Crossroads4Hope Has Just Received a $1.5 Million Grant from the Margaret A. Darrin Charitable Trust

Crossroads4Hope, A Network of Cancer Support, has received a $1.5 million grant from the Margaret A. Darrin Charitable Trust. The gift will enable Crossroads4Hope to scale their reach and impact using a community public health model led by social work and powered by technology, including their MyGo2Support direct to mobile patient and caregiver support program, as well as the roll-out of their Health Champion Program. The organization provides people diagnosed with cancer, caregivers and family members with support, education, information, resources and access to a multidisciplinary team of professionals, all fundamental to every cancer journey and accessible at no charge.

Insmed Ranks No. 1 on Science’s 2024 Top Biopharma Employers List

Bridgewater-based BioNJ Member Insmed has earned the top ranking in Science’s 2024 Top Employers Survey. “It is a tremendous honor to have been named the No. 1 employer in Science’s annual survey for the fourth consecutive year,” said Will Lewis, Chair and Chief Executive Officer of Insmed. “This past year has been transformational for our company, as we’ve demonstrated the strength of our commercial and pipeline programs, continued to fuel the innovation engine behind our early stage research, and enhanced our culture while growing to more than 1,200 employees around the world. Looking to the future, I am filled with pride and excitement as I think about the talent, dedication and potential of our team as we strive to make a real difference in the lives of patients with serious diseases.”

Celldex Announces Barzolvolimab Met All Primary and Secondary Endpoints With High Statistical Significance in Positive Phase 2 Study in Chronic Inducible Urticaria

Hampton-based BioNJ Member Celldex Therapeutics, Inc. announced positive results from the Company’s Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)cold urticaria (ColdU) and symptomatic dermographism (SD). The study includes patients who remain symptomatic despite treatment with antihistamines. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival. CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them — exposure to cold temperatures in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD.

Soligenix Receives Hong Kong Patent for Improved Production of Synthetic Hypericin

Princeton-based BioNJ Member Soligenix announced that the Hong Kong Patent Office has granted the patent entitled "Systems and Methods for Producing Synthetic Hypericin". The newly issued patent's claims are directed to a novel, highly purified form of synthetic hypericin manufactured through a unique proprietary process. Synthetic hypericin is the active pharmaceutical ingredient in HyBryte™, the company's photodynamic therapy for the treatment of cutaneous T-cell lymphoma (CTCL), set to initiate a confirmatory Phase 3 clinical trial before the end of the year. The same active ingredient is also used in SGX302, a potential topical treatment for plaque psoriasis. This new granted patent (HK1260757) is a related patent to US Pat. Nos. 10,053,413 and 10,526,268, previously issued in the United States, and is in the same family as another patent granted in Europe. (2,571,507) and issued U.S. patents for methods of synthesis (US Pat. No. 8,629,302), as well as other granted patents throughout the world.

Otsuka’s Sibeprenlimab Shows Promise in Phase III IgA Nephropathy Trial

BioNJ Member Otsuka, with a site in Princeton, has reported positive interim results from its ongoing Phase III trial evaluating sibeprenlimab, an investigational treatment for adults with immunoglobulin A nephropathy (IgA nephropathy). Engineered by Otsuka subsidiary Visterra, sibeprenlimab is a monoclonal antibody targeting the immune pathogenic cascade of IgA nephropathy. The disease, also known as Berger's disease, can progress to end-stage kidney disease (ESKD) over time. Otsuka Pharmaceutical Development and Commercialization Executive Vice-President and Chief Medical Officer John Kraus said: "The positive interim data from this trial suggest that by targeting APRIL, we could provide a new therapeutic strategy for people living with this progressive kidney disease.”

Otsuka Announces Positive Interim Results from the Phase 3 Trial of Sibeprenlimab for the Treatment of Immunoglobulin A Nephropathy in Adults

BioNJ Member Otsuka, with a site in Princeton announced positive topline interim data from the ongoing Phase 3 clinical trial of sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgA nephropathy) in adults. Sibeprenlimab is an investigational, anti-APRIL monoclonal antibody (A PRoliferation-Inducing Ligand) that blocks a key initiating step in the immune pathogenic cascade of IgA nephropathy by limiting Gd-IgA1 production and immune complex formation. IgA nephropathy is a progressive, autoimmune, chronic kidney disease that can lead to end-stage kidney disease (ESKD) over the lifetime of most patients. Otsuka was previously granted Breakthrough Therapy designation for sibeprenlimab following favorable results of the Phase 2 ENVISION clinical trial.

PTC Therapeutics Announces FDA Acceptance of Translarna™ NDA Resubmission

Warren-based BioNJ Member PTC Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the New Drug Application (NDA) for Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). "The NDA acceptance for review is a significant milestone that brings us one step closer to providing this important treatment to boys and young men living with nonsense mutation Duchenne muscular dystrophy in the United States," said Matthew B. Klein, M.D., Chief Executive Officer, PTC Therapeutics. "The totality of evidence clearly supports the favorable safety profile and short- and long-term benefits of Translarna for individuals with nmDMD. We look forward to working with FDA throughout the review process."

BeiGene Receives Positive CHMP Opinions for TEVIMBRA® as a First-Line Treatment for Advanced/Metastatic Gastric or Gastroesophageal Junction Cancer and Esophageal Squamous Cell Carcinoma

Hopewell-based BioNJ Member BeiGene, with a site in Pennington, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued positive opinions recommending an extended authorization for TEVIMBRA® (tislelizumab) in gastric or gastroesophageal junction (G/GEJ) adenocarcinoma and esophageal squamous cell carcinoma (ESCC). In G/GEJ adenocarcinoma, the CHMP positive opinion is for TEVIMBRA in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of adult patients with HER2-negative locally advanced unresectable or metastatic G/GEJ cancer whose tumors express PD-L1 with a tumor area positivity (TAP) score ≥ 5%. In ESCC, the CHMP positive opinion is for TEVIMBRA in combination with platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic ESCC whose tumors express PD-L1 with a TAP score ≥ 5%.

Mitsubishi Tanabe Pharma America Presents New Results of RADICAVA ORS® (edaravone) from a Phase 3b Efficacy and Safety Extension Study and a Clinical Analysis of Multiple Studies at NEALS 2024

BioNJ Member Mitsubishi Tanabe Pharma, with a site in Jersey City, announced new findings from two studies of RADICAVA ORS® (edaravone). The company presented results from the MT-1186-A04 Study, a Phase 3b extension of the previously reported MT-1186-A02 study which explored the superiority of investigational once daily dosing versus the FDA-approved on/off regimen of RADICAVA ORS in people living with ALS. MTPA also shared results from primary and post-hoc analyses of RADICAVA ORS compared with Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) historical placebo controls, with evidence suggesting treatment with RADICAVA ORS increased survival outcomes and decreased physical function decline versus controls. “We’re pleased to share the findings of the Phase 3b extension study and an analysis of long-term function,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. 

