Sanofi

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.

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FDA experts call for more data on RSV vaccine safety in infants after Moderna trial pause. Panel seeks additional information before moving forward, emphasizing need for better understanding of immune response in different age groups.

The FDA granted Breakthrough Therapy Designation to Sanofi’s tolebrutinib for non-relapsing secondary progressive multiple sclerosis (nrSPMS), based on positive HERCULES Phase III trial results. Tolebrutinib showed a 31% reduction in six-month confirmed disability progression and nearly double the confirmed disability improvement compared to placebo. Regulatory submissions are underway for FDA and European markets, with ongoing PERSEUS Phase III study for primary progressive MS.

Aaron Siri, aiding Robert F. Kennedy Jr. in selecting federal health officials, has petitioned the FDA to revoke polio vaccine approval. Kennedy, Trump's health secretary nominee, maintains he does not seek to restrict vaccine access, though his partnership with Siri indicates vaccine policy scrutiny. Sanofi manufactures the polio vaccine in question.

Novavax achieved a $50M milestone payment from Sanofi for its COVID-19 vaccine in children, with potential for up to $300M in additional payments and royalties. The combination vaccines for influenza and COVID-19 received Fast Track designation, and the sale of the Czech Republic manufacturing site strengthens financial position.

Novavax achieved a $50 million milestone in its partnership with Sanofi, advancing its COVID-19 vaccine in children and receiving Fast Track designation for combination vaccine candidates. Additional milestones and royalties are potential, solidifying future partnership models.

Novavax achieved a $50 million milestone in its partnership with Sanofi, advancing its COVID-19 vaccine in children. Sanofi's combination vaccine candidates, including Novavax's vaccine, have received Fast Track designation and are in Phase 1/2 trials, potentially leading to further milestones and royalties for Novavax.

FDA grants Breakthrough Therapy designation to tolebrutinib for nrSPMS, based on HERCULES study results showing 31% delay in disability progression and double the confirmed disability improvement rate compared to placebo.