A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.
Pfizer announced positive results from two Phase III trials, one in moderate-to-severe atopic dermatitis and another in pneumococcal disease.
The Dupixent product developed by Sanofi and the French company’s U.S. partner Regeneron won regulatory approval in Europe for moderate-to-severe cases of eczema in adolescents.
Sanofi reported overall net sales increased by 5.5 percent for second-quarter 2019, driven by Sanofi Genzyme, Sanofi Pasteur and emerging markets.
The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals Inc. and Sanofi SA’s drug Dupixent to treat nasal polyps, marking the third major use for the injectable medicine.
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
The U.S. Food and Drug Administration accepted for priority review the license application for the use of Dupixent in adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis
Sanofi SA’s 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.
Sanofi will continue to implement cost savings after having reached a 1.5 billion euros ($1.75 billion) cost reduction target a year ahead of expectations, while several of the company’s key drugs are selling well.
Shares of Realm Therapeutics plunged more than 50 percent after the company’s Phase II atopic dermatitis drug failed to distinguish itself from the control arm in the study.