Pharma, Biotech and Generics Industry News | The Pharmaletter
Dec 17, 2010 · 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+ …
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Trump vs Harris—who's on Big Pharma's side? | Pharmaceutical
Sep 22, 2024 · In the 2024 US presidential election, health policy will remain a key issue for pharma. Both Donald Trump and Kamala Harris have criticized high drug prices, raising uncertainty for the industry. While Trump targeted generics, biosimilars, and international price comparisons during his term, Harris has been associated with pricing transparency and the Inflation Reduction Act (IRA), which ...
Novo Nordisk settles patent lawsuit over Ozempic
Oct 8, 2024 · 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.
US FDA warning over counterfeit drugs bought in Mexico
May 15, 2005 · 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.
Vertex Pharmaceuticals News | The Pharmaletter
Dec 23, 2024 · US drugmaker Vertex Pharmaceuticals’ shares were unmoved on Friday, despite receiving two new regulatory authorizations. 23 December 2024
StemCyte gains FDA nod for cord blood therapy
Nov 25, 2024 · StemCyte has received FDA approval for Regenecyte, a cord blood-derived stem cell therapy for hematopoietic disorders. The company is advancing Phase II trials for long COVID, stroke, and aging-related diseases. StemCyte is also preparing for a listing on the Taipei Stock Exchange, marking a key growth milestone.
FDA panel flags risks as AstraZeneca seeks full Andexxa approval
Nov 22, 2024 · 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.
Sangamo shares jump as FDA clears faster gene therapy pathway
Oct 23, 2024 · Shares in Sangamo Therapeutics (Nasdaq: SGMO) surged around 40% on Tuesday, following the announcement that the US Food and Drug Administration has granted the company a faster path to approval for its gene therapy …
Applied Thera tanks, as FDA slaps CRL on govorestat NDA
Nov 28, 2024 · The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics.