NCI, Sanofi, Spectrum, and more!

Welcome back everybody to another edition of “BioPharma Bitez.” The top news in the industry, as well as one story outside of it. Now with even more branding.

So, to kick it off this week, the NCI head Ned Sharpless has been named the acting FDA Commissioner this week, which the industry has seen as a positive thus far.

Axovant has released a snapshot of their neuro drug candidates this week with a positive patient date for Parkinson’s patients as well as their infantile trail that they are running right now. Which, we all know how difficult it is to get positive data in neuro so that’s a good sign for them.

The FDA has approved an expansion on Regeneron’s and Sanofi’s “Dupixent” this week for atopic dermatitis. Just further expanding the blockbuster drug.

Emerging biotech “BioNTech” is expected to have an IPO in the next few weeks here and they’re expecting to get a record $800 billion for their mRNA program.

And then Spectrum has pulled it’s MAA this week in regards to Neulasta. Which is a lung cancer drug as the FDA has asked for more information in regard to its manufacturing.

So now, the fun fact of the week this week is the U.S., the Midwest especially got hit hard with a bomb cyclone basically a land hurricane of low pressure that dropped a ton of snow in Denver and in the Midwest. As well as high winds and some of the highlights for the damage this week is 26 train boxcars actually got blown off a bridge in New Mexico. And then in Texas, a semi-trailer was actually lifted up and blown over on its side. So there some incredible video online to check that out. So, crazy weather this week has not let up yet in the U.S.

So now, the hot job for the week. I am actually doing quite a bit in regulatory and quality this week, so I’m expanding my network in both areas, whether you’re in GXP expert or any of the GOP’s, GCPs, any of them in quality. Or you’re going to regulatory whether you’re a strategy, operations, or CMC, please feel free to share this video and let me connect with them. I am happy to be a resource for you as you’re job hunting or you just want to hear about what’s going on in industry. I am also working in pharma manufacturing. So, if you know any MSATs or senior engineers, or anybody that specializes in an upstream-downstream, anything like that feel free to share this information. It’s a good news story and I appreciate the referral. So, thanks again for tuning in, I look forward to seeing you all next week for another edition of “BioPharma Bitez.”