Soligenix Receives European Patent for Improved Production of Synthetic Hypericin

Princeton-based BioNJ Member Soligenix, Inc. announced that the European 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. This new European granted patent (EP3423428) is a related patent to US Pat. No. 10,053,413, previously issued in the United States (US). HyBryte™ is a novel, first-in-class, photodynamic therapy that combines synthetic hypericin, a highly potent photosensitizer that is applied to the cancerous CTCL skin lesions and activated using a safe, visible light treatment.

BeiGene’s BGB-16673 Receives U.S. FDA Fast Track Designation for CLL/SLL

BioNJ Member BeiGene, with a site in Hopewell, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BGB-16673, an orally available investigational Bruton’s tyrosine kinase (BTK) targeting chimeric degradation activation compound (CDAC), for adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have been previously treated with at least two prior lines of therapy, including BTK inhibitor (BTKi) and B-cell lymphoma 2 (BCL2) inhibitor. The designation was requested based on the potential for BGB-16673 to address an unmet medical need for patients CLL/SLL whose disease has progressed. Data from ongoing first-in-human Phase 1/2 (NCT05006716) highlighted the tolerable safety and promising efficacy in heavily pretreated patients with R/R CLL/SLL.

Cellares Completes First cGMP Cell Shuttle at IDMO Smart Factory in Bridgewater

Cellares, an Integrated Development and Manufacturing Organization dedicated to clinical and commercial-scale cell therapy manufacturing, is commissioning the first current good manufacturing practices Cell Shuttle at the IDMO Smart Factory in Bridgewater. This marks an important milestone on the way to a fully fitted facility, which will be capable of producing up to 40,000 standard CAR-T cell therapy doses per year, or up to 100,000 doses of novel, two-day process CAR-T cell therapies. The Bridgewater IDMO Smart Factory is a clinical and commercial-scale cell therapy manufacturing innovation. The facility integrates advanced, end-to-end, walk-away automation technologies, including the Cell Shuttle and the Cell Q. Where the Cell Shuttle automates cell therapy manufacturing, the Cell Q automates quality control, both in-process QC as well as release testing. Interconnected software systems enable, for example, the auto-generation of electronic batch records, reducing human labor as well as opportunities for operator error.

Agile Therapeutics Inc. Announces Completion of Acquisition by Insud Pharma, S.L.

Princeton-based Agile Therapeutics, Inc. announced the completion of the acquisition of Agile by Insud Pharma, S.L. The former holders of Agile common stock voted to approve the acquisition at a special meeting of stockholders. Upon closing of the acquisition, former shareholders of Agile became entitled to receive $1.52 per share in cash, net of assumed liabilities and estimated transaction costs for an approximate total enterprise value of $45 million. Insud completed its acquisition of Agile through the merger of an indirect, wholly owned subsidiary of Insud with and into Agile, with Agile continuing as the surviving company and becoming an indirect subsidiary of Insud, pursuant to a definitive merger agreement. With the completion of the transaction, Agile will no longer be listed on any public market.

Alecensa Approved in Japan for the Additional Indication of Adjuvant Treatment for People With ALK-Positive Early Stage Non-Small Cell Lung Cancer

BioNJ Member Chugai Pharmaceutical Co., with a site in Berkeley Heights, announced that the Ministry of Health, Labour and Welfare (MHLW) has approved the additional indication of Alecensa® (generic name: alectinib), a Chugai originated antineoplastic agent/ALK inhibitor, for “adjuvant therapy for ALK fusion gene-positive non-small cell lung cancer.” The approval is based on results from the ALINA study, a global Phase 3 study conducted in patients with completely resected ALK-positive early NSCLC stage IB (tumors ≥ 4 cm) to IIIA (UICC/AJCC 7th edition). In the study, Alecensa reduced the risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.0001) compared with platinum-based chemotherapy in people with completely resected IB to IIIA ALK-positive NSCLC.

