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More than 100 nongovernmental organizations (NGOs) have urged the World Trade Organization (WTO) to extend a waiver of intellectual property rights to help developing nations access COVID-19 treatments and vaccines during the pandemic. Read More
The FDA is unlikely to help Merck’s chances of getting a positive recommendation from the agency’s Oncology Drugs Advisory Committee today for its blockbuster drug Keytruda (pembrolizumab) for a new indication. Read More
Former FDA Commissioner Stephen Hahn is voicing support for making the FDA its own federal agency independent of HHS and for enacting protective measures against political interference. Read More
Moderna President Stephen Hoge explained that one of the capacity constraints beyond the amount of drug product available is how many vials that can be filled in a given period. Read More
COVAX officials say 240 million doses of the AstraZeneca/Oxford University vaccine will be distributed by the Serum Institute of India during the first half of the year. Read More
The FDA has revised its Emergency Use Authorization (EUA) for COVID-19 convalescent plasma, allowing only plasma with high antibody titers and only for hospitalized patients with early infections or patients with impaired immunity. Read More
The European Medicines Agency (EMA) is reviewing Eli Lilly’s antibody cocktail as a potential treatment for COVID-19 patients who don’t require supplemental oxygen and are at high risk of progressing to severe disease. Read More
As U.S. vaccinations against COVID-19 gain momentum, health officials are using new tools to gather postmarket safety data, including a new early warning system called V-Safe. Read More
The FDA intends to publish draft guidance in the next several weeks outlining the data it will require for modifying authorized vaccines to address new COVID-19 viral variants, according to FDA Acting Commissioner Janet Woodcock. Read More
Consulting giant McKinsey has agreed to pay $573.9 million to settle a lawsuit brought by the attorneys general of 49 states, the District of Columbia and five U.S. territories over work it did for opioid painkiller manufacturers. Read More
The COVAX vaccine program aims to distribute almost 340 million vaccine doses during the first half of the year, according to its latest distribution plan unveiled yesterday. Read More
Moderna said it is in discussions with the FDA over a proposal to fill its COVID-19 vaccine vials with up to 50 percent more doses to help increase the pace of inoculations in the U.S. Read More