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Good morning, everyone, and welcome to another working week. We hope the weekend was relaxing and invigorating. Our own respite was refreshing, especially having taken an extended break. Now, though, that familiar routine of deadlines, meetings, and growing to-do lists has returned. So time to reach for a cup of stimulation and browse the tidbits as you brace yourself for a busy day. Hope all goes well and do keep in touch …

Roche reported that a late-stage clinical trial showed its new Gazyva blood cancer drug failed to deliver significant improvements over its older Rituxan medicine, Reuters reports, and the findings are a setback in its fight against competition from biosimilars. Gazyva did not significantly reduce the risk of disease worsening or death for people with previously untreated form of lymphoma.


The Institute for Clinical and Economic Review is soliciting suggestions for improving its approach to assessing the value of medicines. The move comes in response to criticism — notably, from drug makers — that the nonprofit uses controversial methods and often fails to give companies sufficient time to respond. ICER expects to revise its so-called value framework for use starting in January 2017.

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  • Although FDA describes the brodulamab suicides as a “late appearing” safety signal it had been rumored in the dermatology community for some time. It is the reason Amgen dumped the drug in the first place, knowing that even if the drug were to be approved it would come with suicidality warnings, and given that the interleukin blocker market is already crowded with much safer drugs the market share would be quite small.

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