FDA Policy/General

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Sevion Therapeutics and Eloxx Pharmaceuticals, a clinical stage company developing therapeutics for genetic diseases caused by non-sense mutations, have agreed to an acquisition transaction. Under the agreement, Eloxx will become a wholly owned subsidiary of Sevion.

Bristol-Myers Squibb and Qiagen have entered into an agreement to explore using next-generation sequencing technology to develop gene expression profiles as predictive or prognostic tools for use with BMS’ novel immuno-oncology therapies in cancer treatment.

The Stago Group has completed the acquisition of HemoSonics, a company specialized in developing point-of-care testing solutions. The transaction gives Stago the patented SEER technology (Sonic Estimation of Elasticity via Resonance) and its associated Quantra Hemostasis Analyzer.

Inspyr Therapeutics and Lewis and Clark Pharmaceuticals have entered into an agreement to create an integrated company to develop a pipeline of novel therapeutics. Under the agreement, Inspyr will purchase Lewis and Clark in an all-stock transaction. Inspyr will become an integrated biopharmaceutical company focused on advancing a broad pipeline of novel therapies to treat cancer, inflammation, and other serious diseases. Inspyr’s lead product candidate Mipsagargin, a novel prodrug therapeutic for cancer, is being developed initially for hepatocellular carcinoma.

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