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IRA Changes to Part D Risk Access to Medicines

Few federal health care programs have been more successful than Medicare Part D, which provides prescription drug coverage to seniors and Americans with disabilities enrolled in Medicare. While some provisions of the Inflation Reduction Act (IRA) are likely to strengthen Part D and address some of the affordability challenges patients face, the law’s price setting provisions threaten access to medicines.

Dr. Scott Gottlieb on the Medicare Drug Cost Battle as President Biden Targets Drug Prices

Former FDA Commissioner Dr. Scott Gottlieb joins 'Squawk Box' to discuss the latest in Medicare's drug cost battle, as the Biden administration is expected to release a list of 10 drugs for which Medicare will negotiate prices, and more. 

PODCAST: A Major Overhaul of Prescription Drug Prices

A year ago, Congress overhauled the way drugs for older Americans get paid for, by giving Medicare the power to bargain with drug makers over prices in the biggest change to health care for more than a decade. The Biden administration began its implementation. Sheryl Gay Stolberg, who covers health policy for The Times, discusses the decades long battle for bargaining power and Rebecca Robbins, who covers the pharmaceutical industry for The Times, explains its potential to reshape the business of drugs in America.

NJ Drugmakers’ Products Among First Targeted for Medicare Price Negotiations

The U.S. Centers for Medicare and Medicaid Services (CMS) released its list of drugs selected for the inaugural round of Medicare Drug Price Negotiation Program, saying talks with participating drug companies will begin in 2023 and any settled prices will take effect in 2026. In weighing in on CMS’ announcement, BioNJ, the State’s life sciences trade association, expressed “serious and significant concerns” and a hope that policymakers “will consider more effective opportunities” to implement programs “that will truly lower the costs that patients face."



"The government’s arbitrary, opaque and unpredictable process for deciding the price of medicines will drive research and investment away from potentially lifesaving treatment options for Medicare patients,” the organization said in a statement.

“The companies targeted by this policy account for a substantial proportion of all investment in R&D across the life sciences which will be severely diminished and undermined as a result,” BioNJ said. Additionally, the group believes seniors “may not actually benefit” from the price setting and could instead see their access to medication restricted.

Insmed Announces Positive Topline Results from Phase 3 Arise Study of ARIKAYCE® (AMIKACIN LIPOSOME Inhalation Suspension) in Patients With NTM Lung Disease Caused by MAC

Bridgewater-based BioNJ Member Insmed Incorporated announced positive topline results from its Phase 3 ARISE study of ARIKAYCE in patients with newly diagnosed or recurrent nontuberculous mycobacterial (NTM) lung infection caused by Mycobacterium avium complex (MAC) who had not started antibiotics. The study met its primary objective of demonstrating that the Quality of Life – Bronchiectasis (QOL-B) respiratory domain works effectively as a patient-reported outcome (PRO) instrument in patients with MAC lung disease. Based on these results, Insmed plans to propose to the U.S. Food and Drug Administration (FDA) that the QOL-B respiratory domain PRO be the primary endpoint for the ENCORE study without any modifications.

Mitsubishi Tanabe Pharma America Presents Positive Results from Pivotal, Phase 3 BouNDless Trial of Investigational ND0612 in People With Parkinson’s Disease Experiencing Motor Fluctuations

BioNJ Member Mitsubishi Tanabe Pharma America, Inc., with a site in Jersey City, announced the presentation of positive results from the pivotal, Phase 3, multi-center, randomized, double-blind double-dummy (DBDD) BouNDless trial of investigational ND0612 – a continuous, 24 hours/day subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD). The study, which evaluated the efficacy, safety and tolerability of ND0612 in comparison to oral immediate-release (IR) LD/CD in people with Parkinson’s disease (PD) experiencing motor fluctuations, met its primary endpoint and the first four secondary endpoints. Following two sequential open-label periods to optimize oral IR-LD/CD and ND0612, study participants were randomized to a 12-week DBDD treatment period with either ND0612 or oral IR-LD/CD. Treatment with ND0612 demonstrated favorable efficacy over IR-LD/CD with a statistically significant increase (p<0.0001) of 1.72 hours in “ON” time without troublesome dyskinesia. 

