Search Results for: drugs

John Carbona on Day 2 of Vatican Stem Cell Meeting including Gurdon Talk

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Below, guest blogger, John Carbona gives us his account (including pictures) of Day 2 of the Vatican Stem Cell Meeting, which included a talk by Nobel Laureate John Gurdon. Note, you can read John’s post on Day 1 of the meeting including more great pictures here. Friday, April 12, 2012 The Second International Vatican Adult …

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Results of FDA Reform Poll: speed up clinical trials & expand compassionate use

The poll I put up asking people their #1 top priority for FDA reform drew relatively big numbers of respondents. Speeding up clinical trials was clearly way out in front at #1. Expanding compassionate use was #2. These were followed by changing policy to no longer define lab-grown stem cells as drugs and FDA being …

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Your stem cell legal documents hub

Below are links to specific court documents and filings in stem cell-related legal proceedings. (I’ve also placed in parentheses links to my posts/analysis on these).  Enjoy, especially you lawyers and investors. It’s a work in progress so expect more cases and documents to appear. In fact, if you have suggested additions please add them (plus …

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Want to get human stem cells intended for clinical use legally across the border? It ain’t gonna be easy

A big issue in the stem cell field is that firms increasingly are doing business in multiple countries. Associated with the increasingly international nature of the stem cell for-profit industry are emerging legal and ethical issues related to the transport of stem cell-based biological drugs across international borders. Think you can just FedEx human stem …

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Celltex on the move: full copy of letter to patients, new slogan, and new video

I requested of Celltex a copy of the email/letter that they recently sent to their patients. They kindly provided me a copy, which you can read here (snap shot of beginning is above). Thank you, Celltex! I also asked Celltex some questions regarding their plan to start having patients treated in Mexico. Unfortunately, they have …

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Taboo topics about iPS cells: updated for 2013

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I’m doing this series called “The Elephant in the Lab” where I discuss controversial or taboo laboratory topics that people are usually too afraid to publicly discuss.  I started with iPS cells (for a description and definition of iPS cells go here) and now have updated this post for 2013 because the field is changing rapidly. iPS …

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Perfect storm dodged: what are three key challenges for stem cell field going into 2013?

I recently attend a conference in Florida called The World Stem Cell Summit. It was very enjoyable and unique in that it brings together and is open to all constituents of the stem cell world. I gave a couple talks and did an “expert” luncheon at this meeting, but what I enjoyed most was talking …

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Money and stem cell ‘miracles’: Pluristem questioned on ethics

Pluristem Therapeutics Inc. is a publicly traded (NASDAQ) biotech Israeli company that is developing stem cell treatments based on the use of expanded placental stem cells called PLX cells. The Pluristem PLX drug is not approved for treating patients at this time in any country, however Pluristem has treated a handful of patients via something …

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New paper on iPS cell metabolomics: striking, yet incomplete metabolic reprogramming

I love collaborative science. I believe it advances science faster. An example? My lab recently collaborated with another lab here at UC Davis of Dr. Oliver Fiehn, a metabolomics guru. Our paper on this just came out in PLOS ONE here. Admittedly, we got scooped by another lab that published the first ever metabolomics paper …

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Will stem cell clinic Celltex reinvent itself after game-changing FDA warning letter?

The FDA warning letter that Celltex received in late September (but that just went public yesterday–see my initial reaction here) is a possible game-changer for that company in my opinion. Why? The letter outlined in great detail the FDA’s concerns with how Celltex manufactures its stem cell product ranging from lack of documentation to concerns about aseptic/sterile …

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