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Helixgate

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STAT+: Pharmalittle: We’re reading about Pfizer’s emergency penicillin program, a Sanofi diabetes drug, and more

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. But what can you do? The world, such as it is, continues to spin. So time to give it a little nudge in a better direction by firing up our spiffy new kettle — the last one overheated — for a cup of stimulation. Given this is the start of the week, we are reaching for Jack Daniels. Yes, this is a real option for aspiring connoisseurs. Feel free to join us. Meanwhile, here are some tidbits to help you along. Best of luck accomplishing your goals today, and of course, do keep in touch. …

The Trump administration proposed to change a policy that is designed to prevent drugmakers from avoiding Medicare price negotiation by adding active ingredients to drugs, STAT tells us. The policy is part of an annual proposed rule that establishes the process that the Centers for Medicare and Medicaid Services uses to choose the next 20 drugs and biologics for price negotiation. Those drugs will be announced by Feb. 1, 2027, and their negotiated prices will take effect in 2029. Iif a company adds a second drug to one that is eligible for negotiation, the FDA considers the resulting combination drug a new product, giving it additional time before price negotiation. Now, the administration is proposing to subject certain types of combination biologics to negotiation in some cases. 

German Health Minister Nina Warken said that drugmakers will not be exempted from cost-cutting measures, after some companies warned ​they may be unable to launch innovative medicines ‌in Europe unless governments agree to pay more than they historically have, Reuters writes. Proposed legislation in Germany ⁠will cap rapidly growing costs in the statutory health ​insurance system. Warken said she realizes many drug companies are under pressure, and the planned legislation is not going to bring them any extra ​revenue. But she maintained Germany remains an attractive location for the pharmaceutical industry ​thanks to reimbursement under the statutory health insurance scheme and opportunities for clinical trials. So exempting the industry from the proposed legislation is out of the question.

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Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. But what can you do? The world, such as it is, continues to spin. So time to give it a little nudge in a better direction by firing up our spiffy new kettle — the last one overheated — for a cup of stimulation. Given this is the start of the week, we are reaching for Jack Daniels. Yes, this is a real option for aspiring connoisseurs. Feel free to join us. Meanwhile, here are some tidbits to help you along. Best of luck accomplishing your goals today, and of course, do keep in touch. …

The Trump administration proposed to change a policy that is designed to prevent drugmakers from avoiding Medicare price negotiation by adding active ingredients to drugs, STAT tells us. The policy is part of an annual proposed rule that establishes the process that the Centers for Medicare and Medicaid Services uses to choose the next 20 drugs and biologics for price negotiation. Those drugs will be announced by Feb. 1, 2027, and their negotiated prices will take effect in 2029. Iif a company adds a second drug to one that is eligible for negotiation, the FDA considers the resulting combination drug a new product, giving it additional time before price negotiation. Now, the administration is proposing to subject certain types of combination biologics to negotiation in some cases. 

German Health Minister Nina Warken said that drugmakers will not be exempted from cost-cutting measures, after some companies warned ​they may be unable to launch innovative medicines ‌in Europe unless governments agree to pay more than they historically have, Reuters writes. Proposed legislation in Germany ⁠will cap rapidly growing costs in the statutory health ​insurance system. Warken said she realizes many drug companies are under pressure, and the planned legislation is not going to bring them any extra ​revenue. But she maintained Germany remains an attractive location for the pharmaceutical industry ​thanks to reimbursement under the statutory health insurance scheme and opportunities for clinical trials. So exempting the industry from the proposed legislation is out of the question.

Continue to STAT+ to read the full story…

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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.

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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.

Continue to STAT+ to read the full story…

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Neumora discards depression asset, lays off staffers after pair of late-stage flops

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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.

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Germany rethinking drug price reforms after Lilly, Boehringer withdraw investments: Reuters

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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.

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