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.
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.
Biden Medicare plan to drastically expand GLP-1 access
Nov 27, 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.
Vertex Pharmaceuticals News | The Pharmaletter
Dec 18, 2024 · US biopharma Vertex Pharmaceuticals today announced results from its Phase II study of suzetrigine, an investigational, oral, highly selective NaV1.8 pain signal inhibitor in people with painful lumbosacral radiculopathy (LSR), also known as sciatica.
FDA approves Novocure’s Optune Lua
Oct 16, 2024 · The US Food and Drug Administration (FDA) has approved Novocure's Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel, for the treatment of adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed on or after a platinum-based regimen.
Access to innovative medicines increasingly delayed in LATAM, …
Nov 28, 2024 · The waiting time for Latin American patients with cancer, central nervous system disorders or rare diseases can take up to 4.75 years from the time a drug receives approval from global health authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), until it is approved by their local authority and is available on the market, writes The Pharma Letter ...
BeiGene gains first-line EU nod for checkpoint blocker
Nov 27, 2024 · The European Medicines Agency has approved Tevimbra (tislelizumab) in combination with chemotherapy for advanced throat and stomach cancers. The approval, based on positive Phase III trial results, comes as BeiGene strengthens its global presence with new headquarters and an $800 million R&D facility in the US. Tevimbra continues to be a key part of the company's portfolio.