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 Asks Endo to Withdraw Opana ER Opioid
(Reuters)—The U.S. Food and Drug Administration said on Thursday it has asked Endo International to withdraw from the market its long-lasting opioid painkiller Opana ER, sending the company’s shares down as much as 13%. “After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer…
FDA Update: Romosozumab’s Uncertain Future; Plus Tocilizumab Approved for GCA
Due to possible heart-related side effects, romosozumab is no longer expected to be approved this year for the treatment of osteoporosis…
U.S. State, Local Government Lawsuits Over Opioids Face Uphill Battle
BOSTON (Reuters)—A growing number of U.S. states, counties and cities are filing lawsuits accusing drug companies of deceptively marketing opioid painkillers to downplay their addictiveness, but some lawyers say the industry’s highly regulated nature could pose a hurdle to their success. Ohio on Wednesday became the latest, and largest, state or local government to bring…
Pfizer Hikes U.S. Prices of 91 Drugs by Average 20% in 2017
(Reuters)—Pfizer Inc. has hiked the price of nearly a hundred drugs by an average of 20 percent so far this year in the U.S., the Financial Times reported on Friday. The U.S. drug maker raised the list price of 91 medicines—including that of its erectile dysfunction treatment, Viagra, and its pain drug, Lyrica—on June 1…
Ixekizumab Eases Psoriatic Arthritis when TNF Inhibitor Fails
NEW YORK (Reuters Health)—The selective interleukin-17A inhibitor ixekizumab improved signs and symptoms of active psoriatic arthritis (PsA) in patients who had failed prior biologic therapy in the phase 3 SPIRIT-P2 trial. The SPIRIT-P2 trial joins the earlier phase 3 SPIRIT-P1 trial, which showed that ixekizumab was safe and effective in PsA patients not previously treated…
NSAIDs Increase MI Risk; Plus New Label Warnings for Canagliflozin
NSAIDs Increase Myocardial Infarction Risk According a recent meta-analysis of real-world non-steroidal anti-inflammatory drug (NSAID) use, NSAIDs may increase the risk of acute myocardial infarction (AMI). The analysis used individual patient data meta-analysis of studies from healthcare databases in Canada, Finland and the U.K. to determine the time course for risk of AMI, as well…
U.K. Competition Watchdog Accuses Merck of Obstructing Biosimilars
LONDON (Reuters)—Britain’s competition watchdog has accused Merck & Co of operating an unfair discount scheme for its medicine Remicade (infliximab) that it said was designed to restrict competition from so-called biosimilar copies. The Competition and Markets Authority (CMA) says it had provisionally found the U.S. company’s European unit, Merck Sharp & Dohme (MSD), had abused…
Heart Safety Clouds Hopes for Amgen, UCB Bone Drug Approval
(Reuters)—Amgen Inc. and UCB SA no longer expect their experimental osteoporosis drug to win U.S. approval this year after a higher rate of serious heart-related side effects were observed in a late-stage clinical trial. The drug, romosozumab, which would be sold under the brand name Evenity if approved, is awaiting an approval decision by the…
Infliximab-abda Becomes 5th Biosimilar Approved in the U.S. & Abaloparatide Approved for Osteoporosis
The FDA has approved infliximab-abda, a biosimilar for treating multiple rheumatic diseases, as well as abaloparatide for treating postmenopausal women with osteoporosis…
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