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October 22, 2019
Executive Summary Shared review memorandum under Office of New Drugs reorg will help eliminate last-minute surprises between disciplines and provide greater consistency between divisions.   The US... Read more
October 22, 2019
Theresa LaVallee joined the Parker Institute for Cancer Immunotherapy in 2017 and is currently VP of translational medicine and regulatory affairs. As part of the institute's efforts to bring precise... Read more
October 22, 2019
Executive Summary US FDA is encouraging common mechanisms of drug testing to enable pharma industry collaboration and avoid redundancy; Pazdur notes that there are many similar PD-1 drugs.   Richard... Read more
October 18, 2019
The growth of personalized medicine in oncology continues to fuel a shift from traditional chemotherapies to immunotherapy. Currently, there are more than 30 immunotherapies approved for use in the... Read more
October 12, 2019
Perhaps one of the biggest opportunities for AI (Artificial Intelligence) is the healthcare industry. According to ReportLinker, spending on this category is forecasted to jump from $2.1 billion to $... Read more
October 9, 2019
The White House sees an opening for a drug pricing deal with House Democrats before the end of President Donald Trump’s first term—provided impeachment doesn’t derail the entire process.   The White... Read more
September 5, 2019
The Trump administration is apparently down to three final candidates for the top FDA job as a deadline for nomination looms. Acting commissioner Ned Sharpless is contending with Stephen Hahn, chief... Read more
September 5, 2019
It has been six months since Scott Gottlieb announced that he would be resigning as commissioner of the US Food & Drug Administration, and there is still no formal nominee to succeed him.   That... Read more
September 4, 2019
Just a few days after a report surfaced noting that HHS Secretary Alex Azar was pushing for controversial secretary for health Brett Giroir to take the helm at the FDA from acting chief Norman “Ned”... Read more
September 4, 2019
The jockeying over who will be the next Food and Drug Administration commissioner intensified Tuesday when former agency heads and dozens of health groups urged the White House to nominate acting FDA... Read more