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NPS Pharma plans to make Natpara available for some patients with hypoparathyroidism in the second quarter of this year, following FDA approval late Friday. Read More
UK healthcare cost watchdogs confirmed Friday that Bayer’s Xarelto is cost-effective for preventing blood clots in patients who have had heart attacks. Read More
Mylan has been awarded another $13.7 million in supplemental damages from GlaxoSmithKline in an ongoing lawsuit against the brandmaker that accuses it of violating a 2007 contract over exclusivity rights to generic antidepressant Paxil. Read More
Australian authorities have suspended a biosimilars naming initiative, pending review, in the wake of a recent World Health Organization proposal on how biosimilars should be named. Read More
The European Medicines Agency is recommending halting sales of 700 drugs that were approved based on testing data provided by CRO GVK Biosciences, following an inspection that found the Hyderabad, India, firm manipulated echocardiogram data. Read More
Drugmakers should notify the European Medicines Agency within 10 days of receiving an initial opinion on a pediatric investigation plan if they plan to request another review. Read More
The FDA warned Thursday that counterfeit versions of Eli Lilly’s popular erectile dysfunction drug Cialis were found in mail to a U.S. customer — marking the first major counterfeit incident of 2015. Read More
Authorities in the UK are urging physicians not to prescribe valproate drugs to pregnant women and to inform women who truly need the drug of potential risks to their unborn children. Read More
The European Medicines Agency has published a 100-page technical guide aimed at helping drugmakers comply with a new global standard on the reporting of individual case safety reports. Read More