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.
The second time around wasn’t lovelier for Lexicon Pharmaceuticals Inc. as it once again made its case before the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee for Zynquista (sotagliflozin) as an adjunct to insulin to improve glycemic control in people with type 1 diabetes and mild to moderate chronic kidney disease.
Evolveimmune Therapeutics Inc. has secured its fourth big pharma investor and its first pharma development partnership in a deal with Abbvie Inc. The multitarget development deal with North Chicago-based Abbvie includes $65 million now, combined between an up-front payment and an equity investment. Branford, Conn.-based Evolveimmune is also eligible for up to $1.4 million in aggregate option fees and milestone payments, as well as tiered royalties on sales of products that are optioned by Abbvie.
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