FDA Policy/General

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Luminex Corp. and Nanosphere have entered into a definitive agreement under which Luminex will acquire Nanosphere for $1.35 per share in an all cash transaction valued at about $58 million. Nanosphere says it will deliver proprietary diagnostic tools for detecting respiratory, gastroenteric and bloodstream infections.

Allergan and Gedeon Richter say their Phase 3 clinical safety and efficacy trial, Venus I, which is evaluating ulipristal acetate in women with uterine fibroids, met all co-primary and secondary endpoints with both ulipristal treatment arms achieving statistically significant results over placebo. The companies say the trial included 157 patients, of which 101 were randomized to receive ulipristal acetate 5 and 10 mg and 56 received placebo.

Pulmonary imaging specialist Vida Diagnostics expanded its collaboration with Olympus Respiratory America, a developer of devices for treating acute and chronic conditions of the lung and a subsidiary of Olympus Corporation. According to the companies, Vida and Olympus will incorporate precision informatics into current and future diagnostic and therapeutic procedural workflows to manage patients with pulmonary diseases. The collaboration is in North America and Europe and will include marketing and development programs in interventional pulmonology, the companies add.

Upsher-Smith Laboratories has begun the first clinical study of its novel small molecule CXCR4 antagonist USL311 in patients with advanced solid tumors alone and in combination with lomustine. The company says it has received orphan drug designation for USL311 from FDA for treating Glioblastoma Multiforme (GBM) and a planned second phase will be conducted in patients with relapsed/recurrent GBM.

Mundipharma Medical Company and Purdue Pharma say that they have taken over full responsibility from Laboratorios Esteve for the clinical, regulatory and commercial development of a potential first-in-class sigma-1 antagonist, after completing Phase 2 studies. According to the companies, MR309/E-52862 binds to sigma-1 in the brain and central nervous system and studies suggest that the novel mechanism of action of MR309/E-52862 will be complementary to those of other analgesic compounds.

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