John Parkinson

Regeneron’s monoclonal antibodies, casirivimab and imdevimab (REGEN-COV), reduced risk of death by 20% in patients hospitalized with COVID-19 who had not mounted their own immune response.

This mutation also known as B.1.617.2, and first discovered in India is making its way westward and is an emerging infection in the US.

With the company reporting its data today and it applying for authorization with regulatory bodies internationally, and later this year with the US Food and Drug Administration (FDA), what does the prospect of this new vaccine mean to people in the US and internationally?

Cartesian Therapeutics has created its therapy, Descartes-30, the first RNA cell therapy for acute respiratory distress syndrome (ARDS), and the company is now recruiting for a clinical trial.

The federal agency has asked Johnson & Johnson to discard its COVID-19 vaccine made at a plant in Baltimore.

The committee members discussed their concerns about having sufficient data to make an informed decision around the risk vs. benefits for looking at potential FDA approvals for vaccines in this population group.

The company’s submission is for teens 12-17 years old and is based on data from its phase 2/3 trial studying its mRNA-1273 vaccine.

The mutation, first identified in India, has been growing here and is disproportionately affecting younger people in the UK. The CDC and the Biden Administration continue to express the importance of vaccination as a way to combat the strain.

In a population-based cohort study with a mean follow-up of 3.6 years, childhood outcomes showed no statistically significant associations with any adverse health conditions.

The company recently began its phase 2/3 trial for its investigational therapy.

With the US Centers for Disease Control and Prevention's recent change to mask guidance for vaccinated people, some confusion ensued and left state governments and businesses scrambling to react to the update.

The government agency will be assessing the safety and immunogenicity of an investigational nanoparticle influenza vaccine.

This is the first oral non-azole treatment for vaginal yeast infections.

If it is approved, this would be the first new antifungal class in the United States in years.

During the COVID-19 surge last year, the federal government stopped the required reporting on healthcare-associated infections (HAI) thus leaving an absence of data and important information on HAI. One study examined the effect the initial pandemic surge had on Clostridioides Difficile infection (CDI) in one hospital.

Do the very freedoms Americans enjoy allow us to make less than optimal choices? And will it prevent us from doing what medical science says is best if needed again?

The company plans to file for Food and Drug Administration (FDA) authorization for the 12-17 year old population in early June.

An investigational therapy demonstrated neutralizing antibodies as well as protection against the virus in preclinical trials.

A study looked at hospital admissions of Medicare patients and saw a large percentage of recurrent Clostridioides difficile infections (rCDI) as the primary diagnosis.

A diagnostic analyzer was studied looking at 3 biomarkers to predict the level of COVID-19, and could potentially serve as a risk stratification tool.

A large retrospective analysis of Medicare patients offers a glimpse of the incidence rates of this patient population and the burdens associated with it.

Study finds communicating on Electronic Medical Record (EMR) led to follow-up with infectious disease providers.

The federal agency elongates the time from 5 days up to 1 month for thawed out doses of the Pfizer-BioNTech vaccine.

A Roche test can be used in individuals not showing signs of symptomatic disease.

A new CDC study demonstrates effectiveness in a population with high exposure to the virus.

As the HIV population ages, a variety of health challenges may arise that typically happen in populations without chronic conditions.

With yesterday’s announcement, a lot of questions remain about how to proceed. One expert weighs in on this significant topic including how masks have substantially helped as a COVID-19 prevention strategy.

The United Kingdom is enrolling volunteers to be purposely exposed and infected with SARS-CoV-2 to learn more about infection, progression, and the immune response to it. A bioethics lawyer offers insights into the deliberation and decision-making that goes into whether human challenge trials should commence.

The CDC Director Rochelle Walensky confirmed the Pfizer-BioNTech vaccine can be administered in children as young as 12 years of age.

The company said its investigational therapy, ibrexafungerp, demonstrated superiority to placebo for treatment of vaginal yeast infections, and is working towards its Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) date next month.