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Uncategorized1 month agoSupreme Court restores access to abortion pill mifepristone through telehealth, mail, and pharmacies
WASHINGTON — The Supreme Court on Monday restored broad access to the abortion pill mifepristone, blocking a ruling that had threatened to upend one of the main ways...
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Uncategorized1 month ago
Celcuity breast cancer win; Odyssey plans $205M IPO; Latus Bio extends Series A
Celcuity’s breast cancer drug wins again: The company said two regimens with its experimental drug gedatolisib succeeded in PIK3CA mutant patients as part of its Phase...
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Uncategorized1 month agoSTAT+: Pump the brakes on AI, buddy; and deposition deadlock
This is the online version of STAT’s weekly email newsletter Health Care Inc. Sign up here. Hey! Are you going to be in Washington, D.C. on May...
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Uncategorized1 month ago
Big Tech Targets Drug Discovery with Wave of Life Science Platforms
Nvidia CEO, Jensen Huang, asserts that accelerated computing has a missing word: application acceleration. The “vertically integrated” and “horizontally open” chip maker is set on building the...
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Uncategorized1 month agoFederal court blocks mailing of mifepristone
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. Good morning and happy Monday. It’s May, and...
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Uncategorized1 month ago
Gene therapy’s evidence problem—lessons from recent FDA decisions
Comprehending the spate of recent rejections in the cell and gene therapy space may require looking no further than early-stage clinical trials of candidates from REGENXBIO,...
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Uncategorized1 month ago
Windward Bio gets $165M to take China-derived drug into Phase 3 asthma trial
A Swiss biotech with two experimental medicines from China, plus an in-house discovery team, has brought in $165 million to advance into late-stage testing. The startup,...
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Uncategorized1 month ago
Passage launches strategic review and 75% layoffs after gene therapy path blocked by FDA
After some tough feedback from the FDA on the path forward for its lead gene therapy, Passage Bio has launched a strategic review and set out...
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Uncategorized1 month ago
First FDA ODAC meeting without Pazdur highlights conceptual challenges with trial
The advisory committee meeting—the FDA’s first drug-related adcomm in nine months—could have been a “more conceptual discussion” about the design of AstraZeneca’s Phase 3 trial of...
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Uncategorized1 month agoNICE recommends Rystiggo for rare autoimmune disease
The National Institute for Health and Care Excellence (NICE) has recommended Rystiggo (rozanolixizumab) as a treatment for adults with antibody-positive generalised myasthenia gravis (gMG). Rystiggo is the first targeted...