Sanofi and CD&R Partner to Fuel Opella’s Ambitions in Consumer Healthcare

Bridgewater-based BioNJ Member Sanofi and CD&R announced a plan to join forces to fuel Opella’s ambitions as a French-headquartered, global consumer healthcare champion. Sanofi and CD&R have entered exclusive negotiations for the potential sale and purchase of a 50% controlling stake in Opella. This new step in Opella’s journey paves the way for the creation of a new, standalone leader in consumer healthcare, while supporting Sanofi’s strategy and increased focus on innovative medicines and vaccines. Sanofi would remain a significant shareholder, backing Opella in its future growth and path to independence. Together, CD&R and Sanofi will support Opella’s growth strategy as a pure-play, global, and fast-moving consumer healthcare company. Bpifrance is expected to participate as a minority shareholder with a c.2% stake.

Dupixent Late-Breaking Positive Phase 3 Data in Chronic Spontaneous Urticaria to be Presented at ACAAI

Bridgewater-based BioNJ Member Sanofi announced positive data from the Phase 3 LIBERTY-CUPID Study C evaluating the investigational use of Dupixent (dupilumab) in biologic-naive patients with uncontrolled chronic spontaneous urticaria (CSU) who receive background therapy with antihistamines. Results showed treatment with Dupixent significantly reduced itch and urticaria activity (itch and hive) scores from baseline, and a higher proportion of patients achieved well-controlled disease status, compared to placebo. Study C enrolled 151 children and adults who were randomized to receive Dupixent (n=74) or placebo (n=77) added to standard-of-care histamine-1 (H1) antihistamines. The safety results in Study C were generally consistent with the known safety profile of Dupixent in its approved dermatological indications. 

Novartis Receives Positive CHMP Opinion for Kisqali® to Help Reduce Risk of Recurrence in People With HR+/HER2- Early Breast Cancer

East Hanover-based BioNJ Member Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization for Kisqali® (ribociclib) for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC), at high risk of disease recurrence, including those with node-negative disease. "One-third of people diagnosed with stage II breast cancer and more than half of those diagnosed with stage III will unfortunately experience a return of their cancer in the long term, often as metastatic disease," said Peter A. Fasching, M.D., Professor of Translational Medicine, University Hospital Erlangen and Comprehensive Cancer Center Erlangen-EMN and NATALEE trial investigator.

Novartis Ribociclib (Kisqali®) Recognized as Category 1 Preferred Breast Cancer Adjuvant Treatment by NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for breast cancer were updated to recommend ribociclib (Kisqali®) as a Category 1 preferred CDK4/6 inhibitor (CDK4/6i) adjuvant therapy for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) in combination with an aromatase inhibitor (AI). Ribociclib (Kisqali) is the only CDK4/6i recommended for both all node-positive disease as well as for patients with no nodal involvement with high-risk disease characteristics, such as tumor size >5 cm, or for tumors sized 2-5 cm, either Grade 2 with high genomic risk/Ki-67 ≥20% or Grade 3. A Category 1 recommendation by the NCCN Guidelines indicates high levels of clinical evidence and uniform consensus among NCCN on ribociclib (Kisqali) as an appropriate treatment for these patients.

Novartis Oral Fabhalta® (iptacopan) Sustained Clinically Meaningful Results at One Year in Phase III C3 Glomerulopathy (C3G) Trial

East Hanover-based BioNJ Member Novartis presented 12-month data from the Phase III APPEAR-C3G study showing that patients with C3 glomerulopathy (C3G) treated with oral Fabhalta® (iptacopan) in addition to supportive care experienced clinically meaningful, sustained results at one year. These data confirm treatment with Fabhalta resulted in clinically meaningful proteinuria reduction, which was seen as early as 14 days, and sustained at 12 months. Similarly, in an open-label period of the study, proteinuria reduction was seen in participants who were switched to Fabhalta. In addition, improvement in estimated glomerular filtration rate (eGFR) slope was observed upon Fabhalta initiation compared to patients' historic rapid decline based on results from a prespecified exploratory analysis. Fabhalta showed a favorable safety profile, with no new safety signals.

Novartis Scemblix® FDA Approved in Newly Diagnosed CML, Offering Superior Efficacy, and Favorable Safety and Tolerability Profile

East Hanover-based BioNJ Member Novartis announced that Scemblix® (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). The accelerated approval is based on major molecular response rate (MMR) at week 48 from the ASC4FIRST Phase III trial that compared once daily Scemblix to all other investigator-selected (IS) standard of care (SoC) tyrosine kinase inhibitors (TKIs) (imatinib, nilotinib, dasatinib, and bosutinib). In the study, Scemblix demonstrated superior MMR rates in both primary endpoints at week 48 vs. IS SoC TKIs and imatinib alone. Continued approval for the newly diagnosed indication may be contingent upon verification and description of clinical benefit from confirmatory evidence.

Novo Nordisk A/S: Oral Semaglutide Demonstrates a 14% Reduction in Risk of Major Adverse Cardiovascular Events in Adults With Type 2 Diabetes in the SOUL Trial

Plainsboro-based BioNJ Member Novo Nordisk announced the headline results from the SOUL cardiovascular outcomes trial. The double-blinded, randomised trial compared oral semaglutide to placebo as an adjunct to standard of care for the prevention of major adverse cardiovascular events (MACE). The trial enrolled 9,650 people with type 2 diabetes and established cardiovascular disease (CVD) and/or chronic kidney disease (CKD). As part of standard of care, 49% of patients received SGLT2i at some point during the trial. The trial achieved its primary objective by demonstrating a statistically significant and superior reduction in MACE of 14% for people treated with oral semaglutide compared to placebo. The primary endpoint of the study was defined as the composite outcome of the first occurrence of MACE defined as cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.

Novo Nordisk A/S: Alhemo® Recommended for European Approval as First Once-Daily Subcutaneous Prophylactic Treatment for People Living With Haemophilia A or B With Inhibitors

Plainsboro-based BioNJ Member Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending approval of Alhemo® (concizumab) as the first once-daily subcutaneous prophylactic treatment for people aged 12 years or older living with haemophilia A or B with inhibitors. Haemophilia is a rare bleeding disorder that impairs the body’s ability to make blood clots, a process needed to stop bleeding. Alhemo® is an anti-tissue factor pathway inhibitor (TFPI) monoclonal antibody that, if approved by the European Commission, will offer the first once-daily subcutaneous prophylactic treatment to people with haemophilia A or B with inhibitors. Alhemo® is designed to block a protein called TFPI in the body that stops blood from clotting.

