FDA Policy/General

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Boston Scientific signed a temporary agreement with C.R. Bard to begin selling a Lutonix drug-coated inflatable balloon, which received FDA approval last October to re-open arteries in the thigh and knee when they are blocked as a result of peripheral artery disease. The device would compete with Medtronic’s In Pact Admiral, which received agency approval last month.

Hospira will collaborate with Pfenex to exclusively develop and commercialize for worldwide sales Pfenex’s biosimilar candidate to Genentech’s Lucentis (ranibizumab injection), a vascular endothelial growth factor inhibitor indicated for neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema (DME), and diabetic retinopathy in patients with DME. According to the companies, Hospira agreed to pay Pfenex $51 million upfront once the collaboration receives antitrust approval. Hospira will be responsible for manufacturing and commercializing the product worldwide.

Actavis says the U.S. Federal Circuit Court of Appeals has issued a temporary injunction to prevent Actavis from further distribution of its generic version of Pulmicort Respules (budesonide inhalation suspension) 0.25, 0.5 mg, indicated to control and prevent asthma symptoms in children ages 12 months to 8 years, pending its consideration of AstraZeneca’s request for an injunction pending appeal.

The International AIDS Vaccine Initiative has received a grant of $350,000 from GSK to support implementation of the Human Vaccines Project, a public-private partnership designed to addres some of the key scientific challenges in vaccine development across diseases.

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