Bristol-Myers Squibb's immunotherapy Yervoy (ipilimumab) will enter the market positioned for wide use, with a broad label for its approval for metastatic melanoma and positive Phase III results for front-line patients.
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Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.
ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.
The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.
