Roche Abandons Dalcetrapib Trial
Disappointing phase-III trial results have led Roche to discontinue all dalcetrapib studies.
Roche has revealed that it is abandoning clinical development of its cardiovascular drug candidate dalcetrapib, following disappointing phase-III clinical trial results.
The dal-Outcomes trial aimed to assess the efficacy and safety of dalcetrapib alongside standard care in patients with stable coronary heart disease following an acute coronary syndrome.
However, Roche said that the independent Data and Safety Monitoring Board (DSMB) has recommended stopping the trial following the second interim analysis of results, which failed to show clinically meaningful efficacy.
As a result, the Swiss pharmaceutical group is terminating all studies in the dal-Heart programme.
Related News
-
News CPHI Podcast Series: The power of proteins in antibody drug development
In the latest episode of the CPHI Podcast Series, Lucy Chard is joined by Thomas Cornell from Abzena to discuss protein engineering for drug design and development. -
.png)
News Amgen sues Samsung biologics unit over biosimilar for bone disease
Samsung Bioepis, the biologics unit of Samsung, has been issued a lawsuit brought forth by Amgen over proposed biosimilars of Amgen’s bone drugs Prolia and Xgeva. -
News CPHI Podcast Series: Why we need to consider women in clinical trials
The latest episode of the CPHI Podcast Series with Lucy Chard covers women's health, specifically women's representation in clinical trials, the associated bias, and the impacts on health for this population. -
.png)
News US FDA does not approve MDMA therapy for PTSD, requests more data
The MDMA-based therapeutic developed by Lykos Therapeutics, a California-based Public Benefit Corporation (PBC), has been reviewed and unapproved by the US FDA. The regulator has requested additional phase III trial data for further safety and efficacy... -
.png)
News Novartis and Viatris latest facing lawsuit over HeLa cell misuse
Global pharmaceutical companies Novartis and Viatris are the latest hit with a lawsuit claim pertaining to alleged misuse of the ‘HeLa’ cell line from the estate of woman whose cancerous tissue cells were taken without consent. -
.png)
News Sanofi invests billions into Frankfurt insulin production site
French pharmaceutical company Sanofi have announced an investment of EUR1.3 billion at their existing BioCampus site in Frankfurt am Main for the expansion of insulin production. -
.png)
News Novel oral Type 1 diabetes drug gains US FDA IND designation
A University of Alabama at Birmingham startup has gained FDA clearance for Investigational New Drug clinical trials for an oral Type 1 diabetes drug, a milestone for diabetes treatment. -
News A Day in the Life of a Vice President in R&D & Engineering
In the Day in the Life of Series, we've already had the chance to get to know a range of people in various roles in the pharma industry. In the latest interview we get a glimpse into the R&D side of things from Jennifer Sorrells, Vice Presiden...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance