QALY Ban Bill Takes Leap Forward

The QALY is a metric used to determine how cost-effective a treatment is based on its ability to return a sick person to perfect health. Even if a treatment helps a chronically ill person to live longer, it will not be categorized as valuable as treatments are aimed at diseases that affect younger and healthier populations. To help us understand how the QALY negatively impacts those with chronic illness, we’re joined by Michael Riotto, a member of Patients Rising, and Bill Smith, a Senior Fellow at the Pioneer Institute.

Washington Must Not 'March In' On NJ Universities, Life Sciences Industry and Patients (Op-ed by Debbie Hart, BioNJ President and CEO)

New Jersey can take pride in the health care narrative it has crafted. Notably, synergies between public and private entities within the Garden State have yielded groundbreaking drugs and solutions to some of the most formidable challenges in public health. In just one recent example, technology originating from Rutgers University and sublicensed to AstraZeneca will play a crucial role in advancing the development of novel cell therapies for the treatment of cancer and immune-mediated diseases. But in a political environment where “drug pricing” clouds policymakers from real solutions to help patients, the Biden administration wants to disrupt the very framework that enables life sciences companies and public institutions to collaborate to find new treatments and cures. Threats to intellectual property, or IP, protections, despite intentions of lowering patient costs, will only dampen innovation and hurt patients waiting for future breakthroughs.

CEOs of J&J, Merck, BMS are Testifying Before U.S. Senate Committee Today — Here’s What That Could Mean

Johnson & Johnson CEO Joaquin Duato, Merck CEO Rob Davis and Bristol Myers Squibb CEO Chris Boerner testified before the U.S. Senate Health, Education, Labor and Pensions Committee regarding prescription drug prices. Senate hearings often become political power plays, where members of the Senate seemingly ask questions to score points with their base rather than get pertinent information.

Debbie Hart, the CEO of BioNJ, said “There is a whole complex system of multiple players who contribute to drug pricing. It is not just the innovators. In fact, prescription drugs only account for 8% to 9% of total health care costs. Therefore, it is difficult to have these conversations without looking and speaking holistically about the entire system and all of the contributors to the price of drugs...Our companies are committed to patients and to innovation every step of the way, and stand ready to work with Congress and the administration to ensure that patients are served around the world while also allowing the investments they are making here and now to drive future innovation."

New Cellares Facility a Win for NJ’s Innovation, Life Sciences Sectors

When Cellares cut the ribbon recently on a first-of-its-kind Smart Factory in Bridgewater, the event marked a moment of potential for the State’s economy as well as for patients desperately in need of the potentially life-saving cell therapies that will be manufactured there. Cellares’ new 118,000-square-foot state-of-the-art Smart Factory is located at 95 Corporate Drive in Bridgewater – a site formerly occupied by Pfizer. It represents the world’s first Integrated Development and Manufacturing Organization Smart Factory dedicated to clinical and industrial-scale cell therapy manufacturing. “The innovation that Cellares is bringing to New Jersey and to patients is first-of-its-kind, best-in-class, and life-altering in every way – exactly what New Jersey is known for,” Debbie Hart, President and CEO of BioNJ and chair of the Commission on Science, Innovation and Technology, who attended the ribbon cutting, said. "This will be impactful in so many ways and on so many fronts – and we could not be more proud.”

Annual BioNJ Dinner Celebrates Innovation, Life Sciences

BioNJ hosted its 31st Annual Dinner Meeting & Innovation Celebration, bringing together industry leaders, representatives and key stakeholders from the Garden State’s life sciences and innovation sectors. Held at the Hilton East Brunswick, the event was the largest to date. At the top, BioNJ President and CEO Debbie Hart noted that more than 700 people registered for this year’s dinner, breaking records across every metric. “Tonight, we come together to express our deep gratitude for New Jersey’s outstanding life sciences ecosystem – fulfilling patients’ dreams around the globe,” said Hart. “Once more, New Jersey’s impact is undeniable – as more than 50% of all novel FDA [U.S. Food and Drug Administration] approvals in 2023 emanated from companies with a footprint in New Jersey. Many of you – reaffirming our identity as the ‘Medicine Chest of the World."

