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From Healing to Harm: The Unintended Consequences of Polypharmacy in Seniors

PharmD Live

People over 65 make up only 14% of the population but account for 56% of hospitalizations for adverse drug events (ADEs) (Agency for Healthcare Research and Quality, AHRQ, 2021). roughly one in five—suffer from an ADE each year (National Institute on Aging, NIH, 2021). British Journal of Clinical Pharmacology, 67(6), 689–700.

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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In 2021, the FDA granted Amgen’s (NASDAQ:AMGN) non-small cell lung cancer (NSCLC) drug Lumakras (sotorasib) an expedited approval, making it the first FDA-approved KRAS inhibitor. In 2021, Amgen agreed to conduct a Phase II study (NCT04933695), which is supposed to complete in May 2024, according to Clinicaltrials.gov.

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Recommended Medical Reference

RX Note

Adverse Drug Reaction Drug Induced Diseases, 2018 Meyler's Side Effects of Drugs, 2015 Antibiotics The Sanford Guide to Antimicrobial Therapy, 2022 Breastfeeding Briggs' Drugs in Pregnancy and Lactation, 2021 Hale's Medications and Mothers' Milk, 2021 Clinical Practice Applied Therapeutics, 2018 Conn’s Current Therapy, 2022 Current Medical Diagnosis (..)

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The future of medical cannabis development in Europe

European Pharmaceutical Review

An observational study of safety and clinical outcome measures across patient groups in the United Kingdom Medical Cannabis Registry. Expert Review of Clinical Pharmacology. Plant cannabinoids: a neglected pharmacological treasure trove. British journal of pharmacology. 2021 Jul;11(4):395-403. Mechoulam R.

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FDA Advisory Committee Review of 2021

Eye on FDA

But before heading into 2022, it is perhaps time to take stock of AdComms and what they did or did not do during 2021. First and foremost is that as noted earlier this year (See August 5, 2021 FDA Adcomms – Is FDA Getting Less Advice? ), there were fewer 2021 meetings held to consider new drug applications than in years gone by.

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AdComms – Is FDA Getting Less Advice?

Eye on FDA

At the same time, looking to 2018 when there were 29 meetings to consider new drugs, the number appears to be falling each year, with only 6 that occurred during the first half of 2021. That said, BT would be a lagging indicator since it can be granted so early in the development process. Fewer meetings – more approvals.

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Twenty Women Leaders In Healthcare Industry

PharmaShots

Designation: Chief Commercial Officer (CCO) and President Award & Nominations: She has her mention in Fortune’s “Top 50 Most Powerful Women” in 2020, 2021, and 2022 ranking 16th, 11th, and 13th respectively. Other Affiliations: She is a fellow of the Royal Society (May 2021) associated with Merck.