Simplifying Global Compliance
Drugmakers that face multiple disputes with doctors over payments reported to the Centers for Medicaid & Medicare Services (CMS) under the Physician Payment Sunshine Act will likely face an audit by the agency. Read More
Three years after placing heavy restrictions on GlaxoSmithKline’s type 2 diabetes drug Avandia, the FDA said Nov. 25 it is relaxing those restrictions in line with its advisers’ recommendations. Read More
Twenty-five drugmakers have agreed to pay the state of Louisiana more than $88 million to settle Medicaid and Medicare fraud charges lodged against them as part of the state’s continuing crusade to recover funds improperly paid out to drug companies. Read More
Amgen’s first long-term trial for its next-generation heart drug evolocumab has shown positive results, heating up the race to develop the emerging class of drugs known as PCSK9 inhibitors. Read More
Regulators in the U.S. and EU have paved the way for a new treatment approach to treat chronic hepatitis C, clearing highly anticipated new drugs from Gilead Sciences and Janssen/Medivir. Read More
Amgen is the latest drugmaker caught up in the FDA’s recent flurry of enforcement letters for false or misleading promotional materials. Read More
President Barack Obama Nov. 27 signed into law a bill that establishes both a nationwide track-and-trace requirement for prescription drugs and a system of voluntary FDA oversight of compounding pharmacies. Read More
Shortly after Duchesnay received FDA approval for its morning sickness drug Diclegis, the agency says the Canadian drugmaker sent a letter to customers touting the drug’s benefits but none of its risks. Read More
The FDA has handed Forest Laboratories and Gedeon Richter a complete response letter asking for more data on cariprazine, the companies’ drug candidate to treat schizophrenia and manic or mixed episodes of bipolar I disorder in adults. Read More
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