LATEST ARTICLES
Brazil
Tauil & Chequer
STF – CONTROLE CONCENTRADO E REPERCUSSÃO GERAL | STJ – REPETITIVOS | TCU – PLENÁRIO | CÂMARA DOS DEPUTADOS | SENADO FEDERAL...
Canada
Smart & Biggar
On March 26, 2024, the Federal Court dismissed Medexus and Medac's action for patent infringement of Canadian Patent No 2,659,662 (the 662 Patent)...
Smart & Biggar
On November 10, 2021, the Minister of Health refused to reassess its decision that Janssen's esketamine hydrochloride product (SPRAVATO)...
DiliTrust Canada Inc.
In the complex world of pharmaceutical contracts, mistakes are costly. Every deal made and every rule imposed come with risks that can negatively impact not only financial outcomes...
DiliTrust Canada Inc.
Efficient contract management in the pharma industry is crucial, considering the sector's unique blend of innovation and stringent regulation. As a cornerstone of industry operations...
Luxembourg
Loyens & Loeff
Op 16 april 2024 bood de minister van Volksgezondheid, Welzijn en Sport (VWS) de Tweede Kamer de uitkomsten van een door EY uitgevoerd onderzoek naar de omvang in en de effecten van private equity in de zorg aan.
Turkey
Esin Attorney Partnership
Türkiye İlaç ve Tıbbi Cihaz Kurumu ("Kurum") geçtiğimiz haftalarda, Tıbbi Cihaz Yönetmeliğinin Ek XVI'sında Listelenen Tıbbi Amaçlı Olmayan...
Esin Attorney Partnership
The Turkish Pharmaceuticals and Medical Devices Authority ("TİTCK") recently published the Communiqué on Common Specifications for Nonmedical Product Groups...
UK
Potter Clarkson
Great innovations have the potential to effect transformational change in all areas of our lives whether that's through providing lifesaving medical treatments, reducing energy...
J A Kemp LLP
Last year we provided a review of 19 EPO Board of Appeal decisions relating to "antibody inventions" that were published between January and December 2022. We have now reviewed the decisions published in 2023.
United States
Venable LLP
On April 15, 2024, Fresenius Kabi announced the U.S. launch of Tyenne® (tocilizumab-aazg), the first Actemra® (tocilizumab) biosimilar to launch in the U.S., after receiving FDA approval in March 2024.
Jenner & Block
A split Federal Circuit panel recently held that the safe harbor provision of 35 U.S.C. §271(e)(1) providing a defense to infringement applies if the allegedly infringing activity is "reasonably related to submitting information" to the FDA.
Winston & Strawn LLP
The Food, Drug, and Cosmetic Act (FDCA or the Act) governs safety, efficacy, and labeling over drugs, cosmetics, dietary supplements, medical devices, and other consumer products.
WilmerHale
This week, the FTC continued its intense regulatory focus on pharmaceutical patents listed in the FDA's Orange Book. As reported in earlier editions of The Interplay...
WilmerHale
Medical device companies have a new regulatory pathway for exporting certain U.S.-origin medical products to Russia, Belarus, Crimea and other regions of Ukraine (i.e., the so-called Donetsk People's...
Foley Hoag LLP
On April 29, 2024, FDA finalized the long-awaited rule to assert authority over the regulation of laboratory developed tests (LDTs) under FDA's existing regulatory framework for medical devices...
Cahill Gordon & Reindel LLP
On March 25, 2024, the Ninth Circuit Court of Appeals affirmed the dismissal of securities fraud claims against biopharmaceutical company Sorrento Therapeutics...
Akin Gump Strauss Hauer & Feld LLP
On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration's (FDA) final rule on the regulation of laboratory developed tests...
European Union
Arnold & Porter
The EU Health Technology Assessment (HTA) Regulation (Regulation (EU) 2021/2282), which entered into force in January 2022, will start to apply from January 2025 for oncology medicines...
Osborne Clarke
The risk categorisation of artificial intelligence (AI) systems can ensure its regulation is proportionate and effective, with the intensity and scope of the risks that AI systems can generate...
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