Five things for pharma marketers to know: Friday, September 26
The US government will fund an expansive research effort to find nondrug options for treating chronic pain in military personnel, the Wall Street Journal reported Thursday. In 13 research projects, investigators will evaluate the use of alternative treatments for conditions like post-traumatic stress disorder, traumatic brain injury, drug abuse and sleep problems. These studies will be funded with $22 million from the NIH's National Center for Complementary and Alternative Medicine, the VA and the National Institute on Drug Abuse. A recent JAMA study says chronic pain affects 44% of the military after combat.
Gilead's HCV combination of Sovaldi (sofosbuvir) and ledipasvir has received a positive opinion from the EU's Committee for Medicinal Products for Human Use, the drugmaker announced Friday. The European Commision will now review the drug, which has the authority to approve the drug for use in the 28 countries of the EU. The combination drug will be known as Harvoni in the EU.
Actavis will keep its Alzheimer's treatment Namenda IR on the market another 60 days after reaching an agreement with New York's Attorney General Eric Schneiderman—Reuters reported Thursday. An antitrust lawsuit was filed against Actavis and its subsidiary Forest Laboratories, which accused the duo of planning to withdraw Namenda IR from the market in order to force US patients to switch to the company's newer formulation, Namenda XR.
There's still time to let FDA know how you feel about its latest proposed social media regulations. The US agency announced Friday it would reopen the comments section for its “Internet/Social Media Platforms with Character Space Limitations” draft guidance. The US regulator stated it was reopening the section “in response to a request for additional time and to allow interested persons more time to submit comments.”
Novartis announced late Thursday that its investigational antibody, secukinumab, a IL-17A inhibitor met its primary endpoints in two Phase-III trials for patients with psoriatic arthritis. The drug improved symptoms of psoriatic arthritis, improved peripheral joint disease and prevented joint damage versus placebo. Novartis plans to submit the drug to regulatory authorities in 2015. Secukinumab was already filed for an indication in moderate-to-severe plaque psoriasis in October 2013, with approvals anticipated in late 2014 or early 2015.