The launch of Sandoz’s Neupogen biosimilar has been temporarily halted. The US Court of Appeals for the Federal Circuit implemented a temporary injunction, reported BioCentury. Amgen, which makes Neupogen, said Sandoz’s biosimilar Zarxio would trigger price erosion that would cause irreparable harm. The FDA approved Zarxio in March. It is the first FDA-approved biosimilar.
GlaxoSmithKline told investors that a generic Advair may challenge the drug’s sales in the US. Analysts told Bloomberg Business that this is the first time the drugmaker has acknowledged that a generic version of Advair could launch. GSK had previously said the inhaler’s complexity makes it resistant to generic competition. Bloomberg said generic Advair is already available in Europe.
The majority of Gilead Sciences’ shareholders voted against creating an annual pricing report that would show the risks associated with product pricing, reported the San Francisco Business Times. The 18% of shareholders who voted for the publication were from the UAW Retiree Medical Benefits Trust of Ann Arbor, Mich. The Securities and Exchange Commission said in March that Gilead had to allow the vote to proceed.
Johnson & Johnson will create an independent panel to review patient requests for unapproved medications. Bioethicist Arthur Caplan will manage the panel, which will consist of doctors, ethicists and patient advocates, reported The New York Times. J&J will fund the panel but will not influence its decisions. The panel will address requests made by seriously ill patients who are not clinical trial participants. The Wall Street Journal explained that although such compassionate use requires FDA approval, drug companies have the final say on whether to provide experimental medications.
An FDA advisory committee is scheduled to vote June 4 whether to endorse or reject Sprout Pharmaceuticals’ drug for hypoactive sexual desire disorder. The drug, flibanserin, is a daily medication intended for premenopausal women. If approved, it would be the first FDA-approved drug for female sexual dysfunction. Sprout resubmitted the drug to the FDA in February after receiving a complete response letter from the agency in 2013 in which the regulator asked Sprout to submit Phase-I trials that showed how flibanserin interacted with other drugs and to assess possible driving impairment.