News & Analysis as of

Labeling Biotechnology

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – June 2024

This latest edition features articles on biotech client Siolta Therapeutics, the use of safety and efficacy findings to extend drug exclusivity periods, life sciences venture financings for clients in 2023, and updated USPTO...more

McDermott Will & Emery

European SPC Manufacturing Waiver Goes into Force

McDermott Will & Emery on

Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more

Faegre Drinker Biddle & Reath LLP

PhRMA and BIO Take Off-Label Communication Into Their Own Hands with New Guidelines

Industry for years has sought clarity on off-label communications. Numerous meetings on the topic have taken place between the U.S. Food and Drug Administration (FDA) and industry, citizen petitions have been filed,...more

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