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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
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
The FDA has published final guidance detailing ways for sponsors of complex generic drug products to improve their discussions with the agency, offering recommendations for requesting and conducting drug development meetings, pre-submission meetings and mid-review-cycle meetings. Read More