The HHS Office of Inspector General will review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523). Among the controversies surrounding the drug’s approval is the use of the accelerated approval pathway, which led the agency to use a surrogate endpoint to approve aducanumab conditionally. […]
HHS
Biden administration invests $3B to accelerate development of next-gen COVID-19 treatments
President Joe Biden’s administration will spend $3 billion in American Rescue Plan money to accelerate the discovery, development and manufacturing of antiviral medicines against COVID-19, HHS announced today. Not only will the Antiviral Program for Pandemics seek to boost the availability of medicines to prevent serious COVID-19 illness and save lives, but it will pursue […]
Xavier Becerra confirmed as HHS secretary
The U.S. Senate narrowly voted to confirm Xavier Becerra as the U.S. Dept. of Health & Human Services (HHS) secretary today. Becerra received the nomination for the position from President Joe Biden in December 2020. Today, the Senate voted 50-49 in favor of Becerra, who will have to resign his seat as California’s attorney general. […]
HHS ends more ventilator contracts as national stockpile fills up
The U.S. Dept. of Health and Human Services (HHS) is reportedly terminating more ventilator contracts as the national stockpile is full. The Hill reported today that HHS is throwing out some of the contracts that totaled $3 billion as the U.S. government sought to supply as many ventilators as possible during the first surge of […]
Ventec, GM complete HHS ventilator contract
Ventec Life Systems and General Motors announced today that they completed their government contract to produce 30,000 ventilators. The two companies kicked off mass production of Ventec’s V+Pro critical care ventilator at GM’s Kokomo, Ind., plant in April, having received a $489.4 million contract from the U.S. Dept. of Health and Human Services to deliver […]
HHS pulls FDA back from regulating some COVID-19 tests
FDA will no longer require a premarket review of laboratory-developed tests during the COVID-19 pandemic, according to a decision announced on the U.S. Department of Health and Human Services website. Such a requirement in the future will need notice-and-comment rulemaking versus guidance documents, compliance manuals, website statements or other informal issuances, HHS said in the decision […]
HHS puts $6.5M more toward COVID-19 testing
The U.S. Department of Health and Human Services (HHS) said today it will provide a total of $6.5 million to help two commercial diagnostic laboratories to expand capacity to conduct up to 4 million additional diagnostic tests for COVID-19 per month. The investments in Aegis Sciences (Nashville, Tenn.) and in Sonic Healthcare USA (Austin, Texas) […]
