View Webinar

Top Priorities for Life Sciences CFOs in 2024

This webinar dives into insights from BDO’s "2024 Life Sciences CFO Outlook Survey", capturing the expectations of industry CFOs.

Hear how CFOs are adapting cash management and investing strategies amidst economic volatility, optimizing tax strategies, prioritizing treatments and drug modalities, and addressing generative AI risks, particularly concerning data privacy.

Bayh-Dole Coalition Statement on the U.S. Patent and Trademark Office’s Flawed Call for Ideas to Accelerate American Innovation

The U.S. Patent and Trademark Office (PTO) recently issued a request for comments “on ways to accelerate and incentivize the commercialization of innovation, including green, critical and emerging technologies.” Click here for a statement on the request written by Joseph P. Allen, Executive Director of the Bayh-Dole Coalition.

Celldex Announces Completion of Enrollment in Phase 2 Study of Barzolvolimab in Patients With Chronic Inducible Urticaria

Hampton-based BioNJ Member Celldex Therapeutics, Inc. announced that patient enrollment has been completed in the company’s Phase 2 clinical study of barzolvolimab for the treatment of the two most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them—temperatures below skin temperature in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD. 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.

Legend Biotech’s CARVYKTI® (ciltacabtagene autoleucel) Becomes the First and Only BCMA-Targeted CAR-T Cell Therapy Approved by the FDA for Second-Line Treatment of Multiple Myeloma

Somerset-based BioNJ Member Legend Biotech Corporation announced the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor (PI), and an immunomodulatory agent (IMiD), and are refractory to lenalidomide. CARVYKTI® is the first and only B-cell Maturation Antigen (BCMA) targeted therapy, including CAR-T therapies, bispecific antibodies, and antibody-drug conjugates (ADCs), approved starting in the second-line of treatment for patients with multiple myeloma. The FDA approval is based on positive results from the CARTITUDE-4 study, which demonstrated that CARVYKTI® resulted in statistically significant and clinically meaningful improvement of progression-free survival compared to two standard of care treatment regimens, pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd), in adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.

FDA Grants Soligenix Orphan Drug Designation for the Prevention and Post-Exposure Prophylaxis Against Sudan Ebolavirus Infection

Princeton-based BioNJ Member Soligenix announced that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in SuVax™, the subunit protein vaccine of recombinantly expressed Sudan ebolavirus (SUDV) glycoprotein, for "the prevention and post-exposure prophylaxis against SUDV infection." The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders, defined as one that affects fewer than 200,000 people in the U.S. In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a Biologics License Application (BLA), and certain tax credits.

FDA Grants Soligenix Orphan Drug Designation for the Prevention and Post-Exposure Prophylaxis Against Marburg Marburgvirus Infection

Princeton-based BioNJ Member Soligenix announced that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in MarVax™, the subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, for "the prevention and post-exposure prophylaxis against MARV infection." The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders, defined as one that affects fewer than 200,000 people in the U.S. In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a Biologics License Application (BLA), and certain tax credits.

New 48-Week Frexalimab Phase 2 Data Support Potential for High Sustained Efficacy in Multiple Sclerosis

Bridgewater-based BioNJ Member Sanofi announced its CD40L antibody, frexalimab, demonstrated sustained reduction of disease activity and favorable tolerability after nearly one year in participants with relapsing multiple sclerosis. From the initial 12-week double-blind period, 97% (125/129) of study participants entered the open-label extension (OLE) of the phase 2 study. Of all participants receiving frexalimab, both on high- and low-dose regimens and participants who switched from placebo at the start of the open-label extension period (week 12), 87% (112/129) remained in the study at the 48-week cut-off. During the OLE, participants in the high- (n=50) and low-dose (n=49) arms continued to receive frexalimab 1200 mg intravenously every four weeks, or frexalimab 300 mg subcutaneously every two weeks, respectively, while those initially receiving placebo switched to the aforementioned high or low dose frexalimab treatment arms (n=12 and n=14, respectively).

