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Clinical / R&D

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Latest From Research & Development

Chronic Fatigue Syndrome Research Takes Leap Forward With NIH Funding

Research centers are collaborating on projects to find causes of disease; Ampligen, Rituxan and KPAX-002 are only drugs in clinical trials.

Research and Development Strategies Neurology

A Biomarker For Bristol: Mutation Burden Shows Promise In Small Cell Lung Cancer

Phase I/II data from Opdivo/Yervoy combination in SCLC provide more evidence that tumor mutation burden is emerging as a biomarker for immunotherapy, but commercial value is unclear and results don't have implications for the all-important CheckMate 227 non-small cell lung cancer trial, analysts say.

Drug Approval Standards ImmunoOncology

Canada Prepares To Publish Draft Rules On Release Of Clinical Data

Following a public consultation earlier this year, Health Canada has asked for expert advice on its plans to allow the release of clinical data that is currently considered confidential. It expects to publish draft regulations this autumn.

Clinical Trials Canada

NIH/Industry Oncology Partnership Aims For Immunotherapy Biomarkers

Part of the Cancer Moonshot program, the five-year, $215 million research collaboration will be mostly funded by NIH with money from the 21st Century Cures Act.

Research & Development Cancer

US FDA's Top Tips For Tumor Agnostic Drug Development

'Although sponsors have conventionally focused on the development of a drug, the strategy of pursuing site-agnostic indications must focus on both drug and biomarker development,' FDA's Richard Pazdur and colleagues write in the New England Journal of Medicine.

Clinical Trials Research & Development

Merck Calls It Quits On Anacetrapib

Despite success in REVEAL outcomes trial, Merck will not submit the for the cholesteryl ester transfer protein (CETP) inhibitor for regulatory approval.

Drug Review Research & Development
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