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.
Astrazeneca plc’s China president, Leon Wang, is under investigation in mainland China, the company said in an Oct. 30 statement. Although details are scant, Astrazeneca said Wang is “cooperating with an ongoing investigation by Chinese authorities,” and the company’s China operations will continue under the leadership of the current general manager of Astrazeneca China.
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