For Bio Industry in N.J., a Celebration — and a Call to Change Narrative

Like so many of the life sciences leaders at the event, Dr. Emer Leahy leads a company that is making life-changing — and life-saving — discoveries for patients around the world who are suffering from illnesses and conditions for which there often is no cure. And like so many in an overflow crowd of more than 700 at the 31st annual BioNJ Innovation Celebration last Thursday night in East Brunswick, the mission is personal. Leahy, upon becoming the new chair of the organization, shared why the work Paramus-based PsychoGenics does — conducting leading-edge research that aims to help those with schizophrenia and other severe mental illnesses — is so important to her. Leahy said she was drawn to neuroscience after seeing two of her cousins suffer from schizophrenia and having a mom suffer from bouts of depression so severe that it isolated her from life itself, she said. It’s the narrative the industry needs to tell more often, she said. “We need to humanize our industry by sharing powerful patient stories of how treatments have changed their lives,” she said.

BioNJ Elects Board Chair, Officers and Trustees

BioNJ, the trade association for New Jersey’s life sciences industry, has announced the election of its 2024 officers and board members. This election preceded BioNJ’s 31st Annual Dinner Meeting and Innovation Celebration, held on Feb. 8 at the Hilton East Brunswick. The newly elected officers are Emer Leahy, Ph.D., MBA, President & CEO of PsychoGenics, as Chair, and Samuele Butera, MPP, President of Janssen Pulmonary Hypertension and Retina, as Vice Chair. Additionally, Jayne C. Gershkowitz, Chief Patient Advocate at Amicus Therapeutics, was re-elected as Treasurer, and Christopher Mortko, Ph.D., MBA, Vice President & Head of HQ Research and Evaluation at Merck Business Development & Licensing, was re-elected as Secretary.

Strengthening a Bond, New Jersey-India Commission Created

The partnership and connections between New Jersey and India are almost too many to mention — but too significant to ignore. You can start with the fact that approximately 5% of New Jersey’s population is South Asian, many of whom are located in dynamic clusters in Edison/Iselin, Jersey City and Robbinsville. Then, add the fact that New Jersey has the highest concentration of Indian companies of any state in the country and that India is second-largest foreign direct investor in the state. All of which leads to this: The two-way trade between New Jersey and India tops $10 billion annually. It’s the reason why New Jersey officially created the New Jersey-India Commission — just the third such commission in State history. The commission members are a who’s who of State leaders in numerous sectors, including Kris Kolluri of the Gateway Development Commission, Indu Lew and Balpreet Grewal-Virk of RWJ Baranabas Health, Jose Lozano of Hackensack Meridian Health, Coleen Burrus of Princeton University, Raj Parikh of Genova Burns, Pavita Howe of BioNJ, Parimal Garg of the Governor’s Office and state Sens. Vin Gopal (D-Ocean Twp.) and Raj Mukherji (D-Jersey City).

Phathom Pharmaceuticals Announces VOQUEZNA® (vonoprazan) Tablets for Erosive GERD and Associated Heartburn Added to Express Scripts National Formularies for Commercial Patients

Florham Park-based BioNJ Member Phathom Pharmaceuticals, Inc. announced the placement of VOQUEZNA® (vonoprazan) tablets for the treatment of adults with Erosive Esophagitis, commonly referred to as Erosive GERD (gastroesophageal reflux disease), and relief of heartburn associated with Erosive Esophagitis on the Express Scripts national formularies, effective immediately. VOQUEZNA is the first and only FDA-approved potassium-competitive acid blocker (PCAB) and the first new class of Erosive GERD treatment to become available in the United States in over 30 years. Commercial access for VOQUEZNA tablets is now estimated at 60 million covered lives in the United States. Erosive GERD, also referred to as Erosive Esophagitis, is a subtype of GERD that affects approximately 20 million people in the U.S. 

Kyowa Kirin Announces First Patient Enrolled in the Phase 2 Clinical Trial Evaluating Tivozanib Eye Drops in Patients With Diabetic Macular Edema

BioNJ Member Kyowa Kirin Co., Ltd., with a site in Princeton, announced the enrollment of the first patient in a Phase 2 clinical trial, multi-center, randomized, double-masked, parallel group study of tivozanib eye drops (KHK4951). This study investigates the efficacy and safety of KHK4951 in patients with diabetic macular edema (DME). Tivozanib, the active ingredient of KHK4951 is a small-molecule vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3 tyrosine kinase inhibitor (TKI) discovered and developed by Kyowa Kirin. KHK4951 is a novel nano-crystalized tivozanib eye drops designed to deliver it efficiently to the posterior ocular tissues and is being developed as a potential treatment option for neovascular (wet) age-related macular degeneration (nAMD) and DME. 

