Maryland’s Attorney General filed charges against Insys Therapeutics over alleged violations of the state’s Consumer Protection Act, saying the company joined local health care providers in an “unfair and deceptive…
In a new attempt to prod action by HHS to lower the price of the opioid-reversing drug naloxone, Sen. Claire McCaskill (D-Mo.) asked HHS Secretary Alex Azar what the department…
A Massachusetts court Wednesday ruled in favor of Janssen in a lawsuit that claimed the Johnson and Johnson subsidiary’s antipsychotic Risperdal (risperidone) caused excessive weight gain. Source: Drug Industry Daily
The Senate this week unanimously passed legislation that would forbid insurers and pharmacy benefit managers from imposing “gag clauses” on drug prices. Source: Drug Industry Daily
The FDA hit Indian injectable drugmaker Auronext Pharma over violations found during a February inspection of the company’s Bhiwadi, Rajasthan facility. Source: Drug Industry Daily
PhRMA released a new report Wednesday highlighting the role of U.S. hospitals in increasing drug costs, showing they mark up prices for patients by an average of nearly 500 percent.…
The FDA Wednesday released a new manual of policies and procedures (MAPP) outlining how it prioritizes manufacturing facilities for routine CGMP surveillance inspections. Source: Drug Industry Daily
The FDA issued new guidance for sponsors of drugs designed to treat hay fever as well as other cold-like symptoms that aren’t caused by allergies. In a pair of final…
Malaysian OTC drug manufacturer AmLion Toothpaste drew a 483 for numerous quality violations including inadequate cleaning procedures. Source: Drug Industry Daily
The FDA is on track to top its fiscal year 2017 record for generic approvals despite receiving fewer ANDA submissions, according to the agency’s latest generic drug activities report. Source:…