access to medicines. These moves, which go into effect January 1, 2024, will come in addition to decisions taken in June 2022 to lower diabetes medicines costs: the launch of an unbranded Lantus biologic at -60% versus Lantus list price, and a cap on out-of-pocket costs on insulin to $35 for all people without insurance. Sanofi’s suite of savings programs ensures that no patient will pay more than $35 for a monthly supply of Lantus. 

Phase 3 Study Shows XTANDI® (enzalutamide) Plus Leuprolide Significantly Improves Metastasis-Free Survival in Men With Non-Metastatic Prostate Cancer

BioNJ Member Pfizer, with a site in Peapack, and Astellas Pharma Inc. announced positive topline results from the Phase 3 EMBARK trial evaluating XTANDI® (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR). Patients enrolled in the trial were randomized to one of three study arms: XTANDI plus leuprolide, placebo plus leuprolide, or XTANDI monotherapy. The study met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with XTANDI plus leuprolide versus placebo plus leuprolide. The study also met a key secondary endpoint with a statistically significant and clinically meaningful improvement in MFS for patients treated with XTANDI monotherapy versus placebo plus leuprolide.

Pfizer Invests $43 Billion to Battle Cancer

BioNJ Member Pfizer, with a site in Peapack, announced that they have entered into a definitive merger agreement under which Pfizer will acquire Seagen, a global biotechnology company that discovers, develops and commercializes transformative cancer medicines, for $229 in cash per Seagen share for a total enterprise value of $43 billion. “Pfizer is deploying its financial resources to advance the battle against cancer, a leading cause of death worldwide with a significant impact on public health,” said Dr. Albert Bourla, Pfizer Chairman and Chief Executive Officer. “Together, Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining the power of Seagen’s antibody-drug conjugate (ADC) technology with the scale and strength of Pfizer’s capabilities and expertise.”  

Pfizer’s ZAVZPRET™ (zavegepant) Migraine Nasal Spray Receives FDA Approval

BioNJ Member Pfizer, with a site in Peapack, announced the U.S. Food and Drug Administration (FDA) has approved ZAVZPRET™ (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults. In its pivotal Phase 3 study, ZAVZPRET was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptom at two hours post-dose. The pivotal study also demonstrated pain relief as early as 15 minutes in a prespecified secondary endpoint versus placebo. “The FDA approval of ZAVZPRET marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer. 

TREMFYA® (guselkumab) Real-World Data Analyses Show Greater Treatment Persistence Than IL-17s in Both Bio-naïve and Bio-experienced Patients Living With Moderate to Severe Plaque Psoriasis

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced new data, showing that initiation of TREMFYA® (guselkumab) was associated with greater treatment persistence compared to secukinumab or ixekizumab in bio-naïve and bio-experienced patients living with moderate to severe plaque psoriasis (PsO), based on pairwise analyses of real-world data. Additionally, in a post-hoc analysis of Phase 3 VOYAGE 2 clinical trial results, TREMFYA demonstrated durable clinical efficacy, itch relief and quality-of-life improvements in patients living with scalp PsO. TREMFYA is the first and only fully human selective interleukin (IL)-23 inhibitor therapy approved in the U.S. for adults with moderate to severe plaque PsO. 

Simcere Zaiming Announces Clinical Collaboration to Evaluate SIM0235, a TNFR2 Monoclonal Antibody, in Combination With Merck’s KEYTRUDA® (pembrolizumab) in a Phase 1 Trial in Advanced Solid Tumors and Cutaneous T-cell Lymphoma

Simcere Pharmaceutical Group Limited announced that Simcere Zaiming entered into a clinical collaboration agreement with Rahway-based BioNJ Member Merck & Co. to evaluate the combination of SIM0235, a potential first-in-class humanized anti-tumor necrosis factor receptor 2 (TNFR2) monoclonal antibody, and MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced solid tumors and cutaneous T-cell lymphoma (CTCL). This is a Phase 1 trial to evaluate the safety, efficacy, pharmacokinetic/pharmacodynamic characteristics and immunogenicity of SIM0235 monotherapy and SIM0235 in combination with KEYTRUDA in patients with advanced solid tumors and CTCL. Tumor necrosis factor receptor 2 (TNFR2) is a member of the tumor necrosis factor receptor superfamily and is primarily expressed on the surface of tumor cells and immune suppressive cells in the tumor microenvironment, leading to immune escape and tumor proliferation.

