Good morning, everyone, and how are you today? We hope the weekend respite was refreshing and invigorating because that all-too-familiar routine of meetings, deadlines, and the like has quickly returned. You knew this would happen, though, yes? So to cope, we are, as always, indulging in numerous cups of stimulation and, of course, invite you to join us. While you do, here are some tidbits to digest, as well. Have a smashing day and do keep in touch …
Biogen is considering selling its hemophilia treatments, which generated nearly $500 million in sales last year, according to Reuters. The biotech has been restructuring its business since October and plans to focus on core therapeutic areas, such as neurology and autoimmune diseases. Biogen has two FDA-approved treatments for hemophilia.
The Senate Special Committee on Aging plans to bring contempt charges against Valeant Pharmaceuticals’s outgoing chief executive officer, Michael Pearson, for failing to appear for a deposition, STAT tells us. Pearson was subpoenaed as part of a probe into drug prices. But Pearson’s lawyer explained that he had “serious concerns” about requiring Pearson to give a deposition, because the committee staff never told him about the topics to be covered. Valeant, meanwhile, urged him to cooperate.
Alkermes may get a sales lift for Vivitrol, a $1,300-a-month shot that helps kill the high from painkillers and heroin, thanks to a White House push to improve access to addiction medicines through expanded Medicaid coverage and extra funding, Bloomberg News says. Unlike methadone, a widely used addiction treatments, Vivitrol is not a narcotic itself, which removes concerns about abuse.
Clovis stock took a hit on Friday after US Food and Drug Administration staffers questioned whether its lung cancer drug was superior to existing treatments and recommended a black box safety warning, Pharma Times says. “It’s ugly, but we think the drug could still get approved, though timing is up in the air and its competitive position may be severely damaged,” Mizuho Securities analyst Eric Criscuolo wrote in a note, Reuters tells us.
The FDA granted priority review to the Roche drug atezolizumab for treating people with locally advanced or metastatic non-small cell lung cancer, Reuters says.
The UK’s National Institute for Health and Care Excellence published draft recommendations rejecting a Celgene drug called Vidaza an option to treat acute myeloid leukemia in some patients, Pharma Times reports.
Pfizer faces more than 100 lawsuits in a federal court in San Francisco claiming that Viagra causes a cell mutation that could develop into melanoma, The National Law Journal writes.
GlaxoSmithKline is closer to facing competition for its Advair Diskus inhaler for treating COPD after the FDA accepted an application from Hikma Pharmaceuticals to sell a generic version, The Telegraph says.
Indian regulators have called for industry feedback on a proposal to replace gelatin in capsules with cellulose, according to InPharma Technologist.