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Biden’s Medicare Price Controls Will Hurt Millions of Americans — We Can, and Must, Do Better

Recently, the Biden administration announced that the manufacturers of the first 10 medicines targeted for the Inflation Reduction Act’s (IRA) price-setting provisions agreed to participate in what some have called a negotiation scheme. What the administration omitted was that manufacturers resisting the “negotiation” are subjected to an exorbitant federal excise tax of up to 1,900 percent on their U.S. sales of the chosen drugs. These strong-arm tactics will not just hurt the companies the administration loves to hate. The effects of this coercion will end up hurting millions of American patients, by limiting their access to medications.   

Increased Use of Prior Authorization in Medicaid is Blocking Access for Patients

Improper use of prior authorization is creating hurdles for Medicaid participants and getting in the way of their ability to access needed care. Prior authorization is generally an insurance company requirement that healthcare providers obtain approval from a patient’s health insurance plan for a medicine before it will be covered. The Office of Inspector General (OIG) recently uncovered that Medicaid Managed Care Organizations (MCOs), the insurance companies that administer Medicaid plans across the country, are leveraging prior authorization policies to pad their own bottom line.  

Soligenix Receives FDA IND Clearance for Phase 2 Clinical Trial of Dusquetide in the Treatment of Aphthous Ulcers in Behçet's Disease

Princeton-based BioNJ Member Soligenix, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 2a clinical trial entitled, "Pilot Study of SGX945 (Dusquetide) in the Treatment of Aphthous Ulcers in Behçet's Disease." The study is designed to evaluate the safety and efficacy of SGX945 (dusquetide) and is expected to begin patient enrollment in the second half of 2024. "We are pleased to have received FDA clearance on our SGX945 Phase 2 pilot trial in aphthous ulcers of Behçet's disease," stated Christopher J. Schaber, Ph.D., President and CEO of Soligenix. "Our previous studies with dusquetide in oral mucositis have clearly validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation. Given the role of the innate immune system in ulcers associated with Behçet's Disease, and the unmet medical need particularly for more severe ulcers such as genital and leg ulcers, we believe that dusquetide may offer significant relief to patients. We are excited to expand dusquetide's development into different innate immune-related inflammatory conditions ,such as Behçet's disease, as a component of our long-term strategy to enhance the value of this unique compound."

EmphyCorp N115 Nonsteroidal Nasal Spray With No Known Side Effects is Treating Patients in a Phase III Clinical Trial for IPF (Coughing and Improved Lung Function)

Flemington-based BioNJ Member EmphyCorp Inc. is a private corporation, specializes in Rx Non-Steroidal Nasal and Oral Spray Technology for the treatment of Interstitial Lung Disease (orphan drug designation), Respiratory Diseases, Long COVID and COVID-19. The Patented N115 Technology Platform has demonstrated efficacy, with no known side effects, in 23 human clinical studies for all lung and sinus diseases tested including COPD, Interstitial Lung Disease (Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Cystic Fibrosis), Long COVID, Allergic Rhinitis, Chronic Rhinitis and Sinusitis. In each Clinical Trial, N115 produced statistically significant increases in all lung functions with the reduction in nasal and respiratory inflammation, a reduction in oxygen radicals, congestion, coughing, fatigue and a reduction of inflammatory cytokines including IL-6, a cause of the cytokine storm in COVID-19 patients.

PsychoGenics Launches an Updated Corporate Identity and Brand

Paramus-based BioNJ Member PsychoGenics Inc. is proud to unveil its refreshed corporate identity and brand. The change underscores the company’s deep expertise and customized solutions dedicated to discovering breakthrough CNS treatments for biopharmaceutical companies, disease research foundations and government agencies. Emer Leahy, Ph.D. President and CEO, PsychoGenics remarked, “Our mission is to help our clients and partners identify breakthrough treatments for severely disabling CNS conditions. Since our inception in 1999, we have taken pride in our contributions, working with hundreds of companies, foundations and Government agencies, and testing countless small molecules and gene therapies that have led to advancements in the treatment of many CNS disorders. Our new brand expresses the essence of our identity and mission.”

AbbVie Announces U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) Updates for Epcoritamab (EPKINLY®/TEPKINLY®) for the Treatment of Relapsed/Refractory Follicular Lymphoma

BioNJ Member AbbVie, with a site in Madison, announced updates from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory (R/R) follicular lymphoma (FL). The FDA has granted Breakthrough Therapy Designation (BTD) to epcoritamab-bysp (EPKINLY®) for the treatment of adult patients with R/R FL after two or more therapies. Additionally, the EMA has validated a Type II application for epcoritamab (TEPKINLY®) for the same indication. If approved, R/R FL would become the second conditionally approved indication for epcoritamab in the European Union. These updates were supported by previously announced results from the Phase 1/2 EPCORE™ NHL-1 clinical trial evaluating the safety and preliminary efficacy of subcutaneous epcoritamab in 128 adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (NHL), including FL.

Genmab Announces Positive Regulatory Updates for Epcoritamab (EPKINLY®/TEPKINLY®) for the Treatment of Relapsed/Refractory Follicular Lymphoma

Princeton-based BioNJ Member Genmab announced regulatory updates from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously. The U.S. FDA has granted Breakthrough Therapy Designation (BTD) to epcoritamab-bysp for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. BTD may expedite the development and review of investigational medicines by the U.S. FDA for serious or life-threatening diseases in cases where preliminary clinical evidence shows that a therapy may provide substantial improvements over available therapies. Additionally, the EMA has validated a Type II variation application for epcoritamab for the same indication.  

