Even though the U.S. already has a National Plan to Address Alzheimer’s Disease, a bipartisan group of U.S. senators is adding its voice to that of nearly 200 national organizations and experts in calling for more. In a recent letter to Health and Human Services (HHS) Secretary Xavier Becerra, the 15 senators requested that he make reducing the prevalence of dementias a departmental priority.
Boehringer Ingelheim International GmbH is the latest drug company to come into the crosshairs of the U.S. Health Resources and Services Administration over its restrictions on giving 340B drug discounts to contract pharmacies.
Even though the U.S. already has a National Plan to Address Alzheimer’s Disease, a bipartisan group of U.S. senators is adding its voice to that of nearly 200 national organizations and experts in calling for more.
While much of the global pandemic response has focused on vaccines, the World Health Organization is now calling on drug manufacturers to ramp up their supply and donations of monoclonal antibodies used to treat COVID-19 infections.
The U.S. Department of Health and Human Services (HHS) reported a rescission of a September 2020 policy that would require that the secretary of health and human Services sign off on any rulemaking by HHS agencies. Despite the firestorm of criticism that followed the issuance of the September 2020 policy, attorney Jim Shehan, of Lowenstein Sandler, told BioWorld that the rulemaking process will remain exceptionally cumbersome, leaving in place a status quo that itself has been the target of repeated criticism.
Plans for offering COVID-19 vaccine booster shots in the U.S. took a big step forward Aug. 18, as Health and Human Services (HHS) public health and medical experts laid out their intention to offer booster shots across the country for people 18 and older beginning the week of Sept. 20 and starting eight months after an individual's second dose.
Rick Bright, who filed a whistleblower complaint last year against the U.S. Department of Health and Human Services (HHS) after he was removed from his position as director of the Biomedical Advanced Research and Development Authority (BARDA), reached an undisclosed settlement with HHS, the U.S. Office of Special Counsel reported Aug. 9.
Instead of waiting for Congress to come up with a solution to reduce drug prices, a trio of U.S. lawmakers told the U.S. Department of Health and Human Services (HHS) it needs to tackle drug prices with the tools it already has – compulsory licensing and march-in rights.
The U.S. Supreme Court has agreed to take up one piece of the 340B conundrum that’s pitting biopharma against hospitals and catching the Department of Health and Human Services in between. The case the court agreed to hear, the American Hospital Association (AHA) v. Becerra, focuses on whether HHS has the authority to cut Medicare reimbursement rates to reflect the steep discounts 340B hospitals get on certain prescription drugs.
As a first step in developing a portfolio of COVID-19 therapies, the European Commission identified five promising candidates June 29, including four monoclonal antibodies under rolling review at the EMA and an immunosuppressant that could have its marketing authorization extended to include the treatment of COVID-19 infections.