Novartis Twice-Yearly Leqvio® Demonstrated Clinically Meaningful, Statistically Significant LDL-C Lowering as a Monotherapy in Patients at Low or Moderate ASCVD Risk

East Hanover-based BioNJ Member Novartis announced positive topline results from twice-yearly Leqvio® (inclisiran) in the Phase III V-MONO study, which met its primary endpoints. Leqvio monotherapy achieved clinically meaningful and statistically significant low-density lipoprotein cholesterol (LDL-C) lowering versus both placebo and ezetimibe in patients who were at low or moderate risk of developing atherosclerotic cardiovascular disease (ASCVD) and not receiving lipid-lowering therapy. V-MONO is the first trial evaluating a small interfering RNA (siRNA) therapy taken as monotherapy to lower LDL-C in patients at low or moderate risk of developing ASCVD. Novartis plans to present results from this trial at an upcoming medical meeting and share with regulatory agencies including the U.S. Food and Drug Administration (FDA).

Tolebrutinib Meets Primary Endpoint in HERCULES Phase 3 Study, the First and Only to Show Reduction in Disability Accumulation in Non-Relapsing Secondary Progressive Multiple Sclerosis

Positive results from the HERCULES Phase 3 study showed that tolebrutinib, Bridgewater-based BioNJ Member Sanofi’s oral brain-penetrant BTK inhibitor, met the primary endpoint of improvement over placebo in delaying time to onset of confirmed disability progression (CDP) in people with non-relapsing secondary progressive MS (nrSPMS). In the HERCULES study, nrSPMS was defined at baseline as having a SPMS diagnosis with an expanded disability status scale (EDSS) score between 3.0 and 6.5, no clinical relapses for the previous 24 months and documented evidence of disability accumulation in the previous 12 months. Preliminary analysis of liver safety was consistent with previous tolebrutinib studies. Multiple sclerosis is a chronic, immune-mediated, neurodegenerative disease that results in accumulation of irreversible disabilities over time. The physical and cognitive disability impairments translate into gradual deterioration of health status and lower quality of life, impacting patients’ care and life expectancy.

Long-Term Follow-Up Data from Phase 3 Study of CAMZYOS® (mavacamten) Underscores Established Efficacy and Safety Profile in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Princeton-based BioNJ Member Bristol Myers Squibb announced new long-term follow-up results from the EXPLORER-LTE cohort of the MAVA-Long-Term Extension (LTE) study evaluating CAMZYOS ^® (mavacamten) in adult patients with New York Heart Association (NYHA) class II-III symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The long-term follow-up efficacy and safety data reinforce the established efficacy and safety profile of CAMZYOS, a first-in-class cardiac myosin inhibitor. With inclusion in both the ESC and AHA/ACC clinical guidelines as a recommended option for when symptoms persist after first-line therapy, CAMZYOS is a standard of care for symptomatic oHCM. Patients experienced consistent and sustained improvements in echocardiographic measures and biomarkers after up to 3.5 years (180 weeks) of continuous treatment, including resting left ventricular outflow tract (LVOT) gradient, Valsalva LVOT gradient, left atrial volume index and N-terminal pro B-type natriuretic peptide (NT-proBNP) levels.

Ordspono™ (odronextamab) Approved in the European Union for the Treatment of Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced that the European Commission (EC) has approved Ordspono™ (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. This marks the first regulatory approval of Ordspono in the world for these patients. Ordspono is a bispecific antibody that acts by linking the lymphoma cell to a killer T cell. “Ordspono marks the first approval from our bispecific antibody platform, which we hope will increasingly contribute to our growing portfolio of practice-changing medicines for oncology and other diseases,” said George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President and Chief Scientific Officer of Regeneron.

