WASHINGTON – The winds of change blew against Biogen Idec Inc. Wednesday, with shares sailing downward 5.8 percent, after the FDA approved the first oral disease-modifying agent for multiple sclerosis, Gilenya (fingolimod), from competitor Novartis AG. (BioWorld Today)

With the first section of its rolling new drug application (NDA) for fidaxomicin submitted to the FDA this week, Optimer Pharmaceuticals Inc. is seeking to be the first company on the U.S. market in 25 years with a new effective oral antibiotic to treat and prevent recurrences of Clostridium difficile infection (CDI), a disease that can cause serious diarrhea and other intestinal conditions, such as colitis, which sometimes results in death. (BioWorld Today)

ADELPHI, Md. – An FDA panel Thursday said the potential risks of tumors, psychiatric effects and heart problems outweighed any benefits of weight loss with Arena Pharmaceuticals Inc.'s Lorquess (lorcaserin). (BioWorld Today)

WASHINGTON – The FDA's approval late Tuesday of Savient Pharmaceuticals Inc.'s Krystexxa (pegloticase), a pegylated uric acid specific enzyme for chronic refractory gout, "symbolizes what a small biotech can do," said President Paul Hamelin. (BioWorld Today)