Welcome back everybody to another edition of “BioPharma Bitez” the top news in the industry as well as one story outside of it.
So, kicking things off, Alkermes says, and LCFD has rejected the NDA for their top-of-the-line depression drug this past week.
GSK is now co-developing a fusion protein immunotherapy with Germany’s Merck KGAA this past week as well.
MacroGenics has gotten statistically significant phase 3 data for its metastatic breast cancer biologic this past week.
Sangamo is switching to its second-gen gene-editing platform after its first-gen gene-editing platform showed that it does work, but it was not clinically improving for patients in the trial that they bring with.
As well, UniQure is touting promising clinical data that is showing the improvement effect of 9 levels in hemophilia B patients this past week. Which, should put some head-to-head with spark therapeutics on what’s being called a “hemophilia B showdown” in the industry.
So, kicking it outside of the industry this week, the head of Harvard’s astrology department is claiming that, “the space rock or asteroid Oumuamua (I guarantee I butchered that) is believed to be a sign of alien technology similar to a light sail that is actually traveling through space because of how fast and how light it is moving in its orbit out of the solar system.”
So, going back to the hot job this week, instead of it being in regulatory this week, I am working a lot in quality and GCP.
So, I am working on a role with a gene-editing company that is looking for an associate for the senior director of the GCP. Also, looking in that range of CQA professionals as well as GCLP.
So, if you think of anybody that may be a good fit, feel free to send them this video and my information.
Thank you all for tuning in this week. I look forward to seeing you all next week for another edition of “BioPharma Bitez.”