FDA Finally Moves to Regulate Compounded Drug Advertising, But Only Slightly
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…
Saphnelo Self-Administration Meets Primary Endpoint in TULIP-SC Phase III Trial
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…
Takeda and VELA to Ship Medicines Across the Atlantic Using First-of-its-Kind Wind-Powered Trimaran
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…
Three WuXi Biologics Manufacturing Facilities Receive GMP Certification from Türkiye İlaç ve Tıbbi Cihaz Kurumu (TITCK)
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…
FDA Targets Nonexistent Loophole in Latest DTC Ad Crackdown
In New DTC Ad Crackdown, FDA Trying to Close a Loophole That Isn’t While the FDA is trumpeting this new initiative as “sweeping reforms” to the way drug companies can…
Novo and Lilly Vie for Obesity Market Leadership With Fresh Regulatory Moves
Novo, Lilly Jostle For Market Lead in Obesity With New Regulatory Efforts Both Novo Nordisk and Eli Lilly are eyeing regulatory advancements for their obesity blockbusters as the European Association…
Sanofi Becomes Latest Pharma to Scale Back Operations in the UK
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…
EASD 2025: Spotlight on Orforglipron, Cardiovascular Potential, and Beyond
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…
Cytokinetics Plans $550 Million Private Placement of Convertible Senior Notes
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,…
Cytokinetics Prices $650M Upsized Convertible Notes to Refinance 2027 Debt
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…
FDA grants Breakthrough Therapy status to Raludotatug Deruxtecan for CDH6+ ovarian cancers
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…
EU approves Novo Nordisk’s oral semaglutide—the first oral GLP-1 RA to cut cardiovascular risks
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…