FDA Takes Long Overdue Baby Step Toward Regulating Compounder Drug Ads A complex state vs. federal regulatory scheme allows drug compounders to advertise drugs without disclosing risks like a pharma company must do. Experts say it’s time for the FDA…
Saphnelo self-administration TULIP-SC Phase III trial meets primary endpoint in patients with systemic lupus erythematosus based on an interim analysis Positive high-level results from a pre-specified interim analysis of the Phase III TULIP-SC trial in patients with systemic lupus erythematosus…
Pioneering sustainable transatlantic transport to cut emissions in pharmaceutical supply chains Takeda (TSE:4502/NYSE:TAK) and VELA Transport today announced their business partnership, with Takeda set to become the first biopharmaceutical company to transport its products between Europe and the U.S. using…
Three WuXi Biologics Manufacturing Facilities Receive GMP Certification from Türkiye İlaç ve Tıbbi Cihaz Kurumu (TITCK) WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that three of its manufacturing facilities in Wuxi – MFG1,…
Sanofi Joins Growing Group of Pharmas Pulling Back From UK Merck, Eli Lilly and AstraZeneca have similarly suspended or outright canceled investments in the U.K. in the past week after a sizeable increase in a mandatory levy in the region…
EASD 2025: Orforglipron in Focus, the Case for Cardiovascular Benefits, More While Eli Lilly’s orforglipron is top of mind heading into the European Association for the Study of Diabetes meeting this week, experts told BioSpace the conference will also provide important insights…
Cytokinetics Announces Proposed Private Placement of $550.0 Million of Convertible Senior Notes Cytokinetics, Incorporated (“Cytokinetics”) (Nasdaq: CYTK) today announced its intention to offer, subject to market conditions and other factors, $550.0 million aggregate principal amount of convertible senior notes due…
Cytokinetics Announces Pricing of Upsized $650.0 Million Convertible Senior Notes Offering; Refinances a Portion of 2027 Convertible Notes Cytokinetics, Incorporated (“Cytokinetics”) (Nasdaq: CYTK) today announced the pricing of its offering of $650.0 million aggregate principal amount of 1.75% convertible senior…
FDA grants Breakthrough Therapy Designation to Raludotatug Deruxtecan for CDH6+ platinum-resistant ovarian and related cancers previously treated with bevacizumab Raludotatug deruxtecan (R-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment…
EU approves first oral GLP-1 RA to cut cardiovascular risk Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved an update to the Rybelsus® (oral semaglutide) label to reflect the cardiovascular…
People taking Novo Nordisk’s Wegovy® experienced reduced food noise and boosted mental well-being Novo Nordisk today announced results from the US-based INFORM survey of people taking semaglutide for weight management (Wegovy®), at the European Association for the Study of Diabetes…
Cholera Deaths Rise for Second Year Despite Available Prevention and Treatment The World Health Organization (WHO) has published its global cholera statistics for 2024, showing an increase in both the number of people who fell sick and died from the disease.…