Soligenix Announces Formation of Behçet's Disease Medical Advisory Board

Princeton-based BioNJ Member Soligenix announced the formation of a Medical Advisory Board to provide medical/clinical strategic guidance to the company as it advances the clinical development of SGX945 (dusquetide) for the treatment of Behçet's Disease. The company previously announced that the U.S. FDA had granted Fast Track designation for dusquetide in the treatment of oral lesions of Behçet's Disease. "We have assembled some of the world's leading experts in this field who collectively have hundreds of publications and have the experience of treating thousands of patients with this chronic condition. The initiation of a Phase 2a clinical study in Behçet's Disease later this year will be another important milestone for our company, and we look forward to working with the MAB to advance this program," stated Christopher J. Schaber, Ph.D., President and CEO of Soligenix.

Palatin Announces Database Lock for PL9643 Meldoy-1 Pivotal Phase 3 Clinical Trial in Patients With Dry Eye Disease (DED)

Cranbury-based BioNJ Member Palatin Technologies, Inc. announced database lock for its PL9643 MELODY-1 pivotal Phase 3 clinical trial evaluating the safety and efficacy of PL9643 versus vehicle in the treatment of dry eye disease (DED). MELODY-1 has two co-primary efficacy endpoints: one clinical sign of DED and one clinical symptom of DED. If one or both co-primary end points are met, the study will be deemed a success and the secondary end points will be evaluated using a hierarchical testing strategy. “We are excited by the database lock and that data analysis by the independent statisticians has commenced. We look forward to reporting top-line results from the PL9643 MELODY-1 pivotal Phase 3 clinical trial later in February,” said Carl Spana, Ph.D., President and CEO of Palatin. 

Tevogen Bio Announces $8M Equity Investment

Warren-based Tevogen Bio Holdings Inc. said it received an $8 million investment in shares of Series A preferred stock of the company. “We are excited to begin our journey as a public company with this additional investment,” Dr. Ryan Saadi, Tevogen’s chairperson and CEO, said. “We believe Tevogen’s patient-centric approach, which merges a focus on affordability with advanced science, is a blueprint for sustainable success in the current era of health care. I am pleased that investors now have the opportunity to participate in Tevogen’s mission to become the very first life science company offering commercially attractive and affordable personalized T-cell therapies for large patient populations in virology, oncology and neurology.” The shares of Series A Preferred Stock will be issued in the first quarter and will be convertible into a total of 2 million shares of the company’s common stock at the election of the holder.

Breaking Barriers in Cancer Care: The American Cancer Society and Pfizer Announce a $15 Million, Three-Year Initiative to Bridge the Gap in Cancer Care Disparities

The American Cancer Society and BioNJ Member Pfizer, with a site in Peapack, announced the launch of “Change the Odds: Uniting to Improve Cancer Outcomes™,” a three-year initiative to bridge the gap in cancer care disparities. Through $15 million in funding from Pfizer, the initiative aims to improve health outcomes in medically underrepresented communities across the United States by enhancing awareness of and access to cancer screenings, clinical trial opportunities, and patient support and comprehensive navigation. “Change the Odds” will initially focus on breast and prostate cancer in medically underserved communities, with the potential to expand to additional cancer types. ACS plans to engage additional partners to extend the reach of the programmatic activities to more individuals and deepen the tangible impact in select communities.

Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Opdivo in Resectable Non-Small Cell Lung Cancer

Princeton-based BioNJ Member Bristol Myers Squibb announced two regulatory acceptances for applications for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). The U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics Application (sBLA) and assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 8, 2024. In late January, the European Medicines Agency (EMA) validated the type II variation application which confirms the submission is complete and begins the start of the EMA's centralized review process. The submissions were based on results from the Phase 3 CheckMate -77T trial, which represents the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of resectable NSCLC, showing statistically significant and clinically meaningful improvements in event-free survival (EFS), the study’s primary endpoint. 

Bristol Myers Squibb and 2seventy bio Share Update on U.S. FDA Oncologic Drugs Advisory Committee Meeting for Abecma in Triple-Class Exposed Multiple Myeloma Based on KarMMa-3 Study

Princeton-based BioNJ Member Bristol Myers Squibb and 2seventy bio, Inc. announced that a notice was published in the Federal Register that the U.S. Food and Drug Administration will convene a virtual meeting of the Oncologic Drugs Advisory Committee on March 15, 2024, to review data supporting the supplemental Biologics License Application for Abecma® (idecabtagene vicleucel) for triple-class exposed relapsed or refractory multiple myeloma based on results from the pivotal Phase 3 KarMMa-3 study. Abecma was recently approved in Japan for patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody based on the KarMMa-3 study, making it the first CAR T cell therapy to receive regulatory approval for use in earlier lines of therapy for patients with relapsed and refractory multiple myeloma. 