Kyowa Kirin Received Approval for Calcimimetics Agent ORKEDIA® TABLETS 4mg in Japan

BioNJ Member Kyowa Kirin Co., with a site in Princeton, announced that the company has received approval from the Ministry of Health, Labour and Welfare for ORKEDIA® TABLETS 4mg (generic name: evocalcet) in Japan. ORKEDIA® TABLETS is an oral calcimimetics agent which suppresses parathyroid hormone (PTH) secretion by acting on the calcium receptors on parathyroid gland cells. The drug is approved in Japan for the treatment of secondary hyperparathyroidism in patients undergoing maintenance dialysis, hypercalcemia in patients with parathyroid carcinoma, and hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy or who experience recurrent primary hyperparathyroidism. Its low dosage, ORKEDIA® TABLETS 1mg and ORKEDIA® TABLETS 2mg have helped many patients in Japan since their launch in May 2018. 

Celularity and Regeneron to Collaborate in Florham Park on Multiyear Cell Therapy Research

Florham Park-based BioNJ Member Celularity has entered into a multi-year research collaboration services agreement with BioNJ Member Regeneron Pharmaceuticals, with a site in Basking Ridge. The agreement’s initial focus is the research on a targeted allogeneic gamma delta chimeric antigen receptor, or CAR-T cell therapy owned by Regeneron designed to enhance proliferation and potency against solid tumors. “The agreement with Regeneron is an important milestone for Celularity that recognizes our expertise in the research of cellular therapies, including the engineering of CAR-T cells. We believe that this relationship paves the way for future industry collaborations leveraging our world-class cell therapy facilities and capabilities,” Dr. Robert Hariri, Celularity’s Founder, Chairman and CEO, said. “We have long admired the exceptional scientific legacy at Regeneron and welcome the opportunity to collaborate with a world leader in innovative medicines.”

Novartis Presents New Long-Term Leqvio® (inclisiran) Data Demonstrating Consistent Efficacy and Safety Beyond Six Years

East Hanover-based BioNJ Member Novartis announced new long-term data from ORION-8, a Phase III open-label extension of ORION-9, ORION-10, ORION-11 and ORION-3 trials. The data demonstrated that with twice-yearly dosing, Leqvio, in addition to statin therapy, provides consistent low-density lipoprotein cholesterol (LDL-C) reduction beyond six years in patients with atherosclerotic cardiovascular disease (ASCVD), increased risk of ASCVD or heterozygous familial hypercholesterolemia (HeFH). ORION-8, the largest clinical trial completed to date with Leqvio, continues to support the consistent long-term efficacy, safety, and tolerability of Leqvio, with a total exposure of more than 8,500 patient-years during the trial's three-year follow-up. Nearly 80% (78.4% (95% CI: 76.8, 80.0)) of patients reached their pre-specified LDL-C targets, and on average, LDL-C levels were reduced by approximately 50% (49.4% (95% CI: 48.3, 50.4)).

Sandoz Receives FDA Approval for Tyruko® (natalizumab-sztn), First and Only FDA-Approved Biosimilar for Relapsing Forms of Multiple Sclerosis

Princeton-based BioNJ Member Sandoz, a Novartis division announced that the U.S. Food and Drug Administration (FDA) has approved its biosimilar Tyruko® (natalizumab-sztn), developed by Polpharma Biologics. Tyruko is approved to treat all indications covered by the reference medicine and is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis (MS). Keren Haruvi, President North America, Sandoz Inc., said, “Of the nearly one million people in the U.S. living with multiple sclerosis, hundreds of thousands experience disease relapse. Tyruko has the potential to extend the reach of natalizumab treatment for these patients, increase healthcare savings and fuel innovation through competition in the market.”

Sandoz Completes Acquisition of Leading Antifungal Agent Mycamine® from Astellas, Reinforcing Leading Global Anti-Infectives Portfolio

Princeton-based BioNJ Member Sandoz, a Novartis division announced it has successfully completed the acquisition of worldwide brand rights for leading systemic antifungal agent Mycamine ® (micafungin sodium, Funguard® in Japan) from Astellas. Through this acquisition of the leading global echinocandin, one of three major antifungal classes, Sandoz significantly reinforces its global hospital offering and leading anti-infectives portfolio. The announcement comes after Sandoz successfully completed the acquisition of GSK’s global cephalosporins portfolio in October 2021. Mycamine® has a global patient base of well over two million. It is a therapy of choice in hospitals and intensive care units worldwide, a proven prophylactic in hematology and oncology patients, and widely used in organ transplants.

