(Reuters)—Canadian drug maker Valeant Pharmaceuticals International Inc. said it had priced its recently approved plaque psoriasis treatment at $3,500 per month, ahead of an expected U.S. launch in the second half of 2017. Brodalumab (Siliq) is the lowest priced injectable biologic psoriasis treatment currently on the market, Valeant says. Drugmakers are facing intense criticism from…
Search results for: Valeant Pharmaceuticals
FDA Approves Valeant’s Drug to Treat Plaque Psoriasis
(Reuters)—The U.S. Food and Drug Administration has approved Valeant Pharmaceuticals International Inc.’s brodalumab (Siliq) to treat adults with moderate to severe plaque psoriasis. Brodalumab is administered as an injection. Brodalumab is intended for patients who are candidates for systemic therapy or phototherapy and have failed to respond, or have stopped responding to other systemic therapies,…
U.S. FDA Panel Backs Valeant Psoriasis Drug with Risk Program
(Reuters)—Valeant Pharmaceuticals International Inc.’s experimental drug to treat psoriasis should be approved as long as certain measures are put in place to mitigate the risk of suicide, an advisory committee to the U.S. Food and Drug Administration concluded on Tuesday. The FDA is not obliged to follow the advice of its advisory committees but typically…
Valeant Psoriasis Drug’s Suicide Risk Hard to Assess, Say FDA Staff
(Reuters)—Valeant Pharmaceuticals International Inc.’s experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said on Friday. The review comes two days ahead of a meeting of outside experts who will advise the FDA on…
Newly Released Documents Show Profit-Seeking Behind Price Hikes at Turing, Valeant
WASHINGTON/NEW YORK (Reuters)—A decision by Turing Pharmaceuticals to raise the price of a lifesaving drug by 5,000% drove up some patient co-pays to as high as $16,000, according to excerpts of documents that congressional committee members released on Tuesday. The excerpts, which are highlighted in memos released by Democrats on the powerful U.S. House of…
Valeant Hires Attorney, Crisis Management Firm as U.S. Scrutiny Mounts
WASHINGTON/NEW YORK (Reuters)—Pharmaceuticals firm Valeant, under mounting pressure from Congress and prosecutors over its drug pricing, has hired an attorney in Washington, D.C., and crisis public relations experts with political connections, according to sources familiar with the matter. The move, confirmed by sources and through documents viewed by Reuters, signals a shift for Valeant Pharmaceuticals,…
FDA Approves Combination Therapy for OA Pain, but Not Duobrii Lotion for Plaque Psoriasis
The FDA has approved a combination of amlodipine and celecoxib, which may lower serum creatinine, for treating osteoarthritis pain and hypertension…
Drug Industry Group Sues to Stop California Drug Price Law
(Reuters)—The trade group representing U.S. drugmakers on Friday said it has a filed a lawsuit to stop California from implementing a law aimed at reining in prescription drug prices. The Pharmaceutical Research and Manufacturers of America (PhRMA), in a statement, said it filed litigation in the U.S. District Court for the Eastern District of California…
Drug Industry on Tenterhooks as Maryland Price-Gouging Law Nears
(Reuters)—As U.S. consumer outrage grows over prescription drug prices, state authorities and patient advocates in Maryland are preparing to enforce the nation’s first law designed to punish drugmaker price-gouging. The Maryland Attorney General’s office said it will field complaints and investigate “unconscionable increases” in essential generic medicines when the closely watched law takes effect Oct….
As Drug Prices Drop, Generics Makers Fight Back with Deals
NEW YORK (Reuters)—Generic drug makers are turning to mergers and acquisitions to shield themselves against a concerted effort by U.S. regulators to crack down on steep drug prices. Impax Laboratories Inc, Perrigo Company Plc and Alvogen Inc have been talking to advisers about strategic options for their generics businesses, ranging from acquisitions to increase scale…