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.
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.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aditxt, Bpgbio.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aerovate, Compass, Forus, Hutchmed, Jade, NRG, Pharmaessentia, Takeda, Teva, Werewolf.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Bioarctic, Cardiff, Curevo, Eisai, Novo Nordisk, Recce, Roche, Ventus.
The BioWorld Cancer Index (BCI) took a hit in September, ending the month down 11.52%, a notable slide from its 3.94% decline at the end of July and 9.63% drop by the end of August. The BCI’s performance starkly contrasts with the Nasdaq Biotechnology Index, which jumped 9.09%, and the Dow Jones Industrial Average’s 12.31% gain over the same nine-month period. This marks a stark reversal for the BCI, which had a standout year in 2023, closing with a 76.26% gain.
Equillium Inc. plans to continue on its own with itolizumab – now the top pipeline priority – as Ono Pharmaceutical Co. Ltd. Is letting expire the option for rights to the monoclonal antibody, designed to target the CD6-ALCAM signaling pathway.
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