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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
The agency aims to develop “a robust infrastructure, cloud-forward plans, clear and efficient external data interfaces, and a focus on cybersecurity.” Read More
The FDA released a new plan on Wednesday for using data to help bridge the “persistent gap” between scientific innovations and the technology needed to develop them into therapies. Read More
Following an agency-wide e-mail from the Acting FDA Commissioner marking an increased focus on emerging technologies, the agency has forged a research partnership with the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to spur innovation in advanced manufacturing. Read More
Following an agency-wide e-mail from the Acting FDA Commissioner marking an increased focus on emerging technologies, the agency has forged a research partnership with the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to spur innovation in advanced manufacturing. Read More