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Eli Lilly’s Olumiant (baricitinib), a powerful anti-inflammatory used to treat rheumatoid arthritis, has once again proven its mettle against COVID-19. Read More
The nonprofit generic drugmaker Civica said that it’s going to manufacture three different insulin biosimilars that, if approved, will be distributed at prices that are “significantly lower” than the cost of insulin products that are currently available on the market. Read More
Therapies based on the human gut microbiome are in the news with one company, Osel, releasing encouraging phase 1b data and another, Finch, receiving an FDA clinical hold during a phase 3 recruitment. Read More
The results suggest that treatment with a one-time CRISPR-based therapy has the potential to substantially reduce levels of a disease-causing protein. Read More
Pfizer is putting a positive spin on a C. difficile vaccine study that missed its two primary endpoints but scored some wins on secondary targets. Read More
The FDA has released final guidance for industry on the agency’s approach for overseeing requests for the importation of unapproved finished dosage form drugs by applicants preparing medicines for market launch of a pending new drug application (NDA), an abbreviated new drug application (ANDA) or biologics licensing applications (BLA) regulated by the agency’s Center for Drug Evaluation and Research (CDER). Read More
Carvykti, a new CAR-T cell therapy developed by Legend Biotech and Janssen, is now approved for patients with relapsed or refractory multiple myeloma who have already received four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. Read More
FDA clinical holds saw a sharp increase in 2021, propelled in large part by holds on cell and gene therapy trials, according to an analysis by investment banking firm Jefferies that evaluated holds over the past 12 years. Read More
Sanofi and Regeneron added another brick to their joint Dupixent franchise with more phase 3 data confirming the antibody’s benefit in eosinophilic esophagitis, a chronic inflammatory disorder that can increase the risk of esophageal cancer. Read More
AstraZeneca and Daiichi Sankyo have released promising results from a phase 3 study of Enhertu (trastuzumab deruxtecan), saying the drug significantly improved both progression-free and overall survival in patients with HER2-low metastatic breast cancer. Read More
Kodiak Sciences’ antibody designed to treat age-related macular degeneration with eye injections every three to five months was no better than Regeneron Pharmaceutical’s Eylea (aflibercept), the currently approved drug for the condition, injected every two months, Kodiak reported. Read More