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Even in the midst of the COVID-19 pandemic, not all vaccine news has to do with the coronavirus: Pfizer said this week that the FDA has accepted for priority review a biologics license application (BLA) the company filed for its vaccine against a form of streptococcus that can lead to fatal infections. Read More
Johnson & Johnson (J&J) has cut enrollment from 60,000 to 40,000 for its global phase 3 ENSEMBLE 1 trial evaluating COVID-19 vaccine candidate JNJ-78436735 as a single-dose regimen. Read More
Moderna has begun dosing adolescents in a phase 2/3 trial evaluating messenger RNA-based vaccine candidate mRNA-1273 and plans to enroll 3,000 U.S. participants aged 12 to 17. Read More
The FDA is very likely to grant Emergency Use Authorization (EUA) for Pfizer’s COVID-19 vaccine following a 17-4 advisory committee vote (with one abstention) Thursday in support of emergency clearance, meaning vaccinations of high-risk patients could start as soon as this weekend. Read More
Sinopharm, a state-owned Chinese drugmaker, has received full approval from the United Arab Emirates (UAE) for its inactivated COVID-19 vaccine, making the UAE the first nation outside China to grant such approval. Read More
The advocacy group Public Citizen said Wednesday that it had written to the HHS’ Office of Inspector General urging it to “investigate the unprecedented and inappropriate close collaboration” between the FDA and Biogen over the company’s biologics license application (BLA) for approval of the potential blockbuster Alzheimer’s drug aducanumab. Read More
Azurity Pharmaceuticals downplayed the serious risks and overstated the benefits of its leukemia drug Xatmep (methotrexate) oral solution in the text of a promotional email sent to healthcare professionals, according to a Nov. 24 “untitled letter” from the agency’s Office of Prescription Drug Promotion (OPDP). Read More
The University of Oxford has attempted to clarify the dosing error it and AstraZeneca (AZ) made in a clinical trial assessing COVID-19 vaccine AZD1222, following divergent reports between the two of what exactly transpired. Read More
With FDA emergency authorization seeming very likely for Pfizer’s COVID-19 vaccine within days, all 50 states and U.S. territories have finalized their individual “microplans” for distribution and administration, according to an Operation Warp Speed official. Read More