Pfizer Announces Positive Top-Line Results from Phase 3 Study of ABRYSVO® in Adults Aged 18 to 59 at Increased Risk for RSV Disease

BioNJ Member Pfizer, with a site in Peapack, announced positive top-line immunogenicity and safety data from the ongoing pivotal Phase 3 clinical trial MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness), evaluating a single dose of ABRYSVO versus placebo in adults 18 to 59 years of age at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD). Adults with certain underlying chronic conditions are at increased risk of developing, and being hospitalized for, RSV-associated LRTD. Among U.S. adults 18 to 49 years of age, 9.5 percent have a chronic condition that puts them at risk of severe RSV disease and this percentage rises to 24.3 percent among persons 50 to 64 years of age.

Antiepileptic Drug Fycompa® Injection Formulation Launched in Japan

Nutley-based BioNJ Member Eisai Co., Ltd. announced that the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa® (perampanel hydrate) for intravenous (IV) infusion has been launched in Japan. The injection formulation of Fycompa received manufacturing and marketing approval on January 18, 2024 and was included in the Japan’s National Health Insurance (NHI) Drug Price List. Fycompa is a first-in-class AED discovered at Eisai’s Tsukuba Research Laboratories. The agent is a selective, noncompetitive AMPA receptor antagonist that is postulated to reduce neuronal hyper-excitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. Two oral formulations of Fycompa are available in Japan: a tablet and a fine granule formulation.

Findings Presented at ACC.24 Showed XARELTO® (rivaroxaban) Reduced the Risk of Clinically Significant Bleeding and Net Adverse Clinical Events or Rehospitalization

New Brunswick-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced a new analysis of data from the PIONEER AF-PCI clinical trial demonstrating that XARELTO® (rivaroxaban) was associated with a reduced risk of clinically significant bleeding (CSB), and net adverse clinical events (NACE; a composite of clinically significant bleeding [CSB] or major adverse cardiovascular event [MACE]) or rehospitalization compared to warfarin among both elderly and non-elderly patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), a nonsurgical procedure designed to relieve narrowing or occlusion of the coronary artery. The PIONEER AF-PCI exploratory trial enrolled 2,124 patients with nonvalvular AF undergoing PCI, of whom 729 (34.3%) were elderly. Patients were randomized to either rivaroxaban- or warfarin-based antithrombotic regimens.

CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients With Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy

New Brunswick -based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.1 With this approval, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse. FDA approval is based on positive results from the Phase 3 CARTITUDE-4 study, which demonstrated that the earlier use of CARVYKTI® reduced the risk of disease progression or death by 59 percent compared to standard therapies—pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd)—in adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.

KRAZATI (adagrasib) in Combination With Cetuximab Demonstrates Clinically Meaningful Activity as a Targeted Treatment Option for Patients With Previously Treated KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer (CRC)

Princeton-based BioNJ Member Bristol Myers Squibb announced data from the cohorts of the Phase 1/ 2 KRYSTAL-1 study evaluating KRAZATI® (adagrasib) in combination with cetuximab for the treatment of patients with previously treated KRAS-mutated locally advanced or metastatic colorectal cancer (CRC). With a median follow up of 11.9 months in 94 patients, KRAZATI plus cetuximab demonstrated an objective response rate, the primary endpoint, of 34%, median progression-free survival of 6.9 months (95% CI, 5.7-7.4), and median overall survival of 15.9 months (95% CI, 11.8-18.8) in pre-treated patients with KRASG12C-mutated locally advanced or metastatic CRC. The median duration of response was 5.8 months. Disease control was observed in 85% of patients. The safety profile for KRAZATI plus cetuximab was manageable and consistent with previous reports, and with the known safety profile of each drug individually.

Bristol Myers Squibb Presents New Pooled Interim Long-Term Safety and Metabolic Outcomes Data from the EMERGENT Program Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Society

Princeton-based BioNJ Member Bristol Myers Squibb announced interim long-term safety, tolerability and metabolic outcomes data from its Phase 3 EMERGENT program evaluating KarXT (xanomeline-trospium) in adults with schizophrenia. “These long-term safety results and metabolic outcomes from the EMERGENT program are extremely encouraging, allowing us to further understand the tolerability profile of KarXT in people living with schizophrenia,” said Roland Chen, M.D., Senior Vice President and Head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb. “It is promising to see that over one year of treatment, KarXT was not associated with burdensome side effects, specifically weight gain and metabolic dysfunction, as well as extrapyramidal symptoms, which underscores its potential to provide a meaningful and differentiated option for people living with schizophrenia.”

Bristol Myers Squibb Presents New Interim Long-Term Efficacy Data from the EMERGENT-4 Trial Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Society

Princeton-based BioNJ Member Bristol Myers Squibb announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia. “We are pleased to see a continued and consistent meaningful reduction in symptoms of schizophrenia across 52-weeks in an outpatient setting, beyond what was seen in the short-term, in-patient five-week trials (EMERGENT-2 and EMERGENT-3),” said Roland Chen, M.D., Senior Vice President and Head, Immunology, Cardiovascular and Neuroscience Development, Bristol Myers Squibb. “We look forward to continued conversations with the FDA and to sharing additional data from the EMERGENT program later this year.”

Novartis Kesimpta® Six-Year Efficacy Data Show Substantial Benefits in Recently Diagnosed Treatment-Naïve People With Relapsing Multiple Sclerosis

East Hanover-based BioNJ Member Novartis announced data from the ALITHIOS open-label extension study showing sustained efficacy of first-line, continuous Kesimpta® (ofatumumab) treatment for up to six years in recently diagnosed – defined as starting treatment within three years of initial diagnosis – treatment-naïve people living with relapsing multiple sclerosis (RMS). These efficacy outcomes included 44% fewer relapses; 96.4% and 82.7% reductions in MRI lesions (Gd+ T1 and neT2), respectively; and 24.5% and 21.6% fewer 3- and 6-month confirmed disability worsening (CDW) events, respectively, versus those who switched to Kesimpta from teriflunomide. A separate analysis of the overall ALITHIOS population showed similar efficacy with continuous Kesimpta treatment, which was also well-tolerated with a consistent safety profile up to six years.

New Novartis Data Show Early Addition of Twice-Yearly Leqvio® (inclisiran) Following Maximally Tolerated Statin Therapy Significantly Reduces LDL-C in ASCVD Patients in Real-World Setting

East Hanover-based BioNJ Member Novartis announced new data demonstrating the early addition of twice-yearly Leqvio® (inclisiran) to maximally tolerated statin therapy, prior to guideline-recommended ezetimibe, in a real-world setting significantly reduced low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD), including those with a history of an ASCVD-related event, who could not reach their goal on statin therapy alone. In the V-INITIATE study, patients receiving Leqvio experienced significant reductions in LDL-C compared to those receiving usual care (60% vs. 7%, respectively; p<0.001), which consisted mostly of statin therapy alone (73%). Four in five patients receiving Leqvio achieved the guideline-recommended LDL-C goal of <70 mg/dL compared to just one in five patients receiving usual care (81.8% vs. 22.2%, respectively; p<0.001).

New Novartis Fabhalta® (iptacopan) Data Show Clinically Meaningful and Statistically Significant Proteinuria Reduction of 38.3% Versus Placebo for Patients With IgA Nephropathy (IgAN)

East Hanover-based BioNJ Member Novartis presented results from a pre-specified interim analysis of the Phase III APPLAUSE-IgAN study of Fabhalta® (iptacopan), an investigational Factor B inhibitor of the alternative complement pathway, in patients with IgA nephropathy (IgAN). In the analysis, patients treated with Fabhalta achieved a 38.3% (p<0.0001) proteinuria reduction (as measured by 24-hour urine protein to creatinine ratio [UPCR]) at 9 months when compared to placebo on top of supportive care. Proteinuria reduction is an increasingly recognized surrogate marker correlating with progression to kidney failure and has been used as an endpoint in IgAN clinical trials to support accelerated approvals. The study also showed that Fabhalta was well tolerated with a favorable safety profile consistent with previously reported data.

