Sanofi

Sanofi's tolebrutinib, an oral BTK inhibitor, received FDA breakthrough therapy designation for nrSPMS. HERCULES trial showed 31% delay in disability progression and double the confirmed disability improvement rate vs. placebo, but noted liver enzyme elevations. Regulatory submissions ongoing in US and EU, with PERSEUS trial for primary progressive MS ongoing.

The global Acute Myeloid Leukemia Therapeutics Market is projected to grow at a CAGR of 13.4% during 2024-2032, driven by advances in targeted therapies and immunotherapies.

U.S. agency warns Sanofi of potential sanctions for altering 340B Drug Discount Program payments, instructing immediate halt.

Focke Ziemssen, Michelle Sylvanowicz, Winfried M. Amoaku, Tariq Aslam, Bora Eldem, Robert P. Finger, Richard P. Gale, Laurent Kodjikian, Jean-François Korobelnik, Xiaofeng Lin, Anat Loewenstein, Paul Mitchell, Moira Murphy, David R. Owens, Nick Parker, Ian Pearce, Francisco J. Rodríguez, Jude Stern, S. James Talks, David T. Wong, Tien Yin Wong, and Jane Barratt disclose various financial interests including travel grants, personal fees, advisory board memberships, speaker fees, research sponsorship, and consulting roles with companies such as Allergan, AbbVie, Alimera, Bayer Healthcare, Biogen, Boehringer Ingelheim, Janssen, Novartis, Novo Nordisk, Merck, Regeneron, Roche, Sanofi, and others.

Foracort led with Rs 82 crore in sales, followed by Augmentin and Glycomet GP. Urology grew 18%, dermatology 16%, and cardiac/pain relief 13%. Respiratory therapies grew due to air pollution. Cold Preparation Ethicals and paracetamol subgroups performed well. VMN and dermatology segments grew significantly. Sun Pharma led with an 8% market share. 746 new SKUs were introduced, and 3,024 SKUs saw PTR changes.

FDA grants Breakthrough Therapy designation to tolebrutinib for treating nonrelapsing secondary progressive multiple sclerosis (nrSPMS), based on HERCULES study results showing delayed disability progression and increased disability improvement compared to placebo. Tolebrutinib is the first brain-penetrant BTK inhibitor for MS to receive this designation.

SK bioscience gains HREC approval for Phase I/II trials of mRNA-based Japanese encephalitis vaccine GBP560, targeting diseases like Lassa fever. Trials to assess safety, immunogenicity in 402 adults, with interim results expected by 2026. Supported by CEPI, the project aligns with '100 Days Mission' for rapid vaccine development.

Sanofi files Form 6-K as a foreign private issuer under the Securities Exchange Act of 1934 for December 2024, indicating use of Form 20-F.

Aaron Siri filed a petition to revoke the polio vaccine's federal approval, questioning its safety and efficacy. The vaccine, invented in 1955, eradicated polio in the U.S. and has prevented millions of cases globally. Siri seeks a double-blind trial and label changes, also targeting 13 other vaccines for aluminum content.

Sanofi's tolebrutinib, an oral BTK inhibitor, received FDA Breakthrough Therapy designation for non-relapsing secondary progressive multiple sclerosis (nrSPMS). Data from the HERCULES study showed tolebrutinib delayed disability progression by 31% and doubled confirmed disability improvement rates. Regulatory submissions for approval are underway in the U.S. and EU. Tolebrutinib is also being evaluated for primary progressive MS, with data expected in 2025.