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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. The Orange Book is the reference, and it allows the FDA to declare something [to be] therapeutically equivalent.

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ACI’s 23rd Advanced Summit on Life Sciences Patents

FDA Law Blog: Biosimilars

In a year of major change and outstanding questions, growing scrutiny on patent protection and drug pricing, and uncertainty around global price control measures and the Inflation Reduction Act, understanding the implications of new leadership and emerging mandates is critical. Hyman, Phelps & McNamara, P.C.s

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ACI’s 21st Annual Paragraph IV Disputes

FDA Law Blog: Biosimilars

Raimondo Exploring the On-Sale Bar and Applicability of Prior Art Orange Book Delisting Attempts Navigating ODP and Patent Family Dynamics Hyman, Phelps & McNamara, P.C.s

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Panel urges FDA to remove warnings on hormonal menopause therapy

BioPharma Dive

In his 2024 book Blind Spots — and again during Thursday’s panel — he questioned the evidence showing higher cancer risk and argued that MHT may actually prevent cardiovascular and cognitive diseases. You can unsubscribe at anytime. Makary has previously been critical of the warnings on MHT and advocated for its greater use. TechTarget, Inc.s

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Pfizer's former R&D head takes on drug pricing misconceptions in new book

PharmaVoice

John LaMattina has something to say about the industry — and he hopes patients are listening.

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STAT+: Drugmakers rely on ‘use codes’ to vastly expand the nature of their patent claims, STAT analysis shows

STAT

Once the Food and Drug Administration approves a medicine, this information is filed in the Orange Book , a key registry that plays a crucial, behind-the-scenes role in sorting out the competitive landscape in the pharmaceutical industry.