New Shingrix Data Demonstrate 100% Vaccine Efficacy in the Prevention of Shingles in Adults Aged 50 and Over in China

Warren-based BioNJ Member GSK announced positive results from the first-ever efficacy trial of Shingrix (Recombinant Zoster Vaccine or RZV) in China. These results come from the post-license Phase IV trial (ZOSTER-076), which evaluated the efficacy and safety of RZV in preventing shingles in adults aged 50 and over. The trial included almost 6,000 participants randomized 1:1 to the RZV or placebo group and followed in an observer-blind design. No cases of shingles were reported among the participants who received RZV, compared to 31 cases in the placebo arm. The results are in line with findings from the pivotal Phase III trials ZOE-50 and ZOE-70 investigating the efficacy and safety of RZV, showing vaccine efficacy was up to 97% in adults aged 50 and over, over a follow-up period of approximately four years.

GSK’s Regulatory Submission Accepted for Review by Japanese Regulator for Use of Nucala (mepolizumab) in Adults With Chronic Rhinosinusitis With Nasal Polyps

Warren-based BioNJ Member GSK announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has accepted for review a supplementary new drug application (sJNDA) for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients. The sJNDA is based on results of the pivotal phase III MERIT trial which studied the efficacy and safety of mepolizumab over a 52-week period in a population of Japanese, Chinese and Russian patients with inadequately controlled CRSwNP or eosinophilic chronic rhinosinusitis (ECRS) as well as data from the global phase III SYNAPSE study, which explored the effect of mepolizumab vs. placebo in more than 400 patients with CRSwNP.

Semaglutide 2.4 mg Shows Large Reductions in Heart Failure-Related Symptoms and Physical Limitations in People With Heart Failure With Preserved Ejection Fraction and Obesity

Plainsboro-based BioNJ Member Novo Nordisk announced results from the Phase 3 STEP HFpEF trial showing that compared with placebo, once-weekly semaglutide 2.4 mg led to large reductions in heart failure-related symptoms, physical limitations and improvements in exercise function, and resulted in greater weight loss in adults with heart failure with preserved ejection fraction (HFpEF) and obesity. HFpEF comprises roughly half of all heart failure cases and is associated with a high burden of symptoms and physical limitations affecting daily life, including fatigue, shortness of breath, reduced ability to exercise and swelling of extremities. The majority (80%) of people with HFpEF also live with overweight or obesity, which is linked to a higher burden of symptoms, worse physical function and lower quality of life.

U.S. FDA Approves Bristol Myers Squibb’s Reblozyl® (luspatercept-aamt) as First-Line Treatment of Anemia in Adults With Lower-Risk Myelodysplastic Syndromes (MDS) Who May Require Transfusions

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has approved Reblozyl® (luspatercept-aamt) for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions. This expanded indication to the first-line setting is based on interim results from the pivotal Phase 3 COMMANDS trial, in which Reblozyl demonstrated superior efficacy of concurrent RBC transfusion independence (RBC-TI) and hemoglobin (Hb) increase compared to epoetin alfa, an ESA, regardless of ring sideroblast status. These results underscore Reblozyl’s ability to address chronic anemia earlier in the treatment journey in a broader range of patients.

Long-Term Follow-Up Data from Two Phase 3 Studies of CAMZYOS® (mavacamten) Demonstrate Consistent and Durable Response in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (HCM)

Princeton-based BioNJ Member Bristol Myers Squibb announced new long-term follow-up results from two Phase 3 studies evaluating CAMZYOS® (mavacamten), a first-in-class cardiac myosin inhibitor, in adult patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Results from the 56-week analysis of the VALOR-HCM long-term extension (LTE) study were published in JAMA Cardiology, and results from the cumulative 120-week analysis of the EXPLORER cohort of the MAVA-LTE study were presented at the European Society of Cardiology Congress. Treatment with CAMZYOS demonstrated sustained improvements across key study endpoints in both the original CAMZYOS group over 56 weeks and those transitioned to the placebo cross-over group over 40 weeks. 

