PERTH, Australia – As the Delta variant of SARS-CoV-2 sweeps across the globe, drugs like Roche Holding AG’s interleukin-6 receptor inhibitor Actemra (tocilizumab) are being used, often off-label, to treat serious cases of COVID-19. That usage, however, is resulting in serious drug shortages that may leave some without treatment options.
PERTH, Australia – As the Delta variant of SARS-CoV-2 sweeps across the globe, drugs like Roche Holding AG’s interleukin-6 receptor inhibitor Actemra (tocilizumab) are being used, often off-label, to treat serious cases of COVID-19. That usage, however, is resulting in serious drug shortages that may leave some without treatment options.
The Biden administration’s rollout of a COVID-19 booster plan before the FDA has even approved a booster admittedly is a “judgment call,” U.S. health officials acknowledged Aug. 18. But rather than a judgment call, “the introduction of booster doses should be evidence-driven and targeted to the population groups in greatest need,” the World Health Organization advised in an interim statement issued a week before the White House COVID-19 Response Team’s announcement.
Interim data for Soberana-02, a Cuban COVID-19 conjugate vaccine, surpassed the threshold set by the WHO, according to the Finlay Institute of Vaccines (IFV) in Havana that developed it, although the results have not been peer reviewed.
LONDON – The World Health Organization (WHO) is to set up a channel for confidential reporting of illegal, unregistered, unethical or unsafe human genome editing research, as part of a new governance framework it is proposing to develop.
LONDON – The World Health Organization (WHO) is to set up a channel for confidential reporting of illegal, unregistered, unethical or unsafe human genome editing research, as part of a new governance framework it is proposing to develop.
The World Health Organization (WHO) reported a new set of guidelines regarding screening and treatment of cervical cancer, endorsing DNA testing for human papillomavirus (HPV) as the recommended test method.
The World Health Organization’s (WHO) guidance for ethics and governance for artificial intelligence (AI) in health discusses several issues regarding regulation, including the question of transparency for the algorithm’s source code. The WHO paper is not prescriptive on this and several other issues, however, raising the prospect that regulatory entities will not be discouraged from adopting policies that run afoul of intellectual property concerns and thus impede advances in AI.
The World Health Organization (WHO) and the Global Fund to Fight AIDS, Tuberculosis and Malaria signed a cooperation and financing agreement to implement 10 initiatives in 2021 through 2023 aimed at addressing persistent challenges impeding global progress against the three diseases and protecting hard-won gains from new pandemics like COVID-19.
Biopharma companies need to provide unredacted access to both positive and negative clinical data for all new drugs and vaccines, whether the drugs have been rejected, authorized for emergency use, or granted full or conditional approval, according to the World Health Organization (WHO) and international regulators. “The COVID-19 pandemic has brought into sharp focus the need for improved transparency of medical research,” said EMA Executive Director Emer Cooke, who also chairs the International Coalition of Medicines Regulatory Authorities (ICMRA).
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