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The FDA plans to clear up questions about the types of off-label information drugmakers may communicate to physicians and payers in a series of guidances planned for later this year that will address four key areas that have long tripped up industry. Read More
Teva cleared a major hurdle last week in its bid to launch a generic version of Bristol-Myers Squibb’s hepatitis B drug Baraclude after a federal appellate court upheld a lower court’s decision invalidating the drug’s patent. Read More
Manufacturer Hospira’s 2005 withdrawal of its leucovorin injection was not done for effectiveness or safety reasons, the FDA said, paving the way for new ANDAs on the generic anemia drug. Read More
Makers of drugs to treat opioid-induced constipation need not conduct further large, long-term cardiovascular outcomes safety trials, an FDA advisory panel concluded last week, instead urging the agency to require postmarket observational studies. Read More
The European Medicines Agency (EMA) approved a controversial policy last week that will grant researchers access to detailed clinical trial data submitted in support of drug approvals. Read More
The FDA has issued a warning letter to Mexican biologics maker Instituto Bioclon for significant GMP deviations including failures to ensure adequate environmental monitoring and employee training.
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British authorities continue to investigate 21 cases of blood poisoning in babies who received potentially contaminated batches of an intravenous liquid feed at neonatal intensive care units in England, but said the manufacturer of the product was following good manufacturing practice guidelines. Read More
Unsanitary lab coats, hairnets and facemasks were among the problems cited in a warning letter to compounding pharmacy Medaus, the latest compounder to receive a warning from the FDA. Read More
A federal appeals court needs to rethink its definition of “a patient” or risk upholding a dangerous precedent in future Hatch-Waxman cases after a recent patent ruling on the colon cleanser Suprep, trade groups BIO and PhRMA argue in a joint legal brief. Read More
A Massachusetts insurer filed a lawsuit this week against Takeda and Eli Lilly in the U.S. District Court for the Western District of Louisiana for allegedly hiding cancer risks of its type 2 diabetes drug Actos. Read More