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Dr. Reddy’s Laboratories is recalling drugs used to treat seizures and high blood pressure from the U.S. market due to dissolution and potency issues. All of the affected products were manufactured at DRL’s Bachupally, Hyderabad, India, facility, FDA enforcement reports show. Read More
Japanese drugmaker Eisai on Friday launched a granulated formulation of its antiarrhythmic agent Tambocor to treat children with rapid heart rate. Read More
Relying on a U.S. Supreme Court precedent involving Actavis, the Third Circuit Court of Appeals ruled Friday that patent settlements in pay-for-delay cases can face antitrust scrutiny even if they do not include cash. Read More
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