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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An experimental Valeant Pharmaceuticals drug for treating psoriasis carries a potential risk of suicide that is difficult to assess due to limited data, according to a preliminary review by US Food and Drug Administration staffers. An FDA advisory panel meeting is scheduled to meet Tuesday to determine whether to recommend the drug for approval. FDA staffers note some doctors may not be equipped to assess suicide risks.

Former Valeant Pharmaceuticals chief executive Michael Pearson sold nearly $100 million of his stock in the beleaguered drug maker this month, but the company maintains he remains a significant shareholder with more than 3.5 million shares, Reuters says. Meanwhile, Valeant board member Bill Ackman told CNBC that Valeant has no plans to sell core assets like Bausch & Lomb, and short seller Andrew Left is again shorting the stock, TheStreet reports.

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AstraZeneca said its experimental Tagrisso lung cancer drug met its primary endpoint in a late-stage study assessing safety and efficacy as a second-line treatment for certain kinds of lung cancer, Reuters says.

Martin Shkreli is scheduled to go on trial in June 2017 to faces securities fraud charges, according to Reuters.

Johnson & Johnson’s DePuy unit asked a federal appeals court to expedite the appeal of its $151 million loss in a product liability lawsuit brought over its Pinnacle metal-on-metal hip implant, MassDevice writes.

European regulators approved Celgene’s Revlimid to treat patients with relapsed and refractory mantle cell lymphoma, a rare form of aggressive non-Hodgkin’s lymphoma, PharmaTimes tells us.

China’s Food and Drug Administration approved GlaxoSmithKline’s Cervarix vaccine for human papillomavirus, which can lead to cervical cancer, Reuters informs us.

A brain cancer patient died from bleeding in the skull shortly after being injected with a Ziopharm Oncology gene therapy directly into the brain tumor, according to TheStreet.

An Indian court will hear an appeal in which Roche claims a court failed to observe due process under law while granting biosimilar status for versions of its Avastin cancer drug, LiveMint says.

Doctors Without Borders criticized Pfizer and GlaxoSmithKline for refusing to lower the price of their pneumonia vaccines, making it harder to treat refugee children in Greece and elsewhere, CBS News says.

Pfizer struck a deal with Russia’s NovaMedika to build a new lab facility in Kaluga, located about 200 miles southwest of Moscow, according to Forbes.

MRC Technology, a UK charity fund, reaped $150 million by selling part of its royalty interest in Merck’s Keytruda cancer drug, Reuters reports.

  • 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.

    http://www.sugarconebiotech.com/?p=912

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