The drug and device industries have a lot hinging on the results of the Nov. 5 U.S. presidential and congressional elections. Tax policies. The reach of the FTC. Legislation aimed at drug prices, competition, pharmacy benefit managers and lab-developed tests. Cabinet and agency appointments that could reshape Medicare drug negotiations, the 340B program, FDA Orange Book device patent listings, regulatory flexibility and Bayh-Dole march-ins. And that’s just the top of the list. Read More
The nearer-looming threat of a biosimilar from Amgen Inc. to heavyweight Regeneron Pharmaceuticals Inc.’s age-related macular degeneration (AMD) VEGF therapy, Eylea (aflibercept), along with other issues, pressured shares of the latter (NASDAQ:REGN) since reporting third-quarter earnings Oct 31. But Wall Street pundits are not altogether aligned on how serious the scenario might be. After the earnings update, Regeneron’s stock fell 12%, from $925 to $819.96, and closed Nov. 1 at $843.60, up $5.40. Read More
Just ahead of the EMA setting out its latest thinking on regulation in the new era of artificial intelligence (AI), the industry has put forward its position on how to ensure AI rules enable, rather than hinder, the drug development and approval process. Read More
Through September 2024, biopharma firms secured $720.56 million in nonprofit deals, up in value through July and also marking a 21% rise from the $593.23 million in the first three quarters of 2023, though still falling short of 2019-2022 levels. Grants saw an even sharper surge, jumping 131% year-over-year from $1.66 billion to $3.84 billion in the same period, falling short only of 2020 in value. Read More
Shares of Essa Pharma Inc. tanked Nov. 1 after the company said it is terminating all trials of masofaniten, its N-terminal domain androgen receptor inhibitor and sole clinical-stage program, following a disappointing readout from a phase II study in metastatic castration-resistant prostate cancer. The stock (NASDAQ:EPIX) hit a 52-week low, closing at $1.40, down $3.80, or 73%. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Bioarctic, Cardiff, Curevo, Eisai, Novo Nordisk, Recce, Roche, Ventus. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aerovate, Compass, Forus, Hutchmed, Jade, NRG, Pharmaessentia, Takeda, Teva, Werewolf. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aditxt, Bpgbio. Read More
