A clinical trial in RA patients has established the pharmacokinetic similarity of ABP 798 and rituximab…
Ibuprofen an Option for Early Pain Control after Hip Replacement
NEW YORK (Reuters Health)—Combining paracetamol (acetaminophen) with ibuprofen does not cut postoperative use of morphine in a clinically meaningful way relative to ibuprofen alone, in patients undergoing total hip arthroplasty (THA), results of a Danish randomized trial suggest. “Although the combined use of paracetamol and ibuprofen reduced immediate postoperative morphine consumption compared with paracetamol alone…
Quinacrine Shortage & What the ACR Is Doing about It
The FDA recently conducted an inspection of the only manufacturer that had FDA approval to import quinacrine. Unfortunately, the manufacturer did not pass inspection and was put on an import alert. This effectively shuts down any importation of quinacrine to the U.S. until the manufacturer goes through the necessary steps to be re-inspected or until…
U.S. Government Proposes Rule Overhauling Drug Industry Rebate System
NEW YORK (Reuters)—The U.S. government proposed a rule to end the industry-wide system of after-market discounts called rebates that pharmacy benefit managers receive from drugmakers, a practice that has been under scrutiny. If finalized, the rule would change a system that has been in place for decades and that increasingly has been criticized for obfuscating…
U.S. Senate Finance Committee Invites Pharma Execs to Testify
WASHINGTON (Reuters)—A powerful U.S. Senate committee on has invited seven pharmaceutical companies to testify at a hearing later this month examining rising prescription drug prices. Sen. Chuck Grassley (R-IA), chairman of the Senate Finance Committee, and Sen. Ron Wyden (D-Ore.), ranking member of the committee, invited executives from AbbVie Inc., AstraZeneca PLC, Bristol-Myers Squibb Co.,…
Canada Approves Erelzi for PsA; Plus FDA Moves to Increase Access to Naloxone
Health Canada has approved Erelzi, which is biosimilar to Enbrel (etanercept), for treating psoriatic arthritis in adults…
FDA Advisory Committee Votes in Favor of Romosozumab Approval
An FDA advisory committee voted 18-1 in favor of approving romosozumab to treat postmenopausal women with osteoporosis.
Not-for-Profit to Offer 20 Generic Drugs in 2019 to Alleviate Shortages
(Reuters)—A new not-for-profit supplier of generic drugs formed by a consortium of hospitals systems said it expects this year to be able to provide about 20 products to alleviate shortages of medicines used during surgeries and to treat life-threatening conditions, such as septic shock. Since the start-up of Civica Rx spearheaded by Intermountain Healthcare was…
FDA Update: Priority Review for Non-Opioid Treatment & New Warning for Fluoroquinolones
The FDA has granted priority review to a non-opioid, postoperative pain treatment, HTX-011…
The Eliminating Kickbacks in Recovery Act of 2018—What Does It Mean?
It should not be a surprise to anyone that the U.S. is facing a national opioid crisis. It may be a surprise, however, that the federal government recently passed a law to address this crisis—a law that may have a profound impact on many healthcare facilities, some of which are not involved in the substance…
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