Merck Drops Zocor Combo, But Keeps Going With Tredaptive

A brief mention in an SEC filing revealed that Merck has ceased the development of a combination cholesterol pill; the once hot ‘0524 program had languished in late-stages for several years.

Merck & Co. Inc.is cancelling development of a Zocor-based combination of its cholesterol product Tredaptive, but the firm is still moving forward with the statin-free combination of niacin and the novel anti-flushing compound laropiprant.

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Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 

Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.

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The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.

EMA’s Newly Qualified AI Tool To Boost MASH Market Dynamics

 

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Combating Bioequivalence Data Fraud: Indian CROs Face Mandatory Registration

 

As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.

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Combating Bioequivalence Data Fraud: Indian CROs Face Mandatory Registration

 

As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.

US Approach To Cell And Gene Therapy Regulations ‘Less Strict’ Than EU

 

Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.

Japan Expands Priority R&D List For Regular Vaccinations

 
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Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.