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STAT+: Obesity drug Wegovy gets FDA approval to add cardiovascular benefits on its label

STAT

regulators approved a label expansion for Novo Nordisk’s obesity drug Wegovy to tout its benefits for the heart, a move that could boost demand and insurance coverage for the already highly popular treatment. Novo said it has also filed for a label expansion in Europe and a decision is expected this year.

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Off-label treatment for alcohol use disorder is linked to slower liver decline, study suggests

STAT

But a different medication, one frequently used off-label for the condition, could provide greater benefit to patients with alcohol-associated liver disease, a new study suggests.  WASHINGTON — There are three FDA-approved drugs for treating alcohol use disorder.

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STAT+: FDA alters warning label for Carvykti CAR-T, although link to secondary cancers is unclear

STAT

The Food and Drug Administration issued a change to the warning label for Legend Biotech and Janssen’s myeloma CAR-T, Carvykti or cilta-cel, adding that some secondary blood cancers have occurred following treatment for multiple myeloma with the cell therapy. 

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STAT+: Lawmakers want FTC to probe big PBMs over private-label biosimilar deals

STAT

In reality, the arrangements actually resemble private-label distribution, but the lawmakers worry these agreements could cause consumers to pay higher prices. These new business units have since used these deals as springboards to market the medications to health plans.

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STAT+: New Wegovy analysis could boost Novo Nordisk’s bid to expand drug’s label in heart failure

STAT

Novo Nordisk’s obesity drug Wegovy cut the risk of severe complications in patients with a common form of heart failure, according to a new analysis that could boost the company’s efforts to expand the label for the blockbuster treatment. of those who received placebo.

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STAT+: ‘Skinny labels’ on generic medicines saved Medicare $15 billion over a recent six-year period

STAT

The provision is known as skinny labeling, which refers to a move by a company that seeks regulatory approval to market a generic or biosimilar medicine for a specific use, but not for other patented uses for which the brand-name drug is prescribed. In short, this is a so-called carve-out.

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STAT+: Solicitor general urges Supreme Court to review ‘skinny labeling’ and generic drug access

STAT

Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs. solicitor general urged the U.S.

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