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STAT+: Pharmalittle: We’re reading about FDA guidance on AI, meds releasing ‘forever chemicals,’ and more

STAT

As of last October, the agency had received more than 500 drug submissions with AI components going back to 2016, with a large number in the areas of oncology, neurology, and gastroenterology.   Most of the compounds came from commonly prescribed medications including antidepressants and statins.

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STAT+: Pharmalittle: We’re reading about copycat weight loss drugs, ADHD prescriptions spiking, and more

STAT

Food and Drug Administration wants bulk production of copycat versions of popular weight-loss drugs to stop, but telehealth companies and compounding pharmacies that have fueled widespread use of the knockoffs have other plans , The Wall Street Journal writes. In 2016, Ionis won approval for an infusion called Spinraza.

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MindMed aims for Nasdaq listing after Compass’ magic mushroom-fuelled IPO

pharmaphorum

Founded in 2016 by husband and wife entrepreneur team George Goldsmith and Ekaterina Malievskaia, Compass is already backed by investors including PayPal co-founder Peter Thiel and German entrepreneur Christian Angermayer. million with its IPO on Friday and shares are still significantly above their launch price of $17.

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Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

The FDA Law Blog

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. If FDA recommends a substance not be controlled, DEA cannot control it.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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Low Dose Naltrexone and Hashimoto’s

The Thyroid Pharmacist

You may be familiar with naltrexone, which is an FDA-approved medication that has been used since the 1980s for opioid withdrawal. LDN can be taken in the form of a compounded tablet, capsule, liquid, or transdermal formulation. It’s also best to work with a compounding pharmacy that can help you titrate your dose correctly.

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Evaluating NMR relaxometry for antibody identification

European Pharmaceutical Review

NMR relaxation methods distinguish between components (phases or compounds) that have different molecular mobilities For monoclonal antibodies, identification methodologies can employ chromatography, spectroscopy, isoelectric focusing, capillary electrophoresis and peptide mapping techniques. 2016; 37(3): 117–24. Cited 2023Feb].