Novavax has acquired Czech Republic-based Praha Vaccines, a unit of Cyrus Poonawalla Group for about $167m. The transaction covers a biologics manufacturing facility and related assets in Bohumil, Czech Republic. It is estimated that the acquired facility will enable an annual capacity of more than one billion doses of antigen for Novavax’s Covid-19 vaccine candidate, NVX‑CoV2373, from next year.
Roche has started a Phase III clinical trial of its Actemra/RoActemra (tocilizumab) in combination with Gilead Sciences’ remdesivir to treat hospitalised patients with severe Covid-19 pneumonia. Expected to commence enrolment next month, the trial will enrol around 450 patients worldwide.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has paused the international COPCOV clinical trial of hydroxychloroquine led by the University of Oxford amid safety concerns, as reported Reuters. The French government and regulatory authorities also banned the use of hydroxychloroquine as an experimental treatment for Covid-19 and halted trials of the anti-malarial.
The European Medicines Agency (EMA) is working to establish an infrastructure to effectively track Covid-19 vaccines in the real world. The EMA has signed a contract with Utrecht University and Pharmacovigilance Research Network to carry out preparatory research into data sources and approaches for monitoring the safety, effectiveness and coverage of Covid-19 vaccines in clinical practice.