FDA Policy/General

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Helsinn and MEI Pharma have entered into a licensing, development and commercialization agreement for pracinostat, a Phase 3-ready drug candidate for treating acute myeloid leukemia and other potential indications. Under the agreement, Helsinn will get exclusive worldwide rights, including manufacturing and commercialization rights, and will be responsible for funding the product’s global development. MEI Pharma will receive near-term payments of $20 million, and will be eligible to receive up to $444 million in potential development, regulatory and sales-based milestone payments. As part of the development and commercialization agreement, the companies will also collaborate to explore an optimal dosing regimen of pracinostat in combination with azacitidine for treating high-risk myelodysplastic syndrome.

Cambridge, MA-based Radius Health says new results published last month in JAMA from its late-stage trial in women with osteoporosis showed that 2,463 female osteoporosis patients in the ACTIVE Phase 3 trial, when treated with a daily injection of abaloparatide for 18 months, had a significantly greater reduction in the incidence of new vertebral fractures when compared to placebo. The company says the reduction was less strong on nonvertebral fractures when compared to placebo, however it had a P value of 0.049.

Regeneron Pharmaceuticals signed an agreement with the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services (HHS) to manufacture and study two antibody therapies for the potential prevention and treatment of Middle East Respiratory Syndrome. The company says HHS will provide funding to Regeneron of up to $8.9 million to support packaging and labeling of the antibodies for human use, the preparation and submission of an IND application with FDA.

Lycera Corp. has initiated a Phase 2 clinical trial of its clinical-stage candidate, LYC-30937-enteric coated, in patients with ulcerative colitis. The company says the UPSTART study is expected to enroll up to 120 patients and will evaluate the efficacy and safety of LYC-30937-EC given orally once daily in subjects with active ulcerative colitis.

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