New Secondary Analysis of Phase 3 Data Demonstrates That INPEFA® (Sotagliflozin) Benefited Heart Failure Patients Regardless of Diabetes Duration

BioNJ Member Lexicon Pharmaceuticals, Inc., with a site in Bridgewater, announced that a post-hoc analysis of Phase 3 data from the SCORED clinical trial demonstrated that INPEFA® (sotagliflozin) reduced the risk of major adverse cardiovascular events (MACE) and heart failure (HF) events across the spectrum of diabetes duration. Researchers noted that HF patients with longer durations of diabetes derived greater benefit from INPEFA, even controlling for similar baseline HbA1c, yet all patients regardless of diabetes duration benefited from the therapy. Diabetes duration is a well-established significant risk factor for cardiovascular (CV) disease and its progression. People with longer diabetes duration have a higher CV disease risk. The objective of this analysis of SCORED, one of two pivotal studies that led to FDA approval of INPEFA for heart failure in May 2023, was to evaluate if diabetes duration modifies the efficacy of INPEFA. The primary endpoint was a composite of CV death, HF hospitalization, and urgent heart failure visit events. Secondary endpoints included MACE: CV death, nonfatal heart attack and nonfatal stroke.

Bepirovirsen Granted SENKU Designation in Japan for Chronic Hepatitis B

Warren-based BioNJ Member GSK announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted SENKU (formerly known as SAKIGAKE) designation for bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB). SENKU designation is granted based on the level of innovation, severity of disease, and prominent efficacy. The goal of SENKU designation is to increase early patient access to innovative medicines through an expedited review process to treat serious conditions and fill an unmet medical need. The designation is based on results from the Phase IIb B-Clear and B-Sure trials which evaluated the efficacy, safety and durability of response of bepirovirsen in people with CHB. A confirmatory Phase III program, B-Well, is ongoing.

GSK’s Nucala (mepolizumab) Approved in Japan for Treatment of Adults With Chronic Rhinosinusitis With Nasal Polyps

Warren-based BioNJ Member GSK announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients, limited to those who are inadequately controlled with standard treatment. The approval is based on results of the phase III MERIT trial, which studied the efficacy and safety of mepolizumab over a 52-week period in a population of Japanese, Chinese and Russian patients with inadequately controlled CRSwNP, supported by data from the global phase III SYNAPSE study, which explored the effect of mepolizumab vs. placebo in more than 400 patients with CRSwNP. CRSwNP is a chronic condition that affects 1% to 4% of the general population, of whom 40% have uncontrolled disease.

European Commission Approves Expanded Age Indication for GSK’s Arexvy, the First Respiratory Syncytial Virus (RSV) Vaccine for Adults Aged 50-59 at Increased Risk

Warren-based BioNJ Member GSK announced that the European Commission has authorized Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50-59 who are at increased risk. Since June 2023, GSK’s RSV vaccine has been approved in Europe for adults aged 60 and over for the prevention of RSV-LRTD. Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk for severe consequences from an RSV infection compared to those without these conditions. RSV can exacerbate these conditions and lead to pneumonia, hospitalization or death.

In a First-of-Its-Kind Fixed Dose Study, Once Weekly Insulin Efsitora Alfa Leads to A1C Reduction Similar to Daily Insulin

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced positive topline results from the QWINT-1 and QWINT-3 Phase 3 clinical trials evaluating once weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes using basal insulin for the first time (insulin naïve) and in those who have switched from daily basal insulin injections, respectively. In these long-term treat-to-target trials, efsitora showed non-inferior A1C reduction compared to the most frequently used daily basal insulins globally. QWINT-1 evaluated the efficacy and safety of once weekly efsitora compared to once daily insulin glargine for 52 weeks. The trial randomized adults with type 2 diabetes who are insulin naïve to receive either efsitora once weekly in a single-use autoinjector or insulin glargine once daily. Efsitora was titrated across four fixed doses at four-week intervals, as needed for blood glucose control.

Lilly and EVA Pharma Collaborate to Expand Access to Baricitinib in Low- to Middle-Income Countries

BioNJ Member Eli Lilly and Company, with a site in Branchburg, and EVA Pharma announced that the companies have entered into an agreement to expand access to baricitinib to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. Discovered by Incyte and licensed to Lilly, baricitinib is for the treatment of rheumatoid arthritis, alopecia areata, atopic dermatitis, and COVID-19. This collaboration is part of the Lilly 30x30 initiative, which aims to improve access to quality health care for 30 million people living in resource-limited settings annually by 2030.This collaboration announced today relies on both EVA's pan-African reach and its strong local manufacturing capabilities that meet global standards, enabling Lilly to reach more people in low- to middle-income countries.

