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Coronavirus Update: iSPOCs, Fake Drugs & Data Protection Concerns

 
• By Ian Schofield

In addition to our daily in-depth coverage of key events relating to the COVID-19 pandemic, we’re bringing you a periodic round-up of other developments. This edition covers events at EU and member state level, as well as initiatives by international regulators.

Covid19_Stamp_WorldMap
National actions continue in an effort to stem the spread of the coronavirus • Source: Shutterstock

With the pandemic continuing its deadly spread, individual countries are taking steps to address the growing number of COVID-related drug shortages, and regulator-industry cooperation is the order of the day. The increased risk of fake and unlicensed medical products has been highlighted, as have concerns about the data protection aspects of using technology to understand the spread of the coronavirus.

Supplies of vital medicines used for treating hospitalized COVID-19 patients are beginning to run dry in some EU member states....

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US Tariffs And The EU’s Critical Medicines Act: Lessons On Nearshoring And CMO Diversification

 
• By Francesca Bruce

Nearshoring production and diversifying contract manufacturing networks can help companies stave off cost increases that will be reflected in higher medicine prices.

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• By Vibha Sharma

Eli Lilly and PharmaMar were set to make their case before the European Medicines Agency this week as part of re-examination procedures for their respective drugs Kisunla and Aplidin.

Gilead’s Lenacapavir Up For EMA Verdict Amid Packed CHMP Meeting Agenda

 
• By Vibha Sharma

The European Medicines Agency’s, human medicines committee, the CHMP, is this week poised to issue opinions on potential marketing approvals for 17 products.

Gene Therapy Elevidys Among Six Orphan Drugs Awaiting EU Marketing Verdict

 
• By Vibha Sharma

The European Medicines Agency is expected to decide whether to recommend EU-wide marketing authorization for six orphan-designated medicines that are all already approved in the US.

More from Geography

EMA Poised To Decide On Fate Of Lilly’s Kisunla And PharmaMar’s Aplidin In EU

 
• By Vibha Sharma

Eli Lilly and PharmaMar were set to make their case before the European Medicines Agency this week as part of re-examination procedures for their respective drugs Kisunla and Aplidin.

After Sarepta Reversed Course On Elevidys, Could An Adcomm Be Next?

 
• By Derrick Gingery and Mandy Jackson

One option for the FDA going forward could be holding an advisory committee meeting on its safety concerns after Sarepta agreed to stop all shipments of its DMD gene therapy.

Advocates Want New Bipartisan PBM Reform Package To Stand Alone

 
• By Leslie Small

A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.