Derek Lowe's commentary on drug discovery and the pharma industry. An editorially independent blog from the publishers of Science Translational Medicine. All content is Derek’s own, and he does not in any way speak for his employer.

By Derek Lowe

Posts tagged with "Clinical Trials"

• Clinical Trials

  Sangamo’s Gene Therapy Results

  5 September, 2018

  Let the arguing commence! That’s my response to the announcement this morning by Sangamo, a company that’s been trying to do gene therapy in the clinic. They’re not a CRISPR outfit, though – they’re using an alternate technique for gene silencing, using zinc finger regions instead. Even at that level, there’s mor… Read More

• Cancer

  Real-Time Approval

  22 August, 2018

  Here’s an example of the current regulatory framework – you may like it, you may not, but if you’re doing drug research you should know that it’s going on. The way it’s traditionally worked – for decades – has been that a company develops a drug, runs clinical trials, etc., puts together a (huge) data… Read More

• Alzheimer's Disease

  Biogen and Eisai: Let the Alzheimer’s Arguing Commence

  26 July, 2018

  Well, the tease is over: Biogen and Eisai have released data on their Alzheimer’s antibody, BAN2401. And the situation is messy, as many had feared. The top-line results are mostly positive, but there are several confounding factors that make them a matter of argument (see below). The companies were scheduled to go public with the… Read More

• Alzheimer's Disease

  The Case of Verge Genomics

  17 July, 2018

  A number of people have passed along the recent press stories about Verge Genomics, a new company out of YCombinator that has just raised $32 million for neuroscience drug discovery. Now that, as literally anyone who’s ever done it can tell you, is a hard field of a hard field, and I wish Verge good… Read More

• Alzheimer's Disease

  Biogen And Eisai Tease an Alzheimer’s Result

  6 July, 2018

  OK, we have kind of a complicated situation today. Biogen and Eisai have press-released what appear to be positive results for an anti-amyloid antibody therapy for Alzheimer’s. Since every single other attempt in this area has failed, often at great expense, what are we to make of this? Well, the first thing to say is… Read More

• Business and Markets

  Welcome to Right to Try

  21 June, 2018

  Update: Brainstorm has now abandoned their Right-to-Try approach. Who’s next? That didn’t take long. That didn’t take long at all. The federal “Right to Try” bill was just signed the other week, and we already have a company that’s willing – no, eager – to try it out. I will now cruelly caricature som… Read More

• Clinical Trials

  Gene Therapy for Duchenne

  19 June, 2018

  I have said unkind things about Sarepta’s drug for Duchenne muscular dystrophy, Exondys (eteplirsen). That’s because I did not think that there was enough information to approve it at the FDA, and I had trouble believing that its biochemical effects were enough to be meaningful in general. I have no reason to modify those opinions… Read More

• Clinical Trials

  Finger-Pointing at Celgene

  14 June, 2018

  Just what is going on at Celgene? They’ve had some odd recent setbacks (such as as the failure of Mongersen), and another such acquisition, Ozanimod, had its filing recently rejected by the FDA. Several things about that incident were eyebrow-raisers – for one, it’s rare for a large, established company to get an outright refusal- Read More

• Alzheimer's Disease

  An Alzheimer’s Statement

  12 June, 2018

  “Despite this latest setback, Eli Lilly remains committed to plunging through this concrete wall headfirst. This is a sad day for our WallBreaker 2020 program, and some of our longtime head bashers will recall similar periods during SkullButt 2012 and ConcreteCracker 2016. But we continue to believe that the only way past this wall is… Read More

• Cancer

  More Thoughts on AbbVie’s Rova-T Implosion

  5 June, 2018

  I wrote a couple of months ago about the disappointing results that AbbVie had obtained with their cancer stem cell therapy “Rova-T” (rovalpituzumab tesirine) in small-cell lung cancer. This was the antibody-drug conjugate that they’d purchased from Stemcentryx – OK, let’s clarify that, they bought Stemcentryx out comp… Read More