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+ …
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.
Oblenio Bio | The Pharmaletter
Nov 7, 2024 · 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 …
BRIEF—Centauri given $1.25m to advance antimicrobials
Nov 25, 2024 · 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.
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.
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 ...
Kura and Kyowa Kirin sign ziftomenib deal | The Pharmaletter
Nov 21, 2024 · 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.
Novartis extends radiopharma lead with new collab
Nov 19, 2024 · Novartis has partnered with Ratio Therapeutics to develop next-gen SSTR2-targeted radiotherapeutics for tumors like neuroendocrine and lung cancers. Ratio will receive up to $745 million, contributing its Trillium and Macropa platforms, while Novartis advances development and commercialization, expanding its radiopharma portfolio.
Sandoz launches first FDA-approved generic of Abraxane
Oct 11, 2024 · Swiss generic and biosimilar medicines major Sandoz today announced that it has launched a generic paclitaxel formulation in the USA, the first generic to its reference medicine to be approved by the US Food and Drug Administration (FDA).
Patient dies in Neurogene trial | The Pharmaletter
Nov 25, 2024 · 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).