Tirzepatide Reduced Sleep Apnea Severity by Up to Nearly Two-Thirds in Adults With Obstructive Sleep Apnea (OSA) and Obesity

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced positive topline results of the SURMOUNT-OSA Phase 3 clinical trials that showed tirzepatide injection (10 mg or 15 mg) significantly reduced the apnea-hypopnea index (AHI) compared to placebo, achieving the primary endpoints. Percentage change in AHI was a key secondary endpoint in both studies. AHI records the number of times a person's breathing shows a restricted or complete block of airflow per hour of sleep and is used to evaluate the severity of obstructive sleep apnea (OSA) and the effectiveness of treatment outcomes. Tirzepatide is the only approved GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) treatment for chronic weight management, commercialized as Zepbound® in the U.S. and Mounjaro® in some global markets outside the U.S.

Ferring Pharmaceuticals and SK Pharmteco Enter into Commercial Gene Therapy Manufacturing Deal

Parsippany-based BioNJ Member Ferring Pharmaceuticals and SK pharmteco today announced an agreement to scale up commercial manufacturing capacity for the drug substance of Ferring’s intravesical gene therapy Adstiladrin® (nadofaragene firadenovec-vncg) for ensuring long-term future supply. Following technology transfer, SK pharmteco, a contract development manufacturing organisation (CDMO), will be qualified as another source for manufacturing, testing, and release of the medicine, subject to regulatory approval by the U.S. Food and Drug Administration (FDA). Adstiladrin® was approved by the FDA in December 2022 for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

GSK’s 5-in-1 Meningococcal ABCWY Vaccine Candidate Accepted for Regulatory Review by US FDA

Warren-based BioNJ Member GSK announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate. The Prescription Drug User Fee Act (PDUFA) action date for a regulatory decision by the U.S. FDA on this application is 14 February 2025. GSK’s 5-in-1 MenABCWY vaccine candidate combines the antigenic components of its two well-established meningococcal vaccines with demonstrated efficacy and safety profiles, Bexsero (Meningococcal Group B Vaccine) and Menveo (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine). The MenABCWY combination will target the five groups of the bacteria Neisseria meningitidis (Men A, B, C, W and Y) that cause most invasive meningococcal disease (IMD) cases globally.

New Long-Term Data Show Shingrix Continues to Provide High Protection Against Shingles in Adults Aged 50 and Over for More Than a Decade

Warren-based BioNJ Member GSK announced positive data from the ZOSTER-049 long-term follow-up Phase III trial which followed participants for up to approximately 11 years following initial vaccination with Shingrix (Recombinant Zoster Vaccine or RZV). The final trial data demonstrates that RZV maintains efficacy against shingles for more than a decade in adults over 50. Phil Dormitzer, Senior Vice President, Head of Vaccines R&D, said, “These data go far beyond the typical long-term follow-up period for a trial, tracking the efficacy of vaccination for some participants as they aged into their 70s, 80s and 90s. With the vaccine now included in many national immunization programs around the world, these data add to the body of evidence on the extended long-term protection against shingles and provide further confidence to inform public immunization strategies.”

