FDA Policy/General

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QT Vascular has submitted an investigational device exemption to FDA to begin the pivotal study of Chocolate Touch, its drug-coated balloon, in the U.S. The company says the balloon has a unique nitinol constraining structure that cause it to open in a controlled uniform fashion compared to conventional PTA balloons.

BD (Becton, Dickinson and Co.) will collaborate with Sight Diagnostics Ltd. to introduce the Parasight Malaria Detection Platform in India. The companies says the platform uses computer vision technology to analyze blood samples for malarial parasites.

Allergan broke ground on a $200 million expansion of its Waco, TX facility to add 322,000 square feet of manufacturing space to the current facility. According to the company, the expansion will upgrade its manufacturing capabilities and capacity by adding a new raw material dispensary, an automated bulk formulation suite and ten new state-of-the-art production lines and warehousing space.

Lannett Company plans to co-develop a generic insulin pharmaceutical product for the U.S. market with Chinese partner YiChang HEC ChangJiang Pharmaceutical. Lannett says it will be responsible for clinical and regulatory steps for the product, currently in late stage development, so that I can be submitted to FDA.

AbbVie and CytomX Therapeutics have entered into a collaboration to co-develop and co-commercialize Probody drug conjugates against CD71 or transferrin receptor 1, which is highly expressed in a number of solid and hematologic cancers and has attractive molecular properties for efficient delivery of cytotoxic payloads to tumor cells. The companies says Probody therapeutics are designed to enhance the tumor-targeting features of an antibody and reduce drug activity in healthy tissues.

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