Few of the pundits and tea-leaf readers handicapping the chances for approval of once-daily inhaled Breo (fluticasone furoate /vilanterol) in the wake of last month's FDA advisory panel were surprised by the agency's go-ahead for the chronic obstructive pulmonary disease (COPD) treatment from GlaxoSmithKline plc and Theravance Inc. Read More
Practically overnight, Affymax Inc. went from being lauded as a biotech success story and Wall Street darling to become one of the sector's biggest disappointments, and now, according to the latest 10-Q filing, the Palo Alto, Calif.-based firm might be nearing its end. Read More
In a footnote to its recent 10-Q filing, Pfizer Inc. shared results of a March meeting with the FDA to discuss a June 2011 complete response letter (CRL) for Remoxy (oxycodone) saying that it may not continue development, and if so, it would not have a response to the CRL before mid-2015. Read More
The typical goal of stem cell therapies is to get the mature cells they produce to take up permanent residence in patients. But there is one therapeutic area where the opposite is true: Scientists are injecting stem cells that function as temporary drug delivery vehicles for brain tumors. Read More
LONDON – Creabilis SA reported positive Phase IIb results for its topical TrkA kinase inhibitor CT327 in the relief of chronic pruritus (itch) caused by psoriasis, paving the way for a Phase III study designed to gain approval for treating itch in any dermatological disease. Read More
• Salix Pharmaceuticals Ltd., of Raleigh, N.C., reported product revenue totaling $202.6 million for the first quarter, up 18 percent over the same period in 2012. Read More
• iCo Therapeutics Inc., of Vancouver, British Columbia, said it priced its overnight market offering, issuing an aggregate of about 9.17 million units priced at C35 cents (US35 cents) apiece. Read More
• Oxygen Biotherapeutics Inc., of Morrisville, N.C., reported Friday that a 20-to-1 reverse stock split of its common stock is effective. The split was approved by the company's stockholders at a special meeting held on April 26 and was approved by the board on that same date. Read More
• Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, said it is progressing into the placebo-controlled portion of its Phase II trial of LX4211 in patients with Type I diabetes after identifying the once-daily 400-mg dose as the appropriate treatment for the expansion phase of the trial. Read More
• Eli Lilly and Co., of Indianapolis, said the Phase III PRELUDE study of enzastaurin, which explored the molecule as monotherapy in preventing relapse in patients with diffuse large B-cell lymphoma, failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy. Read More
• ScinoPharm Taiwan Ltd., of Tainan, Taiwan, and Coland Holdings Ltd., of Hong Kong, formed a strategic alliance to develop a series of generic oncological drugs for mainland China. Read More
Follow-up analyses of the RV144 trial of Sanofi SA's ALVAC HIV and VaxGen Inc.'s AIDSVAX B/E HIV vaccine by a team from Duke University has provided evidence that the competition of two different types of antibodies may have lowered the efficacy of the vaccine. Read More
