Sanofi

Recent landmark cases, EPO's G2/21 and U.S. Supreme Court's Amgen v. Sanofi, have reshaped biotechnology patenting by emphasizing sufficiency of disclosure and enablement. G2/21 allows post-filing evidence if credibly disclosed, while Amgen v. Sanofi requires comprehensive disclosure for broad claims. Practitioners now favor data-heavy applications and layered claims to balance breadth and sufficiency, with increased focus on freedom-to-operate and competitor monitoring.

The UAE is investing in genomics to revolutionize healthcare, with initiatives like the Emirati Genome Programme and the National Genome Strategy. These efforts aim to personalize medicine, improve diagnostics, and enhance public health. Challenges include ethical implications, data protection, and regulatory compliance.

Fanaroff: Research grants from American Heart Association and National Institutes of Health; consulting fees from Abbott Laboratories. Vora: Consulting fees from Medtronic. Mehran: Institutional research grants from AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb/Sanofi, CSL Behring, Eli Lilly/Daiichi Sankyo, Medtronic, Novartis, OrbusNeich; consulting fees from Boston Scientific, Abbott Vascular, Medscape, Siemens Medical Solutions, Roivant Sciences Inc, Sanofi; consulting (no fees) for Regeneron Pharmaceuticals Inc; institutional consulting fees from Abbott Vascular, Spectranetics/Phillips/Volcano Corporation, Bristol Myers Squibb, Novartis, Watermark Research; Executive committee member for Janssen Pharmaceuticals and Bristol Myers Squibb; <1% equity in Claret Medical and Elixir Medical. Granger: Research grants from Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Pfizer, Armetheon, AstraZeneca, US Food and Drug Administration, GlaxoSmithKline, The Medicines Company, Medtronic Foundation, Medtronic Inc, Novartis; consulting fees from Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Pfizer, Abbvie, Armetheon, AstraZeneca, Eli Lilly, Gilead, GlaxoSmithKline, Hoffmann-La Roche, The Medicines Company, National Institutes of Health, Novartis, Sirtex, Verseon, Apple, Medscape, LLC, Merck, Novo Nordisk, Roche Diagnostics, Rho Pharmaceuticals. Goodman: Research grant support and/or speaker/consulting honoraria from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Daiichi-Sankyo, Eli Lilly, Esperion, Fenix Group International, Ferring Pharmaceuticals, GlaxoSmithKline, HLS Therapeutics, Janssen/Johnson & Johnson, Luitpold Pharmaceuticals, Matrizyme, Merck, Novartis, Novo Nordisk A/C, Pfizer, Regeneron, Sanofi, Servier, Tenax Therapeutics, Heart and Stroke Foundation of Ontario/University of Toronto, Canadian Heart Research Centre and MD Primer, Canadian VIGOUR Centre, Duke Clinical Research Institute, PERFUSE. Aronson: Employee of Bristol Myers Squibb. Windecker: Institutional research and educational grants from Abbott, Amgen, Bayer, BMS, CSL Behring, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, Polares, Sinomed. Alexander: Research grants from Bristol Myers Squibb, Boehringer Ingelheim, AstraZeneca, CryoLife, CSL Behring, US Food and Drug Administration, National Institutes of Health, Sanofi, VoluMetrix; consulting fees from Pfizer, Bristol Myers Squibb, AbbVie Pharmaceuticals, CSL Behring, Novo Nordisk, Portola Pharmaceuticals, Quantum Genomics, Teikoku Pharmaceuticals, VA Cooperative Studies, Zafgen. Lopes: Research grants from Bristol Myers Squibb, Pfizer, Amgen, Inc, GlaxoSmithKline, Medtronic PLC, Sanofi Aventis; consulting fees from Bristol Myers Squibb, Pfizer, Boehringer Ingelheim, Bayer AG. The other authors report no conflicts.

Companies are adopting inclusive business models to reach low-income countries, but outcomes are mixed with unclear patient reach. R&D focus is insufficient, especially in low-income countries, risking exclusion of diverse populations and limited product access. Voluntary licensing and technology transfers are crucial for sustainable access, yet activities have slowed, with limited efforts in sub-Saharan Africa.

Vir Biotechnology's treatments for chronic hepatitis delta, tobevibart and elebsiran, received a positive opinion for orphan drug designation from the EMA. The company will present Phase 2 SOLSTICE trial data at The Liver Meeting. The orphan drug status in the EU offers incentives and market exclusivity. The FDA granted fast track designation to the combination of tobevibart and elebsiran in June 2024. Vir's financials show a strong liquidity position and positive analyst sentiment.

Recent landmark cases like EPO's G2/21 and U.S. Supreme Court's Amgen v. Sanofi have reshaped biotechnology patenting, emphasizing sufficiency of disclosure and enablement. The G2/21 decision allows more use of post-filing evidence if credibly disclosed, while Amgen requires comprehensive disclosure for broad claims. Practitioners now focus on detailed applications, multiple claim layers, and strategic disclosure to navigate the complex landscape.

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Muse, an AI tool developed by Formation Bio, OpenAI, and Sanofi, aims to accelerate drug development by optimizing clinical trial patient recruitment, initially focusing on multiple sclerosis. It uses AI to analyze scientific literature, define optimal patient profiles, and generate targeted recruitment materials, potentially speeding up trial completion and treatment availability.

Medicus Pharma Ltd appoints Faisal Mehmud, MD as Chief Medical Officer and promotes Edward Brennan, MD, FACS to Chief Scientific Officer & Head of R&D, focusing on expanding drug development pipeline and commercializing novel non-invasive treatments for basal cell carcinoma.