Lilly Releases Zepbound® (tirzepatide) Single-Dose Vials, Expanding Supply and Access for Adults Living With Obesity

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced Zepbound® (tirzepatide) 2.5 mg and 5 mg single-dose vials are available for self-pay for patients with an on-label prescription, significantly expanding the supply of Zepbound in response to high demand. The single-dose vials are priced at a 50% or greater discount compared to the list price of all other incretin (GLP-1) medicines for obesity. This new option helps millions of adults with obesity access the medicine they need, including those not eligible for the Zepbound savings card program, those without employer coverage, and those who need to self-pay outside of insurance. Patrik Jonsson, Executive Vice President, and President of Lilly Cardiometabolic Health and Lilly USA, said, "These new vials not only help us meet the high demand for our obesity medicine, but also broaden access for patients seeking a safe and effective treatment option.

Johnson & Johnson Seeks First Approval of Nipocalimab to Treat Broadest Population Living With Antibody Positive Generalized Myasthenia Gravis

New Brunswick-based BioNJ Member Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of nipocalimab globally for the treatment of people living with generalized myasthenia gravis (gMG). The application included data from the Phase 3 Vivacity-MG3 study which showed that outcomes for a broad population of antibody positive participants who received nipocalimab plus standard of care (SOC) were superior compared to those who received placebo plus SOC. The primary endpoint of the study measured improvement in the MG-ADL score from baseline over 24 weeks and study participants included anti-AChR+, anti-MuSK+, and anti-LRP4+ antibody positive adults, which account for approximately 95 percent of the gMG patient population, making Vivacity-MG3 the first-and-only study to demonstrate sustained disease control in these subtypes.

Leqembi® (lecanemab) Authorized for Early Alzheimer’s Disease in Great Britain

Nutley-based BioNJ Member Eisai Co., Ltd. and Biogen Inc. announced that the humanized amyloid-beta (Aβ) monoclonal antibody “Leqembi®” (brand name, generic name: lecanemab) has been granted a Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain. Lecanemab is indicated for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in adult patients that are apolipoprotein E ε4 (ApoEε4) heterozygotes or non-carriers. Lecanemab becomes the first treatment for early AD (MCI and mild dementia due to AD) that targets an underlying cause of the disease, to be authorized in a country in Europe. Lecanemab selectively binds to Aβ aggregate species, with preferential activity for toxic Aβ protofibrils (as well as fibrils, which are a major component of Aβ plaques).

Merck and EyeBio Announce Initiation of Phase 2b/3 Clinical Trial for Restoret™ for the Treatment of Diabetic Macular Edema

Rahway-based BioNJ Member Merck & Co. and EyeBio, a wholly-owned subsidiary of Merck & Co., announced the initiation of the Phase 2b/3 BRUNELLO trial evaluating Restoret™ (MK-3000, formerly EYE103) for the treatment of diabetic macular edema (DME). MK-3000 is an investigational, potentially first-in-class tetravalent, tri-specific antibody that acts as an agonist of the Wingless-related integration site (Wnt) signaling pathway. The initiation of the BRUNELLO trial is based on results from the open-label, Phase 1/2 AMARONE study of MK-3000 in patients with DME and neovascular age-related macular degeneration (NVAMD). BRUNELLO is a randomized, double masked Phase 2b/3 trial ( NCT06571045 ) evaluating the efficacy and safety of two dose levels of intravitreal (IVT) Restoret (MK-3000) versus active control ranibizumab in patients with DME. Eligible patients will be randomized 1:1:1 to receive low and high dose regimens of MK-3000 or ranibizumab every four weeks for the first year. 