Calliditas Announces Primary Endpoint Successfully Met in Phase 3 NefIgArd Trial Evaluating Nefecon®nin IgA Nephropathy

Calliditas Therapeutics with a site in Hoboken, announced positive topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon (TARPEYO®/Kinpeygo® (budesonide) delayed release capsules) versus placebo in patients with primary IgA nephropathy (IgAN). “This is truly a great outcome for IgAN patients. This reflects sustained impact on kidney function across the entire study population with a treatment which was specifically designed to treat IgAN by downregulating pathogenic IgA1 antibodies at their presumed source and we believe this dataset supports regulatory filing for full approval based on the Phase 3 study population,” said CEO Renée Aguiar-Lucander.

Glenmark Receives Acceptance from U.S. FDA on its IND Application for GRC 54276 to Proceed With a Phase 1/2, First-in-Human Clinical Study of the Molecule for the Treatment of Patients With Advanced Solid Tumors and Lymphomas

Glenmark Specialty SA, the subsidiary of Glenmark Pharmaceuticals Ltd., with a site in Mahwah, received acceptance from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application for GRC 54276 to proceed with a Phase 1/2, first-in-human, clinical study of GRC 54276 for the treatment of patients with advanced solid tumors and lymphomas. GRC 54276 is an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor developed by Glenmark. HPK1-regulated functions are involved in nearly every step of the cancer-immunity cycle making it an attractive target for immuno-oncology. By inhibiting HPK1, GRC 54276 is designed to potentially enhance the patient’s own immune system to fight cancers.

Glenmark Pharmaceuticals Receives ANDA Approval for Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg and 300 mg

Glenmark Pharmaceuticals, with a site in Mahwah, has received final approval by the United States Food & Drug Administration (U.S. FDA) for Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg and 300 mg, the generic version of Cleocin®1 Hydrochloride Capsules, 75 mg, 150 mg and 300 mg, of Pfizer Inc. Glenmark’s Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg and 300 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA. According to IQVIATM^TM sales data for the 12-month period ending January 2023, the Cleocin® Hydrochloride Capsules, 75 mg, 150 mg and 300 mg market2 achieved annual sales of approximately $33.6 million.

U.S. Veterans’ Health Administration (VHA) Provides Coverage of LEQEMBI™ (LECANEMAB-IRMB) Two Months After LEQEMBI’S FDA Accelerated Approval for Veterans Living With Early Stages of Alzheimer’s Disease

Nutley-based Eisai Co., Ltd. announced that the U.S. Veterans’ Health Administration (VHA) is providing coverage of LEQEMBI™ (lecanemab-irmb) to veterans living with early stages of Alzheimer’s disease (AD). VHA healthcare professionals meeting the criteria set forth by the VHA can prescribe LEQEMBI to veterans who fit the VHA’s criteria and the U.S. Food and Drug Administration’s (FDA) current label. The VHA’s careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD. If approved under the traditional pathway, the FDA will update the label for LEQEMBI, which will include new data that has been evaluated by the FDA. 

EISAI Publishes Societal Value of LECANEMAB Using Phase 3 Clarity Ad Data in Peer-Reviewed Neurology and Therapy Journal

Nutley-based Eisai Co., Ltd. announced the publication of updated results from an evaluation estimating the societal value of anti-amyloid-beta (Aβ) protofibril antibody lecanemab (generic name, U.S. brand name: LEQEMBI™) in people living with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) using data from the Phase 3 clinical study, Clarity AD by applying a validated disease simulation model, AD Archimedes Condition Event (AD ACE) model from the healthcare payer and societal perspectives in the United States, in the peer-reviewed journal Neurology and Therapy. While the healthcare payer perspective focuses on direct care costs (e.g., outpatient and inpatient services, medications, intervention costs, nursing home and home healthcare services), the societal perspective further considers societal costs (e.g., productivity loss and informal care costs).

LEO Pharma Presents Late-Breaking Positive Phase 2a Efficacy and Safety Results of LEO 138559 in Moderate-to-Severe Atopic Dermatitis at the 2023 AAD Annual Meeting

LEO Pharma, with a site in Madison, announced that a Phase 2a trial evaluating the efficacy and safety of investigational agent LEO 138559 in adults with moderate-to-severe atopic dermatitis met its primary endpoint. LEO 138559 is an investigational agent and its efficacy and safety are subject to further larger trials. LEO 138559 is an investigational monoclonal antibody currently in Phase 2 development for the treatment of moderate-to-severe atopic dermatitis, which blocks the IL-22RA1 receptor subunit thereby inhibiting the effect of the interleukin-22 (IL-22) cytokine – known to be elevated in patients with atopic dermatitis. LEO 138559 potentially also inhibits to some extent the effects of cytokines IL-20 and IL-24; however, this remains to be fully understood.

