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Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law Blog: Biosimilars

The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. California Stem Cell Treatment Center, Inc., Stem Cell Clinic, LLC , 998 F.3d

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Chrysophanol induces apoptosis and ferroptosis of gastric cancer cells by targeted regulation of mTOR

Chemical Biology and Drug Design

The present paper showed an apoptosis- and ferroptosis-inducing action of chrysophanol on gastric cancer cells. The tumour killing effects of chrysophanol possible owing to its targeted regulation on mTOR. Screening by GEO software indicated that the mTOR signalling pathway is possibly regulated by chrysophanol.

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Serum Glucocorticoid-Regulated Kinase-1 in Ischemia-Reperfusion Injury; Blessing or Curse [Minireview]

ASPET

The family of serum-glucocorticoid-regulated kinase (SGK) consists of three paralogs- SGK-1, SGK-2 and SGK-3 with SGK-1 being the better studied. Indeed, recognition of the role of SGK-1 in regulation of cell survival and proliferation has led to introduction of a number of small-molecule inhibitors for some types of cancer.

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Hsa?miR?503?5p regulates CTDSPL to accelerate cisplatin resistance and angiogenesis of lung adenocarcinoma cells

Chemical Biology and Drug Design

Hsa-miR-503-5p negatively regulates CTDSPL, suggesting its potential as a target to overcome cisplatin resistance in LUAD. The results showed that hsa-miR-503-5p showed high expression, while its target gene CTDSPL presented decreased expression in LUAD. Hsa-miR-503-5p also had high expression in cisplatin-resistant LUAD cells.

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In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties

Agency IQ

BY CHELSEY MCINTYRE, PHARMD FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. This proposed rule has been in the works for over 20 years, during which time the regulation of drug compounding has gone through many changes.

FDA 59
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Is Your In Vitro Diagnostic Exempt from Investigational Device Exemption Regulations?

The Premier Consulting Blog

1] However, if certain criteria are met, many in vitro diagnostic (IVD) devices are released from IDE regulations. This blog post discusses how device studies are classified and explores scenarios where DVDs qualify for exclusion from IDE regulations. b) Exempt studies that do not require an IDE.

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Gutamin7 – Presentation

The Pharma Data

Product Name: Gutamin7 – Presentation. Click here to get Gutamin7 – Presentation at discounted price while it’s still available… All orders are protected by SSL encryption – the highest industry standard for online security from trusted vendors. ClickBank is the retailer of products on this site.