Lisata Therapeutics Announces First Patient Treated in the Cholangiocarcinoma Cohort of the BOLSTER Trial of LSTA1, a Novel Tumor-Targeting and Penetrating Peptide

Basking Ridge-based BioNJ Member Lisata Therapeutics, Inc. announced treatment of the first patient in the cholangiocarcinoma cohort of the BOLSTER Trial by Dr. Ian Hu, a principal investigator of the study, at The University of Texas MD Anderson Cancer Center in Houston, Texas. The company had previously announced the first patient in the head and neck squamous cell carcinoma cohort of the study had been treated. The BOLSTER trial is a Phase 2a, double-blind, placebo-controlled, multi-center, randomized study evaluating LSTA1 when added to standard-of-care (“SOC”) versus SOC alone in patients with either advanced second-line head and neck squamous cell carcinoma, second-line esophageal squamous cell carcinoma, or first-line cholangiocarcinoma. The BOLSTER trial is a basket trial being conducted at approximately 40 sites in North America, Europe, and Asia-Pacific.   

Boehringer Ingelheim Receives Approval for SENVELGO® in Europe: The First Oral Liquid Medication for Diabetic Cats

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, has received marketing authorization from the European Commission for SENVELGO® (active ingredient: velagliflozin), marking a significant step for the treatment of feline diabetes in Europe. Globally, SENVELGO® is the first once-daily liquid oral solution for the reduction of hyperglycemia in cats with non-insulin-dependent diabetes mellitus. This breakthrough innovation will make it easier for cat owners to fit the treatment of feline diabetes into their daily lives. Pet owners can give the once daily oral liquid solution with a small amount of food or directly into the cat’s mouth. As soon as one week after beginning treatment, SENVELGO® improves the clinical signs of diabetes that cats experience by reducing elevated blood glucose levels and minimizing the risk of clinical hypoglycemic events.   

Boehringer Ingelheim and IBM Collaborate to Advance Generative AI and Foundation Models for Therapeutic Antibody Development

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, announced an agreement that will enable Boehringer to use IBM’s foundation model technologies to discover novel candidate antibodies for the development of efficient therapeutics. Boehringer will be using an IBM-developed, pre-trained AI model that will be further fine-tuned on additional Boehringer proprietary data. “IBM has been at the forefront of creating generative AI models that extend AI’s impact beyond the domain of language” said Alessandro Curioni, Vice President Accelerated Discovery, IBM Research. “We are thrilled to now bring IBM’s multimodal foundation model technologies to Boehringer, a leader in the development and manufacturing of antibody-based therapies, to help accelerate the pace at which Boehringer can create new therapeutics.”

Boehringer Ingelheim Expands Immuno-Oncology Portfolio With the Acquisition of Bacterial Cancer Therapy Specialist T3 Pharma

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, announced the acquisition of privately held T3 Pharmaceuticals AG (“T3 Pharma”). T3 Pharma has developed a proprietary therapy platform that uses live bacteria to deliver immune-modulating proteins to cancer cells and tumor micro-environments. Despite the significant transformation of the cancer treatment landscape by immunotherapies, long-term remissions only occur in 15-20% of cancer patients. Boehringer Ingelheim aims to considerably increase this rate by utilizing complementary immuno-oncology platforms such as T-Cell Engagers (TcEs), oncolytic viruses, and cancer vaccines, which have the potential to turn cold tumors into hot ones, extending the benefits of immunotherapy to more patients in need.  

Chugai Launches Phesgo Subcutaneous Combination for the Treatment of HER2-Positive Breast and Colorectal Cancer

BioNJ Member Chugai Pharmaceutical Co., with a site in Berkley Heights, announced that it launched Phesgo® combination for Subcutaneous Injection MA, IN [generic name: pertuzumab (genetical recombination), trastuzumab (genetical recombination) and vorhyaluronidase alfa (genetical recombination) ] (hereafter, Phesgo), antineoplastic agent / anti-HER2 humanized monoclonal antibody for the treatment of “HER2-positive breast cancer” and “Advanced or recurrent HER2-positive colorectal cancer that has progressed following cancer chemotherapy and is not amenable to curative resection.” Phesgo had been approved by the Ministry of Health, Labour and Welfare (MHLW) and was listed on the national health insurance (NHI) reimbursement price list. Phesgo, this subcutaneous fixed-dose combination without preparation contains the same monoclonal antibodies as Perjeta and Herceptin, and also a vorhyaluronidase alfa (genetical recombination) combined in a single vial.   

Novo Nordisk A/S: Semaglutide 2.4 mg (Wegovy®) Cardiovascular Outcomes Data Presented at American Heart Association Scientific Sessions and Simultaneously Published in New England Journal of Medicine

Plainsboro-based BioNJ Member Novo Nordisk announced the primary results of SELECT, its landmark phase 3 cardiovascular outcomes trial investigating the effects of once-weekly semaglutide 2.4 mg (Wegovy®) in adults with established cardiovascular disease (CVD) and overweight or obesity without diabetes. The data were published in the New England Journal of Medicine. “For the first time, we have evidence that semaglutide 2.4 mg improves cardiovascular outcomes in at-risk patients with BMI of 27 and above with established CVD, without diabetes,” said Dr Michael Lincoff, lead study author, vice chair for research in the Cleveland Clinic Department of Cardiovascular Medicine, and a paid consultant for Novo Nordisk. “The three-point MACE risk reduction observed in SELECT suggests the potential for a new option in obesity treatment, addressing some of the leading causes of preventable death worldwide.”  