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as First-Line Treatment of Unresectable or Metastatic Urothelial Carcinoma in Adults

Rahway-based BioNJ Member Merck & Co. announced that the European Commission (EC) has approved KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults. The decision follows the adoption of the European Society for Medical Oncology and European Association of Urology clinical guidelines recommending the combination as the preferred first-line treatment for these patients, regardless of platinum eligibility. This approval by the EC also follows the positive recommendation from the Committee for Medicinal Products for Human Use received in July 2024, which was based on results from the first interim analysis of the Phase 3 KEYNOTE-A39 trial (also known as EV-302), which was conducted in a research collaboration with Pfizer (previously Seagen) and Astellas.

Merck Receives European Commission Approval for WINREVAIR™ (sotatercept) in Combination With Other Pulmonary Arterial Hypertension (PAH) Therapies, for the Treatment of PAH in Adult Patients With Functional Class II-III

Kenilworth-based BioNJ Member Merck & Co. announced that the European Commission (EC) has approved WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with World Health Organization (WHO) Functional Class (FC) II to III, to improve exercise capacity. WINREVAIR is the first and only activin signaling inhibitor therapy for PAH approved in all 27 member states of the EU, as well as Iceland, Liechtenstein and Norway. WINREVAIR works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH. The EC approval of WINREVAIR is based on safety and efficacy results from the Phase 3 STELLAR trial.

Merck Announces Phase 3 Trial Initiation for Bomedemstat, an Investigational Candidate for the Treatment of Certain Patients With Essential Thrombocythemia

Rahway-based BioNJ Member Merck & Co. announced the initiation of Shorespan-007, a pivotal Phase 3 clinical trial evaluating bomedemstat, an investigational orally available lysine-specific demethylase 1 (LSD1) inhibitor, for the treatment of patients with essential thrombocythemia (ET) who have previously not received cytoreductive therapy. Essential thrombocythemia is a chronic, rare blood disorder and is the most common type of myeloproliferative neoplasm. Global recruitment of the Shorespan-007 trial has begun, with patients now enrolling. “The standard of care in essential thrombocythemia has remained unchanged for decades, and patients are in need of new options that have the potential to not only improve disease control, but also improve their quality of life,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck Research Laboratories.

Ascendis Pharma and Royalty Pharma Enter into $150 Million Royalty Funding Agreement

Princeton-based BioNJ Member Ascendis Pharma A/S and Royalty Pharma plc announced that Ascendis Pharma Bone Diseases A/S, a wholly-owned subsidiary of Ascendis Pharma A/S, has entered into a $150 million capped synthetic royalty funding agreement with Royalty Pharma based on U.S. net sales of YORVIPATH. “We are pleased to again partner with Royalty Pharma, a leading funder of innovation across the biopharma industry, as we launch YORVIPATH in the U.S. as the first and only FDA approved treatment of hypoparathyroidism in adults,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “This transaction reflects the significant value of YORVIPATH and our commitment to reduce our cost of capital while maintaining flexibility to support our global commercial capabilities.”

Forbes Names 32 NJ Firms to Best Employers List

Forbes recently released its Best Employers By State 2024 list to highlight the employers that are keeping their workers satisfied. Of the 1,294 organizations that made the list, 32 are based in New Jersey — and three of those cracked the top 10. All of the included Garden State companies landed in the top 100. To determine the rankings, Forbes partnered with market research firm Statista to survey more than 160,000 employees working for U.S. companies with at least 500 people. Employees were asked questions such as how likely they were to recommend their employer on a scale of zero to 10 and how they’d evaluate employers they’d worked for within the past two years. Congratulations to BioNJ Members Merck & Co., Johnson & Johnson, Rutgers University, Inspira Health Network, New Jersey Institute of Technology, Princeton University, Novartis and Hackensack Meridian Health for making the list. 

Dr. Reddy’s Receives Positive CHMP Opinion from European Medicines Agency for its Proposed Rituximab Biosimilar

Princeton-based Dr. Reddy’s Laboratories Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the launch of its proposed biosimilar Rituximab candidate DRL_RI (ITUXREDI®) in European markets. Dr. Reddy’s had previously received the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility located in Hyderabad, India. As part of the established approval process, the CHMP positive opinion will now be reviewed by the European Commission (EC), following which a decision will be made on the grant of marketing authorization in the European Union (EU) member countries, and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.

