On the basis of data from multiple clinical trials, the FDA has approved certolizumab pegol for treating moderate to severe plaque psoriasis…
Lilly’s Lupus Treatment Succeeds in Mid-Stage Trial
(Reuters)—Eli Lilly & Co said its drug to treat autoimmune disease lupus met the main goal of a mid-stage trial, positioning the drugmaker to begin a bigger study later this year. The data come two weeks after U.S. health regulators approved the drug, baricitinib, under the trade name Olumiant, with a far more restrictive label…
AbbVie’s RA Drug Succeeds in Late Stage Study
(Reuters)—Abbvie Inc. says its experimental drug met the main goal of halting progression of moderate to severe rheumatoid arthritis (RA) in a late-stage trial. The drug, upadacitinib, was tested as a monotherapy in patients who have not been treated with chemotherapy agent methotrexate. Upadacitinib, which belongs to a class of drugs known as JAK inhibitors,…
FDA Approves Denosumab for Glucocorticoid-Induced Osteoporosis
Denosumab is now approved to treat adults with glucocorticoid-induced osteoporosis…
FDA Updates Ixekizumab Label to Include Genital Area Psoriasis
Ixekizumab is the first agent approved by the FDA for treating plaque psoriasis to include labeling for psoriasis in the genital area…
FDA Clears Pfizer’s Xeljanz for Inflammatory Bowel Disease
(Reuters)—The U.S. Food and Drug Administration said on Wednesday that it had approved Pfizer Inc’s drug, Xeljanz, to treat adults with moderate-to-severe active ulcerative colitis. The effectiveness of Xeljanz (tofacitinib) in treating ulcerative colitis was shown in three controlled clinical trials, including two trials that showed the drug caused disease remission in about 17-18 percent…
Trump Says Drug Companies to Announce “Massive” Price Cuts Soon
WASHINGTON (Reuters)—President Donald Trump on Wednesday said he expects major drug companies to slash prices on their products in two weeks, but did not provide details on which companies would do so or how such reductions would be made. Health care lobbyists in Washington said they were caught by surprise and had no idea what…
Gap in Regulating Biotech Drug Copies Prompts WHO to Step In
LONDON (Reuters)—Cut-price copies of expensive biotech drugs promise to slash the cost of treating serious diseases, including cancer, in rich and poor countries alike -but uneven regulation has created a lopsided market. Now the World Health Organization (WHO) is stepping in to assess the quality of such so-called biosimilars, offering a global stamp of approval…
Recro Pharma’s Non-Opioid Pain Shot Fails to Get Approval from FDA
(Reuters)—Recro Pharma’s IV meloxicam, a non-opioid injection, did not get approval from the U.S. Food and Drug Administration because the agency said the drug’s pain-relieving effect did not meet its expectations. The company said it plans to meet with the FDA to find solutions. Unlike the drug’s oral version, which has been on the market…
Novartis Receives EU Approval for Infliximab Biosimilar Zessly
ZURICH (Reuters)—Novartis said its Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases. Zessly is approved for use in all indications of the reference medicine including rheumatoid arthritis, adult and pediatric Crohn’s disease, adult and pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis,…
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