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The UK’s healthcare watchdog says it needs more evidence before it can determine if off-label use of Alexion’s Soliris is effective in preventing the recurrence of a rare kidney disease in patients who have undergone transplants. Read More
The FDA Monday published dozens of product-specific draft guidance documents offering recommendations on the design of bioequivalence studies to support ANDAs. Read More
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