Princeton’s Curio Takes Next Step With Investment Round

Princeton-based Curio Digital Therapeutics has completed a double-digit investment round. Participants in the investment round included RYSE Asset Management, ONCE, Bridge Point Capital and Avestria. A specific funding figure was not disclosed. In April, Curio received U.S. Food & Drug Administration approval for its lead product, MamaLift Plus. The prescription-only digital therapeutic is the first to treat postpartum depression. PPD affects as many as 1-in-7 women who have given birth in the U.S. — or approximately 500,000 women annually. The new investment aims to support continued commercialization with health plans and insurers in the U.S., U.K. and India. Curio is working with different stakeholders who seek to engage with its data and underlying Connected Care platform, which spans post-natal depression, fertility and menopause.

Navigator Medicines Raises $100M in Series A Funding

Scotch Plains-based Navigator Medicines announced $100 million in Series A financing alongside the in-licensing of newly acquired autoimmune portfolio from IMBiologics Corp. The company, which was founded earlier this year as a subsidiary of Sera Medicines, has bought itself a pipeline of OX40L-targeted mono- and bispecific antibodies. “I am thrilled to join Navigator at this exciting time to advance NAV-240 through the clinic and we are deeply grateful for the support of our partner, IMBiologics and our investors,” Dr. Dana McClintock, Chief Medical Officer of Navigator Medicines, said. “NAV-240 has the potential to make an impact on patients living with autoimmune diseases, and our Series A funding will be pivotal in accelerating its development alongside other exciting programs within our pipeline.”

Bayer Partners With RNA Drugmaker to Develop New Cancer Therapies

Whippany-based Bayer and biotechnology company NextRNA Therapeutics said they have partnered to develop a new kind of small molecule drug for cancer, agreeing to a collaboration deal that could be worth more than half of a billion dollars. The two companies will use NextRNA’s technology to advance two small molecule drugs that target cancers driven by dysregulated long non-coding RNA. Under the deal, NextRNA could receive up to $547 million, including an upfront payment the companies did not disclose. The companies also did not specify the types of cancer or specific drug targets they will pursue, but indicated they aim to develop the two programs for indications with “high unmet need.” The first program is already in preclinical testing at NextRNA, while Bayer will hold an option to select another target for joint development.

PsychoGenics Awarded $3M Small Business Research Grant to Find Treatments for Rare Disorders

Paramus-based, BioNJ Member PsychoGenics was awarded a Fast Track Small Business Innovation Research grant by the National Institute of Mental Health, worth up to $3 million over four years. The funding will support PsychoGenics in using eCube, its artificial intelligence-enabled EEG platform, along with its advanced machine learning tools, to identify novel applications for existing drugs targeting rare diseases. “We are honored to once again receive SBIR grant support from the NIH for this groundbreaking project. By leveraging our expertise in drug discovery and advanced machine learning techniques to find new applications for existing treatments in rare diseases, we expect to make a rapid, positive impact for patients with limited or no treatment options. If successful, this approach can be expanded to address even more rare diseases,” Emer Leahy, Ph.D., CEO of PsychoGenics, said.

Pfizer Launches PfizerForAll™, a Digital Platform that Helps Simplify Access to Healthcare

BioNJ Member Pfizer, with a site in Gladstone, introduced PfizerForAll , a user-friendly digital platform designed to make access to healthcare and managing health and wellness more seamless for people across the U.S. The new, end-to-end experience will support the millions of Americans affected annually by common illnesses like migraine, COVID-19 or flu, and those seeking to protect themselves with adult vaccinations. By bringing together critical resources and services into a single destination, PfizerForAll helps individuals and their families cut down on the time and steps needed to take important health actions like getting care, filling prescriptions, and finding potential savings on Pfizer medicines.

