Pharma, Biotech and Generics Industry News | The Pharmaletter
2025年1月2日 · In some good news for the US vaccines developer, whose stock has fallen 66% in the past 12 months, Moderna on Friday announced ongoing support from the US Department of Health and Human Services (HHS) to accelerate the development of mRNA-based pandemic influenza vaccines.
Pharma USA 2025 - The Pharmaletter
2025年1月13日 · A leading meeting for commercial, marketing, medical affairs, patient engagement, RWE, market access and patient leaders.
Oblenio Bio | The Pharmaletter
2024年11月7日 · The company was launched by Aditum Bio in November 2024. Oblenio Bio was formed in conjunction with an exclusive option and license agreement with launched by Aditum Bio to develop LBL-051, a novel tri-specific T-cell engager developed using …
US FDA warning over counterfeit drugs bought in Mexico
2005年5月15日 · The US Food and Drug Administration is warning the public about the sale of counterfeit versions of Pfizer's Lipitor (atorvastatin) and Viagra (sildenafil), and an unapproved product promoted as a "generic" version of Eli Lilly's Evista (raloxifene) to US consumers at pharmacies in Mexican border towns.
Zealand blindsided by FDA rejection of glepaglutide
2024年12月20日 · Zealand Pharma faces a setback as the FDA issues a complete response letter for glepaglutide, requiring a new Phase III trial for short bowel syndrome. The decision centers on the need for efficacy evidence at the proposed dosing frequency, delaying the program’s progress in the USA, though EU submission plans remain intact. Shares dropped 10% amid investor concerns.
FDA approves Novo Nordisk’s Alhemo | The Pharmaletter
2024年12月22日 · This article is accessible to registered users, to continue reading please register for free.. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week.
2024: Emergent trends in pharma and biotech
2024年12月30日 · The life sciences industry experienced volatility in 2024, marked by pipeline growth, biologics breakthroughs, and evolving GLP-1 therapies. Challenges in trials, manufacturing, and commercialization persisted, driving adoption of AI and innovative pricing models as the sector prepares for further innovation in 2025.
Vertex Pharmaceuticals News | The Pharmaletter
2025年1月10日 · US biopharma Vertex Pharmaceuticals has entered an exclusive collaboration and license agreement with China’s Zai Lab for the development and commercialization of Vertex’s povetacicept (pove) in mainland China, Hong Kong SAR, Macau SAR, Taiwan region and Singapore (the licensed territory).
Novo Nordisk settles patent lawsuit over Ozempic
2024年10月8日 · Novo Nordisk (NOV: N) has reached a settlement with Mylan Pharmaceuticals, part of Viatris (Nasdaq: VTRS), concluding a US patent lawsuit over diabetes drug Ozempic (semaglutide). The lawsuit aimed to protect Ozempic’s market exclusivity until 2032. Mylan and Natco Pharma are developing a generic version, with exclusivity for six months after approval.
Pharmaceutical Industry News | The Pharmaletter
2025年1月9日 · Medicines Discovery Catapult (MDC), the UK government-backed life sciences service dedicated to driving productivity and impact in drug R&D, has strengthened its executive team with the appointment of a chief commercial officer …