Category: News Commentary

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals ages 12 years and older.

High levels of mucosal antibodies in the airways reduce the risk of being infected by omicron, but many do not receive detectable antibodies in the airways despite three doses of the SARS-CoV-2 vaccine. These are the findings of a study published today in The New England Journal of Medicine, led by researchers at Karolinska Institutet and Danderyd Hospital in Sweden.

Tumor cells are notoriously good at evading the human immune system; they put up physical walls, wear disguises and handcuff the immune system with molecular tricks. Now, UC San Francisco researchers have developed a drug that overcomes some of these barriers, marking cancer cells for destruction by the immune system.

Novartis today announced it is investing in next-generation biotherapeutics with the creation of a fully integrated, dedicated USD 300m scientific environment that will bolster its capacity and capabilities for early technical development of biologics. Spanning both drug substance and drug product development, the multi-year investment will be implemented across existing Novartis locations in Switzerland, Slovenia and Austria,

A Phase 3 clinical trial evaluating the antiviral tecovirimat, also known as TPOXX, is now enrolling adults and children with monkeypox infection in the United States. Study investigators aim to enroll more than 500 people from clinical research sites nationwide. Interested volunteers can visit the ACTG website (clinical trial A5418) for more information.

Researchers from the University of Oxford and their partners have today reported new findings from their Phase 2b trial following the administration of a booster dose of the candidate malaria vaccine, R21/Matrix-M™ – which previously demonstrated high-level efficacy of 77% over the following 12 months in young west African children in 2021.

Pfizer Inc. (NYSE:PFE) today announced that its investigational Group B Streptococcus (GBS) vaccine candidate, GBS6 or PF-06760805, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of invasive GBS disease due to the vaccine serotypes in newborns and young infants by active immunization of their mothers during pregnancy.

A new paper in European Heart Journal – Digital Health, published by Oxford University Press, indicates that social-distancing measures like total lockdown have a measurable impact on vascular health. The study compared the impact on the health of people living in a partial vs. a total lockdown during the beginning of COVID-19.

Cedars-Sinai investigators have developed an investigational therapy using support cells and a protective protein that can be delivered past the blood-brain barrier. This combined stem cell and gene therapy can potentially protect diseased motor neurons in the spinal cord of patients with amyotrophic lateral sclerosis, a fatal neurological disorder known as ALS or Lou Gehrig’s disease.

Monoclonal antibodies are laboratory-designed treatments tailor-made to fight specific infections. In early 2021, the U.S. Food & Drug Administration issued emergency use authorization for two monoclonal antibodies (bamlanivimab/etesevimab and casirivimab/imdevimab) for the treatment of mild to moderate COVID-19 in high-risk, non-hospitalized patients.