FDA Policy/General

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India’s Natco Pharma has signed a licensing agreement with Gilead Sciences, which allows Natco to sell generic versions in 91 developing countries of its hepatitis C treatment Sovaldi (sofosbuvir) and combination therapies using the active ingredient.

Pfizer is closing a manufacturing plant in Foothill Ranch, CA that makes vitamins and is laying off 70 employees at the plant. It is also says it will cut an unspecified number of jobs at its Cambridge, MA research center, which opened 6/2014.

Asterias Biotherapeutics says its Atlanta-based Shepherd Center has begun enrolling patients for a Phase 1/2a clinical trial of AST-OPC1 (oligodendrocyte progenitor cells) in newly injured patients with sensory and motor complete cervical spinal cord injury (SCI). The company says the completed Phase 1 trial of AST-OPC1, which met its primary endpoints of safety and feasibility when administered to five patients with neurologically complete, thoracic SCI.

Cerulean Pharma has signed a clinical research agreement with the GOG Foundation Inc. to conduct an open-label Phase 1b clinical trial of its product candidate, CRLX101, in combination with weekly paclitaxel in patients with relapsed ovarian cancer. The partners expect to enroll up to 18 patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer beginning in the second quarter.

AbbVie will buy Sunnyvale, CA-based Pharmacyclics for about $21 billion. The firm manufactures Imbruvica, approved in more than 40 countries for treating chronic lymphocytic leukemia, mantle cell lymphoma; and Waldenstrom's macroglobulinemia.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome