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.
Bristol-Myers plans to divest Celgene’s psoriasis drug
Acquisitions, Analysts, Autoimmune Diseases, Autoimmune Disorders, Blockbusters, Business, Cancer, European Commission, Immunology, M&A, Plaque Psoriasis, Psoriasis, Shares, Stocks, Tyrosine Kinase 2 Inhibitors, U.S. Federal Trade Commission (FTC)Bristol-Myers Squibb Co. offered to divest Celgene Corp.’s psoriasis treatment Otezla to allay concerns raised by the U.S. competition regulator, and pushed back the closing of their $74 billion deal.
The U.S. drug regulator approved Palatin Technologies and Amag Pharmaceuticals’ drug to restore sexual desire in premenopausal women.
Lynparza was approved as a first-line maintenance treatment for a type of advanced ovarian cancer by the European Commission.
Vertex Pharmaceuticals Inc. will apply for regulatory approval during 2019 for the company’s triple combination of drugs to treat the life-shortening genetic condition cystic fibrosis.
BioMarin’s Hemophilia A Gene Therapy Shows Promise in Clinical Trial
Analysts, Breakthrough Therapy Status, Clinical Data, Clinical Trials, European Medicines Agency, European Medicines Agency (EMA), Factor VIII Inhibitors, FDA, Gene Therapy, Hemophilia A, Orphan Drug Designation, Priority Medicines (PRIME) access, R&DSan Rafael, Calif.-based BioMarin Pharmaceutical announced positive Phase III clinical trial results for the company’s gene therapy, valoctocogene roxaparvovec, for adults with hemophilia A.
Shares of North Carolina-based BioCryst Pharmaceuticals were down more than 53 percent after the company released data from a Phase III trial that underwhelmed analysts.
U.S. drugmaker Merck & Co. Inc. agreed to buy Peloton Therapeutics Inc. for $1.05 billion in cash, gaining access to the privately held company’s lead kidney cancer drug candidate.
Eli Lilly and Co. pulled ahead in a three-way race with Amgen Inc. and Teva Pharmaceutical Industries Ltd. in attracting new patients to a new class of migraine drugs, and seeks to build on that advantage by stressing that the company’s therapy can completely prevent headaches in a small percentage of patients.
The U.S. Food and Drug Administration approved Pfizer Inc.’s oral drug tafamidis to treat a rare and fatal heart disease called transthyretin amyloid cardiomyopathy.
