Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Dec 2021
EMA's drug safety committee (PRAC) confirmed the risks of of myocarditis and pericarditis with COVID-19 messenger RNA (mRNA) vaccines.
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Roche awarded 2022 Drug Discovery of the Year for Evrysdi®
The development team behind Roche’s Evrysdi® (risdiplam), the first mRNA splicing modifier to be approved, have been honoured with the BPS’s Drug Discovery of the Year Award 2022.
Novel platform technology to enhance in-process monitoring of cell biomanufacturing
A new microfluidics tool, the Dynamic Sampling Platform, could improve biomanufacturing of cell therapies by reducing the cost of analysing bioreactor contents.
Astellas and Dyno Therapeutics to develop AAV gene therapy vectors
Astellas and Dyno Therapeutics will develop adeno-associated virus (AAV) vectors for gene therapy directed to skeletal and cardiac muscle.
EMA initiates rolling review of Valneva’s COVID-19 vaccine (VLA2001)
The European Medicines Agency (EMA)'s human medicines agency (CHMP) begins a rolling review of Valneva's COVID-19 vaccine VLA2001 following positive preliminary results.
MHRA approves Xevudy (sotrovimab) to treat COVID-19
The Medicines and Healthcare products Regulatory Agency (MHRA) approve sotrovimab for people with mild to moderate COVID-19 infection and at least one risk factor for developing severe illness.
Sanofi to acquire Origimm Biotechnology to develop acne vaccine
Sanofi has entered into an agreement to acquire Origimm Biotechnology to add a potential first-in-class vaccine for acne to their pipeline.
CHMP issue positive opinion on Comirnaty® for five to 11 year olds
The human medicines committee issue a positive opinion on the COVID-19 vaccine Comirnaty® in children aged five to under 12 years.
NICE recommends osimertinib for non-small cell lung cancer (NSCLC)
Over 600 people may benefit as NICE publishes final draft guidance recommending osimertinib within the Cancer Drugs Fund.
Amgen named to Dow Jones Sustainability World Index for eighth year
Amgen ranks in top 10 percent of biotech companies and demonstrates strengths in business ethics, philanthropy and environmental reporting.
FDA approves new imaging drug to identify ovarian cancer lesions
The US Food and Drug Administration (FDA) approves Cytalux to help identify cancerous lesions during ovarian cancer surgery.
EC approve Zeposia® to treat ulcerative colitis
The European Commission (EC) has granted Zeposia® (ozanimod) a marketing authorisation to treat people with ulcerative colitis.
AZD7442 reduces COVID-19 risks by 83 percent in Phase III trial
A separate treatment trial showed 88 percent reduced risk of severe COVID-19 or death when treated within three days of symptom onset.
Sanofi invests $180 million in Owkin’s AI to advance oncology pipeline
Sanofi invests $180 million equity in Owkin’s artificial intelligence (AI) and federated learning to advance oncology pipeline.
NICE recommends risdiplam for spinal muscular atrophy
The new draft guidance recommends Evrysdi (risdiplam) to treat spinal muscular atrophy as part of a managed access agreement (MAA).