This week Pfizer seeks Emergency Use Authorization for their COVID-19 oral antiviral; A meta-analysis found commonly prescribed drugs were linked to orthostatic hypotension; A novel treatment is approved for polycythemia vera; A new program has been cleared to allow individuals to carry out remote endoscopy procedures; And the largest to date psilocybin trial shows promise in treatment-resistant depression.
Currently, psilocybin, a serotonin receptor agonist, is classified as a Schedule I drug in the US.
This week on the pod, there’s positive news for the COVID-19 oral antiviral candidate, Paxlovid; The CDC expands a recall for aromatherapy sprays connected to fatal cases of a rare tropical disease; The first eye drop to treat presbyopia is approved; An alternative to naloxone gets fast tracked; And a study compares the migraine treatments erenumab and topiramate.
FDA Advisory Committee votes on whether the Pfizer-BioNTech vaccine should be authorized in 5 to 11 year olds; The Moderna vaccine elicits strong antibody responses in pediatrics; Trial results shed light on booster dose efficacy; Shingrix is recommended for immunocompromised patients; A novel treatment is approved for macular edema associated with uveitis; And Pepaxto is withdrawn following new findings.
This week: The FDA authorize boosters for Moderna and Janssen and okay ‘mixing and matching’ of vaccines for the booster dose. The first interchangeable biosimilar to Humira is approved. Also there’s approvals in dry eye disease, pain management and opioid overdoses.
This week the USPSTF update aspirin recommendations for those 60 years and older; The FDA take a stance on needle-free devices for injecting dermal fillers; REMS requirements are updated for isotretinoin products; A new treatment is approved for pediatric congenital athymia; An Emergency Use request is submitted for an oral antiviral COVID treatment; And the FDA advisory panel vote on boosters for the Moderna vaccine.
Dr Preeti N. Malani, Chief Health Officer at UM, joins us to talk about the current state of COVID-19, including vaccine hesitancy, mandates, boosters and how the future may unfold.
The Pfizer-BioNTech COVID-19 vaccine gets Emergency Use Authorization for booster doses in certain individuals; A smaller vaccine dose appears safe and effective in children; A survey sheds light on parents’ thoughts on child COVID vaccination; Janssen share booster data for their vaccine; Remdesivir efficacy data in COVID-19 patients, And Opzelura is approved for atopic dermatitis.
The FDA weigh up mandatory education for opioid prescribers; There’s an increase in the sale of strong psychoactive THC products; Brukinsa and Exkivity gain approval, respectively; And a number of supplement companies received FDA warning letters.
Patients treated with gammaCore experienced clinically meaningful benefits.
