FDA Policy/General

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Catalent Pharma Solutions has broken ground on a $34 million extension to its Madison, WI biologics manufacturing facility. When completed, the additional 22,000 square feet of space will accommodate two 2,000 liter single-use bioreactor systems, allowing the company to support late-phase clinical and commercial production of up to 4,000 liter batches. The new footprint will also support expansion of analytical and process development laboratories, as well as additional office space.

Verastem, Inc. and Infinity Pharmaceuticals have entered into a license agreement under which Verastem licensed exclusive worldwide rights to develop and commercialize Infinity’s oncology product candidate duvelisib, an oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma for treating hematologic cancers. Under the agreement, Verastem will pay Infinity up to $28 million in milestone payments.

Fresenius has acquired lung- and cardiac-focused medtech company Xenios from German venture capital group Zukunftsfonds Heilbronn for an undisclosed amount. Xenios was formed in 2013 after Novalung and Medos Medizintechnik were acquired by the group. Xenios develops and produces systems for lung and cardiac assistance, and employs more than 260 employees.

Boston Scientific has acquired the LumenR Tissue Retractor System from LumenR LLC, a privately held Newark, CA-based company. The device is currently in development for use during endoscopic resection of lesions in the colon, esophagus or stomach. It is designed to improve endoscopic sub-mucosal dissection and endoscopic mucosal resection procedures which are less invasive alternatives to conventional surgery for the removal of precancerous lesions and malignant tumors in the gastrointestinal tract.

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