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Purple Book Biologics Patent Litigation

American Conference Institute (ACI)

[Virtual Conference] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - October 2024

Venable LLP on

Welcome to Venable’s BiologicsHQ Monthly Injection – October 2024...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - July 2024

Venable LLP on

Welcome to Venable’s BiologicsHQ Monthly Injection – July 2024...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

McDermott Will & Schulte

An Early Holiday Present for Generics? Legislation Requiring Greater Disclosure by Brands Passes the Senate

McDermott Will & Schulte on

Earlier this month, two bills intended to promote generic competitiveness by presenting a clearer idea of the patent landscape covering reference products passed the full Senate, albeit with amendments. These laws, if...more

K&L Gates LLP

The Name Game Continues: AbbVie Files Supplemental Citizen Petition Raising Additional Concerns Regarding Biosimilar Labeling

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AbbVie previously filed a citizen petition to the FDA arguing against its interim labeling requirements for biosimilars under the Biologics Price Competition and Innovation Act (“BPCIA”). In its supplemental petition, AbbVie...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Announces "Purple Book"

The new phone book is here? No, but close. The Food and Drug Administration ("FDA") announced on Friday that it has published its first listing of approved biologic drugs. The list will be supplemented with approved...more

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