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Pharmaceutical Industry › Foreign Entities

Goodwin

Major Life Sciences Licensing Deal Trends in China in 2023

Goodwin on

This is the first of two articles focused on 2023 life sciences deals in China. The second article, which is coming soon, looks at trends in M&A.  In 2023, there were 240 reported life sciences licensing deals in China,...more

Gardner Law

FDA Issues Numerous Warning Letters

Gardner Law on

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Barnea Jaffa Lande & Co.

ICA Request for Information: Foreign Company Fined

Barnea Jaffa Lande & Co. on

The Israeli Competition Director General recently announced he had reached an agreement with the British pharmaceutical company Leadiant Biosciences. According to the agreement, Leadiant undertook to pay ILS 110,000 to the...more

Porter Hedges LLP

Anticipating President Biden’s Intellectual Property Policy in an Historical Context

Porter Hedges LLP on

Presidential administrations have affected intellectual property (IP) policy since the very beginning of United States history. In his first State of the Union address in 1790, President George Washington addressed patents....more

Hogan Lovells

FDA expands mutual reliance and harmonization with trusted foreign regulators for inspectional oversight - PIC/S GMP guide aims to...

Hogan Lovells on

The U.S. Food and Drug Administration’s (FDA) commitment to expand mutual reliance with trusted regulatory partners may be a silver lining for biomedical innovation during an unprecedented public health emergency. ...more

American Conference Institute (ACI)

[Virtual Event] FCPA & Anti-Corruption for the Life Sciences Industry - April 14th, 10:00 am - 6:00 pm EDT

American Conference Institute (ACI) on

Virtual Forum on the FCPA & Anti-Corruption for the Life Sciences Industry will take place on April 14, 2021 (Eastern Daylight Time). This is the only practical, comprehensive anti-corruption event that is truly tailored to...more

Knobbe Martens

Venue in Hatch-Waxman Cases Tied to Acts of ANDA Submission

Knobbe Martens on

VALEANT PHARMACEUTICALS v. MYLAN PHARMACEUTICALS - Before Newman, O’Malley, and Taranto. Appeal from the District Court of New Jersey - Summary: Venue in Hatch-Waxman cases is proper only in districts where actions...more

Mintz - Intellectual Property Viewpoints

New revised USMCA trade deal affects intellectual property rights, but not exclusivity period for biologics

Mintz - Intellectual Property Viewpoints on

On December 10, 2019, an agreement was reached between the United States, Mexico, and Canada on amendments to the U.S.-Mexico-Canada Agreement (“USMCA”). The USMCA, if ratified by each respective country, would replace the...more

Hogan Lovells

FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

Hogan Lovells on

Earlier yesterday, FDA published the final guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” which updates April 2016 draft guidance that covers the design, operation, and monitoring of systems...more

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