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Posts tagged with "Clinical Trials"

  • Business and Markets

    Sarepta’s Duchenne Therapy Is A Lot Further Away

    I wrote here about Sarepta, a small company having plenty of difficulty getting a therapy for Duchenne muscular dystrophy through the FDA. At that point, the problem was the accelerated-approval pathway, but things have now gotten a good deal worse. Following a meeting with regulators in September, the biotech spelled out a new set of… Read More
  • Business and Markets

    Sunesis Fails with Vosaroxin

    When last heard from, Sunesis was trying to get some last compounds through clinical trials, having cut everything else possible along the way (and having sold more shares to raise cash). Their lead molecule has been vosaroxin (also known as voreloxin and SNS-595), a quinolone which has been in trials for leukemia. Unfortunately, the company… Read More
  • Business and Markets

    The Case of Northwest Biotherapeutics

    There have been a lot of strong words exchanged about Northwest Biotherapeutics (NWBO), a small Maryland-based company developing a brain cancer vaccine. Over at Fierce Biotech, they’re wondering why this program was picked by the UK authorities as their first official “Promising Innovative Medicine”, given the scarcity of data (a… Read More
  • Clinical Trials

    Messed-Up Clinical Studies: A First-Hand Report

    This makes for a very disturbing read. The author details his participation in a clinical trial for an asthma therapy being developed by Amgen at a clinic in Newport Beach (CA). He doesn’t say what the drug was, but my guess is that it’s brodalumab, an anti-IL17 antibody which has been in trials for asthma… Read More
  • Biological News

    Update on Alnylam (And the Direction of Things to Come)

    Here’s a look from Technology Review at the resurgent fortunes of Alnylam and RNA interference (which I blogged about here). But now Alnylam is testing a drug to treat (familial amyloid polyneuropathy) in advanced human trials. It’s the last hurdle before the company will seek regulatory approval to put the drug on the market. Although… Read More
  • Business and Markets

    Clinical Trial Fraud

    Bizarre news from Evotec – see what you make of this press release: Evotec AG was informed that US company Hyperion Therapeutics, Inc. (“Hyperion”) is terminating the development of DiaPep277(R) for newly diagnosed Type 1 diabetes. In a press release published by Hyperion on 08 September 2014 at market opening in the US, the compa… Read More
  • "Me Too" Drugs

    Novartis Impresses Where Others Have Failed

    There is some good news from the clinic today. Novartis reported data on LCZ696, a combination therapy for congestive heart failure, and the results have really grabbed a lot of attention. (The trial had been stopped early back in March, so the news was expected to be good). This is a combo of the angiotensin… Read More
  • Cancer

    Exelixis Against the Wall

    Exelixis is a company with a very interesting history, but that’s in the sense of “much rather read about it than experience it”, like the interesting parts in a history book. At one point they had a really outsized pipeline of kinase inhibitors, to the point where it could be hard to keep track of… Read More
  • Clinical Trials

    Drug Repurposing

    A reader has sent along the question: “Have any repurposed drugs actually been approved for their new indication?” And initially, I thought, confidently but rather blankly, “Well, certainly, there’s. . . and. . .hmm”, but then the biggest example hit me: thalidomide. It was, infamously, a sedative and remedy for mornin… Read More
  • Clinical Trials

    Amicus Fights Its Way Through in Fabry’s

    Perseverance is a critical variable in drug discovery. Too little of it, and you are absolutely guaranteed to fail – no drug has ever made it to market without trying the patience of everyone involved. Too much of it, and you are very nearly guaranteed to waste all your money: most drug development projects don’t… Read More