LEO Pharma Presents Late-Breaking Positive Phase 3 Results of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (CHE) at AAD 2023

LEO Pharma, with a site in Madison, presented positive results from the DELTA 1 trial. DELTA 1 is a pivotal Phase 3 clinical trial with delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor for the potential treatment of adults with moderate to severe chronic hand eczema (CHE). The safety and efficacy of delgocitinib cream is under investigation and has not been evaluated by any health authority. The DELTA 1 trial randomized 487 adults with moderate-to-severe CHE to twice-daily delgocitinib cream 20 mg/g (n=325) or cream vehicle (n=162) for 16 weeks followed by a 36-week extension trial. The primary endpoint was the proportion of patients with moderate to severe CHE who achieved an Investigator’s Global Assessment (IGA)-CHE score of 0 (clear) or 1 (almost clear: barely perceptible erythema only) with a ≥2 point improvement from baseline at Week 16.

LEO Pharma Presents New Adbry™ (tralokinumab-ldrm) Data in Adolescent Population from ECZTRA 6 and ECZTEND Trials at AAD 2023 Annual Meeting

LEO Pharma, with a site in Madison, presented new clinical data from the ECZTRA 6 and ECZTEND trials of Adbry™ (tralokinumab-ldrm), marketed outside of the U.S. under the tradename Adtralza®, in adolescent patients aged 12 to 17 years with moderate-to-severe atopic dermatitis (AD). The use of Adbry in adolescent patients aged 12-17 is currently under clinical investigation and the safety and efficacy have not been fully evaluated by the U.S. FDA. New data from the ECZTRA 6 trial showed that Adbry significantly reduced the abundance of Staphylococcus aureus in the lesional and non-lesional skin of adolescents with AD after 16 weeks. S. aureus is consistently found in the skin lesions of patients with AD and contributes to skin irritation and infections. 

LEO Pharma and ICON Enter a Strategic Partnership to Propel Clinical Trial Execution Within Medical Dermatology

LEO Pharma, with a site in Madison, and ICON announced a strategic partnership that will enable LEO Pharma to scale clinical trial execution that is patient-centric and cost effective, and which will support the company’s overall ambition of building one of the most effective and efficient clinical portfolio execution organisations in the industry. The mission of the partnership is to improve the lives of dermatology patients with access to innovative clinical trials and the launch of new medicines. The partnership will operate under the acronym of PACE, reflecting the requirement to move quickly to address today’s clinical development challenges. It also represents LEO Pharma and ICON’s shared values of Passion, Agility, Communication and Excellence in delivery. 

Bristol Myers Squibb Announces Progress Toward Long-Term Inclusion & Diversity Goals and Health Equity Commitments

Princeton-based BioNJ Member Bristol Myers Squibb announced meaningful progress toward its global inclusion & diversity goals and health equity commitments, meeting and exceeding some goals ahead of schedule. In 2020, Bristol Myers Squibb (BMS) and the Bristol Myers Squibb Foundation, an independent charitable organization, each committed $150 million over five years, totaling $300 million to address health equity efforts by 2025. BMS and the Foundation are on track to achieve many of their respective goals and have exceeded some ahead of schedule. Progress against the four priority areas include: 1) Health Equity, 2) Increasing clinical trial diversity, 3) Diversifying suppliers and 4) Diversifying company workforce.

Angel Match Program

The Angel Match Program was designed to disburse funding from the State Small Business Credit Initiative (SSBCI), a federal program administered by the U.S. Department of Treasury. Its purpose is to propel the creation of an entrepreneurial ecosystem that stimulates innovation and economic development, providing employment opportunities for New Jersey residents. This program matches angel investors’ direct investment in early stage, product-based technology companies within targeted industries on a 1-to-1 basis with unsecured convertible notes ranging from $100,000 to $500,000.