Gilead Sciences Expands Liver Portfolio With Acquisition of CymaBay Therapeutics

BioNJ Member Gilead Sciences, with a site in Morris Plains, announced a definitive agreement under which Gilead will acquire CymaBay for $32.50 per share in cash or a total equity value of $4.3 billion. The addition of CymaBay’s investigational lead product candidate, seladelpar for the treatment of primary biliary cholangitis (PBC) including pruritus, complements Gilead’s existing liver portfolio and aligns with its long-standing commitment to bringing transformational medicines to patients. “We are looking forward to advancing seladelpar by leveraging Gilead’s long-standing expertise in treating and curing liver diseases,” said Daniel O’Day, Chairman and CEO, Gilead Sciences. “Building on the strong research and development work by the CymaBay team to date, we have the potential to address a significant unmet need for people living with PBC and expand on our existing broad range of transformational therapies.”

Novartis to Acquire German Biotech MorphoSys for $2.9B, Expanding Cancer Drug Pipeline

East Hanover-based BioNJ Member Novartis has struck a deal to buy German biotech firm MorphoSys, a developer of cancer treatments, for 2.7 billion euros ($2.9 billion), as the Swiss drugmaker expands its roster of cancer treatments. Novartis said it will offer MorphoSys shareholders 68 euros per share in cash, a 94% premium to the average price of the stock over the past month before news of the acquisition broke. The deal is expected to close in the first half of 2024 if the offer is accepted by at least 65% of shareholders. The deal will give Novartis access to pelabresib, a treatment MorphoSys is developing to treat myelofibrosis, a rare kind of bone marrow cancer.

New Data Demonstrate Clinical Safety, Benefit and Durability of Nexviazyme® Across a Wide-Range of Pompe Disease Patient Groups

Bridgewater-based BioNJ Member Sanofi announced new data suggests treatment with Nexviazyme® (avalglucosidase alfa) meaningfully improved ptosis, or drooping eyelid, in pediatric patients with infantile-onset Pompe disease (IOPD) over nearly three years. These findings, from the Phase 2 Mini-COMET study long-term extension, will be featured at the 20th annual WORLDSymposiumTM, along with debut data (positive safety results) from the Phase 3 Baby-COMET trial, the first study of avalglucosidase alfa in never-before-treated patients with IOPD, and the first study in over 20 years of any treatment in naïve IOPD patients. Ptosis (drooping eyelid) impacts ~50% of IOPD patients, potentially causing vision loss and decreased quality of lifei. Nexviazyme is a monotherapy approved in the US and other markets for juvenile and adult patients with LOPD. 

DREAMM-7 Phase III Trial Shows Blenrep Combination Nearly Tripled Median Progression-Free Survival Versus Standard of Care Combination in Patients With Relapsed/Refractory Multiple Myeloma

Warren-based BioNJ Member GSK announced results from an interim analysis of the DREAMM-7 Phase III head-to-head trial evaluating Blenrep (belantamab mafodotin) combined with bortezomib plus dexamethasone (BorDex) versus daratumumab plus BorDex in second-line and later treatment of relapsed or refractory multiple myeloma. Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “The substantial progression-free survival benefit and strong overall survival trend compared to a daratumumab standard of care combination reinforce our belief in the potential for belantamab mafodotin used in combination to redefine the treatment of multiple myeloma at or after first relapse. We plan on sharing these results with health authorities worldwide.”

GSK’s Regulatory Application for Shingrix for the Prevention of Shingles in At-Risk Adults Aged 18 and Over Accepted for Review by China National Medical Products Administration

Warren-based BioNJ Member GSK announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted for review the regulatory application of Shingrix (Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster) in adults aged 18 years and over at increased risk. Recombinant Zoster Vaccine (RZV) is a non-live, recombinant subunit adjuvanted vaccine given intramuscularly in two doses and was initially approved in 2019 by the NMPA to prevent shingles in adults aged 50 years and over. The NMPA application is informed by six clinical trials in patients aged 18 years and over who had undergone recent blood-forming cells (stem cell) transplantation, kidney transplant or have blood cancer, solid tumor or HIV.

