MPR Weekly Dose

The FDA decide to decline COVID-19 treatment; Booster doses authorized for children; A direct to consumer test to detect COVID-19, influenza, and RSV; And a wearable furosemide delivery system accepted for review.

Treatment approved for hospitalized COVID-19 patients; Update on Varenicline supply; Limits have been set for the Janssen COVID-19 vaccine; Safety alert issued for a COVID-19 test; And certain hemodialysis machines may carry the potential for chemical exposure.

This week: USPSTF recommendations on aspirin use to prevent cardiovascular disease; Veklury indication expanded; Accupril Lots recalled; Legal action on counterfeit HIV medication; And the White House releases plan to tackle the overdose epidemic.

This week: the halting of the sabizabulin trial in COVID-19; Emergency Use Authorization to be requested for booster dose in 5 to 11 year olds; Diversity in Clinical Trials; Myopericarditis risk compared for COVID-19 vaccines vs other vaccines; And survey results of unvaccinated attitudes following FDA approval.

A second booster dose for some COVID-19 vaccines is authorized; Sotrovimab has its use limited due to the BA.2 Omicron subvariant; An investigational oral antiviral gains Fast Track designation; PreHevbrio hepatitis B vaccine now available; And the FDA update a safety communication regard the risk of thyroid dysfunction in infants following the use of contrast media containing iodine.

Allergy treatment gets over-the-counter approval; Anaphylaxis treatment recalled; Phase 3 trial results for investigational sciatica treatment; FDA alert regarding at-home COVID tests; And the resubmitted Biologics License Application for teplizumab for type 1 diabetes is accepted. 

In this week's special episode of The Weekly Dose Podcast we interview Dr Tobias Janowitz, a medical oncologist, assistant professor at the Cold Spring Harbor Laboratories and adjunct professor at the Feinstein Institutes. Dr Janowitz was part of a team that recently conducted a phase 2 clinical trial assessing high doses of famotidine in adults with COVID-19. The trial was conducted completely re...

A new injection is approved for opioid overdose; The Advisory Committee on Immunization Practices releases vaccine schedules; The FDA provides a list of approved COVID-19 tests; A trial of an investigational spontaneous urticaria treatment is stopped; And the first condom is authorized for anal intercourse.

This week in COVID related news, a heartburn medication shows benefit in patients; Bebtelovimab is authroized; Veklury is shown to retain antiviral activity against variants. Away from COVID, a functionally scored carbidopa/levodopa tablet is now available for Parkinson disease, and the FDA issue a ketamine compounding warning.

This week: news of millions of courses of a COVID-19 oral antiviral being provided to the US government for distribution throughout the country; There's a draft guidance for novel nonopioid analgesics; Possible strangulation warning for enteral feeding tubes; A new treatment has been approved for cold agglutinin disease; And a treatment is under review for HFrEF.

This week: The approval of a second COVID-19 vaccine; Pfizer and BioNTech submit for Emergency use of their vaccine for children under 5; Pfizer have also stopped development on a potential drug treatment to reduce cardiovascular risk and severe hypertriglyceridemia; And new dosing options for a HIV drug.

Use of monoclonal antibodies restricted due to Omicron; Veklury given the go-ahead as an outpatient treatment; New data produces a reconsideration for Pepaxto withdrawal; And there's a new treatment approval for unresectable or metastatic uveal melanoma.

This week we have news of two new approval for atopic dermatitis; Warnings around counterfeit HIV treatments; Zydelig indications withdrawn; CDC pediatric influenza vaccine study results; And an FDA warning against a particular brand of COVID-19 antibody tests.

This week: Novel insomnia treatment; The FDA comment on magnesium hypertension claim; Transmucosal buprenorphine linked to dental decay; Researchers assess changes in menstrual cycle in relation to COVID vaccines; And experts have their say on the best diets for 2022.

Contraindication added to Janssen COVID-19 vaccine; Pfizer announce final results for their COVID-19 oral antiviral; A new treatment for benign prostatic hyperplasia; REMS change for CAR T-cell therapy, and Rinvoq gains approval for active psoriatic arthritis. 

This week we bring you up to speed on a lot of COVID-related news, despite the emergence of Omicron, there is positive news; Evusheld has become the first pre-exposure prophylaxis for COVID-19; Data shows that the Pfizer-BioNTech booster dose offers protection against Omicron; Monoclonal antibody therapy is authorized for kids; Heterologous boosting may be more beneficial than homogeneous; and imp...

We made it to 100! This week Pfizer seeks Emergency Use Authorization for their COVID 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 treat...

This week 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. 

The FDA 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: big news announced in COVID-19, with the FDA stating that mixing and matching of vaccines for the booster dose is authorized. The first interchangeable biosimilar to Humira is approved. Also there's approvals for 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 approved for pediatric congenital athymia; An emergency use request submitted for an oral antiviral COVID treatment; And the FDA advisory panel vote on boosters for the M...

Dr Preeti Malani, Chief Health Officer at UM, joined us to talk about the current state of the COVID-19 pandemic, including vaccine hesitancy, mandates, boosters and how the future may unfold.

The Pfizer-BioNTech vaccine gets Emergency Use Authorization for booster dose in certain individuals; A smaller dose appears safe and effective in children; Janssen share booster data for their vaccine; A survey sheds light on parents' thoughts on child COVID vaccination; Remdesivir efficacy data in COVID-19 patients, And Opzelura is approved for atopic dermatitis.

This week 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 approvals for lymphoma and NSCLC, respectively; And a number of supplement companies received FDA warning letters. 

This week we have news on pediatric influenza vaccine guidance; Moderna submit data for their COVID-19 booster dose; There's new FDA warnings for some JAK inhibitors; Trudhesa nasal spray is approved; And the FDA places a clinical hold on a gene therapy for phenylketonuria.