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The Federal Circuit appeals court has denied AstraZeneca’s effort to block Mylan’s launch of a generic version of the acid reflux blockbuster Nexium, paving the way for additional competition for the drug. Read More
Genzyme received a 16-observation Form 483 from the FDA for not conducting risk assessments and other quality lapses at a facility where bulk drug substances are made. Read More
Drugmakers should limit the amount of acetaminophen in pediatric liquid drugs to 160mg/5mL and include a statement highlighting the concentration on the container and labeling to reduce the chance of overdose, the FDA says. Read More
Members of the House Energy & Commerce Committee are giving the FDA until Aug. 14 to provide information on whether NIH included any statements about quality control, sterility or cGMP compliance in INDs it filed with the agency. Read More
Takeda’s diabetes drug Actos, which has caused the company to pay nearly $2.4 billion to settle lawsuits over cancer risks, did not increase the risk of bladder cancer in a large postmarketing study, the drugmaker says. Read More
Drugmakers want to know when changes to chemical, manufacturing and controls in NDAs, ANDAs and BLAs must be reported to the FDA, saying draft guidance lacks clear criteria and examples. Read More
Japan’s Pharmaceuticals and Medical Devices Agency was quicker to approve more new drugs in 2014 than its U.S. and EU counterparts, according to a new study released by the Centre for Innovation in Regulatory Science. Read More