GSK’s RSV Vaccine, Arexvy, Accepted Under Priority Review in US for the Prevention of RSV Disease in Adults Aged 50-59 at Increased Risk

Warren-based BioNJ Member GSK announced that the U.S. Food and Drug Administration (FDA) has accepted under Priority Review an application to extend the indication of GSK’s adjuvanted respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease. If approved, GSK’s RSV vaccine would be the first vaccine available to help protect this population. Arexvy is currently approved in the U.S. in adults aged 60 and over for the prevention of lower respiratory tract disease (LRTD) caused by RSV. The application is supported by positive results from a phase III trial [NCT05590403]4 evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to underlying medical conditions.

GSK Receives U.S. FDA Fast Track Designation for Bepirovirsen in Chronic Hepatitis B

Warren-based BioNJ Member GSK announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB). Fast track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The designation was requested based on the potential for bepirovirsen to address an unmet medical need for CHB, a serious and life-threatening condition. Data from the phase IIb trials B-Clear and B-Sure, which evaluated the efficacy, safety and durability of response of bepirovirsen in people with CHB, were submitted in support of the application. A confirmatory Phase III programme, B-Well, is ongoing.

GSK Completes Acquisition of Aiolos Bio

Warren-based BioNJ Member GSK plc announced that it has completed the acquisition of Aiolos Bio (Aiolos), a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with respiratory and inflammatory conditions. As previously announced, the acquisition of Aiolos includes AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter phase II clinical development for the treatment of adult patients with asthma. AIO-001 could expand GSK’s respiratory biologics portfolio to potentially reach the 40% of severe asthma patients with low T2 inflammation (a type of overactive immune response associated with asthma).2 AIO-001 has the potential to be administered every six months due to its high potency and long half-life, which could redefine the standard-of-care.

Investigational Targeted Oral Peptide JNJ-2113 Demonstrated Positive Results in Moderate-to-Severe Plaque Psoriasis in Phase 2b Study Published in New England Journal of Medicine

New Brunswick-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced publication in the New England Journal of Medicine of the Phase 2b FRONTIER 1 trial results for JNJ-2113.1 JNJ-2113 is the first and only investigational targeted oral peptide inhibitor designed to block the IL-23 receptor. IL-23 plays a critical role in pathogenic T-cell activation in moderate-to-severe plaque psoriasis (PsO) and underpins the inflammatory response in PsO and other dermatological and gastroenterological IL-23-mediated diseases. The FRONTIER 1 clinical trial achieved the primary and all secondary efficacy endpoints evaluating JNJ-2113 in adults with moderate-to-severe plaque PsO. The primary endpoint of the study was a reduction from baseline of at least 75 percent in the Psoriasis Area and Severity Index score (PASI 75 response) at Week 16. 

Janssen Submits Type II Extension of Indication Application to the European Medicines Agency Seeking Approval of RYBREVANT®▼ (amivantamab), in Combination With Lazertinib, for the First-Line Treatment of Patients With EGFR-Mutated Non-Small Cell Lung Cancer

New Brunswick-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 lazertinib, for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations. “Patients with NSCLC with common EGFR mutations face a five-year survival rate of just 19 percent. This, coupled with the significant physical and emotional burden of the disease, reinforces the high unmet medical need we must urgently address,” said Catherine Taylor, Vice President, EMEA Medical Affairs, Therapy Area Strategy, Janssen-Cilag AG. 

Johnson & Johnson’s Nipocalimab Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Individuals at High Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

New Brunswick-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for nipocalimab for the treatment of alloimmunizeda pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN). Nipocalimab is currently the only therapy reported to be in clinical development for the treatment of alloimmunized pregnant individuals at risk of severe HDFN, a serious and rare condition that occurs when the blood types of a pregnant individual and the fetus are incompatible, potentially causing life-threatening anemia in the fetus or infant. The data from the proof-of-concept Phase 2 open-label UNITY clinical trial provided support for the BTD.

Johnson & Johnson Reports Positive Topline Results for Nipocalimab from a Phase 3 Pivotal Study in Generalized Myasthenia Gravis (gMG) and a Phase 2 Study in Sjögren’s Disease (SjD)

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced topline results from the pivotal Phase 3 VIVACITY study of nipocalimab in adults living with generalized myasthenia gravis (gMG) as well as the Phase 2 DAHLIAS study of nipocalimab in adults with Sjögren’s disease (SjD). Nipocalimab has demonstrated clinical effect in four autoantibody-driven diseases within the past year, including hemolytic disease of the fetus and newborn (HDFN) and rheumatoid arthritis, in addition to gMG and SjD. In the Phase 3 VIVACITY study in gMG, nipocalimab met the primary endpoint, achieving statistically significant reduction in MG-ADLa score from baseline over weeks 22 to 24 compared with placebo (PBO). gMG is a chronic, life-long, rare, and highly debilitating autoantibody-driven neuromuscular disease characterized by fluctuating muscle weakness.

