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The Issue with Reissue: PTE Edition

FDA Law Blog: Biosimilars

Even though the PTE provisions established in the Drug Price Competition and Patent Restoration Act are forty-plus years old, courts are still grappling with questions about how to best implement the Patent Term Extension.

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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

This pathway’s expanded use and shifting Centers for Medicare & Medicaid Services (CMS) policies are reshaping reimbursement practices and therapeutic equivalence standards for 505(b)(2) drugs. From 2003 to 2023, 943 drugs were approved through the 505(b)(2) pathway.

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Do We Really Pay More for Prescription Drugs in the United States?

Pharmacy Times

Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” with the objective of lowering drug prices, namely on branded drug products, for American consumers. How Does Drug Pricing in the US Compare With Other Countries? REFERENCES 1.

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PEPFAR funding protection offers “hope” for people living with HIV

Pharmaceutical Technology

PEPFAR was launched under President George Bush in 2003, and by August 2024, it had provided $120bn of funding for HIV/AIDS treatment, prevention and research. How will RFK Jr’s American dream for vaccines play out?

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STAT+: Boehringer Ingelheim layoffs are a sign of dysfunctional Humira biosimilar market

STAT

  The price of Humira rose 470% in the 20 years following its launch in 2003 to reach upward of $84,000 annually. List prices of Humira biosimilars are as much as 85% lower.    Continue to STAT+ to read the full story…

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NHC Comments on Request for Information: Medicare Transaction Facilitator (MTF) for the Medicare Drug Price Negotiation Program

Putting Patients First Blog

NHC Comments on Request for Information: Medicare Transaction Facilitator (MTF) for the Medicare Drug Price Negotiation Program (PDF) November 13, 2023 Benjamin Stidham, Contract Specialist Centers for Medicare & Medicaid Services U.S. Drug Distribution Data 2019. 5 Salako, A., Ullrich, F., and Mueller, K. Alexandr, G.,

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What You Need to Know about Celiac Disease

Putting Patients First Blog

About Beyond Celiac Since 2003, Beyond Celiac has been the leading patient advocacy and research-driven celiac disease organization working to drive diagnosis, advance research and accelerate the discovery of new treatments and a cure. Beyond Celiac is here to help.