LATEST ARTICLES
Brazil
Tauil & Chequer
STF – CONTROLE CONCENTRADO E REPERCUSSÃO GERAL | STJ – REPETITIVOS | TCU – PLENÁRIO | CÂMARA DOS DEPUTADOS | SENADO FEDERAL...
Koury Lopes Advogados
Instrução Normativa, que passa a vigorar em Junho, traz lista de autoridades estrangeiras aprovadas pela Anvisa para registro otimizado de dispositivos médicos e dispositivos médicos IVD;
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...
Gun + Partners
On April 4, 2024, the Industry Report on Medical Devices, prepared by the Turkish Medicines and Medical Devices Agency ("Agency") to present the current state of the market...
Gun + Partners
Türkiye İlaç ve Tıbbi Cihaz Kurumu ("TİTCK") tarafından tıbbi cihaz sektöründeki son yıllardaki gelişmeler ile birlikte pazarın mevcut durumunu ortaya koymak üzere hazırlanan...
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
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...
Foley & Lardner
Artificial intelligence continues to be one of the most talked about business trends.
J A Kemp LLP
Food systems are responsible for a third of anthropogenic greenhouse gas emissions, and already half of the world's habitable land is devoted to agriculture.
Crowell & Moring LLP
The Food and Drug Administration (FDA) has published revised draft guidelines in the Federal Register on promotional labeling and advertising considerations for the biologic and biosimilar industry...
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