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AstraZeneca (AZ) and Amgen disclosed that their investigational asthma drug tezepelumab failed to achieve its primary endpoint of reducing dependence on oral corticosteroids while keeping asthma symptoms stable. Read More
The National Institutes of Health (NIH) has paused enrollment of critically ill COVID-19 patients in a phase 3 trial of various blood thinners, one of three international trials evaluating whether a full or lower dose of anticoagulants in hospitalized COVID-19 patients is more effective. Read More
Malvern, Pa.-based biotech Ocugen and India’s Bharat Biotech have agreed to work together to develop the Indian company’s COVID-19 vaccine for use in the U.S., a product that is already far along in clinical trials. Read More
Vaccine makers are currently evaluating if a new, highly contagious COVID-19 strain identified in the UK could slip past their shots, but Pfizer/BioNTech, Moderna and others are confident their vaccines will protect against the new mutation, which is likely already in the U.S. Read More
CanSino Biologics has enrolled more than 20,000 participants in a global phase 3 study of its COVID-19 vaccine candidate, Ad5-nCoV, co-developed with a research arm of the Chinese military. Read More
Oxford University released new trial data last week that raises further questions about the most effective dosing regimen for Oxford’s COVID-19 vaccine candidate, AZD1222, that is being co-developed with AstraZeneca and how it came to pass that two different dosing regimens were pursued. Read More
COVID-19 vaccine developers are faced with an ethical quandary — whether to let phase 3 trial participants become “unblinded” and to receive authorized vaccines as they become available, which could hinder the collection of meaningful trial data. Read More
Moderna has revealed that it was impacted by last week’s cyberattack on the European Medicines Agency (EMA), during which hackers compromised agency computer systems and accessed vaccine regulatory submission documents for Pfizer/BioNTech’s and Moderna’s COVID-19 vaccines. Read More