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The FDA is moving to ease industry fears that ANDAs filed after September of this year will receive priority over earlier applications simply because they were filed before the law required the agency to assign review deadlines to new applications. Read More
Canada's Tekmira Pharmaceuticals received FDA clearance to provide its TKM-Ebola RNA interference therapeutic to patients with suspected or confirmed cases of the deadly disease. Read More
The European Ombudsman has accused EU regulators of blocking access to drug safety reports and other public documents in a new case that observers tell DID is part of the watchdog’s ongoing effort to bring greater transparency to the pharmaceutical industry. Read More
India’s drug regulatory authority has abruptly withdrawn a guideline for setting prices on many branded-generic drugs, a move that could help manufacturers press their case in a lawsuit against the government’s drug-pricing policies. Read More
Pfizer and Ranbaxy have asked a federal judge to follow his own precedent and dismiss all remaining class-action lawsuits alleging the companies colluded to delay generic versions of Pfizer’s blockbuster cholesterol drug Lipitor. Read More
Two New York congressmen have become the latest on Capitol Hill to question a proposed FDA rule that would give generics firms the same authority to change drug labels as brandmakers, a rule that GPhA has threatened to challenge in court if necessary. Read More
Generics firm Par Pharmaceuticals has agreed to pay Salix Pharmaceuticals $100 million to settle a patent infringement lawsuit over its version of Salix’s heartburn drug Zegerid. Read More
Drugmakers say they will be forced to abandon social media due to proposed FDA requirements to present both risk and benefit information in character-limited social media messages — a requirement they contend the agency doesn’t even follow. Read More
Drug sponsors applying to include products on the Australian registry should submit both favorable and unfavorable information with their nonclinical study reports, according to amended guidance. Read More