Regulators recommend remote inspections for use post-pandemic
A review of remote regulatory inspections has recommended that they be used in conjunction with on-site visits to enable GxP oversight post-pandemic.
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Beovu® shows positive results in two-year Phase III trial
Beovu® maintained best-corrected visual acuity (BCVA) and reduced central subfield thickness (CSFT) in diabetic macular edema patients.
EMA recommends RoActemra in adults with severe COVID-19
The European Medicines Agency (EMA)’s human medicines committee (CHMP) recommends extending RoActemra's indication to include COVID-19 patients receiving systemic treatment.
FDA authorises Evusheld for COVID-19 prevention
The US Food and Drug Administration (FDA) issued an emergency use authorisation for AstraZeneca’s Evusheld for the pre-exposure prophylaxis of COVID-19.
Digital pill tracks HIV prevention pill adherence with 98 percent accuracy
Scientists found digital pill systems to be a 98 percent accurate intervention to help men adhere to pre-exposure prophylaxis (PrEP) regimens.
AstraZeneca and Ionis to develop and commercialise eplontersen
AstraZeneca has entered into a new global development and commercialisation agreement with Ionis Pharmaceuticals for eplontersen.
Six COVID-19 boosters are safe and effective, shows Phase II study
Study finds six different COVID-19 vaccine boosters increase immunity and pose no safety concerns, although immune responses varied.
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Dec 2021
EMA's drug safety committee (PRAC) confirmed the risks of myocarditis and pericarditis with COVID-19 messenger RNA (mRNA) vaccines.
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.