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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. With this long regulatory review period, the PTO granted the statutory-maximum five-year patent term extension.

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Life sciences VC Omega Funds closes $647m funding round

Pharmaceutical Technology

EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Ross Law July 21, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook According to Omega Funds, it has raised $2.5bn since launching in 2004.

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Panel urges FDA to remove warnings on hormonal menopause therapy

BioPharma Dive

An arm of the trial arm involving use of estrogen only was also stopped early in 2004 due to an apparent increased risk of stroke. You can unsubscribe at anytime. The study was stopped early in 2002 after researchers observed an increased risk of breast cancer and heart disease. Please select at least one newsletter. TechTarget, Inc.s

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STAT+: ‘Learning each other’s language’: FDA, patent office seek to work together to lower drug prices

STAT

Celgene later submitted study data to the Food and Drug Administration in its application for regulatory approval, but did not simultaneously seek additional patents on these other forms for another five years — in 2004.

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STAT+: Dutch group sues AbbVie for human rights violations stemming from Humira pricing

STAT

billion by “abusing” its position in the marketplace and keeping prices high. billion worth of Humira in the Netherlands between 2004 and 2018, when its patents provided a monopoly. The company sold approximately $2.3 Continue to STAT+ to read the full story…

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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

The review was impacted by Brexit and the COVID-19 pandemic, which compounded existing issues surrounding high drug pricing and patient access that had been brewing since 2016 and highlighted several shortcomings in the EU’s pharmaceutical system. THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION; 2004.

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Happy 40th Anniversary Hatch-Waxman! We’re Celebrating By Providing Access to a New Archive

FDA Law Blog: Biosimilars

Hatch Foundation’s For cheap generic drug prices, you can thank 40 years of Hatch-Waxman We Work For Health’s Hatch-Waxman Act: Celebrating 40 Years of a Balanced and Innovative Drug Ecosystem Tradeoffs’ Race to the Bottom Series FDA CDER Conversations – 40th Anniversary of the Generic Drug Approval Pathway The U.S.

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