EAGLE-1 Phase III Data Show Potential for Gepotidacin as a New Oral Treatment Option for Uncomplicated Urogenital Gonorrhoea (GC) Amid Growing Resistance to Existing Treatments

Warren-based BioNJ Member GSK announced positive results from the pivotal EAGLE-1 Phase III trial for gepotidacin, a potential first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urogenital gonorrhoea (GC) in adolescents and adults. The results from EAGLE-1 are based on a primary endpoint of microbiological response (success or failure of eliminating the bacterial cause of gonorrhoea) at the Test-of-Cure (ToC) visit 3-7 days after treatment. The trial showed that gepotidacin (oral, two doses of 3,000mg) was non-inferior with 92.6% success rates when compared to 91.2% success rates for intramuscular (IM) ceftriaxone (500mg) plus oral azithromycin (1,000mg) combined therapy, a leading combination treatment regimen for gonorrhoea.

Phase 3 SELECT-GCA Study of Upadacitinib (RINVOQ®) Showed Positive Results in Patients With Giant Cell Arteritis

BioNJ Member AbbVie, with a site in Madison, announced positive top-line results from SELECT-GCA, a Phase 3, multicenter, randomized, double-blind, placebo-controlled study, showing upadacitinib (RINVOQ®; 15 mg, once daily) in combination with a 26-week steroid taper regimen achieved its primary endpoint of sustained remissiona from week 12 through week 52 in adults with giant cell arteritis (GCA). In this study, 46 percent of patients receiving upadacitinib 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission compared to 29 percent of patients receiving placebo in combination with a 52-week steroid taper regimen (p=0.0019). GCA is an autoimmune disease that causes inflammation of the temporal and other cranial arteries, the aorta, and other large and medium arteries. GCA generally impacts elderly patients older than 50 years, most commonly between the ages of 70 and 80 years. Women have the highest risk of developing this disease, which can cause headache, jaw pain and changes in or loss of vision, including sudden and permanent loss of vision.

AbbVie Announces Late-Breaking Data at AAN Supporting Long-Term Safety and Efficacy of Atogepant (QULIPTA®) for Preventive Treatment of Migraine

BioNJ Member AbbVie, with a site in Madison, announced an interim analysis of an ongoing Phase 3, open-label 156-week extension study evaluating the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with chronic or episodic migraine. The overall long-term safety results were consistent with the known safety profile of atogepant in chronic and episodic migraine, and no new safety signals were identified. These results also support improvements in key efficacy outcomes, including reduction in monthly acute medication use days. "We understand that migraine is a complex disease and AbbVie is steadfast in our commitment to alleviating the considerable burden facing migraine patients," said Dawn Carlson, Vice President, Neuroscience Development, AbbVie.

Evotec and Variant Bio Enter Strategic Partnership to Discover and Develop Fibrosis Treatments

Princeton-based BioNJ Member Evotec SE and Variant Bio, Inc. announced a collaboration agreement to identify a best-in-class treatment for diseases caused by fibrosis. The strategic partnership leverages Variant Bio’s cutting-edge genomic discovery capabilities and VB-Inference platform as well as Evotec’s extensive expertise in antifibrotic drug discovery. Evotec will identify best-in-class small molecules targeting a key fibrotic pathway with strong genetic support identified by Variant Bio and progress the program towards the selection of a clinical development candidate(s) using Evotec’s integrated end-to-end R&D platform. Additionally, the collaboration includes an opportunity to evaluate unrelated nephrology targets based on human multi-omics data with Evotec’s molecular patient database (“E.MPD”).

Teva Confirms Efficacy and Safety of AJOVY® (fremanezumab) for the Prevention of Migraine With Results from Phase 3 Trial in China

Parsippany-based BioNJ Member Teva Pharmaceutical announced results from a Phase 3 study evaluating the efficacy and safety of AJOVY for the prevention of migraine in adult Chinese patients. In the study, AJOVY achieved primary endpoint and all secondary endpoints, significantly reducing the number of migraine days experienced per month, demonstrating superior efficacy over placebo. All key secondary endpoints were also met including measures for early onset of efficacy during the first month, responder rate analysis defined as 50% reduction of migraine days and reduction of acute headache medication use over 3 months after first use. Study data also show AJOVY was safe and well tolerated with no emerging safety signals. 

