Search Results for: mesoblast

Mesoblast gets FDA RMAT; List of 10 total designations so far

August 23, 2022 / By / 13 Comments
Mesoblast-e1514313188176

Australian stem cell biotech Mesoblast announced that it has received regenerative medicine advanced therapy (RMAT) designation from the U.S. FDA. This is very good news for the company and an encouraging development for the field. Interestingly, last month the FDA clarified that there is expanded RMAT designation that can include gene therapies too. At the Meeting …

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Stem cell therapy review of good news: UC Davis, Asterias, Cynata, Mesoblast, ViaCyte

February 1, 2021 / By / 2 Comments
VC-01-post-implant-final1-e1503703572933, viacyte

It’s a difficult, but very important road to conclusively prove that an investigational stem cell therapy is both safe and effective in order to get final approval FDA or equivalents in other countries. For this reason, it is beneficial to highlight even small, but positive steps forward including encouraging pre-clinical data. Today I’m doing a …

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Stem cell news bites: Mesoblast, BioTime, MS, FDA Warning, & More

February 1, 2021 / By / 4 Comments
Mesoblast-stock

Stem cell studies continue to make big news with a mixed bag of trends, and some good stem cell news and others not so much. Mesoblast ($MESO) had its stock suspended for quite so time recently in anticipation of a big announcement. When that news came today it was discouraging in the form of its partner …

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Mesoblast stock on hold: Poll if you expect good or bad news

February 1, 2021 / By
Mesoblast_Ltd

Adult stem cell biotech Mesoblast ($MESO) is in the unusual situation currently of having its stock on hold. This is a relatively rare event and usually portends some kind of major news. The hold is expected to run from June 1 to June 10. Mesoblast will announce ““material corporate developments with respect to certain assets …

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Mesoblast (MSB) buys Osiris (OSIR) stem cell unit

February 1, 2021 / By / 1 Comment

The Australian stem cell biotech Mesoblast (MSB) has reportedly reached a deal with the American stem cell biotech Osiris (OSIR) to buy Osiris’ mesenchymal stem cell (MSC) unit. This is a big development in the MSC field. Osiris and Mesoblast are two major players in this particular subfield of the stem cell world so this deal, …

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Viacyte & Mesoblast present at CIRM Meeting

February 1, 2021 / By / 1 Comment

Allan Robins of Viacyte (pictured at left–sorry for the fuzzy image) and Paul Simmons of Mesoblast presented this morning at the CIRM Grantee Meeting. Both talks were outstanding. Robins went first. He started by saying how Viacyte had a productive pre-IND meeting with the FDA last year. I believe a target for them is to …

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20 stem cell & regenerative medicine predictions for 2024

January 10, 2024 / By / 4 Comments
Stem cell, crystal ball, predictions

Each year I make predictions for the stem cell and regenerative medicine field for the following year. Today’s prediction post is focused on what to expect in 2024. You can also see my stem cell predictions for 2023 and my grades on how I did. I also have made a video version of these predictions so please …

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2023 stem cell predictions grades reflect wild year for regenerative medicine

December 27, 2023 / By / 1 Comment
stem cell predictions

Every year I make stem cell and regenerative medicine predictions. Looking at my predictions for 2023, they reflect a wild year but in many ways a good one overall. Below I have graded my 2023 predictions. Overall, my crystal ball gave solid results. Some of the predictions have been condensed to keep things concise, but you …

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3 cell therapy companies doing well: Vertex, Vericel, & Regeneron

November 15, 2023 / By / 5 Comments
Vericel, Cell Therapy Companies

Cell therapy companies face many hurdles. I wrote recently about four cell therapy biotechs that have been really struggling. Blogging here at The Niche for more than a dozen years, I’ve seen many companies even go under. That’s bad news for the field, for patients, and for investors. Today I wanted to highlight some cell therapy …

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Weekly reads: late Macchiarini retractions, stem cells & Lululemon

October 28, 2023 / By / 8 Comments
Paolo-Macchiarini

Paolo Macchiarini is one of a small group of people in the stem cell universe whose misconduct has blown up in the press. Piero Anversa, Haruko Obokata, Hwang Woo-Suk, and some operators in the unproven stem cell clinic sphere come to mind. Macchiarini published quite a few seriously problematic papers, some of which just hung …

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