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Drugmakers spend an average of $1.3 billion in research and development costs to get a new medicine to market, according to a new study reported in JAMA this week, a number considerably lower than a 2016 Tufts report citing development costs of $2.8 billion. Read More
Four of eight complex trial designs submitted in the FDA’s complex innovative trial design (CID) pilot program have been accepted for review, the agency said Monday. Read More
Participation of women in clinical trials of drugs approved by the FDA increased dramatically in the past year, rising from 56 percent of trial participants in 2018 to 72 percent in 2019, but ethnic diversity in trials overall remained steady, according to the agency’s latest Drug Trials Snapshot Summary Report. Read More
Nearly 600 pediatric drugs across various therapeutic areas are currently being tested in clinical trials, according to a report from the Pharmaceutical Research and Manufacturers of America (PhRMA). Read More
Janssen Pharmaceuticals is joining forces with HHS to develop a vaccine candidate for COVID-19 and the Johnson and Johnson subsidiary is prepared to produce it on a large scale. Read More
FDA Commissioner Stephen Hahn yesterday announced actions the agency is taking to speed development of treatments and diagnostic tests for the novel coronavirus, as several drugmakers race to develop a vaccine. Read More
The FDA released two final guidances yesterday outlining the agency’s approach to drug-drug interaction (DDI) studies for DDIs mediated by cytochrome P450 (CYP) enzymes and transporters. Read More
Death rates for metastatic cancers have dropped by 5 to 6 percent annually for elderly patients the past three years, in part because of two “game-changing drugs” approved almost a decade ago by the FDA, according to the American Cancer Society (ACS). Read More
For the second year in a row Novartis has been named the most innovative pharma company in the industry by the Innovation Index, a collaboration between CNS Summit and IDEA Pharma. Read More