FDA Policy/General

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Patricia Industries has acquired Toronto, Canada-based medical device company Laborie from Audax Private Equity. Laborie develops technology for the diagnosis and treatment of urologic and gastrointestinal disorders. Its sales were $117 million in fiscal year 2018.

Pfizer has agreed to buy San Francisco biotech Medivation for about $14 billion. The company’s prostate cancer drug Xtandi, generates about $2 billion in annual sales and has the potential to more than double, according to analysts.

Regeneron Pharmaceuticals says it will manufacture and study two antibody therapies identified by its VelociGene and VelocImmune technologies, for preventing and treating Middle East respiratory syndrome under an up-to-$8.9 million agreement with HHS’ U.S. Biomedical Advanced Research and Development Authority (BARDA). BARDA agreed to provide the funding to support packaging and labeling of the antibodies for human use, the preparation and submission of an IND application with FDA, and a National Institutes of Health-conducted clinical trial in healthy volunteers, according the company.

Amgen is reporting positive top-line results from a primary analysis of its Phase 3 study evaluating the safety and efficacy of Prolia (denosumab) compared with risedronate in patients receiving glucocorticoid treatment. According to the company, the study met all primary and secondary endpoints at 12 months and the data showed that treatment with Prolia for 12 months, compared to risedronate, led to significantly greater gains in bone mineral density at the lumbar spine and total hip, both in patients receiving continuing glucocorticoid therapy and in patients initiating glucocorticoid therapy.

Exalenz Bioscience will collaborate with Conatus Pharmaceuticals to use the BreathID Methacetin Breath Test to monitor patients in a Phase 2b clinical trial evaluating emricasan, Conatus’ investigational treatment for patients with chronic liver disease. According to the companies, the ENCORE-PH multicenter trial is expected to begin this year and is designed to evaluate the safety and efficacy of emricasan in patients with liver cirrhosis associated with nonalcoholic steatohepatitis and severe portal hypertension.

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