AstraZeneca and Daiichi Sankyo have announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to their supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan). This review is for the treatment of adult patients…
Eli Lilly and Company (NYSE: LLY) announced a significant $4.5 billion investment to establish the Lilly Medicine Foundry, a state-of-the-art facility for advanced manufacturing and drug development. This innovative center will enable Lilly to explore new methods for medicine production…
Forge Biologics, a key player in Ajinomoto Bio-Pharma Services and a leading manufacturer of genetic medicines, has announced the launch of its FUEL™ manufacturing platform. This innovative platform aims to provide developers of adeno-associated virus (AAV) gene therapies with a…
ImmunoTek Bio Centers, the largest independent operator and developer of blood plasma donation centers in the United States, is thrilled to announce its participation in International Plasma Awareness Week (IPAW) from October 7-11, 2024. During this special week, the community…
The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease (COPD) who have an eosinophilic phenotype and whose condition remains inadequately controlled. Dupixent is the first biologic…
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from the Phase III REGENCY study of Gazyva®/Gazyvaro® (obinutuzumab) in patients with active lupus nephritis. The study revealed that a higher percentage of patients treated with Gazyva/Gazyvaro in combination…
As British Columbians head to the polls on October 19, the Gastrointestinal Society is drawing attention to a critical issue: BC PharmaCare’s refusal to fund over 30 essential medications that are covered in most other provinces. This gap in coverage…
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) has announced that it has filed for regulatory approval to launch a Phase 1/2a clinical trial for ARO-INHBE, its investigational RNA interference (RNAi) therapeutic aimed at treating obesity. The company also plans to seek regulatory…
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) has announced the appointment of Catherine Owen Adams as its new Chief Executive Officer (CEO), succeeding Steve Davis. Adams will also join the company’s Board of Directors. “We are thrilled to welcome Catherine Owen Adams…
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for their Omicron KP.2-adapted monovalent COVID-19 vaccine (COMIRNATY® KP.2). This…
Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) have announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for OPUVIZ™ 40 mg/mL solution for injection in a vial,…
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have received a recommendation for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for their Omicron KP.2-adapted monovalent COVID-19 vaccine (COMIRNATY®…