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German drugmaker BioNTech and China’s Fosun Pharmaceutical Group have announced that the Pfizer/BioNTech COVID-19 vaccine candidate, BNT162b2, will be evaluated in a phase 2 study in China, building on an agreement the companies signed in March. Read More
The new head of the European Medicines Agency (EMA), Emer Cooke, said she is “hopeful” that the agency will grant a conditional marketing authorization for a COVID-19 vaccine by Christmas. Read More
The European Commission (EC) last week adopted an ambitious drug access strategy inspired by the COVID-19 pandemic that proposes allowing generics manufacturers to sidestep having to get patent permissions during public health emergencies. Read More
United Biomedical’s nonprofit vaccine subsidiary, Covaxx, said it has secured supply deals worth $2.8 billion for more than 140 million doses of its COVID-19 vaccine candidate, UB-612, in “multiple countries,” including Brazil, Ecuador and Peru. Read More
AstraZeneca’s COVID-19 vaccine candidate is facing another potential delay as the company plans to undertake a new global clinical trial to confirm the vaccine’s 90 percent efficacy based on a one-and-a-half-dose regimen. Read More
The rapid four-in-one diagnostic is used on the GeneXpert System, and its largest model can run up to 80 tests at a time and process approximately 2,000 tests daily, Cepheid said. Read More
The European Commission (EC) has entered into an advance purchase agreement with Moderna for up to 160 million doses of its COVID-19 vaccine candidate, mRNA-1273, which has demonstrated 94.5 percent efficacy in a phase 3 clinical trial. Read More
The U.S. is ready to distribute Pfizer’s COVID-19 vaccine despite its need for extremely cold temperatures, Gen. Gustave Perna, chief operating officer of Operation Warp Speed, said yesterday, adding that the company is taking a “very aggressive approach” to testing the distribution strategy. 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