STAT

MARCH 18, 2024

The biggest enticement that large pharmacy benefit managers offer to the employers that hire them is drug rebates — a steady stream of money sent back to their clients, a tangible symbol of the discounts that PBMs are able to wrangle out of pharmaceutical companies. Continue to STAT+ to read the full story…

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Biosimilars Drug Pricing Documentation Pharmaceutical Companies 363

Safe Biologics

FEBRUARY 1, 2024

Comments may be submitted here until April 30, 2024. UPCOMING EVENTS WHO 78th INN Consultation Geneva, Switzerland – March 19, 2024 ASCO Annual Meeting Chicago, IL – May 31-June 4, 2024 BIO International Meeting San Diego, CA – June 3-6, 2024 DIA Global Annual Meeting San Diego, CA – June 16-20, 2024

Biosimilars 130

Biosimilars Documentation Drug Pricing 130

Pharma in Brief

JANUARY 10, 2024

We also flag what to watch out for in 2024. Expected highlights for 2024 include a final PTA regime, more details on PMPRB drug pricing guidelines and national pharmacare, and fall-out from the US mass drug importation program targeting Canadian medicines.

Drug Pricing 52

Drug Pricing Documentation Biosimilars Vaccines 52

Pharma in Brief

NOVEMBER 12, 2023

The Board previously indicated that a second phase of consultation in 2024 would focus on the development of new Guidelines. The scoping paper states that the Board intends to finalize new Guidelines in 2024. The Board indicated that a “What We Heard” document will be released in 2024.

Drug Pricing 52

Drug Pricing Documentation 52

FDA Law Blog: Biosimilars

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

Drug Pricing 45

Drug Pricing Biosimilars Dosage Documentation 45

Safe Biologics

MAY 10, 2024

From the post: The HHS Budget in Brief document describes the policy objective simply enough: “ Permit Biosimilar Substitution without Prior FDA Determination of Interchangeability” and clarifies that this means “deem all approved biosimilars to be interchangeable with their respective reference products”.

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Biosimilars Drug Pricing Documentation Labelling 130

Proxsys Rx

APRIL 19, 2024

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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Specialty Pharmacies Hospitals Drug Pricing Packaging 52