U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Breyanzi (lisocabtagene maraleucel) to expand its current indication to include the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who received a prior Bruton tyrosine kinase inhibitor (BTKi) and B-cell lymphoma 2 inhibitor (BCL2i). The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 14, 2024. Priority Review designation underscores the high unmet need and the significant advancement Breyanzi may offer this patient population for which there is no standard of care and limited treatment options.  

Bristol Myers Squibb and 2seventy bio Provide Update on U.S. FDA Review of sBLA for Abecma (idecabtagene vicleucel) in Earlier Lines of Therapy for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma

Princeton-based BioNJ Member Bristol Myers Squibb and 2seventy bio, Inc. announced the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) will meet to review data supporting the supplemental Biologics License Application (sBLA) for Abecma (idecabtagene vicleucel) for earlier lines of triple-class exposed relapsed or refractory multiple myeloma (RRMM) based on results from the pivotal Phase 3 KarMMa-3 study. The companies anticipate that the committee will review data related to the secondary endpoint of overall survival (OS). The companies look forward to continuing discussions with the FDA and participating in the ODAC meeting to reinforce the potential of Abecma to deliver significantly improved outcomes in patients with triple-class exposed RRMM in earlier lines of treatment.   

U.S. Food and Drug Administration Approves Augtyro™ (repotrectinib), a Next-Generation Tyrosine Kinase Inhibitor (TKI), for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (NSCLC)

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Augtyro™ (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Administered as an oral therapy, Augtyro is a tyrosine kinase inhibitor (TKI) targeting ROS1 oncogenic fusions. The approval is based on the TRIDENT-1 study, an open-label, single-arm, Phase 1/2 trial that evaluated Augtyro in TKI-naïve and TKI-pretreated patients. In TKI-naïve patients (n=71), the primary endpoint of objective response rate (ORR), defined as the percentage of people treated within a certain period of time whose tumor size decreased (partial response) or who no longer have signs of cancer (complete response), was 79% (95% Confidence Interval [CI]: 68 to 88).  

GSK Receives Positive CHMP Opinion Recommending Momelotinib for Myelofibrosis Patients With Anaemia

Warren-based BioNJ Member GSK announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of momelotinib for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib. The CHMP opinion is one of the final steps prior to a marketing authorisation decision by the European Commission. If approved, momelotinib would be the only medicine in the European Union (EU) specifically indicated for both newly diagnosed and previously treated myelofibrosis patients with moderate to severe anaemia that addresses splenomegaly and symptoms.  

GSK Announces Major Step Towards Sustainability Ambitions With Advancement of Low Carbon Ventolin Programme to Phase III Trials

Warren-based BioNJ Member GSK announced it will start Phase III trials of a low carbon version of its metered dose inhaler (MDI), Ventolin (salbutamol), using a next generation propellant, in 2024. If successful, it has the potential to reduce greenhouse gas emissions from use of the inhaler by approximately 90%, significantly contributing to GSK’s ambitious net-zero climate targets. Thirty-five million patients with respiratory conditions around the world rely on this inhaler as their rescue medication. However, it accounts for close to half (49%) of GSK’s carbon footprint, as well as contributing to the carbon footprint of global health systems. Significantly reducing the carbon footprint of the propellant in the inhaler is a key milestone in the company’s pathway to net zero.   

GSK Announces Positive Results from DREAMM-7 Head-to-Head Phase III Trial for Blenrep in Relapsed/Refractory Multiple Myeloma

Warren-based BioNJ Member GSK announced positive headline results from a planned interim efficacy analysis of the DREAMM-7 head-to-head Phase III trial evaluating belantamab mafodotin as a second-line treatment for relapsed or refractory multiple myeloma. The trial met its primary endpoint of progression-free survival (PFS) and showed that belantamab mafodotin when combined with bortezomib plus dexamethasone (BorDex) significantly extended the time to disease progression or death versus daratumumab plus BorDex, an existing standard of care for relapsed/refractory multiple myeloma. A strong and clinically meaningful overall survival (OS) trend with nominal p value < 0.0005 was also observed at the time of this analysis, and the trial continues to follow up for OS.  

Dupixent® Significantly Reduced COPD Exacerbations in Second Positive Phase 3 Trial, Accelerating FDA Submission and Confirming Potential to Become First Approved Biologic for this Serious Disease

Bridgewater-based BioNJ Member Sanofi announced the second Dupixent® (dupilumab) investigational Phase 3 chronic obstructive pulmonary disease (COPD) trial (NOTUS) has shown that Dupixent significantly reduced (34%) exacerbations, confirming positive published results from the landmark Phase 3 BOREAS trial. The NOTUS trial also confirmed that treatment with Dupixent led to rapid and significant improvements in lung function by 12 weeks and were sustained at 52 weeks. The NOTUS trial evaluated the investigational use of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled COPD and evidence of type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL). These results were from an interim analysis and, given the overwhelming positive efficacy of the primary endpoint, will be considered the primary analysis of the trial.   