Teva’s New Real-World Evidence Presented at the 2024 AAN Annual Meeting Confirms Effectiveness and Patient Satisfaction for HD Chorea With the 4-Week Titration Kit for AUSTEDO® (deutetrabenazine) Tablets

Parsippany-based BioNJ Member Teva Pharmaceutical announced final results from the HD cohort of the Phase 4 START study, demonstrating positive real-world effectiveness, safety, adherence and satisfaction with the 4-week Titration Kit for AUSTEDO. As a fatal, neurodegenerative disease, HD can cause cognitive deterioration, behavioral and/or psychological problems and uncontrollable body movements known as chorea – a symptom that can have a significant impact on daily activities like eating or talking. “We remain committed to exploring ways to evolve the AUSTEDO treatment experience to meet the needs of the HD community, and these latest real-world data reinforce the role of the 4-week Titration Kit for AUSTEDO in empowering patients with HD chorea to find their optimal dose, adhere consistently to their treatment plan, and achieve effective outcomes,” said Eric Hughes, M.D., Ph.D., Executive Vice President of Global R&D and Chief Medical Officer at Teva.

Teva and Alvotech Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), Biosimilar to 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) injection for subcutaneous use, as a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older. Under the strategic partnership between Teva and Alvotech, Teva is responsible for the exclusive commercialization of SELARSDI in the United States. Ustekinumab is a human monoclonal antibody (mAb) that selectively targets the p40 protein, a component common to both interleukin (IL)-12 and IL-23 cytokines, which play crucial roles in treating immune-mediated diseases like psoriasis and psoriatic arthritis. Alvotech developed and produces SELARSDI using Sp2/0 cells and a continuous perfusion process, which are the same type of host cell line and process used in the production of Stelara.

BrainStorm Cell Therapeutics Announces Peer-reviewed Publication of Biomarker Data from NurOwn's® Phase 3 Clinical Trial in ALS

BrainStorm Cell Therapeutics Inc., with a site in Hackensack, announced the peer-reviewed publication of Phase 3 biomarker data in Muscle and Nerve. The paper, entitled "Debamestrocel multimodal effects on biomarker pathways in amyotrophic lateral sclerosis are linked to clinical outcomes", suggests that debamestrocel or NurOwn®, an investigational cell therapy, may impact key biomarkers in amyotrophic lateral sclerosis (ALS) that are predictive of disease progression. The study analyzed forty-five biomarkers and identified three that are predictive of clinical outcomes in debamestrocel-treated participants, including neurofilaments light (NfL), LAP/TGFb1 and Galcetin-1. Treatment with debamestrocel led to significant changes in 64% of the forty-five analyzed biomarkers, spanning various pathways involved in ALS pathology.

BrainStorm Cell Therapeutics Announces Agreement With FDA on a Special Protocol Assessment (SPA) for Phase 3b Trial in ALS

BrainStorm Cell Therapeutics Inc., with a site in Hackensack, announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS). The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating their adequacy for addressing objectives that support a future BLA (Biologics License Application) in ALS. BrainStorm anticipates commencement of the Phase 3b study in 2024, after reviewing the protocol with investigators, securing study site Institutional Review Board approvals and engaging with appropriate members of the ALS community.

ENHERTU ® Approved in the U.S. as First Tumor Agnostic HER2 Directed Therapy for Previously Treated Patients With Metastatic HER2 Positive Solid Tumors

Basking Ridge-based Daiichi Sankyo and AstraZeneca’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on objective response rate

(ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

Johnson & Johnson to Buy Medical Device Maker Shockwave for $13.1B

BioNJ Member Johnson & Johnson announced it will buy medical device maker Shockwave Medical in a deal with an enterprise value of approximately $13.1 billion, including cash acquired. The transaction was approved by both companies’ boards of directors. The deal helps the New Brunswick-based health care giant boost its portfolio of medical devices, specifically those that use shockwaves to break down calcified plaque in heart vessels, similar to how kidney stones are treated. It also extends Johnson & Johnson MedTech’s position in highest-growth, innovation-oriented segments of cardiovascular intervention. Joaquin Duato, chairman and CEO of Johnson & Johnson, said, “The acquisition of Shockwave and its leading IVL technology provides a unique opportunity to accelerate our impact in cardiovascular intervention and drive greater value for patients, shareholders and health systems.”

