Coronavirus Notebook: EMA Publishes Veklury Clinical Data, Head Of UK Vaccines Taskforce Comes Under Fire

Transparency is the order of the day as Médecins Sans Frontières calls for more disclosure on vaccine deals signed by Sanofi/GSK and other companies. 

Data Transfer
Transparency of data is key where COVID-19 products are concerned • Source: Shutterstock

In two initiatives intended to increase the transparency of its coronavirus activities, the European Medicines Agency has published the clinical data that was used to support the EU marketing authorization of Gilead Sciences, Inc.’s Veklury (remdesivir) for COVID-19, and produced a list of all candidate medicines and vaccines on which the EMA has given advice on companies’ development plans.

The remdesivir data package consists of 64 documents and is available on the EMA’s clinical data website

More from Vaccines

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.

US FDA Vaccine Framework Coming In Weeks, But Details Vague

 

New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 

At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

More from Pink Sheet

EU Shaping Biotech Act To Unleash SME Potential

 

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

New EU Filings

 

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By 

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.