Sanofi

An FDA advisory panel recommended allowing compounding pharmacies to produce peptides like BPC-157 and TB-500, despite FDA staff concerns about safety and efficacy. Sanofi's long-acting insulin pen, Lantus Solostar, faces supply shortages due to increased demand, causing challenges for diabetes patients.

Sanofi is discontinuing its eczema drug as part of a CEO-led pipeline overhaul, citing insufficient improvement over existing treatments like its own Dupixent.

Sanofi's Lantus Solostar insulin pen is experiencing supply issues due to increased demand, causing patients to struggle to find medication. The FDA does not classify the situation as a shortage, but Sanofi is accelerating production to address the problem.

The article highlights ongoing developments in biotech, including discussions on Biogen’s tau therapy for Alzheimer’s at a London meeting, research on daraxonrasib for pancreatic cancer, and U.S. regulatory updates such as HHS guidance on tapering SSRIs and FDA approval of Sanofi’s wearable injector for a myeloma drug.

The European Commission is investigating Sanofi for allegedly violating antitrust rules by running a misleading campaign that disparages CSL Seqirus's Fluad vaccine, portraying it as inferior to Sanofi's Efluelda vaccine. The campaign targeted healthcare professionals in Germany and France, where Sanofi holds a dominant market position, and contradicted national vaccine recommendations in several EU member states.

The European Union has initiated an antitrust probe against France's Sanofi, a drugmaker, over its flu vaccine. The article notes Sanofi's logo at a Paris technology fair.

Brussels has launched an antitrust probe into French drugmaker Sanofi, investigating whether the company conducted a misleading campaign against a rival flu vaccine manufacturer. The competition watchdog is examining potential anticompetitive practices related to flu vaccines.

Sanofi appointed Paulo Fontoura as global head of R&D to rejuvenate its pipeline under new CEO Belén Garijo. Fontoura, a neurologist with prior roles at Xaira Therapeutics and Roche, replaces Houman Ashrafian, who is leaving for an external opportunity.

The article discusses the tension between Germany's health reform and the pharmaceutical industry's competitiveness, focusing on Sanofi's Heidrun Irschik-Hadjieff's warnings about the impact of a proposed dynamic manufacturer discount on future investments. It also touches on digital sovereignty debates in Europe and the role of the 'Power & Policy' podcast in analyzing economic policy decisions.

The FDA approved Sanofi's teplizumab for children aged 8 and older with stage 3 diabetes. The drug underwent a speedy review program but the agency missed its decision deadline of April 21. Sanofi requested to withdraw the drug from the program after Tracy Beth Høeg, a former top drug regulator, disagreed with a staff approval decision.

Sanofi halted a Phase 3 study of its drug riliprubart due to lack of efficacy, while Parabilis Medicines raised $670 million in a record biotech IPO. European countries face conflicts over drug-pricing policies amid budget strains and U.S. pressure.

Sanofi has asked the FDA to pull its type 1 diabetes drug from a speedy review program after a staff decision to approve the drug was disagreed with by the acting Center for Drug Evaluation and Research Director. An experimental drug from Revolution Medicines has shown promise in clinical trials for advanced pancreas cancer. The FDA is rethinking its approach to drug approvals.

Sanofi has asked the FDA to pull its type 1 diabetes drug, teplizumab, out of a speedy drug review program after a dispute over the approval decision. The agency missed its goal date of April 21 to deliver a decision to Sanofi. The dispute involved acting Center for Drug Evaluation and Research director Tracy Beth Høeg.