Sanofi regeneron

Health The U.S. Food & Drug Administration (FDA) regulator gave more positive feedback on the Dupixent eczema treatment being developed by drugmakers Sanofi and Regeneron, the companies said on Tuesday. 06 Nov 2018 02:30PM Bookmark PARIS: The U.S. Food & Drug Administration (FDA) regulator gave more positive feedback on the Dupixent eczema treatment being developed by drugmakers Sanofi and Regeneron, the companies said on Tuesday.The two firms said the FDA had accepted for a priority Review the supplemental Biologics License Application for Dupixent in adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis whose disease was inadequately controlled with "topical therapies" or for whom such treatment was medically inadvisable.Dupixent was launched in the United States in April 2017 for the treatment of moderate-to-severe eczema in adults, and the product is seen as a key sales driver for both Sanofi and Regeneron.(Reporting by Sudip Kar-Gupta; editing by … [Read more...] about Sanofi and Regeneron’s Dupixent gets more positive feedback from US FDA: companies

REUTERS: France's Sanofi SA said on Friday eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma.Dupixent, co-developed with U.S.-based Regeneron, received approval to treat patients with eosinophilic asthma, a rare form of the disease, and those dependent on anti-inflammatory steroids.The drug acts by restraining proteins responsible for the inflammation of airways of the lungs, the root cause of asthma.Dupixent was launched in the United States in April 2017 for the treatment of moderate-to-severe eczema in adults.The drug, a key revenue driver for Sanofi, had worldwide sales of 176 million euros (US$202.5 million) in the second quarter of 2018, of which 151 million euros came from the United States.The drugmaker is also co-developing Dupixent for at least seven other conditions including pediatric asthma, chronic sinus infection with nasal polyps, and adolescent eczema.(Reporting by … [Read more...] about Sanofi drug Dupixent wins FDA approval to treat asthma

Health Sanofi SA said on Friday its skin cancer drug, made in partnership with Regeneron Pharmaceuticals Inc, was approved by the U.S. Food and Drug Administration. 29 Sep 2018 05:15AM Bookmark REUTERS: Sanofi SA said on Friday its skin cancer drug, made in partnership with Regeneron Pharmaceuticals Inc, was approved by the U.S. Food and Drug Administration.The drug, Libtayo, is used to treat skin cancer in patients whose condition has not improved following surgery or chemotherapy.Libtayo will be sold in the United States at a list price of US$9,100 for a three-week treatment cycle.(Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by Shounak Dasgupta) … [Read more...] about Sanofi, Regeneron skin cancer drug gets FDA nod

PARIS: Sanofi missed the boat on immune system-boosting cancer drugs. Now it's trying to catch up.The French drugmaker has hired John Reed, the former top scientist at oncology market leader Roche to head its group research operations. And it is now focusing on a pipeline of 10 medicines that it hopes will help it get a piece of the US$100 billion-a-year cancer drug market.Dmitri Wiederschain, head of Sanofi's immuno-oncology research, acknowledged the company had failed to capitalize on the takeoff of immunotherapy - drugs that activate the body's immune system to attack tumor cells - in the early 2010s.But he said the group could now gain an edge in the next waves of immunotherapy treatments, which include combining different drugs to better target cancer."It is of course a very competitive space but we now have 'foundation assets' to form a better rationale for combinations," he told Reuters in an interview, citing immunotherapy approaches known as PD-1, TGFBeta and the antibody … [Read more...] about Latecomer Sanofi looks to catch next wave of cancer therapies

Health The European Medicines Agency (EMA) will review the Dupixent (dupilumab) and Cemiplimab products being developed by drugmakers Sanofi and Regeneron, the companies said on Tuesday. 03 Apr 2018 01:30PM Bookmark PARIS: The European Medicines Agency (EMA) will review the Dupixent (dupilumab) and Cemiplimab products being developed by drugmakers Sanofi and Regeneron, the companies said on Tuesday.They said the EMA had accepted to review an application for Dupixent as an add-on maintenance treatment in certain adults and adolescents with inadequately controlled moderate-to-severe asthma.They said the EMA had also accepted to review the marketing authorization application (MAA) for Cemiplimab, which is used to treat patients with metastatic cutaneous squamous cell carcinoma (CSCC) - a form of skin cancer - or patients with locally advanced CSCC who are not candidates for surgery.(Reporting by Sudip Kar-Gupta; Editing by Subhranshu Sahu) … [Read more...] about European Medicines Agency to review Sanofi-Regeneron’s Dupixent, Cemiplimab