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To spur greater mutual inspection reliance between the FDA and EU, the agency and Congress are working to grant the EMA access to unredacted inspection reports. Read More
FDA reviewers will revisit Merck’s anesthesia drug sugammadex this week in its fourth review attempt, taking on safety concerns that originally tripped up the candidate in 2008. Read More
Paratek Wins Fast Track for Omadacycline EMA: HBV Vaccines Don’t Cause CRPS or POTS Insys CEO Resigns Amid Opiod Sales Investigation Pfizer Expands Eligibility for Patient Assistance Program Experts: Precision Medicine Not Just for Rare Diseases ArmaGen Nabs Rare Pediatric Disease Designation for Hurler Syndrome Drug Read More
On Thursday, the FDA approved Gilead’s Genvoya, a once-daily complete regimen for adults and pediatric patients 12 years of age and older with HIV-1 infection. Read More
While there is no set timeframe for the release of FDA’s final quality metrics guidance, the agency has plans to recruit volunteers to conduct a “dry run” in the spring to test the collection and sending of data to the agency. Read More
French drugmaker Sanofi is looking to future-proof its diabetes franchise by in-licensing rights to a trio of next-generation diabetes medicines from South Korea’s Hanmi in a deal worth up to $4.2 billion. Read More
The Federal Court of Canada has quashed Health Canada’s import ban on drugs from two Apotex facilities in India, saying the agency proceeded unfairly. Read More
The FDA approved GlaxoSmithKline’s injectable drug Nucala Wednesday for use in patients 12 years and older suffering from severe asthma attacks. It is intended to be used in conjunction with other asthma drugs. Read More
Allegations of price gouging within the pharmaceutical industry reached fever pitch in Washington, D.C., yesterday, with House members calling for hearings, a Senate committee opening an investigation into pricing practices and HHS announcing a hearing on the subject. Read More
FDA Names Permanent Deputy Director for Office of Generic Drugs Report: Generic Drugs Saved U.S. $254 Billion Agilis Wins Orphan Drug Designation for Angelman Syndrome Therapy Roche Reaches Deal With NHS England to Keep Kadcyla on Listing FDA Fast Tracks Opioid Addiction Drug Read More