Lilly's Kisunla™ (donanemab-azbt) Receives Marketing Authorization in Great Britain for the Treatment of Mild Cognitive Impairment and Mild Dementia Due to Alzheimer's Disease in Adult Patients Who Are Apolipoprotein E Ε4 Heterozygotes or Non-Carriers

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for donanemab, an injection for intravenous infusion every four weeks to treat mild cognitive impairment and mild dementia due to Alzheimer's disease in eligible adults in Great Britain. Eligible patients are limited to apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers, which is a requirement for the class of currently approved amyloid-targeting therapies in Great Britain. Donanemab is the only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed. Great Britain is the third major market to approve donanemab, marketed as Kisunla.

Modified Titration of Donanemab Demonstrated Reduction of ARIA-E in Early Symptomatic Alzheimer's Disease Patients in Phase 3b study

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced positive results from the TRAILBLAZER-ALZ 6 Phase 3b study, showing a reduction in amyloid-related imaging abnormalities with edema/effusion (ARIA-E) at the 24-week primary endpoint for people receiving a slightly modified titration of donanemab in adults with early symptomatic Alzheimer's disease (AD). Donanemab is approved under the brand name Kisunla™ in the United States, Japan, Great Britain and other countries. TRAILBLAZER-ALZ 6 is a multicenter, randomized, double-blind, Phase 3b study to investigate the impact of different dosing regimens of donanemab on the rates of ARIA-E and amyloid clearance in adults with early symptomatic AD, which includes mild cognitive impairment (MCI) and the mild dementia stage of disease.

Lilly's Mirikizumab is First and Only IL23p19 Antagonist to Report Long-Term, Multi-Year, Sustained Efficacy and Safety Data for both Ulcerative Colitis and Crohn's Disease

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced results from two, multi-year, Phase 3 studies that showed patients treated with mirikizumab sustained stable, long-term remission across two types of inflammatory bowel diseases (IBD), ulcerative colitis (UC) and Crohn's disease. Mirikizumab is an interleukin-23p19 (IL23p19) antagonist that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. Inflammation due to the overactivation of the IL-23 pathway plays a critical role in pathogenesis of UC and Crohn's disease. Inflammation from UC and Crohn's disease can lead to disruptive symptoms, including bowel urgency, that can result in decreased health-related quality of life and potentially irreversible complications for patients if left untreated. 

Lilly's EBGLYSS™ (lebrikizumab-lbkz) Demonstrated Meaningful Improvement in Skin Clearance and Itch Relief in the Majority of Patients With Moderate-to-Severe Atopic Dermatitis Who Discontinued Dupilumab

New results show BioNJ Member Eli Lilly and Company, with a site in Branchburg, EBGLYSS improved skin (including hand and face) and itch among patients with moderate-to-severe atopic dermatitis (eczema) who were previously treated with dupilumab. EBGLYSS is an interleukin-13 (IL-13) inhibitor that selectively blocks IL-13 signaling with high binding affinity. The cytokine IL-13 is key in atopic dermatitis, driving the type-2 inflammatory cycle in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection. The ADapt study evaluated the efficacy and safety of EBGLYSS in patients with moderate-to-severe atopic dermatitis who were previously treated with dupilumab. To qualify for ADapt, patients must have discontinued dupilumab treatment due to inadequate response, intolerance or an adverse event, or other reasons (including cost or loss of access to the medicine). 

U.S. FDA Approves Pfizer’s RSV Vaccine ABRYSVO® for Adults Aged 18 to 59 at Increased Risk for Disease

BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO ® (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. ABRYSVO now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older. Additionally, it remains the only RSV immunization approved for pregnant individuals at 32 through 36 weeks of gestation to protect infants from birth up to 6 months of age.

Advisory Committee on Immunization Practices Recommends PREVNAR 20® (20-Valent Pneumococcal Conjugate Vaccine) for Adults Aged 50 and Older

BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practice (ACIP) voted to expand its recommendation for the use of certain pneumococcal vaccines, including PREVNAR 20 ® (20-valent Pneumococcal Conjugate Vaccine) for all adults aged 50 and older. This recommendation is pending final approval by the director of the CDC and the Department of Health and Human Services. In the U.S., the 20 serotypes contained in PREVNAR 20 are estimated to cause over 2,000 deaths and more than 65,000 cases of invasive pneumococcal disease (IPD), including bacteremia and meningitis, and community-acquired pneumonia annually in adults aged 50 to 64. 

Bristol Myers Squibb and Evotec Expand Proteomics Partnership

Princeton-based 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. Key scientific achievements drive the expansion of the pipeline of molecular glue degraders in fields beyond oncology, triggering a program-based payment of US$ 50 m to Evotec. Based on potential program-based milestones, the expansion contributes to the deal value. 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™”).

Alvotech and Teva Announce U.S. FDA Approval of Additional Presentation of SELARSDI™ (ustekinumab-aekn), Expanding its Label to Include Further Indications Approved for Reference Product, Stelara® (ustekinumab)

Parsippany-based BioNJ Member Teva Pharmaceutical and Alvotech announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) in a new presentation, 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion. This approval paves the way for SELARSDI to further align its label with the indications of the reference product Stelara® (ustekinumab) in the U.S. at launch, which is expected in the first quarter of 2025. In April 2024, the FDA approved SELARSDI 45 mg/0.5 mL and 90 mg/mL injection in a prefilled syringe for subcutaneous use, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older. 

New Data for Arexvy, GSK’s Respiratory Syncytial Virus Vaccine, Show Potential to Help Protect a Broader Group of Adults at Increased Risk for RSV Disease

Warren-based BioNJ Member GSK announced new preliminary data for Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) in adults aged 18-49 at increased risk for RSV-LRTD due to certain underlying medical conditions and in adults who are immunocompromised. These data show the vaccine’s potential to help protect a broader group of adults at risk from the potentially serious consequences of RSV. In the U.S. alone, the number of adults aged 18-49 with at least one risk factor that could put them at risk for RSV disease could exceed 21 million. The vaccine is currently approved for use in adults aged 60 and above in over 50 countries, and in adults aged 50-59 at increased risk in a number of countries including the US and Europe.

GSK and Cambridge University Announce New Five-Year Collaboration in Kidney and Respiratory Disease

Warren-based BioNJ Member GSK announced it is investing £50 million into a major new five-year collaboration with the University of Cambridge and Cambridge University Hospitals, to accelerate research and development into immune-related diseases. The collaboration, which will be called the Cambridge-GSK Translational Immunology Collaboration (CG-TIC), builds on GSK and Cambridge University’s existing scientific relationship and will aim to find ways to more precisely treat immune-related disease with existing therapies, as well as develop new ones more rapidly. It will do this by enhancing our existing focus on understanding mechanisms of disease onset, disease progression, patient response to therapies and developing translational biomarkers. The collaboration will focus on two disease areas: respiratory and kidney. Kidney disease is estimated to affect 850 million people (roughly 10% of the world’s population) and chronic respiratory diseases around 545 million people.

