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Drugmakers have just over a year to comply with new Canadian regulations requiring evidence of GMP compliance at foreign facilities that make active pharmaceutical ingredients. Read More
The European Commission has cleared the way for Pfizer to acquire Hospira, pending the divestiture of its Remicade biosimilar and certain sterile injectable drugs. Read More
Indian drugmaker Hetero has launched a biosimilar version of Roche’s Rituxan on the subcontinent, with plans to introduce it in key markets outside India through strategic partners. Read More
Pfizer has acquired exclusive rights to market potential generic versions of Teva’s multiple sclerosis drug Copaxone, under an agreement with Synthon. Read More
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