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U.S. FDA accepts application for Indivior’s new schizophrenia drug

The FDA accepted Indivior’s application for its new once-monthly injectable schizophrenia treatment.

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Opioid crisis cost U.S. $504 billion in 2015

Opioid drug abuse cost the U.S. economy as much as $504 billion in 2015, White House economists said in a report.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse

“As we continue to confront the staggering human and economic toll created by opioid abuse and addiction, we’re focused on taking actions that reduce the scope of new addiction by decreasing unnecessary exposure to opioids. …”

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FDA warns against using kratom for opioid addiction

The U.S. Food and Drug Administration warned about the usage of kratom, citing reports of 36 deaths, and said there is no reliable evidence to support its use to treat opioid withdrawal symptoms.

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Investor group presses U.S. drug companies on opioid controls

U.S. shareholder activists are addressing a soaring death toll from opioid drug abuse, asking companies that make and distribute the painkillers to review the risks their businesses could face from their role in the sector.

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New Mexico sues opioid drug manufacturers, distributors

New Mexico sued eight opioid manufacturers and wholesale distributors, becoming the latest state or local government to file a lawsuit seeking to hold corporations accountable for a national drug addiction epidemic.

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Daiichi Sankyo Terminates $650 Million Deal With Charleston Laboratories

After three years Daiichi Sankyo called it quits regarding the company’s partnership with Charleston Laboratories and took a loss of about $250 million.

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Anthem Reaches Goal Two Years Early for Health Plans to Reduce Opioids Filled at Pharmacy by 30 Percent

Anthem Inc. is committed to supporting policy changes that help reduce, prevent and deter opioid use disorder, as well as those that help consumers better access treatment. As part of that commitment, its affiliated health plans just reached the company’s collective goal of reducing prescribed opioids filled at pharmacies by 30 percent during the past five years.

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Insys agrees to resolve Illinois opioid lawsuit

Insys Therapeutics Inc. agreed to pay $4.45 million to resolve a lawsuit by Illinois’ attorney general claiming it deceptively marketed an addictive fentanyl-based cancer pain drug for off-label uses.

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As Congress struggles with healthcare reform, Gottlieb’s FDA is taking action

While the nation’s media was focusing on the unsuccessful attempts by Republicans to pass a successor to Obamacare, a fascinating sideshow has developed in nearby White Oak, Maryland, home of the Food and Drug Administration.

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