GSK Enters Agreement to Acquire CMG1A46 from Chimagen Biosciences to Expand Immunology Pipeline

Warren-based BioNJ Member GSK plc and Chimagen Biosciences announced an agreement for GSK to acquire CMG1A46, a clinical-stage dual CD19 and CD20-targeted T cell-engager (TCE), from Chimagen for $300 million upfront. GSK plans to develop and commercialize CMG1A46 with a focus on B cell-driven autoimmune diseases, such as systemic lupus erythematosus (SLE) and lupus nephritis (LN), with potential to expand into related autoimmune diseases. For over a decade, GSK has been a pioneer in the treatment of lupus. This agreement underscores the importance of novel therapeutic approaches to address the heterogeneity of lupus manifestations and the continued burden, particularly in patients who suffer from severe disease and are refractory to current standard of care.

New SPECTREM Study Findings Reveal TREMFYA® (guselkumab) Effectively Clears Overlooked and Undertreated Plaque Psoriasis

New Brunswick-based BioNJ Member Johnson & Johnson announced that treatment with TREMFYA® (guselkumab) resulted in clear or almost clear skin in the majority of adults with low body surface area (BSA) moderate plaque psoriasis (PsO) with special site involvement who had failed topical treatment. Sensitive or highly visible areas affected by PsO, including the scalp, face, skin folds and genitals, are considered “special sites” and can have significant impact on patients’ daily lives, yet systemic treatment is infrequently provided and this group of patients remains largely undertreated. “Results of the SPECTREM study could represent a new approach to care for patients with low body surface area psoriasis, as the majority of patients treated with TREMFYA achieved clear or almost clear skin,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health, and SPECTREM investigator.

European Commission Approves Expanded Use of HIV-1 Therapy EDURANT® (rilpivirine) in Younger Pediatric Patients

New Brunswick-based BioNJ Member Johnson & Johnson announced that the European Commission (EC) has approved EDURANT® (rilpivirine) for the treatment of HIV-1 infection in adults and children weighing at least 25 kg without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class and with a viral load ≤ 100,000 HIV‑1 RNA copies/ml. To support expanded pediatric use, new 2.5 mg dispersible tablets have been developed for weight-adjusted dosing in children 2 to less than 18 years of age, weighing at least 14 kg and less than 25 kg. The EC’s decision was supported by results from the Phase 2b PAINT (NCT00799864) and PICTURE (NCT04012931) studies, which showed no new safety findings compared with the known safety profile of rilpivirine and that rilpivirine, in combination with other antiretroviral (ARV) therapies, was effective at achieving or maintaining virological suppression in treatment-experienced and -naïve pediatric patients. 

Tevogen Bio Signs Letter of Intent With CD8 Technology to Build $50M R&D and Manufacturing Facility

Warren-based BioNJ Member Tevogen Bio took significant steps toward expanding R&D and manufacturing capabilities. CD8 Technology committed to providing a $50 million, turn-key facility to Tevogen on a first-priority basis for its manufacturing needs to develop off-the-shelf, genetically unmodified T-cell therapeutics to treat infectious disease and cancers. Tevogen announced a $1b+ forecast earlier this month and through this facility, should be able to realize its revenue potential. The proposed facility is intended to support both pre-clinical research and GMP manufacturing capabilities, staffed by Tevogen. “This facility will be instrumental in advancing our mission to bring innovative solutions to market with speed and cost efficiency,” said Ryan Saadi, CEO of Tevogen Bio.

Lexicon Announces Exclusive Licensing Agreement With Viatris for Sotagliflozin in All Markets Outside of the U.S. and Europe

BioNJ Member Lexicon Pharmaceuticals, Inc., with a site in Bridgewater, announced that Viatris Inc. has obtained an exclusive license from Lexicon to commercialize sotagliflozin outside of the United States and Europe in all indications. Lexicon retains sole commercialization rights for sotagliflozin in all indications in the United States and Europe. Sotagliflozin was approved by the U.S. Food and Drug Administration in May 2023 to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease and other cardiovascular risk factors. Viatris chief commercial officer Corinne Le Goff said: “This licensing agreement with Lexicon adds another asset to our expanding innovative portfolio in cardiovascular diseases which gives us the opportunity to further drive accelerated and durable revenue growth in the future.”

Lexicon Announces Completion of Screening in Phase 2B PROGRESS Study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP)

BioNJ Member Lexicon Pharmaceuticals, Inc., with a site in Bridgewater, announced that it has closed screening and expects to complete enrollment ahead of schedule in PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-GRoup, MulticEnter Study in Patients with Diabetic Peripheral Neuropathic Pain) studying LX9211, an orally-delivered, potent, selective, investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1). The company also updated its expectations for the timing of anticipated top-line data, from the second quarter of 2025 to the first quarter of 2025. “We are excited to be ahead of schedule for a near-term completion of PROGRESS for LX9211, with top-line data now anticipated in Q1 of next year,” said Craig Granowitz, M.D., Ph.D., Lexicon’s Senior Vice President and Chief Medical Officer.

New Analysis of Phase 3 Data Demonstrating Renal Protective Benefits of Sotagliflozin to Be Presented at ASN Kidney Week 2024

BioNJ Member Lexicon Pharmaceuticals, with a site in Bridgewater, released a new analysis of its Phase 3 SCORED clinical trial demonstrating the protective effects of sotagliflozin in patients with diabetic kidney disease (DKD). Previous analyses of the SCORED trial have shown that sotagliflozin, a dual SGLT1 & 2 inhibitor, reduced the risk of kidney and cardiorenal composite endpoints in patients with type 2 diabetes (T2D) and diabetic kidney disease (DKD). The objective of this new post hoc analysis of SCORED was to evaluate the effect of sotagliflozin versus placebo on Estimated Glomerular Filtration Rate (eGFR) slope, and the impact of baseline kidney function and glycemia. The eGFR slope assessment is widely used as a surrogate endpoint in cardiovascular and chronic kidney disease trials.

Gilead and Merck Announce Phase 2 Data Showing a Treatment Switch to an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression in Adults at Week 48

BioNJ Member Gilead Sciences, with a site in Morris Plains, and Rahway-based BioNJ Member Merck & Co. announced new results from a Phase 2 clinical study evaluating the investigational combination of islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class HIV-1 capsid inhibitor. At 48 weeks, the novel investigational combination maintained a high rate (n=49; 94.2%) of viral suppression (HIV-1 RNA <50 copies/mL) in virologically suppressed adults, a secondary endpoint of the study. Zero participants had a viral load of ≥50 copies/mL at Week 48. Week 24 results, including the study’s primary endpoint, were previously presented at the 31st Conference on Retroviruses and Opportunistic Infections (CROI).

