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President Trump signed a stopgap funding bill Friday that averts a government shutdown until the end of the week and keeps the FDA at its current fiscal 2020 funding levels. Read More
AstraZeneca (AZ) will soon launch a study evaluating a double-dose regimen of its COVID-19 candidate AZD1222 in combination with adenovirus-based vaccine Sputnik V, developed by Russia’s sovereign wealth fund and using the same technology as the AZ vaccine. Read More
Sanofi and GlaxoSmithKline (GSK) have decided to push back the phase 2b trial of their adjuvanted COVID-19 vaccine after finding it produced only a weak immune response in older patients, delaying the potential delivery of a vaccine that could contribute to the mass vaccination effort in the U.S. Read More
The first U.S. COVID-19 vaccinations are to be given today using Pfizer/BioNTech’s vaccine, following the announcement late Friday that the FDA had granted the first emergency clearance for a coronavirus vaccine, a pivotal and unprecedented moment in the battle against the pandemic. Read More
Gilead Sciences has announced plans to purchase German biotech firm MYR GmbH for an estimated $1.4 billion (€1.15 billion), with the potential for additional milestone-based payments of up to $364.3 million (€300 million). Read More
The FDA said Thursday that it has developed a test for COVID-19 in fecal matter, in an attempt to prevent the disease from being inadvertently transmitted during fecal transplantation. Read More
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