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American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

Robins Kaplan LLP

Liquidia Techs., Inc. v. FDA - Updated 5.2.25

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: FDA refused to approve Liquidia’s drug product, Yutrepia because another company, UTC, maintained marketing exclusivity. Liquidia sued FDA, and UTC intervened. The court granted...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

American Conference Institute (ACI) on

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

McDonnell Boehnen Hulbert & Berghoff LLP

FTC Prevails in Reverse Payment Case

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The Federal Trade Commission (FTC) spent the better part of a decade attacking the practice of innovator drug companies settling ANDA litigation by providing payments to generic applicants challenging the validity of Orange...more

Polsinelli

Update on Pending Legislation: Three New Bills Have the Potential to Affect Generic Pharmaceutical Companies

Polsinelli on

In the first month of the 116th Congress, three bills have been introduced (or re-introduced) that have potential to impact generic pharmaceutical companies. ...more

Hogan Lovells

Major IP reforms foreshadowed in China’s Pharma sector

Hogan Lovells on

On 12 May 2017, the Chinese Food and Drug Administration (the “CFDA”) issued several draft policies aimed at overhauling of the current regulations governing the Chinese pharma and medical device sector (the “Draft...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Proskauer Rose LLP

First Federal Appellate Court Holds a NonCash Reverse Payment Subject to Antitrust Scrutiny: Is the Third Circuit's Decision in...

Proskauer Rose LLP on

Recently, the Third Circuit issued the first federal appellate decision interpreting the Supreme Court's landmark decision in FTC v. Actavis, Inc.[1], potentially greatly expanding the scope of settling parties in reverse...more

McDonnell Boehnen Hulbert & Berghoff LLP

AstraZeneca AB v. Apotex Corp. (Fed. Cir. 2015)

McDonnell Boehnen Hulbert & Berghoff LLP on

Earlier this month, the Federal Circuit rendered a decision on damages in what may be the last of a long-running series of ANDA cases involving AstraZeneca's Prilosec® (omeprazole) franchise. As set forth in the opinion,...more

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