Merck’s Clesrovimab (MK-1654), an Investigational Respiratory Syncytial Virus (RSV) Preventative Monoclonal Antibody, Significantly Reduced Incidence of RSV Disease and Hospitalization in Healthy Preterm and Full-term Infants

Rahway-based BioNJ Member Merck & Co. announced the presentation of positive results from the Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab, the company’s investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season. Results from MK-1654-004, a placebo-controlled Phase 2b/3 pivotal trial evaluating a single dose of clesrovimab administered to healthy preterm and full-term infants (birth to 1 year of age) met all prespecified endpoints, with consistent results through both the 5-month and 6-month time points. The incidence of adverse events (AEs) and serious AEs were comparable between the clesrovimab and placebo groups, and there were no treatment or RSV-related deaths during the study.

Merck’s KEYTRUDA® (pembrolizumab) Receives 30th Approval from European Commission With Two New Indications in Gynecologic Cancers

Rahway-based BioNJ Member Merck & Co. announced that the European Commission (EC) has approved two new indications for KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in gynecologic cancers. The first approval is for KEYTRUDA, in combination with carboplatin and paclitaxel, for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy. The second approval is for KEYTRUDA, in combination with chemoradiotherapy (CRT), for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy. With these decisions, KEYTRUDA is now approved for 30 indications in the EU, including five in gynecologic cancers – three in endometrial cancer and two in cervical cancer.

Merck Acquires Modifi Biosciences

Modifi Biosciences, Inc. has been acquired by Rahway-based BioNJ Member Merck & Co. Under the terms of the agreement Merck, through a subsidiary, has acquired all outstanding shares of Modifi Biosciences for $30 million. Modifi Biosciences shareholders are also eligible to receive potential milestone payments totaling up to $1.3 billion. Modifi Biosciences, a Yale University spinout company formed in 2021, has developed a novel class of small molecules that target cancer cells lacking expression of a key DNA repair protein called O6-methylguanine methyl transferase (MGMT). Modifi Biosciences’ research has been validated through its initial work published by the academic founders in Science in 2022, and subsequent compelling pre-clinical data across a number of tumor models including patient-derived xenograft models of gliomas and other cancers with intrinsic DNA repair defects.

CDC’S ACIP Recommends Merck’s CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Pneumococcal Vaccination in Adults 50 Years of Age and Older

Rahway-based BioNJ Member Merck & Co. announced that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted to update the adult age-based pneumococcal vaccination guidelines and recommends CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for pneumococcal vaccination in adults 50 years of age and older. “The CDC’s decision to lower the age-based vaccination recommendations to begin at age 50 has the potential to be a practice-changing milestone,” said Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. “This recommendation is a significant step forward in efforts to enhance equitable access and may improve vaccination rates. We’re pleased about this progress and thank the CDC for their commitment to addressing invasive pneumococcal disease and pneumococcal pneumonia in adults.”

Merck and Moderna Initiate Phase 3 Trial Evaluating Adjuvant V940 (mRNA-4157) in Combination with KEYTRUDA® (pembrolizumab) After Neoadjuvant KEYTRUDA and Chemotherapy in Patients With Certain Types of Non-Small Cell Lung Cancer (NSCLC)

Rahway-based BioNJ Member Merck & Co. and Moderna, Inc. announced the initiation of INTerpath-009, a pivotal Phase 3 randomized clinical trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, as adjuvant treatment for patients with resectable Stage II, IIIA or IIIB (N2) non-small cell lung cancer (NSCLC) who did not achieve a pathological complete response (pCR) after receiving neoadjuvant KEYTRUDA plus platinum-based chemotherapy. Global recruitment in INTerpath-009 has begun, and the first patients have now started enrolling in Canada. “We are excited to build on our ongoing collaboration with our colleagues at Merck by expanding our research efforts for patients with NSCLC,” said Kyle Holen, M.D., Moderna's Senior Vice President and Head of Development, Therapeutics and Oncology.

A Joint Regional Cohort Study by Shimadzu, Eisai, Oita University, and Usuki City Medical Association Demonstrating the Utility of Blood Biomarkers in Predicting Amyloid Beta Accumulation in the Brain

Nutley-based BioNJ Member Eisai, Shimadzu Corporation, Oita University and Usuki City Medical Association have demonstrated the utility of blood biomarkers in predicting the accumulation of amyloid beta (Aβ) (Note 1) in the brain, a noted cause of Alzheimer’s disease (Note 2), in a cohort study conducted in Usuki City, Oita from November 2022. This joint research attempts to develop Japan’s first diagnostic workflow for mild cognitive impairment (MCI) due to Alzheimer’s disease and mild dementia based on blood biomarkers. Comprising a Phase 1 and Phase 2 study, the Phase 1 study uses frozen samples of blood plasma from a regional cohort collected by a prospective cohort study performed in Usuki City between 2015 and 2019 to evaluate the utility of blood biomarkers in predicting Aβ accumulation in the brain.

AbbVie and EvolveImmune Therapeutics Announce Collaboration and Option-to-License Agreement to Develop Next-Generation Cancer Biotherapeutics

BioNJ Member AbbVie, with a site in Madison, and EvolveImmune Therapeutics, an immuno-oncology company developing next-generation biotherapeutics to overcome the therapeutic challenges of cancer cell resistance to current immunotherapies, today announced a collaboration and option-to-license agreement to develop multispecific biologics for multiple targets in oncology. The discovery partnership will leverage EvolveImmune's T-cell engager platform to develop novel antibody-based therapies for solid and hematologic malignancies. EvolveImmune's proprietary EVOLVE platform is designed to deliver potent, selective and integrated T-cell co-stimulation to amplify and sustain the tumor killing capacity of the T-cells. This approach aims to bypass low tumor immunogenicity, conditionally activate adaptive immunity and reduce T-cell dysfunction to overcome therapeutic challenges in solid and hematologic tumors.

AbbVie to Acquire Aliada Therapeutics, Strengthening Focus in Alzheimer's Disease and Neuroscience Pipeline

BioNJ Member AbbVie, with a site in Madison, and Aliada Therapeutics announced a definitive agreement under which AbbVie will acquire Aliada. Aliada's lead investigational asset utilizing this delivery technology, ALIA-1758, is an anti-pyroglutamate amyloid beta (3pE-Aβ) antibody in development for the treatment of Alzheimer's disease. Aliada is advancing therapeutic candidates using its Modular Delivery (MODEL™) platform, engineered for high-precision CNS drug delivery. The novel BBB-crossing technology targets transferrin and CD98 receptors (TfR and CD98) which are highly expressed in brain endothelial cells. By engineering highly optimized TfR or CD98 binders, this platform is designed to deliver different types of biological cargoes into the brain, including therapeutic antibodies and genetic medicines such as siRNA. ALIA-1758 utilizes TfR to transport a 3pE-Aβ antibody across the BBB to enable degradation and elimination of amyloid beta plaques, a pathological hallmark of Alzheimer's disease.

