Brodalumab Approved for Plaque Psoriasis The U.S. Food and Drug Administration has approved brodalumab, a monoclonal antibody that targets interleukin 17 (IL‑17).1,2 Brodalumab (Siliq) was approved for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed to respond to, or have lost response to, other…
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Brodalumab Approved for Plaque Psoriasis
Brodalumab has received FDA approval for treating plaque psoriasis in adults, with a Boxed Warning against prescribing it for patients with a history of suicidal thoughts or behavior…
FDA Update: Committees Recommend Approvals for Abuse-Deterrent Opioid & Brodalumab
FDA advisory committees recommend the approvals of the abuse-deterrent opioid morphine sulfate for pain and brodalumab for plaque psoriasis…
U.S. Probes Contracts Between Drugmakers, Pharmacy Benefit Managers
(Reuters)—The U.S. Attorney’s Office for the Southern District of New York is investigating contracts between drugmakers and companies that manage prescription benefits, according to regulatory filings. Federal prosecutors have approached at least three companies, including Johnson & Johnson, Merck & Co. and Endo International Plc., demanding information about their contracts with pharmacy benefit managers. Pharmacy…
Etanercept Biosimilar Approved in EU, Plus FDA Reviews Brodalumab for Plaque Psoriasis
An etanercept biosimilar referencing Enbrel and designed to treat multiple autoimmune diseases has been approved for the European market. Also, an application for subcutaneous brodalumab to treat plaque psoriasis has been submitted to the FDA…
Major Drugmakers Push Back in U.S. Price Debate
SAN FRANCISCO (Reuters)—With a backlash brewing over the price of medicines in the U.S., drugmakers are pushing back with a new message: Most people don’t pay retail. Top executives from Eli Lilly and Co, Merck & Co and Biogen Inc. said in interviews with Reuters this week that the media focus on retail, or “list…
Novartis to Pay $390 Million in U.S. Settlement over Pharmacy Kickbacks
WASHINGTON (Reuters)—Novartis Pharmaceuticals Corp. will pay $390 million to settle U.S. charges that it paid specialty pharmacies illegal kickbacks in exchange for inducing patients to refill certain medications, according to an accord announced Friday. The settlement between a U.S. unit of Swiss drugmaker Novartis AG, the federal government and more than 40 states concerns payments…
Obama Nominee to Lead FDA Defends Drug Industry Ties
(Reuters)—President Barack Obama’s nominee to head the U.S. Food and Drug Administration defended his ties to the pharmaceutical industry on Tuesday during a Senate committee hearing that included questions on soaring drug prices. Presidential candidate Bernie Sanders was among the Democrats who grilled Dr. Robert Califf (64), who joined the FDA in January as a…
U.S. Drug Benefit Managers Clamp Down on Specialty Pharmacies
NEW YORK/LOS ANGELES (Reuters)—In recent days, the largest U.S. managers of private prescription drug benefits have cut off at least eight pharmacies that work closely with drugmakers, intensifying scrutiny of a system that helps inflate drug prices, officials at the benefit managers told Reuters. The terminations come from payers who together manage drug benefits for…
XenoPort’s Psoriasis Drug Found Effective in Phase 2 Trial
(Reuters)—Drug developer XenoPort Inc. said on Tuesday its experimental drug was effective in treating psoriasis, sending its shares up 19% in premarket trading. The oral drug met the main goal in a phase 2 trial of patients with moderate-to-severe chronic plaque-type psoriasis, the company said. XenoPort said it expected to start late-stage trials next year…