MPR Weekly Dose

The first COVID-19 vaccine is fully approved by the FDA, we'll go into all that that entails and also news regarding booster doses, off-label recommendations, promising antibody treatments and a BLA submission from Moderna for their vaccine.

This week we have significant news on the status of a third COVID-19 vaccine booster dose, as well as news for an encephalitis vaccine, another jardiance indication, an FDA warning concerning patient wristbands, and Jemperli gets accelerated approval. 

Big news on the COVID-19 vaccine booster dose. The CDC issues new recommendations on vaccines. What protection the Moderna vaccine offers after 6 months. A treatment approved for Pompe disease. And the FDA denies an application for a new roxadustat indication.

The FDA authorizes a postexposure prophylaxis for COVID-19; a new treatment is okay'd for lupus; a higher dose naloxone nasal spray became available; the risk evaluation and mitigation program for Clozapine has had important changes, and finally, Istodax has had an indication withdrawn. 

This week we have news of the FDA requesting a change to statin prescribing labels, a new vaccine for streptococcus pneumoniae, a new plaque psoriasis cream, a stem cell therapy gets fast tracked as a possible Parkinson disease treatment, and there's a new treatment approved for Progressive Familial Intrahepatic Cholestasis (PFIC).

This week on the pod we speak about a fact sheet update for the Janssen COVID vaccine. Pfizer and BioNTech are working on a booster version of their vaccine. A supplement is found to contain a prescription ingredient. There's a new treatment for patients with diabetic kidney disease. And two popular sunscreen brands are recalled due to the presence of benzene.

This week Pfizer recalled their smoking cessation therapy Chantix. A treatment for acute bacterial skin and skin structure infections becomes available. Aduhelm, the newly approved Alzheimer Disease treatment, has its label updated. A blood lead level test is recalled, and there's updates to the cancer drug Keytruda.

The FDA grants Emergency Use to Actemra to treat hospitalized COVID patients. R evisions are been made to the fact sheets for the Moderna and Pfizer BioNTech COVID vaccines to include information related to the risk of myocarditis and pericarditis. A new treatment is approved for some cancer patients allergic to E. coli-Derived asparaginase products. Solosec gets an expanded indication and a new d...

This week the FDA approved a first-in-class switch for an antihistamine nasal spray, a new oral contraceptive, and Pradaxa was approved to prevent venous thromboembolism in pediatric patients. Meanwhile, real-world data on the efficacy of the COVID-`9 treatment remdesivir has been published. 

This week the FDA approved a regenerative skin tissue therapy and a treatment for advanced mastocytosis, while Novavax's vaccine for COVID and a novel treatment for MDD show promise. Also the FDA issue warning concerning hand sanitizers.

This week it's the big one: aducanumab - a treatment for alzheimer disease - got FDA approval. We'll go into that, plus a semaglutide treatment for obesity, a first treatment for Plasminogen Deficiency Type 1, and Moderna have sent a request for an EUA to extend the use of their COVID-19 vaccine to those aged over 12.

On this week's show we have news of migraine prevention treatment, a hexavalent vaccine is approved for pediatrics, there's also an approval for schizophrenia and bipolar I disorder, lumakras gets fast tracked and there's a new diagnostic aid for Autism, and it is artificial intelligence.

This week we have news of a change to the storage of the Pfizer-BioNTech vaccine; A gene therapy gets Fast Track status by the FDA; Vitiligo cream shows promise in clinical trials; And outcomes in atherosclerotic cardiovascular disease are compared for different aspirin dosages.

This week we have news of a COVID-19 vaccine authorization expanded for adolescents; A new postoperative pain treatment; There's a new insulin smart pen devices; Insulin products are recalled; And the FDA grants fast track status to a potential treatment for the rare disease, FSHD.

New guidelines on mask use; J&J vaccine update; Novel major depressive disorder treatment gains Priority Review; A scabies topical suspension; And a device to help stroke rehabilitation. 

The FDA revoke Emergency Use Authorization for bamlanivimab; Issues identified at a Janssen manufacturing facility; Merck halts trials for investigational COVID-19 therapy; A new contraceptive is approved; And Ragwitek has approval expanded.

The latest status on the Janssen vaccine; Updated guidance from the National Institutes of Health on COVID-19 antibody treatments; The FDA changes in-person mifepristone dispensing; Xolair prefilled syringe approved for self-administration in select patients; And the AI world comes to colonoscopies. 

Back to regular programming this week with a summary of the top news, which includes updated travel guidance; Six month efficacy data for the Moderna and Pfizer-BioNTech vaccines; Vial doses increased for Moderna; A new ADHD drug is approved; And the FDA has issued a safety communication regarding the potential increased risk of arrhythmias in patients taking lamotrigine.

With three FDA authorized vaccines being administered throughout the US, but new variants growing in number, we are at a crucial moment in the COVID-19 pandemic.  To get a better understanding of how the future months could unfold, MPR sat down with Dr Joshua Barocas, an assistant professor of medicine at the Boston University School of Medicine and also an Infectious Diseases physician at Boston...

This week we have new study data on the real-world effectiveness of the Pfizer-BioNTech vaccine; The number of Americans who are completing both vaccine doses; A vaccine trial that has started in children; And an approval in acute bacterial skin and skin structure infections. 

This week it's all COVID related news; There's new CDC guidance for those who are vaccinated; A first over the counter test that doesn't require a prescription; Nasopharyngeal povidone iodine and the combo of Bamlanivimab-Etesevimab is assessed; And there's reports of vaccine local reactions.

This week we have news of an indication for the cancer treatment, Keytruda, being withdrawn; Janssen's single dose vaccine gains Emergency Authorization; There's findings on the effectiveness of Ivermectin as a therapy for mild COVID-19; And devices to treat migraine and prevention of sub-concussive head impacts are authorized for marketing.

An FDA warning over pharma company's promo material; Entresto's approval is expanded, There's approvals in homozygous familial hypercholesterolemia and chronic inflammatory demyelinating polyneuropathy; And a migraine device for OK'd for teens.

This week's stories include a caution about remdesivir; New and updated Emergency Use Authorizations; And new approvals in sleep apnea and for Botox.

This week we take a look at the remaining prospective COVID vaccines, that includes AstraZeneca, J&J and Novovax; There's also drug approvals for analgesia and influenza.