AstraZeneca's phase 3 COVID-19 vaccine trial remains on hold in the US as the FDA probe into a patient illness in the UK trial that initiated the global pause continues, the US Department of Health and Human Services Secretary, Alex Azar, told US...
Johnson & Johnson has launched its pivotal global Phase 3 trial for its COVID-19 vaccine candidate: anticipating the first batches of its vaccine will be available for emergency use authorization in early 2021.
Catalent recently announced that it is investing US$130m in an expansion project at its viral vector manufacturing facility located in Harmans, Maryland, with five new manufacturing suites set to respond to a growing customer pipeline and market demand.
Viral vector production capacity has become increasingly constrained in recent years due to increases in the therapies in development, the dosages given and the patient populations targeted. COVID-19 is exacerbating the situation.
Recognizing the industry-wide need to improve adeno-associated virus (AAV) vector manufacturing, Applied Genetic Technologies Corporation (AGTC) has adopted changes intended to increase yield and purity.
Naturally occurring viral vectors of human liver origin may be more effective than vectors grown in cultured lab conditions for liver gene therapy, according to a study published in Science Translational Medicine this month.
A project run by Gavi, the vaccine alliance, and the World Health Organization (WHO) to guarantee fair access to COVID-19 vaccines worldwide, has secured the backing of 64 higher income countries, with more set to sign up in the coming days.
AstraZeneca paused its COVID-19 vaccine trial earlier this month for a safety review – generating headlines across mainstream press worldwide. Such pauses are not uncommon in clinical trials – so what’s the best way to deal with them?
This month marks a major US milestone for biosimilar medicines as five years ago, September 2015, saw the first biosimilar made available to US patients – the Sandoz developed Zarxio (filgrastim-sndz).
Sanofi and GSK will provide the EU with up to 300 million doses of their COVID-19 vaccine candidate, with the agreement suppporting scale-up of manufacturing capabilities in several European countries.