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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
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
Generic drugmaker Aurolife Pharma received an FDA warning letter for water leakage in its plant that affected batches of medicine, powder residue on surfaces that were supposed to have been cleaned, and impurities in a batch of medication. 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
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