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The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended five new medicines for approval and eight treatments for extensions of indication at its July meeting. Read More
“[FDA] could have opened the door to the domestic production of generic insulin, resulting in unprecedented competition in the insulin market, making it more accessible and affordable,” he said. Read More
The resolution is in response to the “CRISPR babies” scandal that erupted following the announcement by researcher He Jiankui who claimed to have used the CRISPR-Cas9 technique to disable the CCR5 gene that allows HIV to infect humans. Read More
Drug companies that don’t adhere to the price requirements would be hit with a fine on all profits made from selling a drug above the HHS-defined “fair price” in the form of a 100 percent tax. Read More
“To demonstrate these effects of the study drug on testosterone levels, the treatment period should be at least twice as long as the dosing interval,” the agency advises. Read More
Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.)’s drug pricing package is headed to the Senate floor, following the Senate Finance Committee’s markup and 19-9 approval yesterday. Read More
The firm also failed to document cleaning procedures after manufacturing a highly potent drug compound before producing a non-hazardous drug compound on the same equipment. Read More
The UK’s National Institute for Health and Care Excellence (NICE) has announced details on a plan to evaluate its approaches towards developing guidance on drugs, medical devices and diagnostics. Read More
Acting FDA Commissioner Ned Sharpless identified four main focal points for the agency in its efforts to advance public health in an agency-wide e-mail sent Tuesday. Read More
The Senate Finance Committee Tuesday unveiled a far-reaching bipartisan legislative package that takes aim at the nation’s high drug prices, an effort that’s been in the works for over half a year. Read More
A federal judge in Delaware denied requests from Genentech to block the launch of biosimilars for its blockbuster treatments Avastin (bevacizumab) and Herceptin (trastuzumab). Following the court’s decision, Amgen and Allergan announced their products Mvasi (bevacizumab-awwb) and Kanjinti (trastuzumab-anns) were available for sale. Read More