(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….
Search results for: Novartis
2 Biosimilars Make Their Way Toward the European Market
Two biosimilar treatments, Rixathon and Imraldi, are moving closer to market release in Europe for the treatment of rheumatic and other diseases…
FDA Responds to New Drug Application for Baricitinib
Oxycodone Tablets Submitted to FDA Filings for oxycodone tablets (Oxaydo) in both 10 and 15 mg doses have been accepted by the U.S. Food and Drug Administration (FDA).1 The submission is based on a pharmacokinetic study demonstrating bioequivalence to the reference drug, oxycodone hydrochloride (Roxicodone) tablets at a 15 mg dose. The product is an…
U.S. Supreme Court Speeds Copycat Biologic Drugs to Market
WASHINGTON (Reuters)—The U.S. Supreme Court on Monday cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling about an expensive class of medicines that can yield billions of dollars in sales for drug companies. The justices, in a 9–0 ruling, overturned a lower court…
FDA to Review Immediate-Release Oxycodone; Plus NICE Recommends Secukinumab
A new formulation of oxycodone in 10 and 15 mg doses is being reviewed by the FDA for treating pain…
U.S. Top Court Debates Making Copycat Biologics Available Sooner
WASHINGTON (Reuters)—U.S. Supreme Court justices on Wednesday struggled over whether to speed up the time it takes to bring to the market copycat versions of biologic drugs, expensive medicines that can generate billions of dollars in sales for drug makers. The nine justices heard arguments in an appeal by Novartis AG of a lower court…
Valeant Prices Psoriasis Treatment at $3,500 Per Month
(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…
Benefits of Secukinumab in Ankylosing Spondylitis May Persist at 2 Years
NEW YORK (Reuters Health)—Secukinumab appears to improve clinical and radiographic outcomes of ankylosing spondylitis (AS) through two years of therapy, according to new results from the MEASURE 1 study. Secukinumab is a fully human monoclonal antibody against interleukin-17A, which is implicated in various pathophysiological features of spondyloarthritis. In a report online Dec. 13 in the…
U.S. Supreme Court to Hear Dispute Over Biologic Drug Sales
NEW YORK (Reuters)—The U.S. Supreme Court on Friday agreed to hear a dispute over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval to begin selling them. The justices will take up an appeal by Novartis AG of a 2015 federal appeals court decision that prevented the…
U.S. Supreme Court Declines to Hear Biologic Drug Patent Fight
WASHINGTON (Reuters)—The U.S. Supreme Court on Monday declined to hear a case over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval before bringing them to the market. The justices opted not to take up Apotex Inc.’s appeal of a July federal appeals court ruling that could…
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