New Drug

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 the family that owned Purdue Pharma, the Sacklers, broad protection from current and future litigation, despite objections from nine states and a branch of the Justice Department.
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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 it helps osteoarthritis patients, it says there are critical safety risks that may cost the partners a straight shot on goal.

The main safety worry is so-called rapidly progressing osteoarthritis, or RPOA, which the companies are aware of. They are looking to run the drug under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) to try to keep a close eye on this issue.

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 brace.

But the hospital never sent her bills to Medicaid, which would have paid for the care in full, and the hospital refused requests to do so.
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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 company has since issued a voluntary recall for all capsules suspected to be contaminated.

(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 also used to provide temporary blood circulatory support to patients for up to 30 days.

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Abstract

Background

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 death. Risk ratios and risk differences were pooled with a random effects model.

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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 form of sufentanil, a potent painkiller commonly used after surgery.

Congress could send its sweeping opioids' package to President Trump by week's end after lawmakers reached an agreement late Tuesday night on a final bill to address the nation's public health crisis.

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.

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 request of the U.S. Food and Drug Administration.
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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.