More FDA Inspection Tales
Science Blog » In the Pipeline
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1w ago
I have in the past mentioned some of the alarming things that FDA manufacturing facility inspectors find in the course of their work, as detailed in the summary letters that are sent to the firms involved. Now, inspecting these facilities is a serious business, and large companies have had to pay some pretty serious fines in the past for violations, up into the hundreds of millions of dollars. And ..read more
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The Pursuit of Perfection
Science Blog » In the Pipeline
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1w ago
Graduate students (and not only grad students) might want to give this piece here at Science a read, because it describes a pretty common problem in the research world. The author describes her problems with trying to get everything right as a beginning research student, and her problems in dealing with her work (and herself) when things didn't go according to plan. That's an absolutely crucial sk ..read more
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There Are Mistakes, And There Are Mistakes
Science Blog » In the Pipeline
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1w ago
I mentioned yesterday how there's a fair amount of the chemistry literature that's just wrong, and I wanted to expand on that today. First off, it's not like this is unique to chemistry - all the sciences have this problem, and to some extent, it's unavoidable. After all, we're in the business of discovering new things, and not all of our data are going to be reliable, nor all our conclusions robu ..read more
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New Hope for Pulmonary Hypertension
Science Blog » In the Pipeline
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3w ago
The FDA has just approved the first drug (sotatercept) to target the real mechanism behind pulmonary arterial hypertension, and that’s very good news. PAH is not a common disease, but it’s very bad news to get: the huge number of capillaries in the lungs start to narrow, increasing the strain on the heart and causing difficulty breathing, and more than 40% of patients are dead within f ..read more
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Too Many Labs Run Like This
Science Blog » In the Pipeline
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3w ago
I wrote here about some of the controversy around the superconductor discovery claims from the lab of Ranga Dias at Rochester, and the story has not taken any positive turns since I did that post. It is widely believed that the various papers on this subject from that lab are not reproducible, and there have been several retractions so far. This piece at Nature will give you the details about that ..read more
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Shifting Views of Frameshifting
Science Blog » In the Pipeline
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3w ago
I mentioned this paper in passing a little while back, while discussing the newly-discovered tendency of modified mRNAs to lead to frameshifted protein production. Frameshifts, for the non-specialists in the audience, are a phenomenon of protein production. The ribosome is reading off the messenger RNA sequence in groups of three bases (codons), and these codons in turn call for particular amino a ..read more
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More on WuXi, And It Isn't Good
Science Blog » In the Pipeline
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3w ago
I wrote here recently about the politically fraught state of the relations of biopharma companies with Chinese outsourcing companies, of which WuXi is probably the most prominent. There are bills in the works in both the House (the BIOSECURE Act) and the Senate that would (among other things) restrict the ability of US companies to work with these contractors. If you know the details of the Federa ..read more
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Ras and the History of Cancer Treatment
Science Blog » In the Pipeline
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3w ago
I found this overview at Cell very interesting - it's a look back to the 1970s and what we knew (and thought we knew) about cancer and possible treatments for it. And it's written from the first-person perspective of Robert Weinberg, who was there to see it all going on. Not until 1976 was it established that a mutated form of a particular gene really could be carcinogenic! There had been plenty o ..read more
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An Update on Human CRISPR
Science Blog » In the Pipeline
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3w ago
I wrote here almost two years ago about Verve Therapeutics and their plans to try human trials of a single-base-editing CRISPR therapy. That post will give you plenty of background, but the short version is that Verve is targeting patients with genetically-driven high cholesterol levels, and they are making a single A-to-G change in the gene for the PCSK9 protein. That one is by now a well-known c ..read more
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Rejuvenating the Blood Cell Population
Science Blog » In the Pipeline
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3w ago
This is a really interesting paper, but to be fair, there have been a lot of really interesting papers in the field of aging and lifespan, and it’s safe to say that not all of them have been as useful as they looked. But this stuff has to be chased down! The authors are specifically looking at the population of blood cells in aging animals (mice, here). These are all coming from haematopoiet ..read more
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