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Cholesterol Guidelines Look High And Low: Statin Market Extended At Both Ends

 
• By Emily Hayes

In shifting away from specific targets and non-statin add-on therapies, new ACC/AHA cholesterol guidelines support treatment of people at relatively low risk for events and more intensive therapy for those at higher risk.

New cholesterol guidelines should expand the statin market from two directions: by pushing aggressive treatment for higher-risk patients and by extending recommendations for treatment to include patients at lower risk than previous versions.

Developed by the American Heart Association and the American College of Cardiology, the guidelines move away from numerical LDL cholesterol...

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• By Vibha Sharma

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US FDA Rare Disease Hub RISEs After Slow Start

 
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The first “Rare disease Innovation, Science and Exploration (RISE) meeting to discuss the choice of control arms for studies in small populations will be Sept. 3 after plans were delayed by ongoing changes at the FDA.

Cancer Drug Combos: US FDA Guidance Offers Options Beyond Factorial Trials

 
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Acknowledging the risks and limitations of factorial designs, draft guidance outlines how sponsors might employ external data, such as registries or patient-level real-world data, for combination cancer therapies.

GDPR Clarity For Pharma: Industry Code Nears EU-Wide Approval After Six-Year Journey

 
• By Vibha Sharma

The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.

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UK Initiative Steps Up Efforts To Tackle Recruitment Bottlenecks In Dementia Trials

 
• By Anabel Costa-Ferreira

A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.

New Advisory Group To Shape UK’s Simplified Informed Consent Process

 
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Although the UK Health Research Authority’s initial proposal for simplified informed consent was rejected by stakeholders, it has yielded valuable insights into reducing trial burden and widening access

Research Advances And Filings Prompt EMA To Revise Alzheimer’s Trial Guideline

 
• By Neena Brizmohun

Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.