1. Scrip
  2. >>Advanced Therapies
  3. >>Cell Therapies

Which Firms Are Most Exposed To Prasad’s Possible Accelerated Approvals Clampdown?

 
• By Andrew McConaghie

Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.

Vinay Prasad (YouTube/FDA)

News that oncologist Vinay Prasad will be the new head of the US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) division sent biopharma shares tumbling on 6 May, as investors feared the effects on tougher approval standards on companies’ commercial prospects.

Although Prasad has now moved to sooth concerns over upheaval to review processes at CBER, which oversees regulation of vaccines,...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Cell Therapies

ASCO: Kite’s Glioblastoma CAR-T Highlights Solid Tumor Progress

 
• By Alaric DeArment

The company presented Phase I data for CART-EGFR-IL13Rα2, showing patient responses in the notoriously hard-to-treat and deadly brain cancer.

ASCO: Kite’s Dual-Targeting CAR-Ts Could Mitigate Toxicity, Resistance

 
• By Alaric DeArment

Gilead’s Kite division presented Phase I data for its next-generation CAR-T therapy KITE-363 in patients with B-cell lymphomas.

Senti’s Computer-Logic Inspired Cell Therapy Shows Early Promise

 
• By Andrew McConaghie

The biotech believes its logic-gated cell therapies can get round the need for ‘clean targets’ which limit CAR-Ts and ADCs.

Strong Data For CARsgen’s CAR-T In Late-Line Gastric Cancer

 
• By Dexter Jie Yan

In first confirmatory randomized controlled trial of any CAR-T therapy in solid tumors, CARsgen’s Claudin 18.2-targeting satri-cel reduced risk of death or disease progression by 63% in Chinese patients with gastric/gastroesophageal junction cancer.

More from R&D

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: Sanofi’s Blueprint buy; AstraZeneca’s breast cancer resistance results at ASCO; BMS and BioNTech’s big bispecific deal; Kymera’s Dupixent in a pill; and Degron’s CEO on pipeline and strategy.

Otsuka’s IgAN Data Top Some Vera Results, But To What End?

 
• By Joseph Haas

Otsuka bested Vera on Phase III immunoglobulin A nephropathy data for proteinuria, but analysts wonder if the difference is especially meaningful.

ASCO: Kite’s Glioblastoma CAR-T Highlights Solid Tumor Progress

 
• By Alaric DeArment

The company presented Phase I data for CART-EGFR-IL13Rα2, showing patient responses in the notoriously hard-to-treat and deadly brain cancer.