Inrad Optics Acquired by Luxium Solutions for $19M

Northvale-based Inrad Optics, which produces and designs optical materials, said it entered into an agreement to be acquired by Luxium Solutions in an all-cash transaction for $19 million. Following the closing of the transaction, Inrad Optics expects to benefit from the significant resources, operational expertise and capacity for investment provided by Luxium, SK Capital and Edgewater. Under the new ownership, Inrad Optics will be able to accelerate investments in technologies that are vital to development of next-generation bent X-ray crystal monochromators for spectroscopy and plasma fusion applications, and large-format, ultrahigh-precision optical components and assemblies.

ADC Therapeutics Accelerates R&D With Genedata Biologics

Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, announced that ADC Therapeutics, with a site in New Providence, has successfully deployed Genedata Biologics® to streamline the development of next-generation ADCs for the treatment of hematological malignancies and solid tumors. "As we scaled up our ADC discovery and development operations, we realized that a robust structured data management system such as Genedata Biologics was essential," said Patrick van Berkel, Ph.D., Chief Scientific Officer of ADC Therapeutics. "When exploring the market, we were thrilled to find a commercial digital platform that is not only purpose-built for ADC workflows but can even support our proprietary conjugation and linker technologies out-of-the-box. After a smooth deployment, our scientists now have real-time access to all critical data, which enables fully informed decision-making."

NJEDA and Princeton University Take Next Steps to Develop AI Hub

Ahead of the first-ever AI Summit hosted by the New Jersey Economic Development Authority (NJEDA) and Princeton University, the partners are issuing a Request for Information (RFI) to seek input on best practices and operational insights for the creation and development of an Artificial Intelligence (AI) Hub, which will help advance New Jersey’s leadership in the field and catalyze innovation in AI technologies. The public feedback received will help the NJEDA and Princeton better understand the scope and characteristics of the AI Hub, with a particular focus on opportunities for collaboration with the private sector. Responses are due by May 31. The AI Hub, which is supported by the NJEDA, will bring together industry leaders, researchers and start-up companies to advance research and development in the emerging field.

NJIT Aims to Be an Innovation Nexus Under Its New Strategic Plan

New Jersey Institute of Technology wants to be a “nexus of innovation.” One that embraces new technology, commercializes groundbreaking research, leverages its diversity and tackles global environmental and socioeconomic challenges. Under its new strategic plan, the Newark-based institution can do just that. The plan, extended through 2030, identifies six priorities, spells out the university’s mission to be a leader in research, innovation and entrepreneurship, and reaffirms its core values, including collaboration, social responsibility, diversity and sustainability. The priorities define student and faculty success, and set goals in digital transformation, external engagement, investment and the realm of research, innovation and entrepreneurship.

NIH Biomedical Research Funding Generates $1.3B in Economic Activity in NJ

Ten New Jersey institutions collectively received $404 million in grants and contracts for biomedical research from the National Institutes of Health (NIH), which directly supported 5,136 jobs and $1.32 billion in economic activity in the state during FY23. The data comes from United for Medical Research (UMR), a coalition of leading research institutions, patient and health advocates and private industry members that advocate for increased NIH funding. Click here for the top NIH funded research institutions and companies in New Jersey. There are 4,322 biopharmaceutical businesses in New Jersey and 104,514 employees, according to the Biotechnology Industry Association’s 2022 annual report. 