Just – Evotec Biologics Expands Development and Manufacturing Agreement With ABL for Broadly Neutralising Antibodies Against HIV

Princeton-based BioNJ Member Evotec announced that its subsidiary Just – Evotec Biologics, Inc. has expanded its relationship with Advanced BioScience Laboratories, Inc., a global contract development and manufacturing organization (“CDMO”) serving the U.S. Government and biopharmaceutical industry. The expansion is under a new contract funded entirely by Federal funds under an indefinite delivery/indefinite quantity (“IDIQ”) contract awarded to ABL from National Institute of Allergy and Infectious Disease (“NIAID”), National Institutes of Health (“NIH”), Department of Health and Human Services, (“DHHS”) under Contract No. HHSN272201700010I/ 75N93023F00001. The new agreement builds on previous collaborations between Just – Evotec Biologics and ABL to design highly efficient manufacturing processes for broadly neutralising antibodies (“bNAbs”) against HIV. 

AbbVie Completes Acquisition of ImmunoGen

BioNJ Member AbbVie, with a site in Madison, announced that it has completed its acquisition of ImmunoGen. With the completion of the acquisition, ImmunoGen is now part of AbbVie. "Together with ImmunoGen, we have the potential to continue redefining the standard of care for those living with cancer," said Robert A. Michael, President and Chief Operating Officer, AbbVie. "The addition of ImmunoGen's treatment for ovarian cancer will accelerate our ability to help patients today, expand our oncology pipeline and drive long-term revenue growth well into the next decade. I want to thank ImmunoGen for their efforts to advance science for patients and we look forward to welcoming our new colleagues to AbbVie."

Merck Animal Health to Acquire Elanco’s Aqua Business

Merck Animal Health, a division of Rahway-based BioNJ Member Merck & Co., announced that it has signed a definitive agreement to acquire the aqua business of Elanco Animal Health Incorporated for $1.3 billion in cash, consisting of an innovative portfolio of medicines and vaccines, nutritionals and supplements for aquatic species; two related aqua manufacturing facilities in Canada and Vietnam; as well as a research facility in Chile. The acquisition is expected to be completed by mid-year 2024, subject to approvals from regulatory authorities and other customary closing conditions. Upon closing, the acquisition will broaden Merck Animal Health’s aqua portfolio with products, such as CLYNAV®, a new generation DNA-based vaccine that protects Atlantic salmon against pancreas disease, and IMVIXA®, an anti-parasitic sea lice treatment.

Catalent to be Acquired by Novo Nordisk Parent for $16.5B to Boost Wegovy Supply

Somerset-based Catalent will be acquired by Novo Holdings — to expand its capacity for popular weight-loss drug Wegovy — for $11 billion. Novo Holdings plans to sell three key facilities to Plainsboro-based BioNJ Member Novo Nordisk, in which Novo Holdings has a controlling interest, shortly after the closing of the merger. Novo Nordisk’s strategy enables an expansion of the manufacturing capacity at scale and speed while providing future optionality and flexibility for Novo Nordisk’s existing supply network. The acquisition is expected to gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.

Ipsen’s Onivyde® rRegimen, a Potential New Standard-of-care First-line Therapy in Metastatic Pancreatic Adenocarcinoma, Approved by FDA  

Basking Ridge-based Ipsen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC). This is the second approval for an Onivyde regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy. “The results from the Phase III NAPOLI 3 trial represent the first positive data for an investigational regimen in first-line metastatic pancreatic adenocarcinoma versus the currently approved nab-paclitaxel and gemcitabine regimen,” said Christelle Huguet, EVP and Head of Research and Development, Ipsen.

Metoject® Subcutaneous Injection Pen (methotrexate) Pen-Type Autoinjector Approved in Japan

Nutley-based Eisai Co., Ltd. and nippon medac Co., Ltd. announced that they have obtained manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the additional formulation of Metoject Subcutaneous Injection for the anti-rheumatic agent, pen-type autoinjector “Metoject® Subcutaneous Injection 7.5mg Pen 0.15mL, 10mg Pen 0.20mL, 12.5mg Pen 0.25mL and 15mg Pen 0.30mL” (methotrexate). Based on the license agreement signed by Eisai and medac GmbH in May 2019, nippon medac will hold the marketing authorization of Metoject, while Eisai will be responsible for product distribution of Metoject in Japan. This formulation incorporates the previously MHLW-approved Metoject Subcutaneous Injection pre-filled syringe formulation in a pen-type autoinjector and was developed to reduce the burden on patients and improve safety during self-injection. 

