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Zogenix Monday sought a temporary restraining order against Massachusetts Gov. Deval Patrick’s recent executive order prohibiting use of the prescription pain drug Zohydro ER in the state. Read More
While the FDA sees great potential for Bayesian statistics in Phase II clinical trials, the agency is not yet ready to endorse the method for Phase III studies. Read More
GlaxoSmithKline alerted consumers that five lots of its OTC weight loss drug Alli may have been tampered with after fielding complaints that a different drug was in some of the bottles. Read More
To help improve drug safety and quality, the FDA and other countries’ drug industry regulators are considering forming a global authority dubbed the International Coalition of Medical Regulatory Authorities, Commissioner Margaret Hamburg says. Read More
Halozyme has temporarily halted another trial due to safety concerns. This time, the drugmaker decided to hit the brakes after patients treated with PEGPH20, a pegylated form of its anti-cancer enzyme rHuPH20, showed increased risk for certain blood clots. Read More
ViiV Healthcare is licensing its HIV drug Tivicay to the Medicines Patent Pool in an effort to increase access to adults and children living with the virus. Read More
The HHS Office of Inspector General (OIG) this year plans to analyze the findings from FDA inspections of generic drugmakers’ facilities to determine the effectiveness of inspections on ensuring the quality of generic medicines. Read More
GlaxoSmithKline alerted consumers that five lots of its OTC weight loss drug Alli may have been tampered with after fielding complaints that a different drug was in some of the bottles. Read More
The FDA said Mar. 27 that all manufacturers have voluntarily complied with an agency ban on selling acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet. Read More