John Parkinson

While the world’s focus remains on COVID-19, beyond this ongoing crisis lingers another that requires leadership, innovation, and collaboration from policy makers, the health care community, and the private sector.

Windtree Therapeutics is in a phase 2 clinical trial for its investigational therapy, Lucinactant, which produces a synthetic surfactant being studied for acute lung injury in patients with COVID-19 and acute respiratory distress syndrome (ARDS).

Cue Health's test is over the counter (OTC) and can be utilized at home.

The Luminex test will be able to detect influenza and COVID-19.

Investigators have discovered active substances that can block the replication of coronavirus and may create a pathway for new therapies.

A review of emergency room records showed a very small percentage of patients had acute ischemic strokes, but for those who did, there was an increased risk of requiring long-term care after hospital discharge.

NeuroRx announced results from its phase 2b/3 trial for its investigational therapy, aviptadil, in patients with severe COVID-19.

Investigational therapy, ibrexafungerp, from Scynexis is being studied for fungal infections and is moving closer towards a goal of FDA approval later this year.

The Biden Administration is set to announce the deal officially about a partnership for the biopharmaceutical companies today.

Beginning this week, the agency is funneling air travelers from 2 African countries to a limited amount of US airports.

The variant, B.1.526, was first found in samples dating back to November.

The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommendation paves the way for the authorization.

In a phase 3 study, rheumatoid arthritis (RA) therapy, tocilizumab, did not improve clinical status or lower mortality in these patients.

An Israeli study finds it had an 85% effect in lowering disease 2 to 4 weeks after administration of the initial vaccination.

In lab studies, neutralizing antibody activity was reported but there was a reduction shown in both m-RNA vaccines.

This new variant, B.1.525, was discovered in both the United Kingdom and Nigeria, and is now in 11 other countries including the United States.

The World Health Organization (WHO) listed the vaccine for emergency use to enable countries who do not have vaccine agreements in place to work towards vaccinating their populations.

CalciMedica has developed Auxora, a calcium release-activated calcium (CRAC) channel inhibitor, and it has shown it can reduce the levels of D-dimer, a key biomarker associated with COVID-19 mortality.

CDC director says this is not mandatory, but is a road map and provides strategies for schools to reopen safely.

Just months removed after its last outbreak, the country is seeing the emergence of another outbreak.

Patients with severe COVID-19 experienced positive benefits reducing mortality and intubation rates when using the therapy along with Decadron and convalescent plasma.

Derek Blechinger, MD, MPH, and a team at the Kaiser Permanente San Francisco Medical Center have developed an HIV prediction model to find patients earlier in the care cycle who could benefit from pre-exposure prophylaxis (PrEP) therapy.

The country announced it is going to study the use of the Johnson & Johnson vaccine for health care workers and will not go forward with plans to use the AstraZeneca vaccine.

The UK announced it is beginning a 2-dose study using one dose of the Pfizer/BioNTech and one dose of AstraZeneca in each individual participant.

The agency limited it Emergency Use Authorization (EUA) for the COVID-19 therapy to the use of high titer COVID-19 convalescent plasma only for the treatment of hospitalized patients early in the disease. FDA is no longer authorizing the use of low-titer plasma in its EUA due to a lack of efficaciousness in further studies.

The company is reporting a reduced transmission after the first and second doses. However, questions are arising on the data around these claims and Switzerland declined to approve the vaccine.

The European Medicines Agency announced today it has recommended granting a commercial marketing authorization (CMA) to the company for its vaccine.

Data for its phase 3 trial shows differing levels of protection for moderate to severe disease depending on the geographic region.

Independent investigators assessed in vitro neutralization potency using the antibody therapy, Regen-Cov, against the B.1.1.7 and B.1.351 strains.

However, there is a six-fold reduction in neutralizing titers in the B.1.351 variant from South Africa, so the company is exploring strategies aimed against new variants.