Drugs

Helsinn, MEI Pharma Agree to Develop Leukemia Drug

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 (AML) 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.

Pracinostat is an oral histone deacetylase inhibitor. FDA recently granted a breakthrough therapy designation for pracinostat in combination with azacitidine for treating patients with newly diagnosed AML who are 75 years of age or older or unfit for intensive chemotherapy. The designation was supported by data from a Phase 2 study which showed a median overall survival of 19.1 months and a complete response rate of 42%, the company says.

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