Organon Completes Acquisition of Dermavant, Including Innovative Dermatologic Therapy, VTAMA® (tapinarof) Cream, 1%

Madison-based BioNJ Member Organon announced the successful completion of its acquisition of Dermavant Sciences Ltd. from Roivant (NASDAQ: ROIV). Dermavant is a company dedicated to developing and commercializing innovative therapeutic solutions in immuno-dermatology. VTAMA ® (tapinarof) cream, 1%, is a novel nonbiologic, non-steroidal topical therapy approved by the U.S. Food and Drug Administration (FDA) for treatment of mild, moderate, and severe plaque psoriasis in adults with no safety label warnings or precautions and without restrictions on location and duration of use or body surface area. The FDA is reviewing a supplemental New Drug Application (sNDA) for VTAMA cream as a potential treatment for atopic dermatitis (AD) in adults and children two years of age and older, with Prescription Drug User Fee Act (PDUFA) action expected in the fourth quarter of calendar year 2024.

Vertex to Present Phase 3 Data Highlighting Suzetrigine’s Potential as a First-in-Class, Highly Selective Pain Signal Inhibitor at the American Society of Anesthesiologists Annual Meeting

BioNJ Member Vertex Pharmaceuticals announced that the company will present its pivotal Phase 3 data on suzetrigine, an investigational, oral, highly selective NaV1.8 pain signal inhibitor for the treatment of moderate-to-severe acute pain, at the annual meeting of the American Society of Anesthesiologists. This will be the first time the suzetrigine Phase 3 data will be presented to the medical community following the January 2024 announcement that the Phase 3 trials were positive. The Phase 3 program included two randomized, double-blind, placebo-controlled trials, one following abdominoplasty surgery and one following bunionectomy surgery, as well as a single arm safety and effectiveness study which enrolled patients with a broad range of surgical and non-surgical pain conditions. Results from all three studies demonstrate compelling and consistent efficacy and safety across multiple acute pain conditions and settings.

Amneal Receives U.S. FDA Approval of New Drug Application for Pyridostigmine Bromide Extended-Release Tablets

Bridgewater-based Amneal Pharmaceuticals, Inc. announced that it has received U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Pyridostigmine Bromide Extended-Release (PB ER) Tablets USP 105 mg. PB ER 105 mg tablets are a once-daily, orally administered product indicated for pretreatment against the lethal effects of soman nerve agent poisoning in adults developed for the U.S. Armed Services and U.S. allies. This product offers potential for improved compliance and steady 24-hour release of the drug’s therapeutic benefit, which is intended to provide an alternative to the current PB product that is administered every eight hours and avoiding the need for service members to self-administer three times a day.

UroGen Announces FDA Acceptance of its New Drug Application for UGN-102

Princeton-based UroGen Pharma Ltd. announced U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for investigational drug UGN-102 (mitomycin) for intravesical solution. UGN-102 could become the first FDA-approved medicine for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 13, 2025. "The FDA acceptance of our NDA is a pivotal moment in our journey to bring UGN-102 to patients,” said Liz Barrett, President and Chief Executive Officer of UroGen. “UGN-102 could be the first FDA-approved medicine for LG-IR-NMIBC, offering a novel approach that could expand treatment options and address unmet needs.”

ENVISION Trial Results Published in the Journal of Urology Report 82.3% Duration of Response 12 Months after Achieving Complete Response for UGN-102, Potentially First FDA-Approved Non-Surgical Treatment for LG-IR-NMIBC

Princeton-based UroGen Pharma Ltd. announced that new long-term durability of response results from the Phase 3 ENVISION study of investigational drug UGN-102 in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC) were published online in the Journal of Urology. “These data demonstrate that treatment with UGN-102 results in a clinically meaningful CR rate and that the durability of the response in patients with LG-IR-NMIBC is robust,” said Sandip Prasad, MD, M.Phil., Director of Genitourinary Surgical Oncology, Morristown Medical Center/Atlantic Health System, NJ and Principal Investigator of the ENVISION trial. “This study adds to the mounting evidence supporting UGN-102 as a potentially valuable treatment option for patients with recurrent LG-IR-NMIBC.”

IDWeek 2024: Shionogi Presents Largest Global Real-World Evidence Study of Cefiderocol Demonstrating Strong Clinical Response Rates Across Seriously Ill Patients

Florham Park-based Shionogi & Co. announced new data at IDWeek 2024 from PROVE (Retrospective Cefiderocol Chart Review), the largest global real-world evidence study of Fetroja®/Fetcroja® (cefiderocol), an innovative siderophore cephalosporin, for the treatment of seriously ill adult patients with certain Gram-negative (GN) bacterial infections, the majority of which were carbapenem-resistant (CR). PROVE is an international, multicenter, retrospective medical chart review study designed to describe the patient characteristics and clinical outcomes in patients treated with cefiderocol for GN bacterial infections in real-world settings between 2020 and 2024. Of the patients included in the analysis, 75.1% had a favorable clinical response to cefiderocol at the end of treatment (defined as resolution or improvement of signs and symptoms as judged by the physician, excluding deaths while on therapy).

LEO Pharma Launches Anzupgo® (delgocitinib) Cream in its Home Market Denmark as the Second Country in the World

In 1908, LEO Pharma A/S – then “Løvens Kemiske Fabrik” – launched new treatments for Danish patients for the first time. 116 years later, the Danish company, with a site in Madison, announced the launch of a new product in Denmark, Anzupgo® (delgocitinib) cream for the treatment of adult patients with moderate to severe chronic hand eczema where topical corticosteroids are inadequate or inappropriate. ”Today is an important milestone for us at LEO Pharma. Chronic Hand Eczema can affect far more than just your skin – including your mental health, your social life and your opportunities to take care of your work or your family. Historically, Chronic Hand Eczema has been an overlooked disease in many countries – but in Denmark, the problem has been recognized for a long time among dermatologists,” said Anja Verhaug, General Manager for LEO Pharma Nordics.

U.S. Pharma Lab to Occupy 163,657 SF at Former J&J Campus in New Brunswick

SL Industrial Partners, a member of the Silverman Group, signed a pre-construction, full-building lease agreement with U.S. Pharma Lab LLC for a 162,657-square-foot build-to-suit facility at the North Brunswick Logistics Center. U.S. Pharma Lab was attracted to the property due to its proximity to the firm’s existing facilities and the convenient commute for employees. The expansion is driven by client business growth, and the new build-to-suit facility will enhance US Pharma Lab’s manufacturing and distribution capabilities. The new building is located at 2 King Arthur Court on the site of a former Johnson & Johnson office building.

CoreWeave to Take 280K SF Space at the NEST in Kenilworth; Invest $1.2 Billion at Facility

CoreWeave, one of the most important AI companies in the country, has signed a long-term lease with an Onyx Equities and Machine Investment Group partnership for the entirety of building 11 at the Northeast Science & Technology Center in Kenilworth, better known as the NEST. CoreWeave plans to convert the 280,000-square-foot former lab and manufacturing building into a state-of-the-art data center. CoreWeave also plans to invest $1.2 billion, and the Onyx Equities-led venture expects to spend over $50 million on the project, which will become CoreWeave’s first data center in New Jersey. “CoreWeave’s commitment to invest over a billion dollars at the NEST campus demonstrates New Jersey’s leading role in artificial intelligence, and our innovation strategies are working,” Governor Murphy said.

