 BIOTECH'S MOST RESPECTED NEWS SOURCE FOR MORE THAN 20 YEARS  |
FDA Grants Accelerated Approval for Talon’s Marqibo It has been a long and turbulent road for Marqibo (vincristine sulfate liposome injection), but South San Francisco-based Talon Therapeutics Inc. fi nally brought it over the goal line. The product received FDA accelerated approval Thursday based on a single-arm study for the treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. “The approval is a significant milestone for the company, and we are delighted that all our hard work over a fi ve-year period by a small dedicated team has fi nally paid off,” Steven Deitcher, president and CEO of Talon,told BioWorld Today. Vincristine, a microtubule inhibitor, is FDA-approved for ALL and Non-Hodgkin’s Lymphoma (NHL) and is widely used in combination regimens for treatment for a variety of adult and pediatric hematologic and solid tumor malignancies. | FDA Ends Orphan Exclusivity For Octapharma Drug Wilate In an agency first, the FDA is rescinding an orphan drug exclusivity, saying it made a mistake two years ago in determining that Octapharma USA Inc.’s Wilate was superior to CSL Behring LLC’s previously approved Humate-P. As a result, Wilate (von Willebrand Factor/Coagulation Factor VIII Complex) will keep its orphan drug designation, but it will lose its seven years of exclusivity. The decision is retroactive to December 2009, when the drug was approved to treat spontaneous and trauma-induced bleeding episodes in certain patients with von Willebrand disease. Wednesday’s decision, which was a response to a citizen petition filed last year by Behring, shows that “exclusivity is not sacrosanct,” Kurt Karst, a director at Hyman, Phelps & McNamara, told BioWorld Today. | |||
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FDA Tackles Nanotechnology Impact on Drug Regulation While the rest of the biotech world seems to embrace the arrival of nanotechnology in drug development, the FDA is still seeking to understand the nuances of products that contain nanoscale materials. The scope of work required in that effort was evident at Thursday afternoon’s meeting of the Center for Drug Evaluation and Research’s (CDER) Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. CDER officials presented a preliminary analysis of data collected from submissions that contain nanomaterials, a description of the risk assessment approach used to evaluate products containing nanomaterials and a summary of CDER research studies focused on understanding the characteristics of products containing nanomaterials. | Infinity Pharmaceuticals Aims to Raise $76.85M Following a decision to terminate development of saridegib under its alliance with Mundipharma International Corp., and subsequent 20 percent headcount reduction, Infinity Pharmaceuticals Inc. said Thursday it would raise about $76.85 million through a public offering of 5.3 million shares of common stock at $14.50 per share. Net proceeds from the offering will be funneled into clinical development of cancer candidates IPI-145 and retaspimycin. Morgan Stanley and Co. LLC And J.P. Morgan Securities LLC are joint book-running managers. There is a 30-day option for underwriters to purchase up to 795,000 additional shares of common stock to cover overallotments. | |||
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