Policy

The plausible mechanism pathway “could accelerate gene therapy/editing development,” analysts at William Blair said Thursday, while adding that additional clarity is needed.

With pricing pressures climbing, Pfizer, Eli Lilly and other major drugmakers are looking to sell their products directly to patients. Analysts are skeptical that these efforts, including those announced to much fanfare from the White House, will result in meaningful reductions in drug spending.

Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.

The agreement will also secure a $150 price for future weight loss pills from Novo Nordisk and Eli Lilly—at least initially.

The search continues for a new leader for the FDA’s Center for Drug Evaluation and Research after George Tidmarsh resigned on Sunday. Deputy Director Mike Davis is in the running, along with Mary Thanh Hai, currently head of the Office of New Drugs.

The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.

According to reporting from Reuters, reviewers at the agency pointed to an inability to differentiate from placebo to justify rejecting the drug, but an FDA office director approved the drug anyway.

Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.

Vinay Prasad, chief of the FDA’s Center for Biologics Evaluation and Research, is planning to publish a paper this month to outline his office’s thinking on accelerating gene editing reviews.

The investment, which will expand Eli Lilly’s existing campus in Puerto Rico, is slated to create 100 new jobs, on top of around 1,000 construction-related roles.