Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

French Trial Tragedy: Who Says What Data Should Be Published?

This article was originally published in Scrip

Executive Summary

While French government inspectors pore over the results of their recent visit to the premises of Biotrial, the CRO that ran the ill-fated Phase I study with the FAAH inhibitor BIA 10-2474, the regulatory agency ANSM has revealed that the product's developer, Bial, has opposed the publication of the preclinical documentation on the drug.

You may also be interested in...



Rerouting Drug Supplies ‘A Priority’ After Brexit Transition Ends

Pharmaceutical companies in the UK have again been asked to ensure they have contingency measures in place to deal with potential supply problems at channel ports – this time in preparation for the UK’s formal departure from the EU’s single market and customs union at the beginning of 2021. The industry is continuing to push for a mutual recognition agreement on drug regulation.

Coronavirus Notebook: A UK Catapult, A Russian Vaccine, And A Cuban Therapy

The UK BioIndustry Association has welcomed the government’s fresh investment in COVID-19 vaccine manufacturing capacity, while Sanofi and GSK are striking European and US deals for their vaccine candidate. A number of potential therapies are also being developed, including products based on interferon and hyperimmune globulin, but Roche/Chugai’s Actemra (tocilizumab) looks like a non-runner.

‘Onshoring’ Not The Way To Tackle UK Coronavirus-Related Demand

A parliamentary committee has come up with some ideas for strengthening the UK’s response to future demand surges due to the spread of COVID-19.

Topics

UsernamePublicRestriction

Register

SC027449

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel