STAT

OCTOBER 28, 2024

Today we take note of the antagonism between gene-editing players Prime Medicine and Tessera Therapeutics, consider the issue of whether the label should be updated on a Merck drug, and more.   Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox. 

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STAT

MARCH 18, 2024

Today we ponder the vast open spaces of Boston’s unused life sciences labs, see a new biopharma IPO in the works, and expect a label expansion for some CAR-T blood cancer therapies.   Sign up  to get our biotech newsletter in your inbox. Read the rest…

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Labelling Drug Pricing Drug Development 261

FDA Law Blog: Biosimilars

APRIL 2, 2024

Perhaps unsurprisingly given the extraordinary focus on drug pricing in the last decade, generic competition—FDA’s only real way to have an effect on drug pricing—tops this year’s list. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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Labelling Biosimilars Drug Pricing Dosage 103

Safe Biologics

NOVEMBER 12, 2023

FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars- Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S.

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Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S.

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Biosimilars Packaging Labelling Drug Development 130

STAT

NOVEMBER 11, 2024

Plus, we note that GLP-1 drugs can increase a person’s risk of aspiration when undergoing surgery. This story first appeared in The Readout newsletter.    Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.    Good morning!

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Labelling Drug Pricing Drug Development 281