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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’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
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
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
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
The FDA is seeking input on the effectiveness of risk evaluation and mitigation strategy (REMS) programs as it weighs whether new methods of communicating drug risks in REMS are needed. Read More
The FDA is investigating reports that emergency contraceptives such as Teva’s Plan B One-Step lose effectiveness in women over 165 lbs. and don’t work at all for women over 175 lbs. Based on its review, labeling changes for the drugs may be forthcoming. Read More
The EMA has put Boehringer Ingelheim's hepatitis C drug candidate faldaprevir on a speedy review pathway based on studies involving 3,300 patients. Read More
Three years after placing heavy restrictions on GlaxoSmithKline’s type 2 diabetes drug Avandia, the FDA said Monday it is relaxing those restrictions in line with its advisers’ recommendations. Read More
Drugmakers have 14 additional calendar days to comment on recently revised GDUFA question-and-answer guidance after technical difficulties prevented stakeholders from submitting comments on Regulations.gov. Read More
Finalized guidance on preclinical considerations for gene and cellular therapies, posted Monday, reiterates the agency’s position that sponsors should focus on five objectives in preclinical trials. Read More