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The House Energy and Commerce Committee has released a new draft of its 21st Century Cures Act that would encourage greater use of observational studies, patient registries and real-world therapeutic use to support approvals of new drugs and improve postmarket surveillance. Read More
The U.S. Attorney’s office filed documents Monday challenging Allergan’s efforts to suppress evidence that it submitted false claims related to its blockbuster ophthalmic drug Restasis. Read More
Republicans on the Senate HELP Committee are taking the FDA to task for failing to shore up policies on biosimilar naming and interchangeability before approving the first biosimilar drug nearly two months ago. Read More
Manufacturers of over-the-counter antiseptics used in healthcare settings will need to submit new safety data to the FDA if they want to keep their products on the market, the agency said Thursday, citing growing concerns about the systemic effects of long-term exposure to certain active ingredients. Read More
Two FDA advisory committees voted late Wednesday to recommend approval of Amgen’s talimogene laherparepvec immunotherapy for patients with metastatic melanoma, overriding FDA reviewers’ concerns that results from a pivotal clinical trial were skewed. Read More
The FDA has agreed to fast track its review of a new indication for AstraZeneca’s blood-thinning drug Brilinta, meaning the therapy could be available for patients with a history of heart attacks by the third quarter of 2015. Read More
The FDA says it plans to provide guidance by year’s end on naming biosimilars, potentially ending much of the confusion over how the products will be labeled and tracked. Read More
Takeda said Wednesday it will pay up to $2.4 billion to settle the majority of U.S. lawsuits involving its diabetes drug Actos, which has been linked to cancer. Read More
Particulates continue to be a major cause of recalled injectables, with Mylan on April 23 recalling eight lots of four drugs after foreign matter was found during quality control tests. Read More