Belviq Gains FDA Approval For Weight Loss, But DEA Review Will Delay Launch With a July 17 user fee date, Vivus' obesity drug Qnexa could beat Arena Pharmaceuticals' Belviq to the marketplace as lorcaserin awaits controlled substance scheduling by the Drug Enforcement Agency.
Flagship Ventures Dives Into Microbiome, Launches Seres Health Only a few biopharmaceutical start-ups have formed in the emerging microbiome space, but VC firm Flagship says its homegrown Seres Health, still somewhat stealthy, is developing a new category of drugs that aim to rebalance microbiome populations causing disease.
FDA's Social Media Guidance: As Industry Waits, How Watchful Should It Be? In the absence of clear policy from the agency, GSK keeps careful eyes on Facebook, but experts disagree on the extent to which drug companies are required to actively monitor social media sites.
Merck/AstraZeneca Stay Tied To Each Other For Another Two Years Merck and AstraZeneca continue a 30-year partnership after coming to terms that could benefit both companies.
NICE Clears Botox For Chronic Migraine, With Therapy "Stopping Rules" With rules in place about when to stop therapy, the U.K.'s National Institute for Health and Clinical Excellence clears Allergan's botulinum toxin, Botox for use as prophylaxis in patients with chronic migraine and who have tried other therapies.
European OTC Switch Still Muted By Regulatory Resistance OTC sales growth is stifled by the EU's "extremely restricted" switch evaluation process, says AESGP Director General Hubertus Cranz. But while prescription revenues shrink as governments tighten budgets, the OTC market is not hampered in this way.