The National Institutes of Health (NIH) today announced the kickoff of a national clinical trials network to test vaccines and other treatments that could prevent infection with SARS-CoV2, the virus that causes infection with the novel coronavirus COVID-19.   The network has been established by the National Institute of Allergy and Infectious Diseases (NIAID) through the merger of four previously existing clinical trials networks that focused on HIV/AIDS.   “Star...

One in four new drugs approved in the US between January 2008 and December 2017 received direct funding from public resources for late stage research or through spin-off companies created from public research institutions, a study published in the BMJ on Wednesday found.  As the drug pricing debate has accelerated in recent months, the debate over whether public or private entities do the majority of drug development work has continued, with the general assumption tha...

US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said Wednesday that while the National Institutes of Health (NIH) has been instrumental to drug discovery and development, she does not think NIH or academics should be in the business of developing new pharmaceuticals. The comments came as part of the first day of a two-day meeting at the National Academies of Sciences, Engineering and Medicine in Washington, DC...

China, Russia and Iran were singled out in a Senate Finance Committee hearing on Wednesday as countries that are looking to either undermine or usurp scientific research conducted with US taxpayer funds. Committee Chairman Chuck Grassley (R-IA) made clear that China is “by far the most prolific offender,” offering the example of attempts by Chinese researchers to steal genetically modified corn seeds in Iowa and send them back to China. “Researchers who are secretly ...

The House Appropriations Committee on Tuesday voted to send its FY 2020 spending bill for the US Food and Drug Administration (FDA) to the House floor, in addition to releasing a report explaining areas where FDA needs to focus its efforts. The funding bill would provide FDA with $3.26 billion in non-user fee funding, an increase of $184 million (6%) above the FY 2019 enacted level. According to the Alliance for a Stronger FDA, the bill is expected to be taken up on the...

The House Appropriations Committee on Wednesday released a draft fiscal year 2020 funding bill for the US Food and Drug Administration (FDA), calling for a $184 million increase in discretionary funding over 2019’s enacted level.   Total funding for FDA, including revenue from user fees, is $5.86 billion, according to the bill. That total is slightly less than the $6.1 billion requested by the Trump Administration for FDA.   “Within this total, the Committee prov...

An argument has been brewing on Capitol Hill and elsewhere that boils down to the theory that US taxpayers are fronting billions of dollars’ worth of public research that translates into early-stage products that are later sold to companies, go on to win FDA approval and then reap millions or billions in sales, although the government never sees a dime of those earnings. With the help of a new Congressional Research Service (CRS) report published Friday and some other m...

Almost a year ago, the National Institutes of Health (NIH) made effective a new policy to better disseminate information from NIH-funded clinical trials through ClinicalTrials.gov, and the agency says that so far, it’s seen some improvements. Back in 2007, section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) established a requirement that "applicable clinical trials" must be registered and information must be submitted to Clinicaltrials.gov. ...

The International Council for Harmonisation (ICH) on Monday began a push toward more transparency, with the release of which members make up its expert working groups and new data on how ICH is funded. "While these experts represent the regulatory and industry association parties that nominate them, this new level of transparency will bring a novel understanding of who contributes to the development of guidelines as well as the roles they play," ICH said. Accord...

Health and Human Services Secretary Tom Price told a House appropriations subcommittee on Wednesday that his agency is working with President Donald Trump on a plan to bring down the cost of pharmaceutical drugs. Citing Trump’s numerous mentions since he took office of a plan for a new "bidding" system, Price said skyrocketing drug prices is an issue that members of Congress on both sides of the aisle are looking to target. In defending Trump’s proposed "skinny" budge...

The massive 21st Century Cures Act, rushed to passage in the waning days of President Barack Obama’s presidency, features a whole host of provisions that will take years for the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) to digest and implement, but it also includes several provisions that must be addressed by 13 March. Among those provisions of the law that must be acted upon within 90 days of the law’s enactment (or by 13 March) inc...

Sen. Patrick Leahy (D-VT) on Tuesday proposed an amendment to the 21st Century Cures bill that would make it more difficult for brand name drugmakers to halt or delay generic or biosimilar competition. The amendment, supported by the Generic Pharmaceutical Association on Tuesday, would promote competition by further encouraging manufacturers to share product samples with generic and biosimilar companies so that more of these lower-cost treatments can be approved by th...