ZURICH (Reuters)—Swiss drugmaker Novartis AG says it will test the malaria drug hydroxychloroquine (HCQ) in a randomized trial to see if the much talked about medicine is actually effective against COVID-19, the illness caused by the novel coronavirus. The company hopes to have data on its efficacy by June, a lead researcher for the trial…
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FDA Accelerates Approvals of Generic Versions of HCQ
On April 7, the FDA approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine Sulfate Tablets USP, 200 mg, for the treatment of: 1) uncomplicated malaria due to P. falciparum, P. malariae, P. ovale and P. vivax; 2) chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; and 3) treatment of acute and chronic…
FDA Update: New Drug Approvals, New & Expanded Indications, & More
ATLANTA—New drug approvals, new and expanded drug indications, and important safety and other updates relevant for rheumatologists were presented by three physicians from the U.S. Food & Drug Administration (FDA) on Nov. 11 at the 2019 ACR/ARP Annual Meeting. New JAK Inhibitor Approved for RA On Aug. 16, 2019, the FDA approved upadacitinib (Rinvoq), an…
FDA Rheumatology Update: New Drug Approvals, Plus Expanded Drug Indications & Safety Concerns
Last year, the FDA was busy with new biologic and other drug approvals, new and expanded drug indications, and important safety updates relevant to rheumatology…
Humira, Rituxan Top List of U.S. Drugs with Biggest Price Increases
NEW YORK (Reuters)—AbbVie Inc.’s rheumatoid arthritis drug Humira (adalimumab) and Roche Holding AG’s cancer drug Rituxan (rituximab) topped a list of seven treatments whose combined 2017 and 2018 price hikes accounted for a $5.1 billion increase in U.S. spending, a report released on Tuesday showed.1 The price hikes were more than twice the rate of…
Amgen Wins U.S. Patent Battle on Arthritis Drug Enbrel
(Reuters)—A U.S. judge on Friday upheld two patents relating to Amgen Inc,’s blockbuster rheumatoid arthritis drug Enbrel (etanercept), denying a challenge by Novartis AG, which is seeking to launch a biosimilar version. The decision was a relief to investors concerned about a competitive threat to Enbrel, which had U.S. sales of $4.8 billion last year….
U.S. Supreme Court Tosses Ruling Against Merck on Fosamax Osteoporosis Drug
WASHINGTON (Reuters)—On May 20, the U.S. Supreme Court threw out a lower court ruling that had revived hundreds of lawsuits accusing Merck & Co. of failing to properly warn patients of debilitating thigh-bone fractures as a result of taking its osteoporosis drug alendronic acid (Fosamax). The nine justices unanimously directed the Philadelphia-based 3rd U.S. Circuit…
Trump Slams Drugmakers, Vows to Let U.S. States Buy Cheaper Medicines Abroad
WASHINGTON (Reuters)—U.S. President Donald Trump slammed the pharmaceutical industry for high prices of prescription drugs on Thursday and vowed to allow U.S. states to buy medicines from other countries if they cost less. Trump, who campaigned on a platform to reduce drug prices for U.S. consumers, has taken few concrete steps to lower medication costs…
U.S. Supreme Court Rejects Allergan Bid to Use Tribe to Shield Drug Patents
WASHINGTON (Reuters)—The U.S. Supreme Court has cast aside pharmaceutical company Allergan Plc.’s unorthodox bid to shield patents from a federal administrative court’s review by transferring them to a Native American tribe. The justices left in place a lower court ruling upholding the authority of a U.S. Patent and Trademark Office tribunal to decide the validity…
Ohio Accuses UnitedHealth’s OptumRx of Drug Overcharges
(Reuters)—Ohio’s attorney general on Monday said he had filed a lawsuit against UnitedHealth Group Inc’s OptumRx unit, saying the pharmacy benefit manager had overcharged the state nearly $16 million for prescription drugs. Ohio Attorney General Dave Yost’s lawsuit followed a probe into the extent pharmacy benefit managers (PBMs) like OptumRx had engaged in pricing practices…
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