NJIT Names John Pelesko Provost and SVP for Academic Affairs

New Jersey Institute of Technology (NJIT) has selected John Pelesko to serve as its next provost and Senior Vice President for Academic Affairs after a nationwide search. Dr. Pelesko, currently the Dean of the College of Arts and Sciences at the University of Delaware (UD), will start on Aug. 1. Dr. Pelesko, an NJIT alumnus who earned a Ph.D. in mathematical sciences from the university, will seek to enhance NJIT’s educational programs and grow its research portfolio through federal, state and industry partnerships. More broadly, he’ll work closely with NJIT President Teik C. Lim and the Board of Trustees to identify, communicate and achieve NJIT’s academic priorities. In addition to his work as Dean at UD, Dr. Pelesko serves as a professor of mathematical sciences. 

NJIT Makes Wozencroft’s CIO Title Official and Adds to Role With VP of Digital Strategy Appointment

New Jersey Institute of Technology announced that Ed Wozencroft, who has been serving as Associate Chief Information Officer since 2021, and interim Co-CIO since August 2022, has been named Vice President for Digital Strategy and Chief Information Officer. Prior to serving at NJIT, Mr. Wozencroft was Director in the Higher Education Enterprise Solutions and Student Lifecycle Solutions practices at Huron Consulting Group and provided executive-level consulting for complex R1 universities such as the University of Washington, Iowa State University and University of Miami. President Teik Lim said, “Throughout his career, Ed has gained significant experience in the development of strategic plans, complex enterprise resource planning implementations, process transformations, directing enterprise web services efforts and forming high-performing cross-functional teams.”

Holy Name Clinical Trial Leads to Approval of New Treatment for Multiple Sclerosis

A recent clinical trial at the Holy Name’s MS Center located in Teaneck has led to the U.S. Food and Drug Administration approval for Briumvi, a new medication that offers renewed hope and more efficient treatment for patients battling multiple sclerosis. The recently approved treatment is the first and only anti-CD20 monoclonal antibody approved for patients with relapsing forms of MS, according to Holy Name officials. The medication can be administered in a one-hour infusion twice a year, following the starting dose. Dr. MaryAnn Picone, Medical Director of Holy Name’s MS Center, said, “Living with a chronic condition like MS creates many lifestyle challenges and may impact your ability to work and manage your daily activities. With the approval of this new therapy, MS patients have a treatment that does not require too much disruption to their typical day.”

Rutgers Health at the HELIX Approved by University Board

Construction will begin this spring on the first of three buildings in the New Jersey Health + Life Science Exchange (HELIX), a public-private development planned in downtown New Brunswick. Rutgers Health at the HELIX will be the new home to Rutgers Robert Wood Johnson Medical School and a Rutgers translational research facility equipped with a variety of labs to advance the work of 80 research teams and put into practice health innovations that will improve individuals’ and public health. The HELIX is designed as an innovation center providing businesses, universities and researchers critical space to work, learn, experiment and collaborate. State-of-the art laboratories, offices, work and learning spaces will come together in the first, 12-story building to foster research, treatment and business breakthroughs.

Virtu Health College of Medicine & Life Sciences of Rowan University

Introducing a Powerful Partnership Like No Other

Rowan University, a top 100 public research institution, and Virtua Health, South Jersey’s largest health system, are working to advance health care education, research and biomedical engineering. Together, they’ve created the Virtua Health College of Medicine & Life Sciences of Rowan University.

Internal Controls Over Clinical Research Collaborations Over Clinical Research Collaborations

An article written by BioNJ Member CohnReznick

Pharmaceutical companies, especially those in the development stage, often enter into collaboration agreements with bigger pharmaceutical companies that have larger cash flows, more resources, and deeper technical know-how and success when it comes to product development. These agreements often cover a wide array of commercial terms and conditions, including detailing the terms over cost sharing, targets milestones, and license ownership. These terms and conditions get discussed and reviewed at various levels within both organizations, including at the senior management and board levels, because such agreements have the potential to materially change the trajectory of the company’s growth and future plans. These agreements also create the roadmap for Day One accounting, accounting through the term of the agreement and the related disclosures throughout the duration of the relationship.

Cell and Gene Therapy Manufacturing: Are We There Yet?

Hosted by ISPE NJ Chapter

March 30, 2023

Cell and Gene Therapy is becoming an important area of biopharmaceuticals as products have been commercialized. In addition, industry has significant amount of clinical phase activity. This event will provide an update on the new and upcoming field of cell and gene therapy relative to current and future manufacturing approaches. Robert Lechich from Global OT-IT Quality Services will provide a short presentation and moderate a panel discussion of industry leaders to cover manufacturing, facilities, quality, technical support and automation perspectives.

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.

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 [email protected] for the discount code.

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 dealmaking opportunities. The month of May will be here before we know it! Register before May 1, 2023 and save.