Acting on the advice of experts, the United States Food and Drug Administration on Tuesday issued new safety-focused guidelines for approval of new COVID-19 vaccines, that would almost certainly delay their emergency approval until after the November Presidential elections. Just hours after the rules were issued, United States President Donald Trump accused the FDA of […] Continue reading ->
Moderna intends to seek US Food and Drug Administration emergency authorization for its COVID-19 vaccine candidate for frontline medical workers by November 25th at the earliest, and only in late January for use in the general population.  That means that the vaccine, if approved on schedule, would only be available for widespread distribution to the […] Continue reading ->
As global stocks of remdesivir, one of the few promising therapeutics for COVID-19, run low, the drug’s maker Gilead Sciences says that voluntary licensing to enable more manufacturers to produce the drug will not help expand access, countering advocates’ calls.  Rather, the lack of a “coordinated global supply chain” is to blame for worldwide shortages […] Continue reading ->
The World Health Organization will establish a new high level review of the Organization’s capacity to respond todisease outbreaks in the framework of the International Health Regulations (IHR) that govern emergency response.  The aim is to ensure that WHO is “as effective as possible in operations as they unfold,” announced Director-General Dr. Tedros Adhanom Ghebreyesus […] Continue reading ->
There is insufficient evidence that treating people hospitalized for COVID-19 with blood plasma from recovered patients is safe and effective – and more randomized clinical trials are thus needed, warned the World Health Organization on Monday.  Evidence overall remains “inconclusive,” said WHO chief scientist Soumya Swaminathan at a WHO press conference on Monday.  She spoke […] Continue reading ->
Italy has become the first nation to require pharmaceutical companies to disclose secret data about any public subsidies it may have received for the development of a new drug, during negotiations over drug pricing and reimbursement with national regulatory authorities, according to a decree published Friday in the nation’s official gazette. The decree, following on […] Continue reading ->