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STAT+: Pharmalittle: We’re reading about Novo targeting compounded obesity drugs, an Amgen ‘at risk’ launch, and more

STAT

Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make , STAT reports. Novo has repeatedly argued that compounded products are risky, stressing that they are not approved by the FDA.

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Does Ozempic make you tired?

The Checkup by Singlecare

The benefits are well-known—and well-documented in the popular press—but what about the potential downsides? That’s how it works its magic for blood glucose and weight loss. Strange side effects, such as Ozempic face and Ozempic butt have also made the news. Are tiredness and fatigue one of them?

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Apixaban vs warfarin: rise of newer anticoagulant

Druggist

Apixaban stops the production of enzymes (chemicals) required for the production of fibrin , a compound (protein) that plays a role in the clotting of the blood. 2011): Apixaban was superior ( better ) to warfarin in preventing stroke/ clots formation in patients with atrial fibrillation. Main results from the trial (Granger et al.,

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

European Pharmaceutical Review

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

FDA 103
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Psychedelics, Pregnancy, and Breastfeeding

The Spirit Pharmacist

Beyond lack of safety data, medical approval, and regulation as illicit substances, psychedelics are powerful serotonergic compounds that have pleiotropic effects across immune, endocrine, and neural systems. J Psychoactive Drugs, 2011. Psychedelics could also have considerable risks. J Psychoactive Drugs, 2013. Labate, B.C.,

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Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

5 It includes cleaning validation master plan, product risk assessment, utility and equipment readiness, analytical method readiness, sampling site selection/grouping, standard operating procedures, validation protocols, execution of validation protocols, personnel training, and the validation documentation package. January 2011.

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Air Quality and Hashimoto’s – Is the Air You’re Breathing Making You Sick?

The Thyroid Pharmacist

I’ve seen a number of airborne toxins showing up as frequent triggers/exacerbating factors for my clients’ autoimmune conditions — mold, volatile organic compounds (VOCs), and artificial/synthetic fragrances, in particular. For cleaning products, only compounds need to be identified. Volatile Organic Compounds (VOCs) .