Drug Development

Pfizer announces the first data from its Metsera-acquired pipeline just ahead of its earnings call, where analysts pressed execs for more details; Merck and Roche also released Q4 and full year earnings, with Eli Lilly, Novo Nordisk and others reporting Wednesday; REGENXBIO hits a regulatory snag ahead of its upcoming PDUFA; more.
FEATURED STORIES
AstraZeneca’s $15 billion pledge to its China operations highlights the country’s advantages. But other regions are also hoping to host more clinical studies.
With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
When the pandemic hit, many companies diverted resources aimed at HIV to COVID-19, which ended up pausing some research efforts.
The company says it plans to file an IND for the candidate, dubbed CFT8919, by the middle of next year.
Companies continue to report promising data for vaccines and therapies against COVID-19. Here’s a look.
This is after Larimar reported deaths in the highest dose levels of a nonhuman primate toxicology study.
Engine is ready to drive its lead program into clinical trials by 2023 while Giiant’s preclinical program will target moderate-to-severe ulcerative colitis.
Emergent said the vaccine candidate against the mosquito-borne illness showed an increase in immune response as measured by anti-chikungunya virus SNA.
Gene therapy is still very much cutting-edge with the potential to cure incurable genetic diseases. Here’s some recent news in the space.
FDA
Ocugen submitted a “Master File” to the U.S. FDA for COVAXIN, the vaccine that has already received authorization in India for people ages 12 and above.
LION-101 is a novel recombinant AAV being developed as a one-time intravenous infusion for the treatment of adult and adolescent patients with Limb-Girdle Muscular Dystrophy Type 2I/R9.