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HPS2-THRIVE Post-Mortem: Lessons Learned For CV Drug Developers

 
• By Emily Hayes

While risks clearly outweigh benefits for niacin as an add-on therapy in the more than 25,000-patient HPS2-THRIVE study, investigators argue that the door is still open for other HDL-raising drugs. One panelist at the ACC meeting where results were presented calls for smaller, more targeted trials in the future.

SAN FRANCISCO – Full results from the HPS2-THRIVE study of Merck & Co. Inc.’s Tredaptive have heightened scrutiny about outcomes studies for cardiovascular drugs and may lead to changes in the way these studies are designed.

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Major Analysis To Help MHRA Fill Gaps In UK Clinical Trials Landscape

 
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A first-of-its-kind review of clinical trial applications submitted to the UK medicines regulator, the MHRA, shows there is a concentration of research in certain disease areas and identifies opportunities to enhance the representation of specific patient groups.

Industry Urged To Respond To EU Expectations On Using Animal Testing Alternatives

 
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Industry Benefits As EU CTIS Hits Global Data Sharing Milestone

 
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The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.

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Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth

UK Promises To ‘Turbocharge’ Clinical Trials As US Tariff Threat Remains

 
• By Andrew McConaghie

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Industry Urged To Respond To EU Expectations On Using Animal Testing Alternatives

 
• By Eliza Slawther

The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.