Princeton’s Curio Takes Next Step With Investment Round 

Curio Digital Therapeutics, a Princeton-based company treating underserved women’s mental health conditions, has completed a double-digit investment round. In April, Curio received U.S. Food & Drug Administration approval for its lead product, MamaLift Plus. The prescription-only digital therapeutic is the first to treat postpartum depression. PPD affects as many as 1-in-7 women who have given birth in the U.S. — or approximately 500,000 women annually. The new investment aims to support continued commercialization with health plans and insurers in the U.S., U.K. and India. Curio is working with different stakeholders who seek to engage with its data and underlying Connected Care platform, which spans post-natal depression, fertility and menopause.

BD Finalizes $4.2B Acquisition of Edwards Lifesciences Critical Care Unit

Franklin Lakes-based Becton, Dickinson and Co. (BD) closed its previously announced $4.2 billion acquisition of Edwards Lifesciences’ Critical Care product group, the medical technology company. More than 10,000 hospitals worldwide use the newly renamed BD Advanced Patient Monitoring’s devices to help medical teams better understand patients’ cardiovascular conditions. The portfolio includes the Swan Ganz pulmonary artery catheter, minimally invasive sensors, noninvasive cuffs, tissue oximetry sensors and monitors. “The health care industry is being redefined by AI, robotics, and autonomous solutions, and our team continues to accelerate the application of these new technologies to improve the quality and cost of patient care around the world,” BD Chairman, CEO and President Tom Polen said in a statement.

Princeton Review Names NJIT a Best College for 33rd Straight Year

New Jersey Institute of Technology has maintained its remarkable run in The Princeton Review’s annual guide to the best universities and colleges in the United States. For the 33rd straight year, NJIT is featured in the guide, which is based on surveys of some 168,000 students. Just 15% of the nation’s four-year institutions made The Best 390 Colleges for 2025. The recognition comes two months after NJIT ranked No. 23 nationally among public schools on The Princeton Review’s list of the Top 50 Best Value Colleges — up 12 places from last year. “These recognitions resonate as we aim to deliver an education that’s exceptional, affordable and holistic, with a focus on hands-on experiences that prime Highlanders for rewarding careers,” NJIT President Teik C. Lim said.

Johnson & Johnson’s Chief Human Resources Officer to Retire; Successor Named

New Brunswick-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that Peter Fasolo, who has spent close to two decades at the company, will retire at the end of the year from his position as Executive Vice President, Chief Human Resources Officer. Kristen Mulholland will succeed Mr. Fasolo. Mr. Fasolo and Ms. Mulholland will work together during a transition period until Mr. Fasolo’s retirement becomes official. Joaquin Duato, Chairman and CEO, Johnson & Johnson, said “Throughout his career, Peter has always led with two principles in the forefront of every decision and recommendation — our Credo values and a deep responsibility to our employees. He leaves a legacy of strong leaders, deep bench strength and an inclusive, caring and patient-focused culture.”

Novartis Q4 Impact and Sustainability Update

In 2023, Novartis made a substantial step in transforming from a diversified healthcare player into a focused innovative medicines company with the successful spin-off of Sandoz. We delivered

strong financial performance, driven by our corporate strategy, purpose and commitment to financial resilience. Overall, our aim is to create value, mitigate risk and do the right thing to build trust with society and we are committed to making progress on our environmental, social and governance priorities.

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. 

Team Science Day 2024

September 16 | Hosted by Foundation for the National Institutes of Health (FNIH)

You can be on the frontier of biomedical science during Team Science Day on September 16 in New York City. Join us as we convene leaders across the public and private sectors, academia and patient advocacy groups to discover what it will take to achieve tomorrow’s breakthroughs.

Navigating the Path from Private to Public

September 19 | 4:30pm-7:30pm | Paramount Club, NYC

Are you ready to embark on the IPO journey? Don’t miss our panel discussion featuring leaders in investment banking, legal affairs, financial reporting, and C-level executives. They’ll share their success stories and the challenges they faced on this journey. After the discussion, enjoy cocktails, hors d’oeuvres and networking opportunities.Gain valuable insights and connect with industry leaders!