AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been officially accepted in the United States. This application targets the treatment of adult patients grappling with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC…
WuXi Biologics, a prominent global Contract Research, Development, and Manufacturing Organization (CRDMO), trading as WuXi Bio (2269.HK), proudly announces its sweeping victory at the 2024 CDMO Leadership Awards. The company secured top honors across all six categories – Capabilities, Compatibility,…
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, referred to as “Astellas”) has received notification from the U.S. Food and Drug Administration (FDA) regarding the acceptance of the company’s supplemental New Drug Application (sNDA). This acceptance pertains to…
Bristol Myers Squibb (NYSE: BMY) announced today the unveiling of data at the American College of Cardiology (ACC) Annual Scientific Session & Expo, scheduled for April 6-8, 2024, in Atlanta, Georgia. Roland Chen, MD, Senior Vice President and Head of…
Roche, a leading healthcare company (SIX: RO, ROG; OTCQX: RHHBY), has announced today the approval by the U.S. Food and Drug Administration (FDA) for its cobas® Malaria test, designed for use on the cobas® 6800/8800 Systems. This milestone marks the…
Novo Nordisk has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion, recommending the marketing authorization for Awiqli® (the branded name for once-weekly basal insulin icodec) for the treatment of…
AbbVie (NYSE: ABBV) has announced today that the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE® (mirvetuximab soravtansine-gynx) for treating folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal adult cancer patients who…
Today, it was announced that Ono has initiated a comprehensive collaboration for drug discovery with the University of Oxford in Oxfordshire, UK. This collaboration aims to explore and validate drug discovery seeds, as well as to obtain screening compounds to…
Legend Biotech Corporation (NASDAQ: LEGN), a leading global figure in cell therapy, has unveiled its inaugural Environmental, Social & Governance (ESG) report. This comprehensive document provides an insight into Legend Biotech’s ESG initiatives, aligned with the Sustainable Accounting Standards Board…
Viatris Inc. recently concluded agreements for a comprehensive global research and development collaboration with Idorsia Ltd (SIX: IDIA), a transaction that was finalized on March 15, 2024. For detailed information regarding this significant transaction, please consult Viatris’ Annual Report on…
Lupin Limited, a global pharmaceutical powerhouse, has secured approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application concerning Doxycycline for Injection USP, 100 mg/Vial (Single-Dose Vial). This green light from the FDA…
Unlocking Project Management’s Role in CDMOs In the intricate web of pharmaceutical and biotech industries, Contract Development and Manufacturing Organizations (CDMOs) stand as pivotal partners, offering indispensable services like API synthesis, formulation, and packaging—essentials for drug manufacturing. Project management emerges…
