Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021
The EMA’s drug safety committee (PRAC) reviewed COVID-19 vaccine risks and issued a new safety signal for Imbruvica with rituximab.
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The EMA’s drug safety committee (PRAC) reviewed COVID-19 vaccine risks and issued a new safety signal for Imbruvica with rituximab.
Pfizer’s RENOIR Phase III trial will evaluate the efficacy, immunogenicity and safety of their respiratory syncytial virus (RSV) vaccine.
Fostamatinib significantly reduced serious adverse effects and risk of death in hospitalised COVID-19 patients, shows Phase II study.
The investigational vaccine tested in sub-Saharan Africa posed no safety concerns but did not provide sufficient HIV protection.
WHO urges supply chain stakeholders to be vigilant, after falsified Covishield COVID-19 vaccines were identified in Uganda, India and Myanmar.
CPI have launched an RNA Centre of Excellence in Darlington to boost development, scale-up and manufacture of RNA therapies and vaccines.
Here, EPR explores some highlights of the UK’s new Life Sciences Vision for the pharma, biopharma and biotech industries, covering topics from funding to regulatory reviews and clinical trial innovation.
Pfizer and BioNTech will submit a supplemental biologics licence application to the FDA for booster dose of COVID-19 Vaccine Comirnaty.
Nathalie Moll, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) gives her take on the industry response to the pandemic; highlighting the benefits of focused effort and what can be achieved through unified collaboration.
Advanced therapies are a ground-breaking new class of medicines that use gene therapy, cell therapy or tissue engineering to treat disease and injury. Rachel Bell, Trainee Patent Attorney at Marks & Clerk, and Ceri Roberts, Scientific Training Manager – Cellular and Molecular Therapies at NHS Blood and Transplant, discuss some…
The CHMP has adopted recommendations to increase manufacturing capacity and supply of COVID-19 Vaccines Comirnaty and Moderna in Europe.
Pfizer and BioNTech's vaccine is the first to be approved by the FDA for the prevention of COVID-19 in people aged 16 years and older.
Zydus’ ZyCoV-D received emergency use authorisation (EUA) in India, becoming the world’s first plasmid DNA vaccine for COVID-19.
AstraZeneca’s AZD7442 reduced the risk of developing symptomatic COVID-19 by 77 percent in PROVENT Phase III study.
The MHRA have approved Ronapreve as the first monoclonal antibody combination product for the treatment of COVID-19 infection in the UK.