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EMA on COVID-19: 'Fast-Tracking Does Not Mean Cutting Corners'

Agency Insists Safety And Efficacy Are Paramount

 
• By Ian Schofield

EMA advises caution on COVID-19 vaccine timelines, but says the outlook is more promising for new treatments.  

EU_Flag_Covid19
The EU's regulator explains its outlook on COVID-19 drug and vaccine development • Source: Shutterstock

The first treatments for COVID-19 could be granted a marketing authorization in the EU as soon as the summer if clinical trial results are positive, but a vaccine is unlikely to be available for another year, according to top executives at the European Medicines Agency.

Using fast-track mechanisms to speed up the development of coronavirus therapeutics and vaccines did not equate to “cutting corners” with...

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EMA Mapping RWD Landscape To Bridge Evidence Gap For Duchenne Drugs

 
• By Vibha Sharma

A new EU study will assess the potential of existing Duchenne muscular dystrophy patient registries and other real-world data sources to address regulatory questions for emerging therapies.

EU Pharma Package: Keep Patients Front & Center In Defining Unmet Medical Need

 
• By Francesca Bruce

EU trilogs on the new pharmaceutical legislation will finalize the role patients will take in influencing the development of a new definition of unmet medical need.

Defining Unmet Medical Need: EU Debate Sparks Concern Over Innovation And Access

 
• By Francesca Bruce

Revision of the EU’s pharmaceutical legislation will include a new definition of unmet need, but getting it wrong could have unintended consequences for pricing and reimbursement.

‘Urgent Need’ To Scale Up Advice Slots Under EU HTA Regulation – EUCOPE

 
• By Eliza Slawther

European regulators could investigate alternative ways of offering early advice to companies in relation to the Health Technology Assessment Regulation, given that official scientific advice slots are limited, a senior figure at EUCOPE says.

More from Geography

CDC Should Boost Vaccine Monitoring Transparency, Communication - National Academies Report

 
• By Sue Sutter

The Immunization Safety Office leveraged a “coordinated network of complementary surveillance systems” to monitor COVID-19 vaccine risks during the pandemic, but its communications faced challenges and were often intertwined with CDC efforts to promote vaccination, NASEM report finds.

Galderma’s Post Hoc Analysis Supports Nemluvio Claims But Clearer Disclosures Needed, NAD Says

 
• By Cathy Kelly

Claims for the dermatological appearing on websites and social media were challenged by Dupixent marketer Sanofi. Galderma said it would comply with the National Advertising Division’s recommendations, a move that underscores the challenging times for DTC advertisers.

India’s R&D Financing Effort: Catalytic To De-Risking Early Innovation?

 
• By Anju Ghangurde

India rolls out amended R&D financial assistance plan targeting certain ‘priority areas’ and calls for proposals from industry and startups. While the corpus is modest, the scheme hopes to enable the ‘Innovate in India’ ecosystem and includes a co-funding provision.