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The FDA released guidance for sponsors of drugs for treatment of life-threatening ailments seeking approval under the agency’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) program. Read More
Almost three dozen state attorneys general have called on the federal government to bypass Gilead Sciences’ remdesivir patents and begin producing the COVID-19 treatment. Read More
Massachusetts-based Partner Therapeutics has secured a $35 million contract from the Department of Defense for clinical trials of inhaled Leukine (sargramostim) for the treatment of COVID-19 patients with acute hypoxemia. Read More
Moderna is offering its COVID-19 vaccine candidate at $32 to $37 per dose for smaller-scale supply agreements, the company’s CEO Stéphane Bancel said Wednesday. Read More
Johnson & Johnson (J&J) has secured a $1 billion contract from the U.S. government to manufacture 100 million doses of its COVID-19 vaccine candidate Ad26.COV2.S. Read More
The FDA hit Las Vegas compounder ACRx Specialty Pharmacy for poor aseptic practices and other GMP failures observed during an inspection last year. Read More