SILVER SPRING, Md. – An FDA advisory panel Tuesday backed approval of InterMune Inc.'s pirfenidone as a treatment for idiopathic pulmonary fibrosis (IPF), a progressive, irreversible, ultimately fatal disease that affects about 5 million people worldwide, including 100,000 Americans. (BioWorld Today)
WASHINGTON - Investors Friday left all doubts aside about InterMune Inc.'s pirfenidone, driving shares of the company up 59.3 percent, despite an FDA review that said the firm's overall Phase III package failed to provide substantial evidence of the drug's efficacy benefit in reducing decline in lung function in patients with idiopathic pulmonary fibrosis (IPF), a progressive fatal disease that affects about 100,000 Americans. (BioWorld Today)
CombinatoRx Inc.'s shares jumped 33.3 percent Tuesday after the company and its U.S. commercialization partner Covidien plc said the FDA had approved Exalgo, a once-daily, extended-release formulation of hydromorphone, for moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. (BioWorld Today)