Phase I

Today, the FDA approved two new drug applications. One is for Spero’s tebipenem HBr oral tablets and the second is CStone’s IND application for CS5001.
Not surprisingly, the week between Christmas and New Year was quiet in terms of clinical trial news. However, there were some announcements. Here’s a look.
Janssen Pharmaceutical has recently applied for Biologics License Application for its relapsed or refractory (r/r) multiple myeloma drug. Here’s all about it.
Ten studies are halted completely. Oral formulations of the drug will continue. Gilead stated that it is confident about the future of the drug’s potential and is working to resolve the vial quality problem.
Pfizer has paused screening and dosing of a Phase Ib study of its experimental gene therapy treatment for Duchenne muscular dystrophy following the unexpected death of a patient.
After their latest trial delivered disappointing results, Pfizer and BioNTech are ready to test if a third dose of their COVID-19 vaccine would trigger an immune response in very young children.
It was an enormously busy week with plenty of announcements from the American Society of Hematology meeting and numerous companies working to get the news out ahead of the holidays and year-end. Here’s a look.
Researchers have published a study describing how chemotherapy and a drug used to treat cardiac failure is able to regress tumor growth of patients with triple negative breast cancer.
Biopharmaceutical companies across the world are fighting an increasingly important battle against COVID-19: the struggle to treat the disease.
The 63rd ASH Annual Meeting and Exposition is wrapping up today, with dozens providing updates on clinical trials and preclinical research. Here’s a highlight of just a few of those stories.
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