Teva Completes Closing of Exclusive Collaboration Deal to Deliver Inflammatory Bowel Disease Treatment

Parsippany-based BioNJ Member Teva Pharmaceutical announced the closing of its collaboration deal to co-develop and co-commercialize asset TEV ‘574 with BioNJ Member Sanofi. TEV '574 is currently in Phase 2b clinical trials for the treatment of ulcerative colitis and Crohn's disease, two types of inflammatory bowel disease. As announced on October 4, 2023, under the terms of the agreement, Teva will receive an upfront payment of $500 million shortly after closing and up to $1 billion in development and launch milestones. Each company will equally share the development costs globally and net profits and losses in major markets, with other markets subject to a royalty arrangement and Sanofi will lead the development of the Phase 3 program. Teva will lead commercialization of the product in Europe, Israel and specified other countries, and Sanofi will lead commercialization in North America, Japan, other parts of Asia and the rest of the world. Initial program results are expected to be available in 2024.

Teva Announces Approval of a Generic Version of Forteo® (teriparatide injection), in the U.S.

Parsippany-based BioNJ Member Teva Pharmaceutical announced the approval of a generic version of Forteo®, in the United States. Market availability of the product in the U.S. is expected in the coming weeks. Teriparatide injection is indicated to treat osteoporosis among certain women and men. “We are thrilled to receive the long-awaited generic approval of this important drug-device combination product,” said Dr. Eric Hughes, Executive Vice President Global R&D and Chief Medical Officer. “This approval showcases Teva’s exceptional strengths in complex generic formulations development and device engineering, which support our ambitions to focus our generics pipeline on medicines that deliver the highest impact to patients. The approval will enhance access to a critical treatment option for patients while serving to demonstrate our strategic goal of sustaining a generic powerhouse.”  

Teva and Royalty Pharma Collaborate to Further Accelerate Olanzapine LAI Program

Parsippany-based BioNJ Member Teva Pharmaceutical and Royalty Pharma announced a collaboration to further accelerate the clinical research program for Teva’s olanzapine LAI (TEV-‘749) by entering into a funding agreement of up to $125 million to offset program costs. Olanzapine LAI (TEV-‘749) is a once-monthly subcutaneous long-acting injection of the atypical antipsychotic olanzapine that is currently in Phase 3 for the treatment of schizophrenia and has the potential to be the first long-acting olanzapine with a favorable safety profile. “Since launching Teva’s Pivot to Growth strategy in May 2023, we have been working on novel and expedited ways to both continue to invest in our robust innovative pipeline while supporting the growth of our in-line businesses,” said Richard Francis, President and CEO of Teva.   

AbbVie to Acquire ImmunoGen, including its Flagship Cancer Therapy ELAHERE® (mirvetuximab soravtansine-gynx), Expanding Solid Tumor Portfolio

BioNJ Member AbbVie, with a site in Madison, and ImmunoGen, Inc. announced a definitive agreement under which AbbVie will acquire ImmunoGen, and its flagship cancer therapy ELAHERE® (mirvetuximab soravtansine-gynx), a first-in-class antibody-drug conjugate (ADC) approved for platinum-resistant ovarian cancer (PROC). The acquisition accelerates AbbVie's commercial and clinical presence in the solid tumor space. Additionally, ImmunoGen's follow-on pipeline of promising next-generation ADCs further complements AbbVie's ADC platform and existing programs. ImmunoGen's oncology portfolio has the potential to help drive long-term revenue growth for AbbVie's oncology franchise. Ovarian cancer is the leading cause of death from gynecological cancers in the U.S. ELAHERE is the first targeted medicine to show meaningful survival benefit in PROC.

Results Published in The Lancet Show UBRELVY® (ubrogepant) Reduces the Headache Phase of a Migraine Attack When Dosed During the Prodrome of Migraine

BioNJ Member AbbVie, with a site in Madison, announced detailed results published in The Lancet evaluating the efficacy, safety and tolerability of UBRELVY® (ubrogepant) 100 mg for the acute treatment of migraine when administered during the prodrome of a migraine attack. The Phase 3 study, PRODROME, showed that UBRELVY given during the prodrome (i.e., 1-6 hours before the predicted onset of headache pain) significantly reduced the likelihood of development of moderate or severe headache and reduced functional disability compared to placebo within 24 hours post-dose. The prodrome is the earliest of four phases of a migraine attack and consists of various symptoms, including sensitivity to light and/or sound, fatigue, and neck pain, that can be an early sign that the headache phase will follow.  

Johnson & Johnson MedTech Acquires Laminar, Focused on Reducing Risk of Stroke in AFib Patients 

Johnson & Johnson MedTech, part of New Brunswick-based BioNJ Member Johnson & Johnson, announced it completed the acquisition of Laminar Inc., a privately held medical device company focused on eliminating the left atrial appendage in patients with non-valvular atrial fibrillation. Laminar joins Johnson & Johnson MedTech as part of Biosense Webster Inc. — a global leader in cardiac arrhythmia treatment. “We are excited to welcome Laminar to Johnson & Johnson MedTech,” said Jasmina Brooks, President, Biosense Webster. “Laminar’s innovative approach will provide Biosense Webster the opportunity to expand our portfolio in this high growth market, complement our electrophysiology and intracardiac echo strengths, and deepen our presence with interventional cardiologists and electrophysiologists. Fueled by the global scale and commercial and clinical strength of Biosense Webster, we are excited to explore the possibilities ahead to reach even more patients with critical unmet need.”

MONARCH Platform for Bronchoscopy Receives Regulatory License for China

Johnson & Johnson MedTech, part of New Brunswick-based BioNJ Member Johnson & Johnson, announced that the MONARCH Platform and MONARCH Bronchoscope have obtained regulatory approval in China. The platform is the first minimally invasive, robotic-assisted technology approved for peripheral lung procedures in China and the first J&J MedTech robotic-assisted technology approved in China. This also marks the first regulatory approval of the MONARCH Platform outside of the United States. The MONARCH Platform, used with the MONARCH Bronchoscope, is intended to provide bronchoscopic visualization of and access to adult patient airways for diagnostic and therapeutic procedures. The device enables physicians to use minimally invasive, robotic-assisted technology for peripheral lung procedures.  

J&J Honored With ‘Extraordinary Employer’ Award by DoD for Programs Serving Military-Connected Employees

BioNJ Member Johnson & Johnson, with offices in New Brunswick, was presented the “Extraordinary Employer Support Award” from the U.S. Department of Defense for the company’s support of National Guard/Reserve employees. The award, which was given by the N.J. State Chair of the DoD Employer Support of the Guard & Reserve organization was presented during the company’s annual Military-Connected Employee Resource Group Summit. Courtney Billington, a U.S. Army veteran who serves as the Head of North American Government Affairs at Johnson & Johnson and the executive sponsor of the J&J Leadership Council, said its commitment to veterans is a passion that can be found companywide. In 2020, the company launched the Office of Military & Veterans Affairs to provide dedicated support and engagement to military-connected employees and the broader military community.

Janssen Submits Application to the European Medicines Agency for RYBREVANT®▼ (amivantamab) in Combination With Chemotherapy for the Treatment of Adult Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer After Failure of Prior Therapy

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a type II extension of indication application to the European Medicines Agency (EMA) seeking approval of RYBREVANT^®▼ (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, after failure of prior therapy including a third-generation EGFR tyrosine kinase inhibitor (TKI). Amivantamab was granted a conditional marketing authorization by the European Commission in December 2021 as the first fully-human, bispecific antibody for the monotherapy treatment of adult patients with advanced NSCLC with EGFR exon 20 insertion mutations after failure of platinum-based chemotherapy

Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy for the Treatment of Patients With EGFR-Mutated Non-Small Cell Lung Cancer Who Progressed on or after Osimertinib

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking the approval of RYBREVANT® (amivantamab-vmjw) in combination with chemotherapy (carboplatin and pemetrexed) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution after disease progression on or after osimertinib. “New treatment options are urgently needed in the post-osimertinib setting, where patients continue to face unacceptable survival rates,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “As we strive to transform the standard of care in patients with EGFR-mutated NSCLC, we are committed to working closely with the FDA during review of this submission for RYBREVANT in this expanded patient population.”  

New VOYAGER PAD Analyses Reinforce Benefit of XARELTO® (rivaroxaban) Plus Aspirin Across High-Risk and Complex Patient Populations With Peripheral Artery Disease (PAD)

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced data from two new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of XARELTO® (rivaroxaban [2.5 mg twice daily plus aspirin 100 mg once daily]) over standard of care (aspirin alone). Data from the two analyses demonstrate the role of XARELTO® in treating both high-risk and fragile patients and those with and without comorbid coronary artery diseases (CAD). Fragile patients with PAD can be at a heightened risk for MALE, defined as a composite of acute limb ischemia (ALI) and major amputation. In this analysis, fragile patients are defined as age greater than 75 years, or weight less than 50 kg or baseline eGFR less than 50 mL/min/1.732.  

Ethicon Introduces ETHIZIA^TM Hemostatic Sealing Patch, Clinically Proven to Stop Disruptive Bleeding

Raritan-based Ethicon, part of BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson, announced the approval of ETHIZIA™, an adjunctive hemostat solution which has been clinically proven to achieve sustained hemostasis in difficult to control bleeding situations. Comprised of unique synthetic polymer technology, ETHIZIA™ Hemostatic Sealing Patch is the first and only hemostatic matrix designed to be equally active and efficacious on both sides. Designed for maximum adaptability, it can be stuffed, rolled, pulled apart, trimmed and tailored making it easy to handle in both open and minimally invasive surgeries.⁵ In 80% of clinical trial patients studied, ETHIZIA™ Hemostatic Sealing Patch stopped bleeding in 30 seconds, an average of six times faster than the leading Fibrin Sealant Patch.   

FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer

Rahway-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). This application is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which aims to improve the efficiency of the review process of applications to ensure that treatments are available to patients as early as possible. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of May 9, 2024.

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Gemcitabine and Cisplatin as First-Line Treatment for Locally Advanced Unresectable or Metastatic Biliary Tract Cancer

Rahway-based BioNJ Member Merck & Co. announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma. “Patients diagnosed with locally advanced unresectable or metastatic biliary tract cancer face a challenging disease with poor survival outcomes, underscoring the need for new treatment options that may help extend their lives,” said Dr. Marjorie Green, Senior Vice President and Head of Late-Stage Oncology, Global Clinical Development, Merck Research Laboratories. “The CHMP’s positive opinion brings us one step closer to providing a new immunotherapy regimen, which has shown an overall survival benefit compared to chemotherapy alone, to these patients in the European Union.”  

