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Merck’s Oncology Strategy: Digging In With Expansion Of Keytruda

 
• By Jessica Merrill

With Keytruda, Merck has shown it has the wherewithal to compete in immuno-oncology against more experienced rivals. Now, as management outlined at ASCO, the company is digging its heels into the field, studying Keytruda in 30 tumor types and evaluating other early stage assets.

Merck & Co. Inc. is a one-trick pony when it comes to cancer drug development – so far. But the big pharma’s success with Keytruda (pembrolizumab) has made the company a surprising frontrunner in the exploding field of immuno-oncology. Now Merck’s success with Keytruda, the first PD-1 inhibitor to reach the market, has given the company pause to reconsider its ability to compete in oncology.

“For many, many years, it was our view within Merck Research Laboratories that we didn’t have much to contribute to...

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More from Clinical Trials

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.

Adaptive Clinical Trials Require ‘Clear And Compelling Justification’

 
• By Vibha Sharma

A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.

Denmark Sets New EU Benchmark With 14-Day Clinical Trial Review Timeline

 
• By Vibha Sharma

Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.

More from R&D

Adaptive Clinical Trials Require ‘Clear And Compelling Justification’

 
• By Vibha Sharma

A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.

Denmark Sets New EU Benchmark With 14-Day Clinical Trial Review Timeline

 
• By Vibha Sharma

Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.