Several major health plans have recently enacted policies regarding coverage status for Remicade (infliximab) and its biosimilars, Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda). Most of these plans are limiting coverage for the biosimilar products to very specific circumstances. Some have also begun denying claims for biosimilars and instructing patients to switch to Remicade. The plans implementing…
Opioid Makers Paid Millions to Advocacy Groups
(Reuters)—Five opioid manufacturers, including OxyContin maker Purdue Pharma LP, have paid more than $10 million to advocacy groups and doctors tied to them, many of whom amplified industry messages supporting the use of the painkillers, a U.S. Senate report said on Monday.1 The report, released by Sen. Claire McCaskill (D-Mo.), says groups who received the…
FDA Receives Reports of Loperamide Abuse
The FDA is seeking to limit the number of loperamide doses per package due to reports of heart-related problems and death from the misuse and abuse of the treatment…
EU Approves Marketing for Ixekizumab in Adults with PsA
In its second indication in the EU, ixekizumab has been approved by the European Commission to treat adults with active psoriatic arthritis…
Upadacitinib Receives Breakthrough Designation, Abatacept Use Expands in Australia & More
The FDA has designated upadacitinib a breakthrough therapy to treat adults with moderate to severe atopic dermatitis…
U.S. Appeals Court Invalidates J&J Patent on Remicade
(Reuters)—A U.S. appeals court on Tuesday upheld a ruling that invalidated a crucial Johnson & Johnson patent on its blockbuster rheumatoid arthritis drug, Remicade (infliximab), limiting J&J’s ability to seek damages from Pfizer Inc. over its launch of a lower-cost version of the drug. The U.S. Circuit Court of Appeals for the Federal Circuit affirmed…
U.S. Lets More Healthcare Workers Prescribe Opioid Addiction Treatment
WASHINGTON (Reuters)—The U.S. Drug Enforcement Administration said on Tuesday it had changed a regulation to allow more healthcare professionals to prescribe a medication used to treat opioid addiction, opening up access in rural America where there are few doctors.1 Prior to 2000, only physicians could treat those with opioid addiction and had to register with…
EU Approves Certolizumab Pegol for Pregnant & Nursing Patients
In the EU, certolizumab pegol has been approved for use in pregnant and nursing women with chronic rheumatic disease…
Delaware Sues Opioid Manufacturers, Distributors Over Epidemic
(Reuters)—Delaware on Friday became the latest state to file a lawsuit accusing corporations of helping fuel the national opioid epidemic, suing a wide range of companies involved in making, distributing and selling prescription painkillers.1 The lawsuit, filed by Delaware Attorney General Matt Denn in a state court, targeted drugmakers Purdue Pharma LP and Endo International…
Kentucky Accuses McKesson of Helping Fuel the Opioid Epidemic
(Reuters)—Kentucky’s attorney general on Monday accused drug distributor McKesson Corp. of helping fuel the opioid epidemic by failing to halt shipments of suspiciously large or frequent orders by pharmacies of prescription painkillers. The complaint by Kentucky Attorney General Andy Beshear was filed in a state court and was one of a flurry of lawsuits by…
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