Preclinical

A new study from Johns Hopkins University Bloomberg School of Public Health suggests the development of dementia is associated with abnormal levels of plasma proteins, and these proteins may be predictive of dementia up to five years before a patient receives a diagnosis.
Medicago and GSK announced their positive interim data from a mid-range study of a plant-based vaccine for COVID-19.
Under the terms of the agreement, Bristol Myers Squibb will take over complete responsibility for the development and commercialization of AGEN1777 and any related products globally.
The U.S. FDA scolded CytoDyn for misrepresenting its clinical trial results for Leronlimab in COVID-19. Here’s what FDA has to say regarding CytoDyn Leronlimab.
FDA
The high court’s decision will prevent Sandoz from launching its biosimilar to Amgen’s blockbuster rheumatoid arthritis drug.
Sanofi and GSK expect to launch a global pivotal Phase III trial of its COVID-19 vaccine in the coming week.
Biogen reported that its gene therapy, cotoretigene toliparvovec, failed to hit the primary endpoint of the Phase II/III XIRIUS trial for X-linked retinitis pigmentosa (XLRP).
Pivotal data from Amgen’s and AstraZeneca’s NAVIGATOR Phase III trial show tezepelumab, a potential first-in-class human monoclonal antibody, reduced asthma aggravations and exacerbations requiring hospitalizations better than placebo in patients with severe asthma.
FDA
Merck announced positive results from the late-stage KEYNOTE-522 study that should support its previous attempt that was stymied by a regulatory advisory committee in February and rejected by the U.S. FDA in March.
Nearly 50 infants with “bubble baby” disease developed a working immune system after they received a gene therapy that contained the AIDS virus, according to a new study.
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