EU approves Sanofi's Dupixent for 'smoker's lungs'
Sanofi and partner Regeneron on Wednesday won European Union approval for wider use of their Dupixent injection in patients with a chronic lung disease, a rare case of the EU clearing a drug faster than the United States.
Sanofi eyes German insulin investment of up to $1.6 bln, source says
French drugmaker Sanofi is nearing a decision to invest between 1.3 billion and 1.5 billion euros ($1.4-$1.6 billion) to upgrade its production of long-acting insulin shots in Germany, a person familiar with the plan told Reuters on Monday.
Sanofi eyes investment of up to $1.6 bln in Germany, Handelsblatt says
French drugmaker Sanofi is nearing a decision to invest between 1.3 billion euros and 1.5 billion euros ($1.4-$1.6 billion) at a major production site in Frankfurt, Germany, where it makes insulin brand Lantus, newspaper Handelsblatt reported on Monday.
Verona Pharma Is Launching Ohtuvayre, Although There Will Be Competition
VRNA received FDA approval for ensifentrine (Ohtuvayre) for the maintenance treatment of COPD on June 26. SNY/REGN's Dupixent represents a potential competitor. As do other drugs in development from SNY/REGN and GSK. Verona has the potential for further growth beyond the current approval, although in the near-term, initial sales seem likely to be a major determinant of the stock's direction.
German vaccine panel endorses Astra-Sanofi's RSV shot for infants
Germany's influential vaccine advisory panel said on Thursday all infants in the country should receive AstraZeneca and Sanofi's antibody therapy to protect them against the common respiratory infection RSV.
Sanofi-backed Formation Bio raises $372 million in late-stage funding round
AI-based drug developer Formation Bio said on Wednesday that it has raised $372 million in a late-stage funding round, with a significant participation from French drugmaker Sanofi.
Sanofi Looks To Sell $20B Icy Hot Division: Likely Bidders Include Advent, PAI Partners, Blackstone, CVC
Sanofi SA SNY is calling for initial bids for its $20 billion consumer health division.
Sanofi's Immunology Business Is Doing A Lot Of Heavy Lifting
Sanofi's shares have not fully recovered since announcing a business strategy change in October 2023, focusing on R&D investments and on separating its consumer healthcare business unit. The company's immunology business, led by Dupixent and other smaller products like Sarclisa, Beyfortus, and Altuviiio, is performing well. The immunology commercial portfolio and pipeline need to do a lot of the heavy lifting to maintain and improve Sanofi's growth profile.
Sanofi: A Leader In Life-Saving Vaccines And Treatments
In recent weeks, Sanofi has pleased investors with progress in the development of its pipeline of experimental drugs. On May 20, 2024, SNY announced additional results from a Phase 3 clinical trial that demonstrated Dupixent's greater efficacy in COPD treatment relative to my expectations. Dupixent sales amounted to 2.84 billion euros in the first three months of 2024, up 22.4% year-on-year.
FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD
Per the FDA, the data submitted by Sanofi (SNY)/Regeneron (REGN) for Dupixent in COPD indication constitutes a major amendment to its previously-submitted data. A final decision is expected by Sep 27.
FDA extends deadline, requests more data on Sanofi's Dupixent for treating 'smoker's lung'
French drugmaker Sanofi and its partner Regeneron said on Friday the U.S. Food and Drug Administration (FDA) requested additional analyses on the efficacy of Dupixent as an add-on treatment in certain patients 'smoker's lung', or COPD.
Sanofi's (SNY) Sarclisa sBLA Gets FDA's Priority Review Tag
The FDA grants priority review to Sanofi's (SNY) sBLA for the Sarclisa combination regimen for transplant-ineligible newly diagnosed multiple myeloma. A decision is due on Sep 27, 2024.
