FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review

Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.

Biden Ramps Up Fight Against High Drug Prices in State of the Union Address

State of the Union Address, Biden Administration, Big Pharma, Drug Prices, Inflation Reduction Act, Medicare Drug Negotiations, Out-of-Pocket Cap Expansion, Private Insurance Protections, Generic Drug Cost-Sharing Limit, Cell & Gene Therapy Access Model, Commercial Drug Sales Rebates

Sionna Secures $182M Series C Funding to Advance Novel Cystic Fibrosis Treatment Pipeline

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Gritstone Bio Implements Workforce Reduction Following Delay in COVID-19 Vaccine Trial

Gritstone Bio, COVID-19 vaccine trial delay, 40% workforce layoffs, Phase 2b CORAL trial, Manufacturing delay, Missed funding, Project NextGen, BARDA contract, Colorectal cancer vaccine