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It seems like every week another large biopharmaceutical company announces a new relationship with a cell and gene therapy (CGT)-focused company, if not an outright acquisition — often for stunning amounts. Read More
AstraZeneca’s COVID-19 vaccine candidate will undergo increased scrutiny by regulators because of the promising but confusing interim analysis results from a late-stage trial that found a one-and-a- half-dose regimen — given by mistake — was significantly more effective than a full double dose. Read More
The FDA yesterday issued a final guidance outlining the process for sponsors and researchers to submit plans for new drug development tools (DDT) to the agency for approval. Read More
AstraZeneca’s (AZ) and the University of Oxford’s COVID-19 vaccine candidate — which has been shown to be 90 percent effective at a one-and-a-half-dose level — could be a godsend for low- and middle-income nations due to its relative ease of distribution, high manufacturing capacity and the not-for-profit price the drugmaker has vowed to offer developing countries “in perpetuity.” Read More
As the countdown begins toward an eagerly anticipated FDA authorization for Pfizer’s COVID-19 vaccine candidate, an advisory committee of the Centers for Disease Control and Prevention (CDC) is meeting today to discuss the phased distribution of coronavirus vaccines. Read More
The UK researchers also found that AbbVie’s HIV antiviral Kaletra (lopinavir/ritonavir) provided no benefit for critically ill COVID-19 patients. Read More
Russia’s Gamaleya Research Institute has reportedly resumed dosing in a phase 3 trial evaluating its COVID-19 vaccine, Sputnik V., but a Russian government spokesperson denies that the study was ever paused. Read More
The Roche Group’s rheumatoid arthritis drug Actemra (tocilizumab) was found to reduce mortality and improve outcomes for high-risk COVID-19 patients, according to researchers from the UK’s Imperial College London. Read More
Researchers at the University of Oxford expect to report results from their phase 3 trials of AstraZeneca’s (AZ) COVID-19 vaccine candidate, AZD1222, before Christmas, the study’s leader said. Read More
The company joins a large wave of biotech firms exploring cell and gene therapy delivery systems for patients with cancer and other incurable diseases. Read More
Both Moderna’s and Pfizer’s COVID-19 vaccine candidates could receive Emergency Use Authorization (EUA) in less than a month and be ready for rollout in a matter of weeks, HHS Secretary Alex Azar said Wednesday, giving hope that high-risk patients could receive a vaccine before the year ends. Read More