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The FDA’s refusal to review Moderna’s mRNA flu vaccine

This week on "The Readout LOUD," everything you need to know about the FDA's controversial decision to block the review of Moderna’s mRNA flu shot.

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STAT+: Trump administration is urged to use a federal law to authorize generic versions of GLP-1 drugs

Public Citizen contends that Novo Nordisk and Eli Lilly's obesity drugs are straining budgets so much that generics should be authorized.

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STAT+: FDA’s rejection of Moderna threatens to stifle broader vaccine industry

Experts say the FDA "moved the goalposts" on Moderna, creating "a destructive precedent that will undermine the future of vaccine development" in the U.S.

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STAT+: The messaging war over Medicaid cuts

This is the web edition of STAT's D.C. Diagnosis newsletter.

Fierce Pharma Asia—Lilly, Innovent go 'beyond traditional licensing'; China indicts AZ; Madrigal inks siRNA deal

Eli Lilly and Innovent Biologics have deepened their ties with a new type of deal. China has indicted AstraZeneca and its former top exec in the country following investigations that emerged in 2024. Madrigal has signed a potential $4.4 billion siRNA deal with a Chinese biotech. And more.

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STAT+: NIH redefines ‘clinical trials,’ dividing researchers

In a long-debated move, the NIH will no longer characterize basic experimental studies involving humans as clinical trials.

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STAT+: A change at the top of Sanofi

And other biotech news brought to you by The Readout newsletter

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STAT+: Pharmalittle: We’re reading about Sanofi replacing its CEO, MFN drug pricing opposed by conservatives, and more

And other pharma news from the Pharmalot campus via the Pharmalittle newsletter

Amid Wegovy pill's flying start in US, Novo CEO eyes Ireland expansion for supply overseas: Bloomberg

Novo plans to invest in an expansion of its facility in Athlone, Ireland, to produce its Wegovy pill for markets beyond the U.S., the company’s CEO, Mike Doustdar, told Bloomberg News in a newly published interview.

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STAT+: Researchers take another look at Apple’s hypertension feature

In this edition of STAT Health Tech: Fundraises by Talkiatry, Big Health, and the accuracy of Apple Watch hypertension feature.

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STAT+: The old Vinay Prasad never left. He just changed jobs

Prasad changed jobs but his conservative regulatory doctrine remains the same, particularly for cell and gene therapies. The approval bar is much higher now.

AbbVie mounts fresh IRA legal challenge over Botox's inclusion in latest drug pricing negotiations list

The company claims Botox should be excluded from Inflation Reduction Act (IRA) pricing negotiations due to its status as a plasma-derived drug, which is meant to be excluded from IRA negotiations.

Alnylam turns profitable even as Amvuttra ATTR revenue disappoints in Q4

Alnylam achieved profitability for the first time in its history in 2025. But disappointing sales performance from Amvuttra in the closely watched ATTR-CM market and some expected turbulence in 2026 are weighing on its shares.

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STAT+: European VCs band together to improve the landscape for biotech startups

A group of European venture capital firms is banding together to try to improve the funding landscape for biotech startups.

Scientists discover protein that rejuvenates aging brain cells

A newly identified protein may hold the key to rejuvenating aging brain cells. Researchers found that boosting DMTF1 can restore the ability of neural stem cells to regenerate, even when age-related damage has set in. Without it, these cells struggle to renew and support memory and learning. The findings raise hopes for treatments that could slow or even reverse aspects of brain aging.

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Why a change in fentanyl use has helped drive fewer overdose deaths

This week on STATus Report, host Alex Hogan explains why a change in fentanyl use has helped drive fewer overdose deaths.

Supreme seasons creative agency portfolio with Broth buyout

Supreme Group has added Broth to the mix of ad agencies it has cooked up in recent years. Backed by a private equity firm, Supreme has bought companies in quick succession to strengthen its marketing and communications capabilities.

CSL's bleak earnings report helps explain why it made CEO switch

One day after CSL revealed that it had suddenly replaced its CEO, the company provided dismal financial figures that helped explain why it is undergoing the leadership change. In its half-year report, CSL said that its net profit plummeted from $2 billion in the second half of 2024 to $384 million during the same period last year.

Sanofi ousts Paul Hudson after ‘bumpy ride’, poaches Merck KGaA CEO to lead the French pharma

Garijo’s appointment restores a single female CEO to the ranks of the top 10 Big Pharma companies

One simple daily change that could slash depression risk

Swapping just an hour of TV a day for something more active could significantly lower the risk of developing major depression—especially in middle age. A large Dutch study tracking more than 65,000 adults over four years found that replacing 60 minutes of TV with other activities cut depression risk by 11% overall, and by nearly 19% in middle-aged adults. The more time people reallocated—up to two