Tevogen Bio’s Effort in Artificial Intelligence, Tevogen AI, Joins Microsoft for Startups

Tevogen Bio announced its Artificial Intelligence effort, Tevogen AI, has joined Microsoft for Startups. This partnership marks a significant milestone for Tevogen, providing unparalleled access to Microsoft’s extensive ecosystem. The partnership is set to accelerate and streamline the development of Tevogen’s proprietary algorithms, significantly advancing its mission to lower the total cost of drug development, expedite drug discovery and deliver life-changing therapies to large patient populations. ”The partnership with Microsoft, the leading innovator in the AI space, is a substantial investment in Tevogen’s goal to provide affordable and accessible therapies. By leveraging Microsoft’s cutting-edge AI technology, Tevogen aims to push the boundaries of what AI can achieve in the biotech industry." said Mittul Mehta, CIO and head of Tevogen AI.

John Theurer Cancer Center First in U.S. to Evaluate New AI Technology

Urologic oncology researchers in the department of Urology at Hackensack Meridian John Theurer Cancer Center (JTCC) at Hackensack University Medical Center —  a research partner with Georgetown’s Lombardi Comprehensive Cancer Center, an NCI-designated comprehensive cancer center — received a significant grant to evaluate a new artificial intelligence-based technology that would enable doctors to better estimate how aggressive a prostate cancer might be after undergoing radical prostatectomy (prostate removal surgery). Such information would allow clinicians to know which patients may need more intensive therapy post surgery. The ArteraAI Prostate Test, an AI-enabled test, is the first of its kind to provide both prognostic and predictive results for patients with localized prostate cancer. Artera’s multimodal artificial intelligence (MMAI) platform leverages a unique algorithm that assesses digital images from a patient’s histopathology biopsy slide and their clinical data.

Rutgers Makes $10M Investment to Become Leader in AI, Data Science

Rutgers University-New Brunswick leaders made an initial investment of $10 million to advance the university’s capabilities and expand the scope of its research and scholarship on artificial intelligence and data science. The university expects to produce groundbreaking insights and practical solutions, through a multipronged program, that will mark it as an innovator in the revolutionary technologies. The program will include: the establishment of a research collaboratory — soliciting ideas for proposals of interdisciplinary research projects, the creation of two new AI- and data science-centric student research programs and new partnerships with governmental agencies and industry leaders. Rutgers Artificial Intelligence and Data Science (RAD) Collaboratory, will be at the center of this vision. The initiative will serve as a virtual hub where university researchers and students can lead efforts to make discoveries and devise practical applications.

Governor Murphy Announces Planned Innovation Center Based in Newark

Governor Phil Murphy today announced that the New Jersey Economic Development Authority (NJEDA) and the New Jersey Innovation Institute (NJII), a corporation of the New Jersey Institute of Technology (NJIT), have launched the NJII Venture Studio, the state’s latest Strategic Innovation Center (SIC). The NJII Venture Studio will focus on accelerating and commercializing intellectual property with a focus on high technology and information technology developed by NJIT, NJII and NJIT’s corporate partners, as well as other academic institutions who contribute to the advancement of the industry. This will be the seventh SIC in New Jersey announced under the Murphy Administration.

NJIT Opens New Center, Expands Opportunities for Entrepreneurship

The New Jersey Institute of Technology has opened the Center for Student Entrepreneurship, which will centralize and grow the university’s resources that expose students to the spirit and skills necessary to think in an innovative mindset. Other entrepreneurship resources at NJIT also welcome undergraduates, but until now these students have not had a center focused solely on them, explained Kathy Naasz, Executive Director of Student Entrepreneurship. “We have a strong foundation already at NJIT. We’re ranked top 50 in student entrepreneurship. And we’re taking it and amplifying it, to ignite the entrepreneurial spirit earlier. Our mission is to radically increase access to and participation in entrepreneurial efforts and learning for all NJIT students,” Ms. Naasz said.

Announcing Apollo Technology Center

We're excited to announce the launch of a brand-new learning space, slated to open in Fall 2025, that will expand STEM Access for ALL students in New Jersey. Located at One Apollo Drive in Whippany, NJ, the Apollo Technology Center is a 20,000 sq. ft., two story learning space featuring eight state-of-the-art middle and high school laboratories, an elementary school lab and a workforce development space. Opening in Fall 2025, the Apollo Technology Center will replace the East Hanover Technology Center and become Students 2 Science’s headquarters.

Brooks, Gitai, Krienen and Skinnider Win Prestigious NIH Awards

Every year, the National Institutes of Health selects a handful of researchers performing innovative blue-sky scientific research to receive funding through its High-Risk, High-Reward Research program. This year, the NIH awarded $207 million in grants to 67 high-risk, high-reward biomedical and behavioral researchers, including four at Princeton: John F. Brooks II, Zemer Gitai, Fenna Krienen and Michael Skinnider. “The High-Risk, High-Reward program champions exceptionally bold and innovative science that pushes the boundaries of biomedical and behavioral research,” said Tara Schwetz, Deputy Director of the NIH for Program Coordination, Planning, and Strategic Initiatives. “The groundbreaking science pursued by these researchers is poised to have a broad impact on human health.”

Libutti Honored With New Title: The Inaugural William N. Hait Director of Rutgers Cancer Institute

Dr. Steven Libutti, who has run the Rutgers Cancer Institute since 2017, was given a more formal title, when he was named the inaugural William N. Hait Director of Rutgers Cancer Institute, a position named in honor of the institute’s founding director. The William N. Hait Endowed Directorship at Rutgers Cancer Institute was established through the donation of $7.4 million raised to honor the pioneering contributions to cancer research and care by Dr. Hait. Dr. Hait, who recently retired as the Executive Vice President, Chief External Innovation and Medical Officer at Johnson & Johnson, has held numerous global leadership positions where he focused his teams on addressing unmet medical needs through breakthrough science, transforming the lives of millions of patients worldwide.

Golden Seeds’ New Jersey Chapter Joins National Chapter in Celebrating its 20th Anniversary; Highlights Success of Supporting Women-Led Companies

The New Jersey chapter of Golden Seeds, supported by First Lady Tammy Murphy and the New Jersey Economic Development Authority (NJEDA), joined the national chapter in commemorating its 20th anniversary at a celebration on Tuesday in Montclair. Golden Seeds is one of the nation’s most active early stage angel investment firms focused on supporting women-led businesses, investing over $185 million into 250 companies since it was established in 2004. The New Jersey Golden Seeds chapter, which was founded in 2020, has invested over $9.7 million in female-led companies.