Retrospective Observational Study Assessing Real-World Clinical Impact of Switching or Continuing Eliquis® or Rivaroxaban Presented at the European Society of Cardiology (ESC) Congress 2023

BioNJ Members, Bristol Myers Squibb and Pfizer Alliance presented results from ATHENS, a retrospective real-world data study showing that switching from Eliquis® (apixaban) to rivaroxaban in Non-Valvular Atrial Fibrillation (NVAF) patients was associated with a higher risk of stroke/systemic embolism (S/SE) and major bleeding (MB) than those who continued Eliquis. “Although some NVAF patients switch direct oral anticoagulants in real-world clinical practice, either for medical or non-medical reasons, there hasn’t been a lot of information gathered on the clinical outcomes of those switches,” said Steve Deitelzweig, M.D., MMM, FACC, SFHM, FACP, RVT, System Chairman for Hospital Medicine,Ochsner Health System. “The study results provide insights about the real-world risk of stroke and major bleeding associated with switching from apixaban to rivaroxaban in patients with NVAF.”

Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron XBB.1.5-adapted COVID-19 Vaccine in the European Union

BioNJ Member Pfizer, with a site in Peapack, and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (COMIRNATY® Omicron XBB.1.5) administered as a single dose for individuals 5 years of age and older, regardless of prior COVID-19 vaccination history. The Committee has also recommended the updated vaccine for children 6 months through 4 years of age as part or all of the primary three-dose vaccination series, depending on how many prior doses they received, or as single dose for those with a history of completion of a COVID-19 primary vaccination course or prior SARS-CoV-2 infection.

Janssen Submits Supplemental Biologics License Application to the U.S. Food and Drug Administration Seeking Approval of RYBREVANT® (amivantamab-vmjw) in Combination with Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer

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 expanded approval of RYBREVANT® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The sBLA is being reviewed by the FDA through the Real-Time Oncology Review (RTOR) program. “PAPILLON is the first randomized Phase 3 study in patients with NSCLC with EGFR exon 20 insertion mutations to show clinically meaningful results,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC.  

Janssen Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of BALVERSA® (erdafitinib) for the Treatment of Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Selected Fibroblast Growth Factor Receptor Gene Alterations

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking full approval of BALVERSA® (erdafitinib), a kinase inhibitor, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) that has susceptible fibroblast growth factor receptor (FGFR)3 genetic alterations, and progressed during or following at least one line of a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor in the locally advanced or metastatic setting or within 12 months of neoadjuvant or adjuvant therapy.

Janssen Announces Update to Phase 3 MACiTEPH Study Evaluating Macitentan 75mg in Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Raritan-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced its decision to stop the Phase 3 MACiTEPH study evaluating macitentan 75 mg in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) due to futility. The decision to stop the trial was made in accordance with a recommendation by the study’s independent data monitoring committee following a pre-planned interim analysis. No new safety signals were observed. The interim results of MACiTEPH do not impact any of the Company's commercialized pulmonary hypertension medicines. Additionally, the pivotal Phase 3 UNISUS study, which aims to establish the superiority of a 75 mg dose of macitentan over the currently available 10 mg dose in patients with pulmonary arterial hypertension, is currently continuing as planned.

Phase 3 MARIPOSA-2 Study Meets Dual Primary Endpoint Resulting in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival for RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy With and Without Lazertinib versus Chemotherapy Alone in Patients with EGFR-Mutated Non-Small Cell Lung Cancer after Disease Progression on Osimertinib

Raritan-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced positive topline results from the three-arm Phase 3 MARIPOSA-2 study evaluating RYBREVANT® (amivantamab-vmjw), a bispecific antibody targeting epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET), given with and without lazertinib, an oral, third-generation EGFR tyrosine kinase inhibitor (TKI), combined with chemotherapy (carboplatin and pemetrexed) versus chemotherapy alone. MARIPOSA-2 enrolled patients with locally advanced or metastatic EGFR exon 19 deletions (ex19del) or L858R substitution NSCLC after disease progression on or after osimertinib.

Sanofi, Meningitis Research Foundation and the Confederation of Meningitis Organisations Ignite a Global Awareness Initiative Against Meningitis With Launch of The Meningitis Flag

Meningitis Research Foundation, the Confederation of Meningitis Organisations (CoMO) and Bridgewater-based BioNJ Member Sanofi join forces to launch ‘The Meningitis Flag’, a global initiative to raise awareness in the fight against meningitis. With the Paris 2024 Paralympic Games opening in exactly one year, and with the support of para-athletes Ellie Challis (Great Britain), Théo Curin (France), and Davide Morana (Italy), this unique global campaign seeks to increase understanding of a disease that remains one of the world’s largest infectious disease killers, and yet is largely preventable. As a premium partner of Paris 2024, Sanofi will leverage the Paris 2024 Paralympic Games momentum to visibly elevate the fight against meningitis, including support for programs that will continue well beyond the Games. 

