Health News Roundup: US FDA approves Cue Health's at-home COVID test; White House vows an improved effort against drug overdoses and more
Following is a summary of current health news briefs. GSK's cancer drug Jemperli gets file acceptance from US FDA GSK said on Tuesday that the U.S. Food and Drug Administration had granted file acceptance for its cancer drug, Jemperli, when combined with chemotherapy to treat adult patients with certain types of endometrial cancer.
Following is a summary of current health news briefs.
GSK's cancer drug Jemperli gets file acceptance from US FDA
GSK said on Tuesday that the U.S. Food and Drug Administration had granted file acceptance for its cancer drug, Jemperli, when combined with chemotherapy to treat adult patients with certain types of endometrial cancer. (The story has been refiled to change the image)
UK government challenge to COVID inquiry to be heard around end-June - lawyer
The British government's legal challenge to the COVID-19 public inquiry will likely be heard on June 30 or shortly afterwards, the counsel to the inquiry said on Tuesday. The government has refused to hand over internal WhatsApp messages it has described as "unambiguously irrelevant" to the inquiry, and has sought a judicial review at London's High Court against the demand.
US FDA approves Cue Health's at-home COVID test
The U.S. Food and Drug Administration on Tuesday approved Cue Health's at-home COVID-19 test, the first coronavirus test to get marketing authorization using a traditional premarket review, the agency said. The FDA had granted emergency use authorization for the test in 2021 to make it available to consumers without a prescription.
Factbox-Britain's COVID inquiry into the handling of the pandemic
Britain is holding a public inquiry into the handling of the COVID-19 pandemic, and the government is already seeking legal action against it even before it has started hearing evidence. Here are the key facts about the inquiry.
Sanofi-AstraZeneca's preventive RSV therapy appears safe- FDA staff
The U.S. Food and Drug Administration's staff reviewers said on Tuesday Sanofi and partner AstraZeneca's experimental therapy to prevent respiratory syncytial virus (RSV) infections in infants appeared safe and effective. The RSV prevention antibody, nirsevimab, showed an overall favorable safety profile in clinical trials, the FDA staff said in documents published ahead of the health regulator's advisory committee meeting on Thursday to discuss the therapy's marketing application.
Merck sues US government to halt Medicare drug price negotiation
Merck & Co sued the U.S. government on Tuesday, seeking to halt the Medicare drug price negotiation program contained in the Inflation Reduction Act (IRA), which it argues violates the Fifth and First Amendments to the U.S. Constitution. This is the first attempt by a drugmaker to challenge the law, which the pharmaceutical industry says will result in a loss of profits that will force them to pull back on developing groundbreaking new treatments.
White House vows an improved effort against drug overdoses
President Joe Biden's administration on Tuesday pledged an improved effort to combat drug overdoses that claimed the lives of about 100,000 Americans last year, using a White House summit to tout a multifaceted approach to tackle synthetic and illicit drugs such as the powerful opioid fentanyl. "Today's summit is needed because the global and regional drug environment has changed dramatically from just even a few years ago," Rahul Gupta, director of the White House Office of National Drug Control Policy, told the summit, being held jointly with public health officials from Mexico and Canada.
Novocure's lung cancer device study raises concerns around commercial use
Novocure Ltd's experimental device to treat a type of lung cancer helped in extending overall survival among patients in a late-stage study, but concerns around its commercial success sent the medical device maker's shares down more than 34% on Tuesday. The device, used with certain chemotherapies and immunotherapies, helps in creating electric fields that disrupt cancer cell growth.
New Zealand curbs disposable vapes to deter the young
New Zealand unveiled measures on Monday to curb vaping by young people, from limits on sales near schools to a ban on some disposable units, as it extends aggressive anti-smoking campaigns. Although the Pacific nation has one of the lowest rates of adult smoking among the 38 nations in the Organization of Economic Cooperation and Development, it has banned future generations from smoking in a push to be "smokefree" by 2025.
EU regulators back WHO's COVID vaccine update recommendation
Europe's medicine regulators on Tuesday backed the World Health Organization's recommendation to update the antigen composition of COVID-19 vaccines to target one of the currently dominant XBB variants ahead of the upcoming autumn vaccination campaign. Advisory groups related to the WHO suggested that, while waiting for more data, the monovalent XBB-containing vaccines could be considered a reasonable choice and individuals at risk of progression to severe disease such as older adults should be given priority, according to European Centre for Disease Prevention and Control (ECDC) and European Medicines Agency (EMA).
(With inputs from agencies.)