News from the World of Clinical Research

ONLY 2 WEEKS to go until Ethics & GCP Forum - Thursday 18th March

With only 2 weeks to go until our biannual Ethics & GCP Forum, places are filling up fast!

This Forum will be running online via Zoom.

BOOK NOW to avoid disappointment while limited spaces are ava…

Moderna, Pfizer ready multi-pronged plans for coronavirus variants

• Moderna and Pfizer are progressing plans to test additional booster shots or modified vaccines tailored to a coronavirus variant originally detected in South Africa, the companies said in separate an…

ICON to acquire PRA Health Sciences in $12bn deal

Dublin-based clinical trials group ICON is set to acquire rival contract research organisation (CRO) PRA Health Sciences in a deal worth approximately $12bn.

What you need to know about the coronavirus right now

Europe reviewing Russia’s COVID-19 vaccine

Europe’s medicines regulator said on Thursday it has started a review of the Sputnik V COVID-19 vaccine developed by Russia’s Gamaleya Institute for possible…

COVID-19 collaborations could ‘unlock’ the potential of the UK’s life sciences sector

A new report by Novartis UK has recommended continuing collaboration across the life sciences sector in the UK after identifying enhanced collective efforts to address the COVID-19 pandemic.

Evidence looks good on COVID vaccines cutting transmission: UK minister

LONDON (Reuters) - The evidence indicates that vaccines are proving effective at cutting the transmission of COVID-19, Britain’s vaccines minister said on Monday ahead of a government announcement on …

Pfizer, BioNTech ask FDA approval to ease temperature requirements for coronavirus shot

• Pfizer and BioNTech on Friday asked the Food and Drug Administration to authorize storage of their COVID-19 vaccine at temperatures between minus 15 and minus 25 degrees Celsius for up to two weeks. …

Ethics & GCP Forum - Updated Agenda!

UPDATED AGENDA

Agenda 

09:30 Online Registration/Dial-in

10:00 Welcome

           Ethics Forum

10:10 MHRA Update incl. Brexit

           Kirsty Wydenbach, Deputy Unit Manager / Senior Medical Assessor…

A gene therapy pipeline takes shape for a cluster of rare diseases

The toxic globules of sugar and fat slowly pile up in the body's cells, accumulating in blood vessels and in major organs like the kidney and heart.

CureVac’s COVID-19 vaccine begins rolling review with EMA

German biopharmaceutical company CureVac has announced the initiation of a rolling review with the European Medicines Agency (EMA) for its mRNA-based COVID-19 vaccine, CVnCoV.

In surprise finding, Roche arthritis drug cuts risk of COVID-19 death in large UK study

• An anti-inflammatory drug from Roche cut the risk of death in patients hospitalized with severe COVID-19, investigators in a massive British trial known as RECOVERY reported Thursday, a definitive fi…

Multiple rolling reviews kick-off for Novavax’s COVID-19 vaccine

Rolling reviews of Novavax’s COVID-19 vaccine have kicked-off in the UK, US, EU and Canada following the recent announcement that the jab demonstrated 89.3% efficacy in a phase III trial.

Ethics & GCP March 2021 Open for Bookings

The ICR Ethics & GCP Forum
Thursday 18th March 2021

Venue: This forum will run virtually online via Zoom