Uncategorized
STAT+: Supreme Court justices appear to signal ‘skinny labeling’ can survive
After months of anticipation, Supreme Court justices heard arguments about a long-standing tactic used by generic companies to carve out a distinct market for a medicine, and did not appear inclined to alter legal standards for the maneuver.
At issue is skinny labeling, which refers to moves by generic companies that seek regulatory approval to market a drug for a specific use, but not other patented uses for which a brand-name medicine is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement.
This tactic has been a key tool for generic companies ever since the Hatch-Waxman Act was signed into law more than four decades ago. The law established the mechanisms by which generic drugs can more readily enter the marketplace. And skinny labeling is one way that Congress attempted to foster more competition and benefit consumers.
After months of anticipation, Supreme Court justices heard arguments about a long-standing tactic used by generic companies to carve out a distinct market for a medicine, and did not appear inclined to alter legal standards for the maneuver.
At issue is skinny labeling, which refers to moves by generic companies that seek regulatory approval to market a drug for a specific use, but not other patented uses for which a brand-name medicine is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement.
This tactic has been a key tool for generic companies ever since the Hatch-Waxman Act was signed into law more than four decades ago. The law established the mechanisms by which generic drugs can more readily enter the marketplace. And skinny labeling is one way that Congress attempted to foster more competition and benefit consumers.
Uncategorized
STAT+: Trump’s obesity drug plan creates a temporary Medicare program that may be hard to end
WASHINGTON — Weight loss drugs will be available to adults 65 and older in Medicare for the first time next month, thanks to a government program that’s supposed to be temporary. It may be difficult to end it.
Medicare is prohibited by law from paying for obesity drugs. The Trump administration is circumventing that law by making the drugs available via a demonstration program.
Initially, Medicare had hoped to push private Medicare insurers to voluntarily cover the drugs via a three-year program called BALANCE, which would have started following a short transitional period. But insurers balked, so the federal government is instead extending the transitional coverage program, called Bridge, until the end of next year.
WASHINGTON — Weight loss drugs will be available to adults 65 and older in Medicare for the first time next month, thanks to a government program that’s supposed to be temporary. It may be difficult to end it.
Medicare is prohibited by law from paying for obesity drugs. The Trump administration is circumventing that law by making the drugs available via a demonstration program.
Initially, Medicare had hoped to push private Medicare insurers to voluntarily cover the drugs via a three-year program called BALANCE, which would have started following a short transitional period. But insurers balked, so the federal government is instead extending the transitional coverage program, called Bridge, until the end of next year.
Neumora Therapeutics is laying off 35% of workers after its most advanced asset failed a pair of Phase 3 studies, sending the biotech’s stock spiraling early Monday.
Uncategorized
Germany rethinking drug price reforms after Lilly, Boehringer withdraw investments: Reuters
Weeks after Boehringer Ingelheim and Eli Lilly retracted billions of dollar in German commitments, the nation’s government is reportedly changing a contentious element of its planned healthcare reforms.
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
STAT+: Trump’s obesity drug plan creates a temporary Medicare program that may be hard to end
Neumora discards depression asset, lays off staffers after pair of late-stage flops
Germany rethinking drug price reforms after Lilly, Boehringer withdraw investments: Reuters
AI Predicts Gene Regulation for Drug Discovery Using Condensate Morphology
Elicio crashes on midstage pancreatic cancer miss but will advance to Phase 3
STAT+: Lilly’s Ajax acquisition may have been worth it
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
-
Uncategorized9 years ago
According to Dior Couture, this taboo fashion accessory is back
-
Endpoints News3 months ago
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
-
Uncategorized9 years ago
Phillies’ Aaron Altherr makes mind-boggling barehanded play
-
Uncategorized9 years ago
Uber and Lyft are finally available in all of New York State
-
Contributors9 years ago
The final 6 ‘Game of Thrones’ episodes might feel like a full season
-
Uncategorized9 years ago
Steph Curry finally got the contract he deserves from the Warriors
-
Uncategorized9 years ago
The old and New Edition cast comes together to perform