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PhRMA, as expected, expressed opposition towards the sweeping bipartisan bill, calling it “the wrong approach” for tackling the nation’s high drug costs. Read More
Drugmakers have been given more clarity on the FDA’s definition of rare pediatric disease and the process for its priority review voucher program in agency draft revised guidance issued Monday. Read More
Some Type II DMF submissions may receive a waiver for noncommercial applications, such as ones from an academic institution, government or non-profit research group. Read More
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