Category Press Releases

TIVDAK® Supplemental Biologics License Application Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer

 Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK® (tisotumab vedotin-tftv) to full approval, for the treatment of…

Read MoreTIVDAK® Supplemental Biologics License Application Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer

FDA Approves Merck’s KEYTRUDA® Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) for the treatment of patients with FIGO…

Read MoreFDA Approves Merck’s KEYTRUDA® Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer

BIO-TECHNE TO SHOWCASE CELL AND GENE THERAPY MANUFACTURING TOOLS AT PHACILITATE ADVANCED THERAPIES WEEK 2024

Bio-Techne Corporation (NASDAQ: TECH) today announced it will present its portfolio of products and solutions to enable cell and gene therapy development and manufacturing at Phacilitate’s Advanced Therapies Week, taking place January 16-19 at the Miami Beach Convention Center in Miami,…

Read MoreBIO-TECHNE TO SHOWCASE CELL AND GENE THERAPY MANUFACTURING TOOLS AT PHACILITATE ADVANCED THERAPIES WEEK 2024

Merck Expands Colorectal Cancer Portfolio Through Licensing Agreement with Inspirna

Merck, a leading science and technology company, today announced a licensing agreement with Inspirna, Inc. (New York, NY) for ompenaclid (RGX-202), a first-in-class oral inhibitor of the creatine transport channel SLC6A8, and SLC6A8-targeting follow-on compounds. Ompenaclid is currently being evaluated…

Read MoreMerck Expands Colorectal Cancer Portfolio Through Licensing Agreement with Inspirna

Novo Nordisk enters into research collaborations with Omega Therapeutics and Cellarity on novel treatment approaches for cardiometabolic diseases

Novo Nordisk, Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”) and Cellarity Inc. today announced that Novo Nordisk has entered into separate research collaborations with each company. The Omega collaboration will leverage its proprietary platform technology to develop an epigenomic controller designed…

Read MoreNovo Nordisk enters into research collaborations with Omega Therapeutics and Cellarity on novel treatment approaches for cardiometabolic diseases

Depixus Launches Technology Access Program With First MAGNA One™ Instrument Placement

Interactomics pioneer Depixus has launched its game-changing MAGNA™ technology access program with the deployment of the first MAGNA One™ beta prototype instrument in the laboratory of Professor Jean-François Allemand, Department of Physics at the École Normale Supérieure (ENS), Paris. Based…

Read MoreDepixus Launches Technology Access Program With First MAGNA One™ Instrument Placement

Esperion and Daiichi Sankyo Europe Announce $125 Million Amendment to Their Collaboration, Including Resolution of Pending Litigation

Esperion Therapeutics, Inc. (NASDAQ: ESPR) and Daiichi Sankyo Europe GmbH (DSE) the Europeanheadquarter organization of the Japanese pharmaceutical company Daiichi Sankyo Co., Ltd. (TSE:4568), announced today a $125 million amendment to their collaboration, which includes anamicable resolution to their commercial…

Read MoreEsperion and Daiichi Sankyo Europe Announce $125 Million Amendment to Their Collaboration, Including Resolution of Pending Litigation

European Medicines Agency Validates Bristol Myers Squibb’s Application for Repotrectinib for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer and NTRK-Positive Solid Tumors

 Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its marketing authorization application for the next-generation tyrosine kinase inhibitor (TKI) repotrectinib as a treatment for ROS1 TKI-naïve and -pretreated adult patients with ROS1-positive locally advanced or metastatic non-small…

Read MoreEuropean Medicines Agency Validates Bristol Myers Squibb’s Application for Repotrectinib for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer and NTRK-Positive Solid Tumors

Beyfortus approved in China for the prevention of RSV disease in infants

AstraZeneca and Sanofi’s Beyfortus (nirsevimab), a long-acting monoclonal antibody, has been approved in China for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants entering or during their first RSV season.1 Beyfortus is anticipated to be available…

Read MoreBeyfortus approved in China for the prevention of RSV disease in infants

Roche enters into a definitive agreement to acquire LumiraDx’s Point of Care technology combining multiple diagnostic modalities on a single platform

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the entry into a definitive agreement to acquire select parts of the LumiraDx group (NASDAQ GS: LMDX) related to LumiraDx’s innovative Point of Care technology. Following closing of the transaction, which is…

Read MoreRoche enters into a definitive agreement to acquire LumiraDx’s Point of Care technology combining multiple diagnostic modalities on a single platform

Hansoh Pharma’s Saint Luolai is added to the National Reimbursement Drug List, opening a new chapter in the long-term treatment for CKD renal anemia in China

On December 13, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security of the People’s Republic of China jointly released the “National Medicines Catalogue for Basic Medical Insurance, Work Injury Insurance and Maternity Insurance (2023)”…

Read MoreHansoh Pharma’s Saint Luolai is added to the National Reimbursement Drug List, opening a new chapter in the long-term treatment for CKD renal anemia in China