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Pharma Companies Are Suspending Trials In Russia – But For Practical More Than Ethical Reasons

 
• By Andrew McConaghie

While pharma is keen to condemn Russia’s aggression, suspension of trials is driven by logistical considerations; US FDA said it stands ready to assist sponsors of disrupted trials in Russia and Ukraine to help ensure the safety of trial participants and integrity of the studies.

Kyiv Medical Supplies March 2022
Medical supplies at a territorial defense unit in Kyiv, Ukraine, 17 March. Pharma has resisted calls to stop medicines supplies to Russia, but the conflict and sanctions have forced many to halt trials in both Ukraine and Russia. • Source: Getty Images

Many of the pharma industry’s biggest companies have over the last week added to their condemnation of Russia’s invasion of Ukraine by declaring a halt to investment in the country and suspension of clinical trials.

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Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

 
• By Neena Brizmohun

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 
• By Eliza Slawther

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.

EU HTA Regulation: Don’t Forget About Vaccines, Industry Warns

 
• By Eliza Slawther

Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.

Industry Keen On ‘Stepwise’ PIPs, But Future Hinges On EU Pharma Legislation Reform

 
• By Eliza Slawther

Industry feedback on a European Medicines Agency pilot that introduced a “stepwise” approach to pediatric investigation plans was positive, but the future of the new model will depend on the outcome of the pharmaceutical legislation negotiations, the agency says.

More from R&D

EMA Initiative To Address Information Overload In CTIS Training Materials

 
• By Vibha Sharma

The European Medicines Agency has launched a phased initiative to consolidate the wide array of training materials for the Clinical Trials Information System, aiming to eliminate duplication, ensure consistency, improve accessibility and enhance user-friendliness.

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 
• By Anju Ghangurde

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.