In the second of two hearings before the U.S. Senate Health, Education, Labor and Pensions Committee on the next iteration of the FDA drug and device user fee agreements, the focus was supposed to be on advancing regulation and innovation. But Ranking Member Richard Burr (R-N.C.) shifted the spotlight April 26 to accountability in his opening remarks and subsequent questioning.
As part of a series of guidances addressing clinical trial diversity, the U.S. FDA issued a draft guidance April 13 focused on improving enrollment of participants from underrepresented racial and ethnic populations.
Elix Inc. has teamed up with Shionogi & Co. Ltd. to validate a retrosynthetic analysis model for drug discovery that will employ chemical reaction data from Shionogi to explore various routes to synthesizing new molecules.
Policymakers shouldn’t look to march-in rights as a simple solution to make medical products more affordable, according to experts speaking at an Information Technology & Innovation Foundation discussion on how using the march-in provisions of the Bayh-Dole Act as price controls would threaten America’s research universities.
Leading clinicians in the U.K. have set out a blueprint for integrating pharmacogenomic testing into prescribing in all cases where there is a known association between a gene variant and how an individual will respond – or not – to a particular drug.
The bipartisan PREVENT Pandemics Act, which seeks to put into U.S. law many of the lessons learned from the COVID-19 pandemic, marked its first milestone March 15, with the Senate Health, Education, Labor and Pensions (HELP) Committee sending it to the full Senate with a do-pass recommendation on a 20-2 vote.
Over the past few years, China has been quick to make promises to improve its regulatory and patent schemes for biopharmaceuticals and medical devices in keeping with its World Trade Organization (WTO) commitments, but it’s been slow to fulfill those promises – at least in the eyes of the Office of the U.S. Trade Representative (USTR).
Since COVID-19 hit the U.S. in 2020, the pandemic has taken more than 800,000 American lives. In that same time, cancer has claimed 1.2 million lives, President Joe Biden said Feb. 2 as he “reignited” the cancer moonshot he first launched in 2016 when he was serving as vice president.
PERTH, Australia – A new parliamentary report, The New Frontier: Delivering better health for all Australians, is recommending significant reforms to the nation’s health care system to ensure Australians have faster access to new drugs and devices. The House of Representatives Standing Committee on Health, Aged Care and Sport examined the range of new drugs and emerging medical technologies that are in development and progressing through the regulatory system in Australia and in other countries.
While comments continue to pour in, both in opposition and support, regarding the U.S. Centers for Medicare & Medicaid Services’ (CMS) proposed national coverage decision that would restrict Medicare coverage of monoclonal antibodies intended to treat Alzheimer’s to those used in CMS- or NIH-approved clinical trials, some groups also are appealing to Health and Human Services (HHS) Secretary Xavier Becerra to step into an HHS agency turf war.
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