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The FDA refuted CytoDyn’s claims about the efficacy of the company’s experimental HIV drug leronlimab as a COVID-19 treatment based on data from two late-stage trials. Read More
Sponsors using master protocols to test new drugs and therapies for treating or preventing COVID-19 should base their analyses on comparisons between control arm participants who were concurrently randomized, the FDA advised in a final guidance released yesterday. Read More
Sanofi and GlaxoSmithKline (GSK) have reemerged as COVID-19 vaccine contenders after their reformulated candidate delivered a strong immune response across all age groups in a phase 2 study. Read More
Although prominent COVID-19 vaccine makers have argued for ramping up production to help meet global vaccine needs as an alternative to waiving intellectual property (IP) rights, several pharma companies, including the world’s biggest generics maker, have been unable to secure such manufacturing arrangements. Read More
In a revised guidance that will stay in effect until the end of the pandemic, the FDA explained how it will deal with drug applications when it is unable to conduct an inspection because of travel restrictions. Read More
A UK study has shown that individuals over 80 years old had significantly higher antibody responses when given their second Pfizer/BioNTech vaccine dose after 12 weeks as opposed to the standard three-week interval. Read More
Manufacturing of Johnson & Johnson (J&J)’s COVID-19 vaccine at Emergent BioSolutions’ Bayview, Md., plant remains on pause as the FDA assesses the company’s response to troubling observations by agency officials at the facility last month. Read More
India’s surging COVID-19 cases threaten to derail the global drug supply as the world’s largest producer of generic drugs is unable to secure critical raw materials. Read More
On Capitol Hill in recent days, Republicans have challenged the Biden’s administration’s support of a World Trade Organization (WTO) proposal to temporarily waive patents for COVID-19 vaccines. Read More