Stealth BioTherapeutics Inc.
http://www.stealthbt.com/
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Latest From Stealth BioTherapeutics Inc.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.
Promising Pathway Act Would Fill Gap For Rare Disease Treatments That Don’t Fit Accelerated Approval, Advocates Say
Bill would enable two-year provisional approval of drugs to treat life-threatening illnesses, such as ALS, based on substantial evidence of safety and early evidence of efficacy. At a Senate committee hearing, rare disease advocates said it would remedy the FDA’s inconsistent application of regulatory flexibility, but a bioethicist cautions it would lower the bar for approval.
Impasse At US FDA Could Mean Stealth Abandons Barth Syndrome Treatment
In an interview with the Pink Sheet, Stealth’s CEO says she is not confident the company could design a clinical trial in the rare disease that would meet the FDA’s expectations.
Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else
Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a recent analysis of FDA approval decisions since 2021.
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Biotechnology
- Large Molecule
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- Stealth Peptides, Inc.
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