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. It includes...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Vaccines

Pink Sheet Podcast: CBER Director’s Political Spin On COVID-19 Vaccines And US FDA RIFs Finalized

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad using an unproven theory to help explain his COVID-19 vaccine decisions and the impact of the recently finalized reduction-in-force at the FDA.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.

Valneva Expects UK And France to Lift Ixchiq Age Restriction Following EMA Decision

 

Other authorities are expected to mirror the European Medicines Agency’s decision to lift the temporary restriction it placed on using Valneva’s chikungunya vaccine in people aged 65 years and older.

Senate Panel Approves US CDC Director Candidate Monarez With Measles Outbreak Growing

 
• By 

The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.

More from Pink Sheet

Sponsors Asked, EMA Delivered: One Handbook To Navigate CTIS

 
• By 

The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.

Will Tidmarsh’s Industry Experience Translate As US FDA’s Chief Drug Regulator?

 

The long-time industry executive led several drug approvals but may have a lot to learn about the intimate details of application review and the Center for Drug Evaluation and Research.

Don’t Look Back: US FDA AdComm Offers No Flexibility For Rexulti’s Post Hoc Bid In PTSD

 

The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder based on conflicting Phase III trials and post-hoc Phase II analyses.