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Rahway-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. The approval is based on data from the Phase 3 KEYNOTE-859 trial, in which KEYTRUDA plus chemotherapy reduced the risk of death by 22% (HR=0.78 [95% CI, 0.70 0.87]; p<0.0001) compared to chemotherapy alone for these patients. Median overall survival (OS) was 12.9 months (95% CI, 11.9-14.0) for KEYTRUDA plus chemotherapy versus 11.5 months (95% CI, 10.6-12.1) for chemotherapy alone.  

Merck to Acquire Caraway Therapeutics, Inc.

Rahway-based BioNJ Member Merck & Co. and Caraway Therapeutics, Inc. announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Caraway Therapeutics for a total potential consideration of up to $610 million, including an undisclosed upfront payment as well as contingent milestone payments. “Caraway’s multidisciplinary approach has yielded important progress in evaluating novel mechanisms of modulation of lysosomal function with potential for the treatment of progressive neurodegenerative diseases,” said George Addona, Senior Vice President, Discovery, Preclinical Development and Translational Medicine, Merck Research Laboratories. “We look forward to applying our expertise to build upon this work with the goal of developing much needed disease-modifying therapies for these conditions.”  

Merck’s V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults, Demonstrated Superior Immunogenicity for 10 of 11 Unique Serotypes Compared to PCV20 in Adults 50 Years of Age and Older

Rahway-based BioNJ Member Merck & Co. announced results from STRIDE-3, a Phase 3 trial evaluating V116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to protect adults. The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults who had not previously received a pneumococcal vaccine. According to CDC data from 2018-2021, the serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 years of age and older. V116 includes eight unique serotypes not covered by currently licensed pneumococcal vaccines, which were responsible for approximately 30% of invasive pneumococcal disease in individuals 65 years of age and older, based on the same CDC data. If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults.  

BeiGene Receives European Commission Approval for BRUKINSA® (zanubrutinib) for the Treatment of Relapsed or Refractory Follicular Lymphoma

Hopewell-based BeiGene announced the European Commission (EC) has granted marketing authorization for BRUKINSA® (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy. This marks the fourth indication in the European Union (EU) for BRUKINSA, which is now approved to treat more patient populations in the EU than any other Bruton’s tyrosine kinase (BTK) inhibitor. In addition to R/R FL, BRUKINSA is approved in the EU as monotherapy for the treatment of adult patients with chronic lymphocytic leukemia, for adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy, and for adult patients with Waldenström’s macroglobulinemia who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemo-immunotherapy.   

BeiGene and Ensem Therapeutics Announce Partnership to Advance Differentiated CDK2 Inhibitor

Hopewell-based BeiGene and Ensem Therapeutics, Inc. announced an agreement for BeiGene to acquire an exclusive global license to an Investigational New Drug (IND) application-ready oral cyclin-dependent kinase 2 (CDK2) inhibitor. “We are committed to developing novel molecules with the potential to transform the therapeutic landscape for cancer patients, and this partnership fits well with our strategic focus on breast cancer as an area with tremendous unmet need for innovative treatment options,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene. “This CDK2 inhibitor from ENSEM complements our internally discovered Phase 1 CDK4 inhibitor, which has the potential to improve upon current CDK4/6 inhibitors in some breast cancer patients and strengthens our early development pipeline in breast cancer and other solid tumors.”  

DAICHIRONA® FOR INTRAMUSCULAR INJECTION for Booster Vaccination Approved in Japan as Omicron XBB.1.5-adapted Monovalent mRNA Vaccine against COVID-19 

Basking Ridge-based Daiichi Sankyo announced that DAICHIRONA® FOR INTRAMUSCULAR INJECTION (DS-5670) for booster vaccination has been approved in Japan as an Omicron XBB.1.5-adapted monovalent mRNA vaccine against COVID-19. Daiichi Sankyo had submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for manufacturing and marketing approval of the Omicron XBB.1.5-adapted monovalent mRNA vaccine in September 2023. Based on the supply agreement with the MHLW, Daiichi Sankyo will commence the distribution of this first-ever Japan-made mRNA vaccine in the coming days and is committed to supply a total of 1.4 million doses in FY2023 for the current special temporary vaccination program against COVID-19 in Japan.

VANFLYTA® Approved in the EU as the First FLT3 Inhibitor Specifically for Patients with Newly Diagnosed FLT3-ITD Positive AML

Basking Ridge-based Daiichi Sankyo announced VANFLYTA® (quizartinib) has been approved in the European Union (EU) for use in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive. VANFLYTA is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which represents about 25 to 30% of all new AML cases. The authorization by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on the results of the QuANTUM-First trial.  

Daiichi Sankyo Reaches Agreement With MHLW to Supply Omicron XBB.1.5-adapted COVID-19 Vaccine (DS-5670) in Japan

Basking Ridge-based Daiichi Sankyo announced that it had reached an agreement with Japan’s Ministry of Health, Labour and Welfare (MHLW) to supply the omicron XBB.1.5- adapted monovalent mRNA vaccine (DS-5670) against the novel coronavirus infectious disease (COVID19). DS-5670 will be used in the current special temporary vaccination program against COVID-19 in Japan that began in Autumn 2023. This agreement was concluded to supply 1.4 million doses in FY2023 under the condition that regulatory approval for DS-5670 should be granted by MHLW. Daiichi Sankyo submitted a supplemental New Drug Application (sNDA) for DS-5670 to the MHLW in September 2023. Daiichi Sankyo is now preparing its production facilities to supply DS-5670, the first Japan-made COVID-19 mRNA vaccine, within this year.   

