Uncategorized
Opinion: STAT+: Did Kennedy just stack the deck on FDA oversight of peptides?
I’ve been waiting for health secretary Robert F. Kennedy Jr. to do something big on oversight of what I call pop peptides, like BPC-157 and GHK-Cu. He had long signaled that he was going to free such peptides from what he saw as a past, misguided FDA that had banned them in 2023.
It’s finally happened — and the way it went down shook me up a bit.
For a few years, a loophole in compounding rules had allowed specialty pharmacies to make and market these peptides. It effectively meant that substances nominated for compounding — even unproven drugs — could be made and marketed by qualified pharmacies while the FDA pondered the nominations. But in 2023, the Food and Drug Administration rightly moved peptides to a no-compounding-allowed status called Category 2 due to concerns about safety and lack of clinical trial data. Now Kennedy is working to undo that with major risks to the public.
I’ve been waiting for health secretary Robert F. Kennedy Jr. to do something big on oversight of what I call pop peptides, like BPC-157 and GHK-Cu. He had long signaled that he was going to free such peptides from what he saw as a past, misguided FDA that had banned them in 2023.
It’s finally happened — and the way it went down shook me up a bit.
For a few years, a loophole in compounding rules had allowed specialty pharmacies to make and market these peptides. It effectively meant that substances nominated for compounding — even unproven drugs — could be made and marketed by qualified pharmacies while the FDA pondered the nominations. But in 2023, the Food and Drug Administration rightly moved peptides to a no-compounding-allowed status called Category 2 due to concerns about safety and lack of clinical trial data. Now Kennedy is working to undo that with major risks to the public.
Uncategorized
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.
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 …
Uncategorized
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.
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
Supreme Court restores access to abortion pill mifepristone through telehealth, mail, and pharmacies
Celcuity breast cancer win; Odyssey plans $205M IPO; Latus Bio extends Series A
STAT+: Pump the brakes on AI, buddy; and deposition deadlock
Big Tech Targets Drug Discovery with Wave of Life Science Platforms
Federal court blocks mailing of mifepristone
Gene therapy’s evidence problem—lessons from recent FDA decisions
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
-
Uncategorized9 years agoThese ’90s fashion trends are making a comeback in 2017
-
Contributors9 years ago
The final 6 ‘Game of Thrones’ episodes might feel like a full season
-
Uncategorized9 years ago
According to Dior Couture, this taboo fashion accessory is back
-
Uncategorized9 years ago
Uber and Lyft are finally available in all of New York State
-
Uncategorized9 years ago
Phillies’ Aaron Altherr makes mind-boggling barehanded play
-
Uncategorized9 years ago
The old and New Edition cast comes together to perform
-
Uncategorized9 years ago
Steph Curry finally got the contract he deserves from the Warriors
-
Uncategorized9 years ago
Disney’s live-action Aladdin finally finds its stars