Merck Initiates Phase 3 Clinical Program for Oral PCSK9 Inhibitor Candidate MK-0616

Rahway-based BioNJ Member Merck & Co. announced the initiation of the company’s Phase 3 clinical program, CORALreef, for MK-0616, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, being evaluated for the treatment of adults with hypercholesterolemia. This is the first Phase 3 clinical program for an oral PCSK9 inhibitor. The first participants are now enrolling in two registrational Phase 3 studies evaluating low-density lipoprotein (LDL) cholesterol reduction: CORALreef Lipids and CORALreef HeFH. Merck also plans to initiate a Phase 3 cardiovascular outcomes study, CORALreef Outcomes by the end of 2023. PCSK9 is a validated target for lowering LDL cholesterol. However, there are no oral PCSK9 inhibitors available to physicians and patients. 

European Commission Expands Merck’s ERVEBO® [Ebola Zaire Vaccine, (rVSVΔG-ZEBOV-GP) live] Indication to Include Children 1 Year of Age and Older

Rahway-based BioNJ Member Merck & Co. announced that the European Commission (EC) has approved an expanded indication for ERVEBO for active immunization of individuals 1 year of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire ebolavirus. The EC’s decision follows the positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) received on July 20, 2023. The vaccine was previously approved for use in the European Union (EU) for individuals 18 years of age or older. The use of ERVEBO should be in accordance with official recommendations. In January 2021, Merck confirmed an agreement with UNICEF to establish the world’s first global Ebola vaccine stockpile with ERVEBO to support future Zaire ebolavirus outbreak preparedness and response efforts. To date, over 500,000 doses of the licensed vaccine have been delivered to the stockpile, which is administered by the International Coordinating Group on Vaccine Provision.

European Commission Approves KEYTRUDA® (pembrolizumab) Plus Trastuzumab and Chemotherapy as First-Line Treatment for HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Expressing PD-L1 (CPS ≥1)

Rahway-based BioNJ Member Merck & Co. announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). This approval by the EC follows the positive recommendation from the Committee for Medicinal Products for Human Use received in July 2023 and was based on results from the Phase 3 KEYNOTE-811 trial. In the study, KEYTRUDA plus trastuzumab and chemotherapy significantly improved progression-free survival (PFS), and objective response rate (ORR), compared to trastuzumab and chemotherapy alone in this patient population. In the study, more than 80% of patients had tumors that were PD-L1 positive.

Long-Term Follow-up Data on Sustained Immunogenicity and Safety for GARDASIL®9 Published in Pediatrics

Rahway-based BioNJ Member Merck & Co. announced new, 10-year long-term follow-up (LTFU) data published in the peer reviewed journal, Pediatrics, for girls and boys who received a three-dose regimen of GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) at 9-15 years old. The LTFU study was conducted from 2009 through 2021 across 13 countries and five continents. “These data highlight the importance of GARDASIL 9 in prevention of certain HPV-related cancers and diseases later in life,” said Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. “HPV-related cancers and diseases are a significant public health issue. These strong study results serve as a reminder that we need to do everything we can to expand and recover vaccination rates globally to help protect all eligible people from certain HPV-related cancers.”

AbbVie Submits Regulatory Applications to FDA and EMA for Risankizumab (SKYRIZI®) in Ulcerative Colitis

BioNJ Member AbbVie, with a site in Branchburg, announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for risankizumab (SKYRIZI®, 1200 mg intravenous [IV] [induction dose] and 180 mg and 360 mg subcutaneous [SC] [maintenance dose]) for the treatment of adult patients with moderately to severely active ulcerative colitis. "While there has been advancement in therapies to treat ulcerative colitis, there is still an ongoing need for additional treatments to help those seeking relief from its disruptive effects," said Roopal Thakkar, M.D., Senior Vice President, Development, Regulatory Affairs and Chief Medical Officer, AbbVie. "These submissions demonstrate our continued commitment to helping people living with IBD, and we look forward to providing a potential new treatment option for the management of ulcerative colitis."