Hovione Acquires ExtremoChem and its Portfolio of Proprietary Sugars to Support Customers With Stabilization and Delivery of Biopharmaceuticals

East Windsor-based Hovione announced it has acquired ExtremoChem Lda (ExtremoChem), an innovative start-up company focused on the synthesis, development and commercialization of bio-inspired synthetic sugars, targeting enhanced stabilization, reduced viscosity and delivery performance of proteins and other biopharmaceuticals. ExtremoChem developed a library of proprietary sugars, synthetic analogues of natural molecules found in extremophiles – organisms capable of withstanding the most uninhabitable environments. These sugars have shown potential in overcoming challenges associated with the stabilization of biopharmaceuticals during production, purification, formulation and transportation. The announcement of this acquisition demonstrates Hovione´s commitment to expand its technology platforms. The company is investing both in new assets and innovative technologies to meet customer demand for integrated and differentiated development and manufacturing services in drug substance, particle engineering and drug product.  

Quest Diagnostics Launches Mobile Phlebotomy Service, Enabling At-Home Specimen Collection

Quest Diagnostics recently launched Quest Mobile™, which the Secaucus-based healthcare company says will make it easier and more convenient for patients to have a specimen collected for lab testing nationwide. Patients can request an appointment for at-home specimen collection with a trained Quest Mobile phlebotomist for a broad range of laboratory tests in the comfort of their home. Based on the most accessible mobile collection healthcare network in the United States, the Quest Mobile service will be available in 44 states. Patients whose physicians or health providers order laboratory testing from Quest, including consumers requesting consumer-initiated testing services from questhealth.com, can now schedule a mobile phlebotomy appointment for a fee.   

MBrace Therapeutics Raises $85 Million Series B Financing to Advance Oncology Pipeline of Innovative Antibody Drug Conjugate Candidates

Summit-based MBrace™ Therapeutics, Inc. (“MBrace”) announced the completion of an $85 million Series B financing, bringing the company’s total raised to $110 million. Funds will be used to support clinical development programs, including a first-in-human clinical trial of lead investigational ADC, MBRC-101. Originally founded in June 2020 by Isan Chen, M.D., Renata Pasqualini, Ph.D., and Wadih Arap, M.D., Ph.D., MBrace is focused on developing lead ADC candidate, MBRC-101, and is advancing its proprietary SPARTA approach, which accelerates the development of antibody-based drugs for personalized medicine. MBrace has generated extensive preclinical data on novel drug candidates in-licensed from Rutgers, The State University of New Jersey.

Start-Up Sauvie CEO Shares Insights on Fundraising and Industry Partnerships

Emerging biopharmaceutical companies must pitch to investors, attract and retain talent and persuade consultants to come on board. This way, the company can develop and test new products and, ultimately, bring them to market. However, it takes even more than that for an early stage enterprise to succeed. Verve Group Consulting Co-Founder and Managing Director Larry Samilow sat down with start-up Sauvie, Inc. CEO Ken Suh to talk about the exciting – and often challenging – years-long effort to bring a product to market. Sauvie, incorporated in May 2022, is headquartered in Short Hills.  

CSIT R&D Seed Grant Pilot Programs, Round 3 - Information Session

December 7, 2023 | 2:00 p.m. | Virtual

The CSIT R&D Seed Grant Pilot Programs aim to enhance the State’s innovative economy by providing financial grants to early stage innovation-based companies to accelerate key product development. The funding assists applicants to transform new discoveries from research-stage into commercially viable products and services, leading to industry and investor interest.

NJEDA Launches $100M NJ Capital Access Fund

The New Jersey Economic Development Authority (NJEDA) announced the opening of the $100 million NJ Capital Access Fund, aimed at providing working capital loans with competitive interest rates to help support New Jersey small businesses. Last December, the U.S. Department of Treasury approved New Jersey’s federal State Small Business Credit Initiative (SSBCI) application, awarding the NJEDA $255 million to create programs that will provide financial and technical assistance to small and micro businesses as well as early-stage, innovation-focused companies located here in the Garden State. In May, the NJEDA announced it approved several firms to manage those resources as well as the creation of several funds to distribute it. This new announcement marks the next step in the process.

Governor Murphy Announces Letter of Intent for Proposed Life Sciences, Health Care and Tech Innovation Hub in Jersey City

Governor Phil Murphy announced that the New Jersey Economic Development Authority (NJEDA) and SciTech Scity LLC (“STS”), have signed a non-binding letter of intent to form a limited liability company to be called “Edge Works” to develop, construct and manage an approximately 120,000-square-foot life sciences, healthcare and tech innovation hub adjacent to the Liberty Science Center in Jersey City, New Jersey. The NJEDA intends to invest up to $20 million in Edge Works. The eight-story business creation hub of STS, will house laboratories, research & development spaces, office suites, co-working spaces for dozens of start-ups, a tech exhibition gallery and a state-of-the-art conference center. In addition to Edge Works, SciTech Scity will also include Liberty Science Center High School, a new public STEM high school for Hudson County; and Scholars Village, consisting of 500 units of residential housing for tech-forward families and individuals.  

