Drug resistance to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors, occurring via secondary mutations or bypass pathways, is frequent among non-small-cell lung cancer patients.
The appointment May 6 of Vinay Prasad as the head of the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) “bodes poorly” for Sarepta Therapeutics Inc.’s development-stage pipeline, said Wainwright analyst Mitchell Kapoor – and Wall Street reflected as much, as the stock (NASDAQ:SRPT) ended that day down 26.6% vs. an XBI drop of 6.6% – this ahead of the after-hours earnings disclosure that pushed the Cambridge, Mass.-based firm down even farther by more than another 20%, with the XBI unchanged.
Researchers from the Access to Advanced Health Institute and collaborating institutions have developed a promising new bivalent vaccine candidate that can protect against both yellow fever and Zika viruses. The study demonstrates that the vaccine elicits robust humoral and cellular immune responses in mice and hamsters and provides complete protection against lethal viral challenges.
U.S. FDA Commissioner Marty Makary is starting to fill the vacancies at the agency that’s seen its senior leadership ravaged by retirements and terminations. Makary’s first pick is Vinay Prasad as the new head of the FDA’s Center for Biologics Evaluation & Research (CBER), the center that oversees vaccines, blood products, allergenics and cellular, tissue and gene therapies.
Human papillomavirus (HPV), particularly the high-risk HPV16 subtype, is a major driver of certain cancers, including cervical, oropharyngeal, anal and penile cancers. The E6 and E7 proteins produced by HPV16 are known to play critical roles in the development of these malignancies, making them attractive targets for therapeutic interventions.
In a paradigm shift from private-sector partners, the U.S. Department of Health and Human Services (HHS) and the NIH announced May 1 the development of Generation Gold Standard, a next-generation, universal vaccine platform that uses a beta-propiolactone-inactivated, whole-virus to target pandemic-prone viruses.
Rheumatoid arthritis (RA) is a chronic autoimmune disorder marked by joint inflammation, cartilage loss and bone damage. Although biological disease-modifying antirheumatic drugs have improved treatment outcomes, the disease remains incurable.
A recent study by researchers from Texas A&M University presented a new vaccine designed to target the ligand-binding domain of the serotonin 2A receptor (5-HT2AR), which resides in the second extracellular loop (EL2) and was previously identified as the key region for receptor activation. The new candidate, called EL2-5HTVac, was shown to provide a long-lasting and selective therapeutic approach to avoid increased bleeding risk complications.
Nervousness about the Trump administration’s attitude to vaccines has spurred the formation of the Vaccine Integrity Project, which has the aim of safeguarding the use of vaccines and ensuring vaccine policy “remains grounded in the best available science,” and is “free from external influence.”