Pharma, Biotech and Generics Industry News | The Pharmaletter
Oct 28, 2024 · India's BIRAC is propelling the country to global biotech leadership. 21 October 2024 As India's bioeconomy soars to a remarkable valuation of $151 billion, the government's Biotechnology Industry Research Assistance Council (BIRAC) has underscored the critical need for innovation and private sector investment to unlock further growth.
Trump vs Harris—who's on Big Pharma's side?
22 September 2024. Scarcely anything unites lawmakers in America these days, but the ostensible iniquities of Big Pharma could be a rare exception. While Donald Trump famously accused the industry of "getting away with murder” on prices, the rhetoric from Democrats has been equally stark, with Vice President Kamala Harris boasting she took on ...
FDA nod for UCB’s 320 mg single-injection Bimzelx for psoriasis
Oct 14, 2024 · The FDA has approved new 2mL pre-filled syringes and autoinjectors for UCB's Bimzelx (bimekizumab-bkzx) to treat psoriasis. Each contains 320mg, offering single-injection options alongside existing 1mL doses. This approval enhances convenience for patients needing a 320mg maintenance dose every eight weeks. The devices launch in Q1 2025.
UK approves new Comirnaty jab targeting latest subvariant
Oct 11, 2024 · The UK's MHRA has approved Pfizer and BioNTech's updated COVID-19 vaccine, Comirnaty (KP.2), for use in adults. This approval, part of the International Recognition Procedure, ensures ongoing protection against new variants, especially for vulnerable populations.
New US Cialis ad to debut at Super Bowl - The Pharma Letter
Feb 2, 2004 · Lilly ICOS will debut a 60-second television ad for its new erectile dysfunction drug Cialis (tadalafil) during the US Super Bowl telecast on February 1. Lilly ICOS began airing 15-second awareness spots for ED during the National Football League's conference championship games on January 18. However, this is the first time TV ads will inform ...
EMA accepts STADA’s filing for AVT03, a proposed denosumab …
Oct 10, 2024 · The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel.
Arda’s $43 million Series A to progress cell depletion therapies
Oct 9, 2024 · Arda Therapeutics, a biotech focused on targeted cell depletion therapies for chronic diseases, has raised $43 million in a Series A round. Led by Andreessen Horowitz, the funding will support Arda's novel strategy of eliminating disease-driving cells, rather than targeting proteins, across fibrotic, autoimmune, and metabolic conditions.
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FDA drug regulation and approval news | The Pharmaletter
Nov 4, 2024 · Shares of Swedish drugmaker Camurus fell almost 10% to 588.50 kroner yesterday after it revealed that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for CAM2029 (octreotide) extended-release injection for the treatment of patients with acromegaly. 23 October 2024.
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.