Tom Nehila Joins New Jersey Innovation Institute Leadership Team as CFO

Newark-based New Jersey Innovation Institute, a New Jersey Institute of Technology subsidiary, announced Tom Nehila as its Chief Financial Officer. Previously working as NJII’s interim CFO, Mr. Nehila was offered the full-time position after demonstrating his strategic leadership and helping to transform the NJII organization. “I look forward to working closely with Tom as we continue to build out our finance department and systems. Tom’s leadership and expertise will complement our ongoing initiatives focused on the growth and scaling of NJII,” NJII President Michael Johnson said. Mr. Nehila’s 30-year experience spans over several industries including telecom, technology, data analytics, media and publishing, professional services and healthcare operations. Prior to joining NJII, Mr. Nehila worked as a consultant to ambitious companies looking to capitalize on the expanding role of CFO.

Johnson & Johnson Names Eugene A. Woods, Chief Executive Officer of Advocate Health, to its Board of Directors

New Brunswick-based BioNJ Member Johnson & Johnson announced that Eugene A. Woods, MBA, MHA, Chief Executive Officer of Advocate Health, has been appointed to its Board of Directors. “Mr. Woods is an exceptional addition to Johnson & Johnson’s Board of Directors,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “Mr. Woods has an impressive career of leading and transforming healthcare systems while prioritizing the delivery of high-quality, equitable patient care. The Board looks forward to working with him as the company continues to focus on healthcare innovation and tackling the toughest health challenges.”

BD Names Former 3M Health Care exec, Dr. Ronald Silverman, as Chief Medical Officer

Franklin Lakes-based BD, also known as Becton, Dickinson and Co., announced that Dr. Ronald “Ron” Silverman, has been named Executive Vice President and Chief Medical Officer. Dr. Silverman will report to Beth McCombs, Executive Vice President and Chief Technology Officer for BD, and serve as a member of the BD Executive Leadership Team. Dr. Silverman will be responsible for leading the company’s medical affairs organization, which includes end-to-end medical affairs across BD’s business units, regions and central team. In this role, he will use medical insights and expertise to advance BD’s pipeline of clinically relevant, innovative solutions that align with evolving patient needs, while also contributing to the safety and compliance of BD’s in-market portfolio of products.  

PDS Biotech Appoints Lars Boesgaard as Chief Financial Officer

PDS Biotechnology Corp., a Princeton-based firm developing a pipeline of targeted cancer immunotherapies and infectious disease vaccines, announced the appointment of Lars Boesgaard as Chief Financial Officer, effective Dec. 4. Mr. Boesgaard has had a career spanning more than 25 years in health care and has deep capital markets and investor relations experience with global clinical and commercial-stage pharmaceutical and biotechnology companies. He has prepared and executed corporate transactions and built financial frameworks for rapidly growing organizations. Prior to joining PDS Biotech, Mr. Boesgaard served as CFO of AM-Pharma B.V. from September 2021 to August. He also served as CFO of Columbia Care from August 2018 to August 2021.

Eagle Pharmaceuticals Announces Management Change

Woodcliff-based Eagle Pharmaceuticals, Inc. announced a change in management. Effective immediately Scott Tarriff, Founder, President and CEO of the company, has announced his retirement from his positions with the company as President, CEO and Director on the company’s Board of Directors. Michael Graves, Eagle Pharmaceuticals’ Chairman of the Board, has assumed the role of Interim Executive Chairman of the Board to lead the management team through this transition. Mr. Graves has served as a member of Eagle’s Board of Directors since November 2013 and as Chairman of the Board since June 2016. Mr. Graves has extensive board experience and is currently Executive Chairman of the Board of Directors of Nanocopoeia, Inc. and a member of the Board of Managers of TopRx, LLC, both privately held companies. Mr. Graves previously served on the Board of Directors of RiboCor, Inc.

The Newark Summit

December 4, 2023 | 7:30 a.m.-5:00 p.m.

Visionary tri-state leaders are convening to discuss the areas driving city growth -- investment, placemaking, development, collaboration and design.

SHOW ME THE RESOURCES! Meet the Staff from the NJEDA and More!

December 5, 2023 | Days Hotel by Wyndham Toms River | 9:30 a.m.-12:30 p.m.

Meet the staff from the NJ Economic Development Authority (NJEDA) and SBDC! Gain valuable information about resources for small business services, the economic benefits of filming with local production, preparing your town clean energy and much more!

2024 Rutgers - New Brunswick Winter Career & Internship Mega Fair

Thursday, February 1, 2024 & Friday, February 2, 2024

Rutgers, New Brunswick is delighted to see your organization's interest in attending the 2024 Winter Career & Internship Mega Fair. Students and alumni from all Rutgers University campuses (New Brunswick, Camden, Newark and RBHS) from all majors are invited to attend. The event is scheduled to take place at the Jersey Mike's Arena from 11:30 a.m. to 3:30 p.m.

BIO International Convention 2024

Hosted by Biotechnology Innovation Organization

June 3-6, 2024

Taking place June 3-6,2024 at the San Diego Convention, the BIO International Convention is the largest gathering of the biotech community in the world. As a member of BioNJ, your organization is eligible for a $200 discount on Premier or General registration rates. And, if you redeem your code during Early Bird registration, your total savings may exceed $400! Contact Randi Bromberg at RBromberg@BioNJ.org for the BioNJ Member code.