Sanofi (France)

NEWS
FDA
Over the next two weeks, the U.S. Food and Drug Administration (FDA) has three upcoming decisions. Here’s a look.
Messenger RNA (mRNA) is a family of RNA molecules that transport genetic information from DNA to the ribosome, where it specifies the amino acid sequence that creates proteins. In theory, by coding your own mRNA, it should be possible to insert it into the cells and turn them into protein factories churning out whatever drug or molecule you program it to.
In October, the Minnesota Attorney General filed a lawsuit against three of the biggest insulin manufacturers over price gouging claims. One month later the American Diabetes Association published recommendations and public policy solutions.
FDA
Yesterday, the Endocrinologic and Metabolic Drugs Advisory Committee had a split vote, 8 to 8, on whether the overall benefits of Zynquista (sotagliflozin) outweiged the risk in order to support approval. This sends things back to the agency to make a final decision, which has a target action date of March 22, 2019.
It didn’t take long for the new leadership structure in the U.S. House of Representatives to take on the pharmaceutical industry. On Monday, the House Committee on Oversight and Reform launched an investigation into prescription drug pricing practices.
Biotech and pharma companies came roaring out of the gate on the first day of the annual J.P. Morgan Healthcare Conference with big deals, expansions and promises of growth and pipeline sustainability.
Tarrytown, NY-based Regeneron Pharmaceuticals and Paris-based Sanofi restructured a 2015 agreement to develop immuno-oncology (I/O) treatments. That deal was scheduled to wrap in 2020, but the revision adds two clinical-stage bispecific antibodies to the collaboration.
Days ahead of the J.P. Morgan Healthcare Conference, Germany-based BioNTech extended its three-year-old collaboration with Sanofi as the companies look to co-develop the first cancer immunotherapy candidate for solid tumors.
Acer Therapeutics, headquartered in Newton, Mass., in-licensed osanetant, a clinical-stage, selective, non-peptide tachykinin NK3 receptor antagonist from Paris-based Sanofi.
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