ENHERTU® Granted Two Breakthrough Therapy Designations in U.S. for Patients Across Multiple HER2 Expressing Cancers

Daiichi Sankyo, with a site in Basking Ridge, announced ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted two additional Breakthrough Therapy Designations (BTDs) in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, and for the treatment of patients with HER2 positive (IHC 3+) metastatic colorectal cancer who have received two or more prior regimens. ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. HER2 overexpression has been observed in 1% to 28% across various types of metastatic solid tumors and in up to 5% of patients with colorectal cancer. 

Mallinckrodt Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate Capsules and Launches Product Used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD)

Mallinckrodt, with a site in Bedminster, announced that its Specialty Generics segment, operating as SpecGx LLC, received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Lisdexamfetamine Dimesylate Capsules 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg. The FDA determined SpecGx LLC's product was bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vyvanse® Capsules of Takeda Pharmaceuticals U.S.A., Inc., in all seven of the RLD's approved strengths. Lisdexamfetamine Dimesylate Capsules are a federally controlled substance (CII) used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and other indications and currently are on the FDA's drug shortage list. 

Eagle Pharmaceuticals Announces Positive Type C Meeting With FDA for EA-114, an Estrogen Receptor Antagonist Used in the Treatment of Metastatic Breast Cancer in Post-Menopausal Women

Woodcliff Lake-based Eagle Pharmaceuticals, Inc. announced a positive Type C meeting with the U.S. Food and Drug Administration. Eagle and the FDA agreed on a path forward to advance the clinical development of EA-114, an estrogen receptor antagonist used in the treatment of breast cancer in post-menopausal women. EA-114 has the potential to provide healthcare providers with a formulation that meaningfully optimizes the dosing regimen for all fulvestrant patients. Eagle currently anticipates filing a new drug application (“NDA”) for EA-114 in 2024. If approved for all uses, EA-114 would allow physicians to provide a personalized treatment regimen to all patients, including specific sub-populations.

Tris Pharma Awarded Up to $16.6M to Advance Treatment for Opioid Use Disorder

Monmouth Junction-based Tris Pharma, Inc., has been awarded a grant expected to provide up to $16.6M over five years from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). Through the Helping to End Addiction Long-term® Initiative (NIH HEAL Initiative®), NIH has awarded grants to fund the optimization of new therapies to prevent and treat opioid use disorder (OUD). Under their NIDA grant, Tris will collaborate with experts at multiple global institutions, including Marc Greenwald, Ph.D., of Wayne State University, and Professor Roberto Ciccocioppo of Unicam: Università degli Studi di Camerino, to complete preclinical through Phase 2 studies evaluating cebranopadol for the treatment of OUD.

Timber Pharmaceuticals to be Acquired by Danish Giant in $36M Deal

Warren-based Timber Pharmaceuticals announced it is being acquired by LEO Pharma, with a site in Madison. The terms of the $36 million deal include $14 million upfront and an additional $22 million contingent on achieving certain milestones. One of its most notable products in development is TMB-001, a late-stage topical reformulation of the active ingredient, isotretinoin – a rare skin disease with no approved prescription therapies available. The TMB-001 reformulation has received an orphan and breakthrough designation by the U.S. Food and Drug Administration and is on track with an action date as early as mid-2025. It has also shown positive results in Phase 2, while Phase 3 recruitment is ongoing in the U.S. and Europe.

CCM Biosciences Launches from Stealth to Advance Portfolio of Proprietary, First-in-Class Therapies and Companion Diagnostic Tests Across Multiple Therapeutic Areas

Mount Laurel-based CCM Biosciences launched from stealth with more than ten drug programs, many of which originated from CCM Biosciences' proprietary drug discovery platforms. CCM Biosciences is partnered with the global chemical and pharmaceutical manufacturing company PMC Group for the Chemistry, Manufacturing, and Controls (CMC) of its drug programs. The CCM-PMC partnership offers a fully integrated ecosystem for the discovery, development, and manufacturing of drug candidates addressing some of the most significant unmet medical needs. The company has raised more than $25M in financing including Series A1 and A2 rounds at a multi-hundred-million-dollar valuation. 