NJEDA to Hold Monthly Office Hours Highlighting Innovation Programs

To respond to challenges faced by New Jersey technology and biotechnology companies in raising capital, the New Jersey Economic Development Authority (NJEDA) is launching monthly Innovation Programs Office Hours to highlight programs offered by the Authority to stimulate the innovation economy. Alternating between in-person and virtual events, these will offer one-on-one sessions with the NJEDA’s Innovation team to discuss programs and networking opportunities with industry stakeholders. Participation in office hours is encouraged for pre-seed, seed, early-stage, and growth-stage startup companies in the technology and life sciences industries, as well as investors seeking opportunities in innovative companies. Programs covered will include direct company investments, such as the Angel Match Program, and investor benefits, such as the Angel Investor Tax Credit Program. For a list of upcoming office hours, which will alternate monthly between in-person and virtual events, click here.

NJEDA Program Helps to Draw Investment Interest into Innovative NJ Startups

The New Jersey Economic Development Authority (NJEDA) continues to accept applications for the New Jersey Entrepreneur Support Program, which was launched in 2020 to help Garden State entrepreneurs navigate COVID-19 related cashflow constraints, then relaunched in March of 2023 in light of challenges in the economy and venture banking system. The $5 million program encourages investors to provide additional funding to businesses by providing an NJEDA guarantee on loans advanced for working capital purposes.

NJ Golden Seeds and Rutgers University Partner for Angel Investing Forum

The New Jersey chapter of Golden Seeds partnered with the Rutgers University Foundation to hold an angel investing forum in New Brunswick earlier this week, bringing entrepreneurs, investors, and alumni together for networking and pitching opportunities to support innovative women-led businesses. Supported by First Lady Tammy Murphy and the New Jersey Economic Development Authority (NJEDA), the New Jersey chapter of Golden Seeds aims to close the funding gap faced by female-led startups and support their success by increasing access to capital and creating mentoring opportunities with angel investors and successful entrepreneurs.

Phase II of NJEDA's Manufacturing Voucher Program is Now Open

The New Jersey Economic Development Authority (NJEDA) opened applications for Phase II of the Manufacturing Voucher Program (MVP). MVP Phase II will make available $20 million in grant funding through a rolling application process to provide New Jersey manufacturers with access to essential equipment, which will enhance efficiency, productivity, and overall profitability in New Jersey. The MVP offers vouchers valued at 30 to 50 percent of the cost of eligible equipment, including installation, up to a maximum award amount of $250,000.

Foundation Venture Capital Group Commits $1 Million to Hackensack Meridian Health’s First Spin-out Company, EValuate Diagnostics

EValuate Diagnostics, the first spin-out company from the Hackensack Meridian Health Research Institute and its Office of Innovation and Commercialization, is the newest addition to Foundation Venture Capital Group’s (FVCG’s) portfolio. FVCG, an affiliate of the New Jersey Health Foundation (NJHF), provided a $1 million commitment towards helping EValuate Diagnostics advance its technologies to make this testing a reality – and save lives of the future. FVCG, an affiliate of the New Jersey Health Foundation (NJHF), provided a $1 million commitment towards helping EValuate Diagnostics advance its technologies to make this testing a reality – and save lives of the future.

NJBIZ Conversations: Hackensack Meridian Health CEO Robert Garrett

In this special edition of NJBIZ Conversations, Robert Garrett discusses his new role, the time he spent in Davos and how the health care industry must evolve to meet urgent global needs. To watch the podcast, click here

Rutgers University – Camden and Samaritan Sign MOU to Advance Palliative Medicine

Rutgers University – Camden Chancellor Antonio Tillis and Samaritan CEO and President Phillip Heath signed a Memorandum of Understanding to establish a Premier Partnership, to expand research, education and community engagement to advance the practice of palliative medicine in the city of Camden and the region. The partnership is the first of its kind for both institutions.

