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The European Medicines Agency Friday recommended under exceptional circumstances Alexion Pharmaceutical’s Strensiq for the long-term treatment of hypophosphatasia, a rare metabolic disorder that weakens bones. Read More
Brazil’s antitrust watchdog has fined Eli Lilly and its local affiliate $11.7 million for filing contradictory and misleading lawsuits in Brazilian courts to maintain exclusive rights to its cancer drug Gemzar. Read More
Two years after issuing guidance on data capture from electronic health records, the FDA’s Center for Drug Evaluation and Research is calling on stakeholders to help demonstrate how the use of electronic source data can help to streamline the clinical trial process. Read More
Following a series of setbacks that included two failed preapproval inspections and 24 citations, Hospira says the FDA has signaled the all-clear for its new Visakhapatnam, India, manufacturing facility and production is underway. Read More
The Court of Appeal in London has upheld Eli Lilly’s vitamin regimen patent for its blockbuster cancer drug Alimta, blocking Actavis from marketing a generic version of the drug until 2021. Read More
A Luxembourg-based nonprofit set up by European pharma groups is one step closer to launching a counterfeit drug repository system, having finalized contracts with three software firms to help implement the system. Read More
The FDA plans to investigate how well people who have suffered hearing loss — specifically older adults — are able to understand the risk information in TV drug ads. Read More
Two institutional buyers of Gleevec want to stop its manufacturer, Novartis, from delaying generic competition of the blockbuster leukemia drug, saying a patent litigation settlement between the brandmaker and generics maker Sun Pharma was construed solely for that purpose. Read More
The FDA wants manufacturers to better control the amount of excess drug or biologic they put in injectable vials and ampules to ensure proper patient dosing. Read More