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…
Japan PM’s Advisers Urge Annual Review of Drug Prices
TOKYO (Reuters)—Prime Minister Shinzo Abe’s economic advisers, hoping to curb Japan’s ballooning healthcare costs, proposed on Wednesday reforms to the way drug prices are set, a step opposed by foreign and domestic drug makers who say the changes will stifle investment. The proposals follow a decision to halve the price of Bristol Myers Squibb Co’s…
Celecoxib & Cardiovascular Death: NSAID Safety Under Review
A recent study showed that at moderate doses celecoxib may be noninferior with respect to cardiovascular safety compared with ibuprofen or naproxen…
Heparin Fails to Prevent Leg, Lung Clots After Arthroscopy, Casting
NEW YORK (Reuters Health)—Low-molecular-weight heparin failed to prevent symptomatic venous thromboemboli in people receiving knee arthroscopy or a lower leg cast, according to a pair of studies conducted in the Netherlands. The treatment is controversial because there is little clear evidence that heparin wards off clots in such instances. The research team, led by Dr. Raymond…
FDA Update on Rituximab & Etanercept; Plus New ACP Gout Guideline
The FDA is considering an application for subcutaneous rituximab and has approved an application for etanercept to treat pediatric patients with plaque psoriasis…
Teva Pharm to Market Medical Cannabis Inhaler in Israel
JERUSALEM (Reuters)—Israel’s Teva Pharmaceuticals has partnered with Tel Aviv-based Syqe Medical to market in Israel medical cannabis for pain management that is administered with an inhaler. The companies said in a statement on Monday that this is the first time the medical cannabis sector has complied with pharmaceutical standards for inhalation, which is the most…
Reinitiating TNF Blockers after Tuberculosis Treatment
A retrospective study showed that patients who have rheumatic disease and develop tuberculosis may be able to resume anti-TNF therapy and other biologic agents…
Transfer of Certolizumab in Breast Milk Not a Concern
NEW YORK (Reuters Health)—There is minimal to no transfer of the tumor necrosis factor (TNF) inhibitor certolizumab (Cimzia) from plasma to breast milk, according to a new study. “These findings are reassuring” and imply that continuing certolizumab treatment is compatible with breastfeeding, Dr. Megan Clowse of Duke University School of Medicine in Durham, North Carolina,…
TNF Inhibitor Tied to Lower Cardiovascular Risk in Psoriasis
NEW YORK (Reuters Health)—Psoriasis patients treated with tumor necrosis factor-alpha (TNF) inhibitors may have a lower risk of major cardiovascular (CV) events than those treated with methotrexate (MTX), according to a new study. “The findings do not surprise me. TNF inhibitors control inflammation better than methotrexate,” lead author Dr. Jashin J. Wu of Kaiser Permanente…
Update on Legislation, Notification Rules Concerning the Substitution of Interchangeable Biologic Drugs
Although the FDA has not yet awarded the title of interchangeable to any biosimilar, legislation that governs their substitution will continue to be a dominant state issue in 2017. Since 2013, 24 states and Puerto Rico have passed legislation regarding interchangeable biologics. As many as 15 states will have biosimilar-related legislation introduced by coalitions in…
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