Kean Enrolls Record Class — in N.J. and Around Globe

Kean University’s efforts to expand its brand and presence throughout the country and around the globe are taking root. This fall, more than 17,000 students (a record) from 82 countries and 35 states are registered at Kean. Kean’s U.S. campuses welcomed the largest-ever number of new students for the first day of classes, with more than 4,000 new freshmen, graduate students and transfer students registered. Kean’s U.S. campuses are projected to educate more than 13,000 students this year, at campuses in Union and Toms River as well as Kean Online.

NJIT’s Largest Freshman Class Also Sets Record for Women, People of Color

The total enrollment at New Jersey Institute of Technology is up 24% since 2013, reaching a new high of 12,600 students — but it’s the type of students enrolling that has university officials especially pleased. Underrepresented minorities also set a new record, making up 50% of the first-year class, underscoring NJIT’s dedication to offering science, technology, education and mathematics education to traditionally marginalized groups. The number of first-year students identifying as Black has nearly tripled since 2013, while Hispanic first-year enrollment has reached over 30% for the second year in a row.

NJ Innovation Institute Names Johnson as Next President

The New Jersey Innovation Institute (NJII) announced the appointment of Dr. Michael Johnson as NJII president. Johnson will begin his tenure on Oct. 10. Working as Managing Director at Visikol and Chief Commercial Officer of MatTek Life Sciences, Dr. Johnson has focused his career on solving the big problems that our world faces by leading the development and commercialization of paradigm-shifting life sciences technologies. Dr. Johnson founded the advanced cell culture and imaging contract research service business Visikol, which he sold in 2021 to Swedish biotech company BICO. At Visikol, Johnson led all scientific, commercial, strategic, operational and finance efforts and attracted all 20 of the top 20 pharmaceutical companies as clients.

Monmouth Medical Center Recognized Among Becker’s 2023’s ‘153 Great Community Hospitals’

Monmouth Medical Center and Monmouth Medical Center Southern Campus located in Lakewood have been recognized by Becker’s Hospital Review’s “153 Great Community Hospitals” for 2023. The community hospitals included on this list are lauded for their clinical excellence, compassionate care and economic impact on their communities. “I am so very proud that both Monmouth Medical Center and Monmouth Medical Center Southern Campus have been included on this best-of-the-best listing by a leading source of cutting-edge health care industry information,” MMC and MMCSC CEO & President Eric Carney said. “And it comes on the heels of both hospitals achieving ‘A’ ratings in the Spring 2023 Leapfrog Hospital Safety Grade.”

HMH Neuroscience Institute to Unveil 1st-in-World Brain Tumor Treatment Option Today

The Dr. Robert H. and Mary Ellen Harris ZAP-X Center for Noninvasive Neurosurgery at Hackensack Meridian Neuroscience Institute of Jersey Shore University Medical Center in Neptune will debut a first-in-the-world treatment for brain tumors. The institute will be the first in the Northeast to use ZAP-X Gyroscopic Radiosurgery for treatment of brain tumors and other conditions of the head and neck. More impressively, it will be the first in the world pairing of ZAP-X with Synaptive MRI. This pairing of technologies will markedly reduce time from diagnosis to treatment. The state-of-the-art technology is set to begin treating patients in September at Jersey Shore University Medical Center, thanks to a significant gift from Mary Ellen Harris and the Golden Dome Foundation.

Wall Street Journal/College Pulse Ranks NJIT No. 2 Public University in the U.S.

New Jersey Institute of Technology is the second-highest ranked public university in the Wall Street Journal/College Pulse 2024 list of the Best Colleges in the U.S. At No. 19 nationally, NJIT is second only to the University of Florida among public universities nationally and to Princeton University among colleges and universities in New Jersey. The new list replaces the former WSJ/Times Higher Education ranking with some similar methodology components. It uses a much larger survey, however, and places more emphasis on student outcomes and feedback from students and alumni. It’s also more exclusive, with only 400 schools awarded. That’s just 20% of the eligible universities examined.

The TiE Women Global Pitch Competition

Hosted by TiE-NJ

November 2023

Calling all women entrepreneurs! Apply now for TIE Women Global Pitch Competition 2023.

The TiE Women Global Pitch Competition is a prestigious event that provides a platform for women entrepreneurs to pitch their innovative ideas and gain recognition and support. This is a great opportunity for women entrepreneurs in New Jersey to gain visibility and access to a Global network, in addition to mentorship and support from the local chapter. More about TiE Women here: www.tiewomen.org