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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 camizestrant in HER2-negative advanced breast cancer, former cancer regulator Harpreet Singh told BioSpace.
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Supreme 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 abortion is provided across the nation.
The order signed by Justice Samuel Alito temporarily allows women seeking abortions to obtain the pill at pharmacies or through the mail, without an in-person visit to a doctor.
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 abortion is provided across the nation.
The order signed by Justice Samuel Alito temporarily allows women seeking abortions to obtain the pill at pharmacies or through the mail, without an in-person visit to a doctor.
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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 3 trial. Last year …
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STAT+: 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 19? I’ll be moderating a Georgetown University panel discussion on vertical integration in health care. Jonathan Kanter, the former top antitrust official at the Department of Justice, also will make remarks. It’s gonna be lit. Reserve a spot here. And as always, a penny for your thoughts: bob.herman@statnews.com.
The Elevance exec you need to know
Lawsuits alleging health insurers defrauded Medicare and other government programs take forever to litigate. Maybe they’re more about the friends you make along the way.
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 19? I’ll be moderating a Georgetown University panel discussion on vertical integration in health care. Jonathan Kanter, the former top antitrust official at the Department of Justice, also will make remarks. It’s gonna be lit. Reserve a spot here. And as always, a penny for your thoughts: bob.herman@statnews.com.
The Elevance exec you need to know
Lawsuits alleging health insurers defrauded Medicare and other government programs take forever to litigate. Maybe they’re more about the friends you make along the way.
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