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Sponsors and manufacturers will have to provide the FDA an annual summary of their compassionate use drug administration under a proposed agency rule released yesterday. Read More
Since February, the FDA has approved nearly 300 manufacturing changes to help speed drugs to market for COVID-19 patients, FDA Commissioner Stephen Hahn said this week. He was touting the agency’s prompt response to the pandemic. Read More
Pfizer confirmed that it plans to charge $19.50 per dose of its COVID-19 vaccine in the U.S., with a total cost of about $40 for a two-dose regimen. Read More
Signa, a Mexican subsidiary of Canadian generic drugmaker Apotex, has received an FDA warning letter for failure to correct manufacturing problems for active pharmaceutical ingredients (API) that were later released into the U.S. market. Read More
Gilead Sciences said it is buying a 49.9 percent stake in Tizona Therapeutics, a company developing first-in-class cancer immunotherapies, for $300 million in a transaction expected to close in the third quarter of this year. Read More
HHS and the Department of Defense have signed their largest deal to date under Operation Warp Speed — a $1.95 billion contract with Pfizer and BioNTech for large-scale production and nationwide delivery of 100 million doses of their COVID-19 vaccine. Read More