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Roche reported that its arthritis drug Actemra (tocilizumab), when paired with the antiviral remdesivir (Veklury) from Gilead Sciences, did not meet the endpoint of improved time to hospital discharge for patients with severe COVID-19 pneumonia. Read More
As part of an industry-wide FDA review, the agency’s Oncologic Drugs Advisory Committee will convene next month to discuss six cancer indication approvals given under the agency’s Accelerated Approval program that haven’t verified their clinical benefit in confirmatory trials as required. Read More
Pfizer and BioNTech announced yesterday that their vaccine was 94 percent effective in preventing asymptomatic COVID-19 infection, based on real-world data from Israel, indicating it could greatly reduce transmission from person to person. Read More
The European Commission (EC) granted Johnson & Johnson (J&J)’s COVID-19 vaccine a conditional marketing authorization yesterday, giving the 27-member bloc a desperately needed alternative as the region faces serious supply delays for previously authorized shots. Read More
A number of EU countries have temporarily put AstraZeneca (AZ) vaccinations on hold after some patients given the shot formed blood clots, but the European Medicines Agency (EMA) said it has no reason to believe the vaccine is responsible. Read More
Nearly two months into the Biden administration, the president has still not nominated a permanent FDA commissioner or spoken publicly on who he’s considering, and a group of six former agency heads are imploring him to prioritize the task. Read More
Moderna has announced that it has begun dosing trial participants with a modified COVID-19 vaccine meant to target the variant SARS-Cov-2 strain first identified in South Africa. Read More
Fresh off the FDA’s March 1 authorization of Johnson & Johnson’s (J&J) single-shot vaccine, President Biden announced that the U.S. has secured an additional 100 million doses of the shot, doubling its original supply agreement with the company. Read More