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AstraZeneca has nabbed an HHS contract worth up to $1.2 billion to speed development and production of the University of Oxford’s promising COVID-19 vaccine candidate. The deal also would lock in the distribution of 300 million doses of the vaccine for the U.S. Read More
In observance of the Memorial Day holiday, Drug Industry Daily will not be published Monday, May 25. The next issue will be published Tuesday, May 26. Read More
The FDA hit a Paterson, New Jersey contract testing laboratory with a warning letter for active pharmaceutical ingredient (API) testing violations. Read More
Covis Pharma has begun a phase 3 trial of its approved asthma drug Alvesco (ciclesonide) in non-hospitalized COVID-19 patients ages 12 years and older. Read More
The World Health Organization (WHO) has adopted a resolution calling for the voluntary sharing of patent rights and product data for COVID-19 countermeasures. Read More
HHS is defending the bidding process that led to its $354 million four-year contract with a Virginia-based startup to manufacture active pharmaceutical ingredients (APIs) and finished drugs for emergency situations. Read More
Two senior FDA officials have recused themselves from involvement in agency approval decisions for coronavirus therapeutics or vaccines due to their oversight roles in the administration’s new COVID-19 research initiative. Read More
The FDA hit California drugmaker Blaine Labs with a warning letter for serious violations at its Santa Fe Springs facility, including the failure to investigate out-of-specification (OOS) test results. Read More