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The commercial launch playbook: Team structure, readiness and execution

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Intellia Therapeutics’s Senior Vice President Maria Natale discusses why the most successful launches are shaped long before approval, with strategy, structure and patient insight at the core.

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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.

Continue to STAT+ to read the full story…

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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+: Where ‘democracy met science,’ 50 years ago

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.

Good morning. At a Cambridge bar on Saturday, I watched straight-seeming couples congregate by a television showing basketball, while a more queer-coded crowd lingered at another showing soccer. I don’t think that’s anything, really, but it was fun. 

This ‘never event’ is happening more frequently

A child born with congenital syphilis could suffer dire consequences: bone deformities, brain damage, blindness, deafness, and more. But that should be a ‘never event’ as public health officials say: A pregnant person can receive an injectable form of penicillin to prevent the infection. Somehow, rates keep going up anyway. Between 2012 and 2024, the U.S. saw an 800% increase in babies born with the disease. And since last year, there’s been a shortage of the drug.

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Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.

Good morning. At a Cambridge bar on Saturday, I watched straight-seeming couples congregate by a television showing basketball, while a more queer-coded crowd lingered at another showing soccer. I don’t think that’s anything, really, but it was fun. 

This ‘never event’ is happening more frequently

A child born with congenital syphilis could suffer dire consequences: bone deformities, brain damage, blindness, deafness, and more. But that should be a ‘never event’ as public health officials say: A pregnant person can receive an injectable form of penicillin to prevent the infection. Somehow, rates keep going up anyway. Between 2012 and 2024, the U.S. saw an 800% increase in babies born with the disease. And since last year, there’s been a shortage of the drug.

Continue to STAT+ to read the full story…

Read More

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Sanofi wins type 1 diabetes nod for Tzield after requesting to revoke CNPV

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Sanofi makes no mention of the Commissioner’s National Priority Voucher. Tzield was awarded the ticket in October 2025, but Sanofi requested withdrawal from the program after former CDER head Tracy Beth Høeg reportedly expressed skepticism of the drug.

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