Hackensack Meridian Researchers Receive $2.2M Federal Grant

Hackensack Meridian Neuroscience Institute at JFK University Medical Center announced they have received a $2.2 million federal grant to study a novel treatment for traumatic brain injuries. Provided by the National Institute of Neurological Disorders and Stroke, part of the U.S. National Institutes of Health, the five-year award will fund a research project titled “Neutrophil Extracellular Traps and Associated Pathogenesis In TBI: A Novel Peptide Therapeutic Strategy.” The proposal is from Mohammed Abdul Muneer, a research scientist and principal investigator for the institute as well as associate professor of neurology at the Hackensack Meridian School of Medicine. The study will look at whether blocking the formation of neutrophil extracellular traps (NET) provides better outcomes after a traumatic brain injury.

Evotec Welcomes Aurélie Dalbiez as Chief People Officer (CPO)

Princeton-based BioNJ Member Evotec announced the appointment of Ms. Dalbiez as the company’s new Chief People Officer, effective 15 June 2024. Ms. Dalbiez will be joining Evotec’s Management Board, bringing with her a wealth of experience and expertise in Human Resources leadership. In her role as CPO, Ms. Dalbiez will oversee the development and implementation of Evotec’s people strategy, focusing on fostering a culture of innovation, collaboration and belonging. With over 25 years of international people leadership experience, Ms. Dalbiez has a proven track record of driving organizational transformation and fostering employee engagement. Prior to joining Evotec, Ms. Dalbiez served as the Chief Human Resources Officer at Corbion N.V., a global bio-based ingredients company.

Bristol Myers Squibb Releases 2023 Environmental, Social and Governance Report Demonstrating Progress and Setting New Long-Term Goals

Bristol Myers Squibb's 2023 Environmental, Social, and Governance (ESG) Report details the company’s meaningful progress, evolved strategy and aspirational goals toward its ESG efforts.

Bayer's Expert Mondays 2024

Select Mondays in March – December 2024

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

2024 SAPA Scientific Symposium

April 20 – Rutgers Robert Wood Johnson Medical School

The 2024 Scientific Symposium, a flagship event of the Sino-American Pharmaceutical Professionals Association (SAPA), will be held in-person on April 20th at Rutgers Robert Wood Johnson Medical School. This SAPA forum will offer a confluence of cutting-edge technologies, versatile innovation platforms, emerging modalities & targets, and new clinical/medical approaches. It’s a space where positive energy will thrive, fostering collaboration among participants. With this event, we aspire to create meaningful impact within the communities we serve.

69th NJ Academy of Science Annual Meeting

April 20 – New Jersey Academy of Science

The NJAS Executive Board cordially invites you to join us in celebrating and fortifying the ongoing projects and collaborations among science, policy and communication. Our aim is to bolster the infusion of scientific and technical expertise into public discourse and collaborations. During this event, we will emphasize the significance of innovation, resilience and addressing health disparities challenges, while also marveling at the collective potential within our community to shape a brighter future for New Jersey. Planned activities include keynote addresses, scientific sessions featuring both junior and senior academy members, workshop sessions and a STEM showcase.

Panel Discussion: Tricks of the Trade — Partnering With Pharma Companies

April 30 – Princeton Innovation Center BioLabs

Panelists with expertise in pharma, biotech, diagnostics, venture and technical and laboratory services, will offer large and small company perspectives on working with value-added partners as well as buy-side and sell-side partnering approaches and business models. This is a great opportunity to interact with experts who have hands-on experience putting together collaborations and creating agreements to advance products and technologies, and secure capital. This program is co-sponsored by Princeton Innovation Center BioLabs, the NJEDA’s New Jersey Bioscience Center and BioNJ.

Deal Making and Structuring Early-Stage Technology and Life Sciences Deals

June 12 – LES NY/NJ Chapter

A panel discussion on the challenges and opportunities associated with technology transfer and licensing from universities to corporates and between emerging companies and more established companies. This program is for University tech transfer professionals, early-stage Life science and technology companies, late-stage companies that recently acquired or in licensed IP originated at early-stage companies.