Bankruptcy judge approves Purdue Pharma plan to resolve opioid claims, giving Sackler family civil immunity
More than two decades after Purdue Pharma launched its blockbuster pain pill OxyContin, a judge approved a bankruptcy plan Wednesday that will grant the drugmaker’s billionaire owners sweeping legal immunity in the opioid epidemic.
Negotiated until the 11th hour, the final terms of the settlement confirmed by U.S. Bankruptcy Court Judge Robert D. Drain grant...
Pfizer-Eli Lilly’s anti-NGF osteoarthritis drug works, but FDA says safety risks ‘remained concerning’
Pfizer and Eli Lilly’s long journey to a potential FDA approval for tanezumab still looked rocky today after review documents from the regulator cast doubt over its safety.
Ahead of an outside expert committee meeting midweek, the FDA as always released its thoughts and discussion points on the drug, and, while finding strong evidence that...
How Rich Hospitals Profit From Patients in Car Crashes
When Monica Smith was badly hurt in a car accident, she assumed Medicaid would cover the medical bills. Ms. Smith, 45, made sure to show her insurance card after an ambulance took her to Parkview Regional Medical Center in Fort Wayne, Ind. She spent three days in the hospital and weeks in a neck...
Mylan Issues Nationwide Recall for Contaminated Ulcer Medication
Mylan (NASDAQ:MYL) announced today that its American-based business issued a voluntary nationwide recall for its ulcer medication after discovering trace amounts of carcinogens in some of its old batches. Three different lots of nizatidine capsules, including both the 150mg and 300mg dose variants, were found to contain small amounts of N-Nitrosodimethylamine (NDMA), and the...
FDA classifies Abbott’s blood pumping system recall as most serious
(Reuters) - The U.S. Food and Drug Administration on Monday classified the recall of Abbott Laboratories’ CentriMag blood pumping system following the death of a patient, as Class 1 or the most serious type of recall.
The CentriMag System pumps blood through a patient for up to six hours during open heart procedures and is...
Risk of Death Following Application of Paclitaxel‐Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials
Methods and Results
A systematic review and meta‐analysis of RCTs investigating paclitaxel‐coated devices in the femoral and/or popliteal arteries was performed. The primary safety measure was all‐cause patient...
FDA set to approve potent opioid for market despite adviser’s objections
The Food and Drug Administration is poised to approve a new form of a powerful opioid for use in hospitals and emergency rooms despite opposition from the head of the committee that reviewed the drug.
The FDA is scheduled to decide by Nov. 3 whether to allow a California company to produce a 30-microgram pill...
California sues maker of Humira, says sales of blockbuster drug boosted through deceptive practices
AbbVie's signature drug Humira is used to treat a variety of autoimmune diseases, including arthritis and psoriasis. (David J. Phillip / Associated Press)
California’s insurance regulator has accused pharmaceutical giant AbbVie of using kickbacks and other illegal practices to boost sales of Humira, one of the best-selling prescription drugs in the world.
Insurance Commissioner Dave Jones...
DOJ files complaint for FDA against seafood processor with listeria issues
The United States filed a civil complaint against Long Island City, NY-based Foo Yuan Food Products Company Inc., its owner and president Hsing Chang, and its secretary Susan Chang, to stop them from preparing and distributing adulterated seafood products in violation of federal law.
The Department of Justice filed the complaint at the...
FDA says reviewing Acadia’s Parkinson’s medication, shares fall
WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Wednesday it was reviewing Acadia Pharmaceuticals’ Parkinson’s medication, the only approved drug used to treat hallucinations and delusions associated with the disease.
CNN first reported that FDA was re-examining the safety of Acadia’s Nuplazid, which was approved by the agency even though there were...