Kean University Announces Dual Degree in Pharmacy With Howard University

Kean University announced that its students now have a faster path to earning a doctoral degree in pharmacy under a new dual degree agreement with Howard University that is designed to encourage more students from underrepresented groups to enter the health care field. Signed during Kean’s ongoing Black History Month celebrations, the accelerated degree program provides qualified students at Kean the opportunity to begin studying at Howard, one of the nation’s most prestigious historically Black research universities, during their senior year. Ultimately, participating Kean students will obtain both a Bachelor of Arts in chemistry from Kean and a Doctor of Pharmacy, or Pharm.D., from Howard in Washington, D.C., in seven years, one year faster than through traditional pharmacy academic programs.

Northeast Science and Technology Center Announces Next Phase

Onyx Equities, managing member of the Northeast Science and Technology (NEST) Center, announced the next phase of the Kenilworth-based campus’ evolution into an international life sciences and biotechnology hub. “The caliber of current lab and biomanufacturing space and related infrastructure at NEST is unparalleled nationally. Merck spared no expense in the build-out and infrastructure redundancy of its world headquarters,” explained Jonathan Scheinberg, Managing Principal and Founder of Outshine Properties. The 100+ acre campus already boasts 2 million square feet of existing facilities, including 1.4 million square feet of state-of-the-art laboratories and biomanufacturing facilities, 500,000 square feet of Class-A professional office space, an existing vivarium, and over 30 acres of redevelopment opportunities. 

First HMH Innovation Hub Spinout Gets $1M Commitment

EValuate Diagnostics, the first spinout company from Hackensack Meridian Health’s Research Institute and its Office of Innovation and Commercialization, received a $1 million commitment from Foundation Venture Capital Group (FVCG). EValuate Diagnostics offers a new platform for the targeted capture of circulating biomarkers, or extracellular vesicles (EVs). The company focuses on developing diagnostic solutions for very early and rapid detection of diseases, like cancer. An affiliate of the New Jersey Health Foundation (NJHF), FVCG’s addition of EValuate to its portfolio will help advance the company’s technologies – turning this kind of testing into a reality and saving lives.

Tris Pharma Appoints Magee as VP, Quality & Compliance

Monmouth Junction-based Tris Pharma, Inc. announced the appointment of Michael Magee as Vice President, Quality and Compliance. “Michael joins Tris Pharma at an incredibly exciting time in which we have an established portfolio of ADHD medications and a diverse pipeline of late-stage assets, and where his proven track record in the pharmaceutical industry will play a key role in further enhancing our ongoing quality assurance and compliance initiatives,” said Ketan Mehta, founder and CEO at Tris Pharma. “With Michael on board, we are well-positioned to navigate our growth and continue delivering on our mission to optimize patient outcomes through differentiated therapeutic approaches.” Mr. Magee will lead and further strengthen Tris Pharma’s continued development and management of quality and compliance operations via the current Good Manufacturing Practices (cGMP) Compliance function of the organization.

Phibro Animal Health Announces Chief Financial Officer Changes

Teaneck-based Phibro Animal Health Corp. announced Glenn David will assume the role of Chief Financial Officer. Richard Johnson, who has been serving as Phibro’s interim CFO since September 2023, will continue with Phibro for a period of time in an advisory capacity to ensure a smooth transition with his successor. Mr. David brings over 30 years of experience in commercial and financial leadership roles. Mr. David’s most recent role was Executive Vice President and Group President, U.S. operations, diagnostics, biodevices and insurance at Zoetis Inc. Prior to that, he served as Executive Vice President and Group President, international operations, aquaculture, biodevices and insurance at Zoetis.

Bristol Myers Squibb Named One of America’s Most JUST Companies by JUST Capital and CNBC

Bristol Myers Squibb is honored to announce it has been recognized as One of America's Most JUST Companies. The ranking, presented by JUST Capital and CNBC, recognized BMS for its commitment to key social responsibilities, including employees, customers, communities and environmental impact. Bristol Myers Squibb earned a spot on the top 100 list and ranked six in the Pharmaceuticals and Biotech industry overall.

Introduction to Advanced Biopharmaceuticals Processing

March 4, 5, 6, 7 and 8 - Rutgers University (New Brunswick, NJ)

This course aims to give the participants an overview of the major biopharma unit operations. Key questions that will be addressed include – What are the underlying physicochemical processes for each unit operation? What are the key features of process design, process analytical technology (PAT), and process development for these unit operations? At the end of the course, the audience will gain a basic understanding of major biopharma unit operations. Case studies will be presented to gain a deeper understanding of these unit operations. Last but not the least, hands on demo of key process steps will be provided, along with review of major operations in a biomanufacturing pilot-plant and bioanalytical lab facility.