Given the evolving COVID-19 situation, U.S. House committee chairs are asking the White House Office of Management and Budget (OMB) to direct federal agencies to immediately extend all public comment periods by at least 45 days beyond the end of the declared national emergency, whenever that may be.
To mitigate COVID-19-related drug shortages, the FDA issued new guidance reminding drug and biologic manufacturers of their legal obligations to notify the agency, in advance, of interruptions or the permanent discontinuance in the manufacturing of certain drugs. It also makes some new recommendations in light of the current emergency.
HONG KONG – Chengdu, China-based Clover Biopharmaceuticals Inc. has teamed up with Emeryville, Calif.-based Dynavax Technologies Corp. on a research collaboration to develop a vaccine candidate to prevent COVID-19.
The stimulus bill passed by the U.S. Senate March 26 on a vote of 96-0 does more than throw $2.2 trillion into the war against COVID-19. “This is not … a stimulus package. It is emergency relief,” Senate Majority Leader Mitch McConnell (R-Ky.) said on the Senate floor before the vote.
The pressure is rising on the Trump administration to activate the Defense Production Act (DPA) for the COVID-19 outbreak as the Senate yet again reconsiders an economic stimulus package. Sens. Brian Schatz (D-Hawaii) and Chris Murphy (D-Conn.) unveiled the Medical Supply Chain Emergency Act in an effort to force the White House to mandate the production of needed supplies, a bill that is likely to languish until Congress can move on economic relief legislation.
President Donald Trump has issued an executive order enabling the Defense Production Act, which gives the U.S. Department of Health and Human Services broader leeway to conscript industrial production to deal with the COVID-19 outbreak.
The U.S. capacity for SARS-CoV-2 testing is limited by several items, including the swabs used to collect patient specimens, but the supply of reagents has been front and center recently. Despite those concerns, several private test makers said they are quickly ramping up production, including Thermo Fisher Scientific Inc., of Waltham, Mass., which said it has enough supplies of all types on hand to provide 2 million reactions per week, a volume that should increase to 5 million per week in April.
As the world goes to war with COVID-19, the U.S. is ripping open the purse strings to fund mobilization against both the coronavirus and the economic devastation it’s causing.
Chronic disease patients are facing serious risks both from keeping away from necessary care settings, as well as from potential COVID-19 infection. One in five chronic disease patients was already starting to avoid seeking care in physician’s offices and hospitals, according to a survey that started early last week of a panel of 1,300 chronic disease patients across several indications.
Sen. Amy Klobuchar (D-Minn.) has posted new legislation that would bolster antitrust enforcement and deter anticompetitive behavior in the private sector, but the bill faces considerable opposition. Glenn Lammi of the Washington Legal Foundation told BioWorld that the legislation would blunt investment in the life sciences due to provisions that would make the possession of a patent an indication of legally actionable anticompetitive behavior.
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