| Senate Investigates Amedisys The Senate Finance Committee is probing whether four home health-care companies boosted in-home therapy visits to trigger higher Medicare reimbursements. online.wsj.com |
Pharmacies Win California Ruling The California Supreme Court handed a legal victory to retail pharmacies that accuse drug makers of conspiring to set prices at artificially high levels. online.wsj.com |
Orexigen Steps Up Pace in Obesity Drug Race EP Vantage submits:The elimination of Vivus (VVUS) from the obesity-drug race has cleared the field for the two remaining competitors, and Orexigen Therapeutics (OREX) stepped-up the pace Thursday with the detailed publication of one of its three phase III trials of Contrave. But whilst investors saw it as good news for the California company and pushed shares up 9% in early trading, observers handicapping the field are still tipping Arena Pharmaceuticals (ARNA) as the favorite.The FDA advisory committee’s rejection of Vivus’ Qnexa centered on safety uncertainties, including the lack of long-term clinical data (Vivus sheds more weight after Adcom rejection of Qnexa, July 16, 2010). Of the two candidates left standing, only Arena’s lorcaserin has come to the FDA with two-year data and no significant safety signals; Contrave has just 56 weeks of safety data behind it and a major concern over blood pressure signals.Complete Story » seekingalpha.com |
Safety Concerns Weigh Heavily on Amag Pharma's Lead Product EP Vantage submits:Shares in Amag Pharmaceuticals (AMAG) have lost half their value since late July, driven to a four-year low on regulatory and safety news. The most dramatic fall came Tuesday from the company’s Monday announcement that it will not appear at an investor conference because of an upcoming FDA meeting over a cardiac safety signal in its lead product, Feraheme (ferumoxytol).For a product that took three tries to pass FDA muster, a new safety concern is a worrying sign, even more so after Amag was forced in February to respond to reports of hypersensitivity reactions; at the time the company noted the event rates were consistent with disclosures in the product labeling. This comes on top of looming changes to reimbursement at US kidney dialysis centers that may price Feraheme, an intravenous iron-replacement therapy for patients with chronic kidney disease (CKD), out of a key market.Complete Story » seekingalpha.com |
FDA to Revoke Knee-Device Approval The FDA said it planned to revoke a medical-device company's right to sell a knee implant called Menaflex after an unprecedented yearlong review concluded the agency erred in allowing it on the market. online.wsj.com |