Pharma, Biotech and Generics Industry News | The Pharmaletter
2010年12月17日 · New York-based Nuvation Bio today announced that the FDA has accepted the company’s new drug application (NDA) for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) for the treatment of advanced ROS1+ NSCLC (line agnostic), for priority review.
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.
BRIEF—Centauri given $1.25m to advance antimicrobials
2024年11月25日 · Centauri Therapeutics secured a £1 million ($1.25 million) grant from PACE to advance its Alphamer technology, targeting multidrug-resistant Gram-negative bacteria. The Alphamer platform utilizes a dual mechanism, attacking bacteria and enhancing pathogen clearance through natural antibodies. This partnership supports Centauri's focus on vulnerable patient populations.
Tiragolumab takes another hit with Phase III miss
2024年11月26日 · Roche’s Phase III SKYSCRAPER-01 trial missed its primary endpoint, with tiragolumab combined with Tecentriq failing to improve overall survival in advanced non-small cell lung cancer. This adds to setbacks in Roche's anti-TIGIT program, facing rising competition from other TIGIT inhibitors like domvanalimab and belrestotug.
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.
Positive Phase III data in narcolepsy from Axsome
2024年11月26日 · system (CNS) disorders specialist Axsome Therapeutics today released encouraging late-stage results for its narcolepsy candidate AXS-12 (reboxetine), sending its shares edging up 2.6% to $100.00 in pre-market activity. November 26, 2024
PanTera | The Pharmaletter
2024年9月12日 · PanTera was founded in 2022 with the primary goal of enabling large-scale production of actinium225 (225Ac), which is crucial to enable a new class of targeted cancer treatments known as Targeted Alpha Therapy.
Patient dies in Neurogene trial | The Pharmaletter
2024年11月25日 · A patient in Neurogene’s (Nasdaq: NGNE) ongoing Phase I/II trial for Rett syndrome - who was dosed on November 5 with 3E15 vg of NGN-401 - has now died from a treatment-related serious adverse event (SAE).
Kailera Therapeutics | The Pharmaletter
2024年10月1日 · Kailera launched in October 2024 with a $400 million Series A financing co-led by Atlas Venture, Bain Capital Life Sciences, and RTW Investments, with participation from Lyra Capital.
Kura and Kyowa Kirin sign ziftomenib deal | The Pharmaletter
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