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
The two day event offers a variety of means for networking and collaboration: Hackathons offering a hyper-interactive session where attendees work as a team to hack strategic issues.
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.
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.
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.
Novo Nordisk’s obesity newcomer monlunabant heads into Phase …
2024年9月20日 · Novo Nordisk has announced positive Phase IIa results for monlunabant, a small molecule oral CB1 inverse agonist for obesity. The trial showed significant weight loss with a 10 mg dose, achieving a 7.1 kg reduction versus 0.7 kg for placebo. Mild to moderate side effects were reported. A Phase IIb trial is planned for 2025
Pharmaceutical Industry News | The Pharmaletter
2025年1月7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 …
FDA panel flags risks as AstraZeneca seeks full Andexxa approval
2024年11月22日 · AstraZeneca faces challenges in securing full FDA approval for Andexxa, its anticoagulant reversal therapy, due to safety concerns raised during an advisory committee meeting. Despite positive data on brain bleeds, higher clotting events in patients treated with Andexxa have cast doubt on its benefits.
Sandoz moves to resolve legacy US generic drug antitrust class …
2024年12月17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.
Second FDA approval for BeiGene’s Tevimbra in 2024
2024年12月27日 · The US Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1), Sino-China biotech BeiGene.