A Delaware federal court ruled that Par’s generic of Ferring’s Prepopik colonoscopy preparation treatment infringed on the company’s patent. Source: Drug Industry Daily

The FDA published new product-specific draft guidances for establishing bioequivalence in 20 drugs and combinations. The agency also revised draft guidances for 12 more substances. Source: Drug Industry Daily

An FDA advisory panel unanimously recommended that the agency approve two biosimilars for the cancer treatments Avastin (bevacizumab) and Herceptin (trastuzumab). Source: Drug Industry Daily

Congress is looking into making statutory changes to the way FDA governs off-label use of medical products and other pre- and postmarket communications between medical manufacturers, physicians and patients. Source:…

Citing safety concerns, Fresenius asked the FDA to withhold approval for an additional indication for Keryx’s sNDA for Auryxia. Source: Drug Industry Daily

An FDA advisory committee voted unanimously Wednesday in favor of the risk-benefit profile for Novartis’ BLA for an innovative new cancer therapy. Source: Drug Industry Daily

Officials from Kentucky, Maryland, Rhode Island and Virginia testified to a house committee yesterday about the opioid epidemic in their states and asked for more assistance to combat the problem.…

The House passed its version of the FDA user fee reauthorization package Wednesday that is expected to bring in $1.42 billion in fiscal 2018, by a voice vote. Source: Drug…

The House Appropriations Committee on Wednesday approved a bill by voice vote that would provide a total of $5.2 billion for the FDA in fiscal 2018—$2.6 billion in discretionary spending…

FDA investigators visiting a Vista Pharmaceuticals plant in Nalgonda, India found equipment used to manufacture drugs riddled with holes and corrosion, according to a warning letter issued July 5. Source:…