Modern Meadow Appoints Williamson as CEO

Nutley-based Modern Meadow has announced that David Williamson, Ph.D., has transitioned from President and Chief Operating Officer to Chief Executive Officer. Dr. Williamson has served in multiple roles within the company since 2015 and will now spearhead its next phase of growth. As CEO, Dr. Williamson will continue executing on the company’s strategic growth plan to create sustainable biofabricated materials that offer new levels of performance, sustainability and design possibilities. With his extensive background in material science, biotechnology and production environments, Dr. Williamson will continue executing Modern Meadow’s strategic growth plan to create sustainable biofabricated materials that offer new levels of performance, sustainability and design possibilities, like BIO-VERA.

Pacira BioSciences Appoints Shawn Cross as Chief Financial Officer

Pacira BioSciences, Inc., with a site in Parsippany, announced the appointment of Shawn Cross as Chief Financial Officer. In this role, Mr. Cross will be responsible for overseeing all aspects of the company’s financial operations. “We are delighted to welcome Shawn as our new Chief Financial Officer and look forward to his leadership and guidance as we invest in long-term growth and value creation while maintaining high standards in resource allocation and execution,” said Frank D. Lee, Chief Executive Officer of Pacira BioSciences. “Shawn brings a strong set of experiences in finance and embraces our values to advance our mission to transform the lives of patients.”

Ascendis Pharma Sustainability & P|ESG Report 2023

Ascendis Pharma remains committed to applying our TransCon™ technology platform, as we continue to grow as a biopharmaceutical company with a primary focus on enhancing patients’ lives. Guided by our Vision 3x3 – building a leading global biopharma company and our commitment to patients, science and passion, we are determined to fulfill our mission by developing therapies that address unmet medical needs. Our commitment to responsible corporate governance underscores our dedication to delivering safe and effective medicines to people who rely on our products. 

Students 2 Science STEM Volunteer Opportunities

Inspire the next generation of STEM leaders – Volunteer at Students 2 Science (S2S), a recognized leader in providing rigorous, hands-on STEM experiences for students in 5th-12th grades. S2S is currently recruiting volunteers for its in-lab ISAAC program, which offers rigorous, hands-on STEM experiences for middle and high school students in state-of-the-art laboratories in East Hanover and Newark, NJ. For more information, click here. To register to volunteer with S2S or if you have any questions, please email info@students2science.org or call (973) 947-4880 ext. 545.

Data-Driven Precision Health: Integrating Genomics, Climate, and the Environment

November 7 | Hosted by Princeton Precision Health

The November 7 conference, a collaboration between Princeton Precision Health and NOAA’s Geophysical Fluid Dynamics Laboratory and co-sponsored by Princeton’s High Meadows Environmental Institute, will bring together an interdisciplinary community from academia, government, and industry to explore research questions at the intersection of human health, climate, and environment. The event aims to spark discussions and inspire new research directions on future health impacts, with a focus on predicting outcomes and developing equitable risk mitigation strategies.

Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation

November 7 | Hosted by FDA Center for Drug Evaluation and Research

This webinar aims to inform stakeholders, particularly those who design, implement and assess risk evaluation and mitigation strategies (REMS), on the recently published guidance REMS Logic Model: A Framework to Link Program Design With Assessment. The REMS Logic Model provides a systematic, structured approach to the design, implementation, and evaluation of a REMS. The aim of applying the REMS Logic Model is to optimize REMS design and improve the way REMS are assessed by developing clear goals, objectives, and strategies that align with the intended outcomes of the REMS.

Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies

November 12 | Hosted by FDA Center for Drug Evaluation and Research

This webinar will discuss the final guidance for the industry Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies which was published in July 2024. This guidance describes the FDA’s recommendations regarding clinical pharmacology considerations for conducting human radiolabeled mass balance studies of investigational drugs. Our FDA subject matter experts will also address recommendations from the guidance including, deciding whether and when to conduct the study, as well as how to design and report results from a human radiolabeled mass balance study. The presenters will communicate when and how to perform these studies, as well as how the results from the mass balance studies can inform the drug development program and consequently inform the safe and effective use of drugs.

New Jersey Manufacturing Voucher Program Phase 3 Informational Webinar

November 12 | Hosted by New Jersey Economic Development Authority (NJEDA)

The New Jersey Economic Development Authority (NJEDA) is offering a third round of funding through the New Jersey Manufacturing Voucher Program (MVP) Phase 3. This program provides grant funding for New Jersey manufacturers to purchase new equipment, with the grant size covering 30% to 50% of the cost of eligible equipment (including installation), up to a maximum award amount of $250,000. Grant recipients of Phase 1 or 2 of this program are not eligible for Phase 3 funding. Complete program and eligibility details will be reviewed during this info session. Participants will also be able to submit questions during the session. Complete updated program information is available at https://www.njeda.gov/mvp3/.

7th Annual Symposium for Life Science Innovation and Development

November 12 | Hosted by NY Metro Builds Bio+

Join NY Metro Builds Bio+ at the Seventh Annual Symposium for Life Science Innovation and Development to hear how private and public investments are driving exponential growth for the life science industry, what new initiatives are furthering innovation in the space and what this means for the Greater NY Metropolitan Area.The symposium will also highlight a new London/UK life sciences chapter and we’ll present the research report from the London life sciences study tour which took place in April 2024.

Life Sciences Innovation Showcase

November 12 | Hosted by Princeton Innovation Center BioLabs, Princeton Innovation, and Rutgers Research

This invite-only event focuses on biotech entrepreneurs, early stage investors, and top tech transfer experts. The day features technology pitches from top New Jersey universities, a panel session, information about resources for New Jersey startups, and carefully curated networking. EARLY STAGE INVESTORS: Meet the next generation of startups and preview the technologies ready to spin out of New Jersey’s top universities — including therapeutics, diagnostics, medical devices, and more. BIOTECH ENTREPRENEURS: Meet the money, learn about the resources you’ll need to successfully start a life science company, and make connections in the New Jersey life science ecosystem. TECH TRANSFER EXPERTS: Connect with your peers, showcase your most promising technologies, and meet investors and serial entrepreneurs looking for their next project.

BIO Tech Transfer Committee/CSBA Session with NCI-SBIR Michael Weingarten

November 14 | Hosted by National Cancer Institute

You are invited to attend an information-sharing session with the National Cancer Institute-Small Business Innovation Research Program Director Michael Weingarten from 12–1 PM on Thursday, November 14 to learn about current seed funding programs, deadlines for submissions within NCI, and ways that your early stage companies within industry and academic settings can successfully compete for these non-dilutive funds where grantees retain their intellectual property rights.

M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms - Implementing the Final Guidance

November 21 | Hosted by FDA Center for Drug Evaluation and Research

This webinar will provide an update and overview on the final M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms guideline including major changes from the draft guideline and FDA’s current bioequivalence (BE) guidance, delineate FDA’s planning on the implementation of M13A, and address questions and provide clarifications based on questions/comments received during public consultation of the draft guideline.