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Novavax is on thin ice, and the latest update isn’t exactly encouraging

STAT

On 2024 guidance, Merck said it expects sales in the range of $62.7-$64.2 Biotech can’t shake the Fed The XBI, a closely watched index of biotech stocks, turned red for the year yesterday, and not because of a clinical disappointment, a drug pricing scandal, or an M&A rumor that came to nothing.

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FDA Approves Amgen’s WEZLANA As Biosimilar to and Interchangeable With Janssen’s STELARA (ustekinumab) – Stelara Is One of the 10 Drugs Selected by CMS for Drug Price Negotiations Under the Inflation Reduction Act

Big Molecule Watch

The licensure and marketing of WEZLANA could affect negotiations with CMS regarding Medicare pricing for STELARA under the Inflation Reduction Act’s Drug Price Negotiation Program. For drugs selected for the first year of the Program, negotiations will end by August 1, 2024.

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December 2023 Newsletter

Safe Biologics

CMS accepted public comments on the Proposed Rule until January 5, 2024. The paper examines the likely negative effects of IRA’s price negotiation provisions, which allow the Centers for Medicare and Medicaid Services to negotiate prices of certain costly drugs, including many biologic medicines. Read it here.

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Tales of the Unsurprised: U.S. Brand-Name Drug Prices Fell for an Unprecedented Sixth Consecutive Year—And Will Fall Further in 2024 (rerun)

Drug Channels

One important update: In the article below, I suggested that the IRA will make high-list/high-rebate products less attractive to Medicare plans. Thanks to the IRA, Part D Plans Will Prefer High-List, High-Rebate Drugs. Click here to see the original post from January 2024. drug pricing. drug pricing.

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October 2023 Newsletter

Safe Biologics

Learn about ASBM’s recent educational activities surrounding IRA Medicare drug price negotiation, interchangeable biosimilars, and other key policy issues affecting patient access to medicines. Read the full BioSpace article here.

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340B Outlook For 2024: Change. Change. And More Change.

Proxsys Rx

And that is why the one 340B prediction we can make for 2024, unequivocally, is repeated three times in this post’s headline. Which means we may see a lot more states putting manufacturers in their place, in 2024. How covered entities should prepare for 340B changes in 2024 Build a qualified 340B team.

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340B Outlook For 2024: Change. Change. And More Change.

Proxsys Rx

And that is why the one 340B prediction we can make for 2024, unequivocally, is repeated three times in this post’s headline. Which means we may see a lot more states putting manufacturers in their place, in 2024. How covered entities should prepare for 340B changes in 2024 Build a qualified 340B team.