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European officials cited Indian API maker Dishman Carbogen Amcis for serous quality failures found during an inspection of its facility in Gujarat. Read More
An FDA investigator found lapses in good manufacturing practices in an inspection of Time-Cap Laboratories’ drug manufacturing and repackaging facility in Farmingdale, New York. Read More
AstraZeneca will manufacture up to 30 million doses of Oxford University’s coronavirus vaccine by September if trials show it to be effective — and 100 million doses for global deployment by year’s end, the UK’s Secretary of State for Business Alok Sharma has announced. Read More
Moderna has reported positive early results from a phase 1 trial of its COVID-19 vaccine candidate, mRNA-1273, with all participants producing antibodies to the virus within 15 days of a single dose. It hopes to launch a phase 3 trial in July in an extremely expedited time frame. Read More
The National Institutes of Health (NIH)’s public-private partnership to work on COVID-19 has decided on six existing treatments to evaluate in trials later this month, and said it looks to have vaccine candidates ready for trials by the start of July. Read More
Trials of pulmonary/respiratory, neurology and rheumatology therapies have the lowest representation of African Americans and other ethnic minorities, while Hispanic/Latinx populations are the most underserved in pivotal oncology trials. Read More
The FDA has turned down a new drug application from Blueprint Medicines for Ayvakit (avapritinib) for treatment of adults with unresectable or metastatic fourth-line gastrointestinal stromal tumor (GIST). Read More