The European Medicines Agency has removed a warning about possible suicidal risks that has been in place on Pfizer's smoking-cessation drug Chantix for the past seven years after an 8,144-patient study showed that the drug does not pose a higher risk of suicidal behaviors. A similar warning on GlaxoSmithKline's Zyban has not yet been changed by European regulators. The FDA said it is reviewing the study.
XenoPort will be acquired by Arbor Pharmaceuticals in a deal worth about $467 million, expanding the latter's product portfolio with the addition of XenoPort's treatments for moderate to severe primary restless legs syndrome. The transaction is expected to be completed in the third quarter of this year.
Venki Ramakrishnan, the president of the UK's Royal Society science body, said biotech crops should be evaluated on a case-by-case basis, and Europe's ban on them should be reconsidered. "With a growing world population -- with a projected need for 50% more food by 2050 -- I don't think we can afford to give up on useful technologies, especially to help poorer countries have a reliable and nutritious source of food," Ramakrishnan said.
Janssen secured conditional approval from the European Commission for Darzalex, or daratumumab, as a treatment for relapsed or refractory multiple myeloma in previously treated patients who experience disease progression. The decision was supported by data from five studies, including an analysis of two that showed patients treated with Darzalex had a median overall survival of 20 months and an overall response rate of 31%.
A follow-on offering has brought in $63 million for Coherus BioSciences. The firm is evaluating its Humira biosimilar, CHS-1420, as a treatment for psoriasis and rheumatoid arthritis in a late-stage trial.
BIO lauded the House of Representatives for passing the Fostering Innovation Act, which would allow emerging growth companies to focus resources on research and development by reforming regulations and extending the JOBS Act's Sarbanes-Oxley Section 404(b) exemption for five more years. "BIO strongly supports this move away from one-size-fits-all regulations, and applauds ... efforts to reduce compliance costs for emerging biotechs and support small business capital formation," BIO CEO and President Jim Greenwood said.
The European Medicines Agency's Committee for Orphan Medicinal Products recommended orphan-drug designation for Akari Therapeutics' Coversin, a second-generation complement inhibitor indicated for the treatment of Guillain-Barre syndrome. Animal studies demonstrated that the drug provided protection against the effects of the disease, Akari said.
The Department of Agriculture has allocated about $21 million to fund efforts to develop regional systems in bioenergy and biobased products and educate and train scientists. Agriculture Secretary Tom Vilsack said the funding "will have a direct impact on local economies now and set us up for a brighter, more innovative future."
The FDA has agreed to review Samsung Bioepis' biologics license application seeking authorization for its SB2 as a treatment for autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, Crohn's disease and psoriasis. The drug, which is a biosimilar version of Johnson & Johnson's Remicade, or infliximab, is being reviewed in Europe under the name Flixabi and is approved in Korea as Renflexis.
FDA staff reviewers raised questions about the effectiveness of Sanofi's type 2 diabetes drug iGlarLixi, a fixed combination of Lantus and lixisenatide, because their assessment found no clear evidence supporting the benefits of adding the lixisenatide component to Lantus. Sanofi is seeking authorization for lixisenatide monotherapy and the combination treatment, and an FDA advisory panel is scheduled to discuss both treatments Wednesday.
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