Gene therapy experts and advocates warning of the sector’s many challenges found a receptive audience in FDA leadership at a regulatory forum Thursday.

Late-stage results Otsuka presented in IgA nephropathy triggered a sell-off in Vera shares. Elsewhere, investors scrutinized Regenxbio’s Duchenne data and a brain drug study failed.

SCHOTT Pharma has announced an investment of €100m ($114m) to expand its manufacturing capacity for sterile RTU cartridges.

During an FDA panel discussion, the US health secretary prioritised easier routes to market for curative therapies.

A study found no rise in ADHD cases, though some drugs for the disorder are still in shortage amid high demand.

Juvenescence has acquired Ro5 to enhance its AI/machine learning capabilities and improve research and development.

The European Commission (EC) has granted marketing authorisation to Sydnexis for its low-dose atropine formulation SYD-101.

Regeneron and Sanofi’s blockbuster Dupixent has transformed the atopic dermatitis market, with future disruptors in the pipeline.

The deal gives Cullinan T cell engagers aimed at BCMA and CD19, which drugmakers are exploring as possible targets for antibody- and cell-based drugs for inflammatory conditions.

Vividion Therapeutics has secured worldwide rights for developing and commercialising VVD-214, the Werner helicase (WRN) covalent inhibitor.

The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool’s rollout.

The alert comes amid some patients accessing GLP-1RAs through unregulated channels, where safety information is often not disclosed.

China’s NMPA has approved Akeso’s PD-1/CTLA-4 bispecific antibody, cadonilimab, to treat persistent, recurrent or metastatic cervical cancer.

AI is revolutionizing the pharma supply chain by automating manual tasks, monitoring risks and providing predictive insights.

The company is one of the first to receive a “platform technology designation,” which could speed the review of certain gene therapy applications it later brings to the regulator.

Enhertu, Datroway and other antibody-drug conjugates developed by Daiichi Sankyo have made the company a leader in a competitive field. Hiroyuki Okuzawa is working to keep it that way.

Breast cancer study results impressed at this year’s meeting, but raised new questions. Doctors also wrestled with how best to use new bispecific antibodies, and expressed concern about looming cuts to science funding.

The investment bank says funding was down 57% last month, to $2.7 billion, and argues the new administration’s FDA restructuring, NIH cuts and drug pricing rules are “exacerbating” the decline.

The deal, which could be worth up to $870 million overall, will give Lilly access to a delivery technology that may help extend the durability of up to four of its weight-loss medicines.

Regeneron licensed a weight loss drug and revealed study data for a pair of muscle-preserving medicines. Elsewhere, two neuroscience biotechs cut deals and Bluebird officially went private.