Clinical research
The FDA rejected Gilead’s New Drug Application, citing Chemistry Manufacturing and Controls (CMC) problems associated with the compatibility of the drug with the proposed container vial.
Pfizer’s Clostridioides difficile infection vaccine failed to hit the mark, BMS announced priority review for Opdivo in resectable Non-Small Cell Lung Cancer, and Saol enlists help from GeneDx.
In 2021, Sanofi earned about $4.2 billion from Dupixent sales, and Regeneron earned about $1.8 billion.
Two new biotech companies launched today: NextRNA to focus on non-coding RNA technology, and Pathalys, with a clinic-ready licensed compound and plans to enter Phase III trials.
Johnson & Johnson’s partner, Legend Biotech, has been awarded FDA approval for its (CAR-T) therapy, Carvykti, for the treatment of multiple myeloma disease.
AstraZeneca and Neurimmune have signed an exclusive global collaboration and licensing deal to develop, manufacture and commercialize NI006 for ATTR-CM.
Positive interim data from the global Phase I trial of single-dose NTLA-2001 demonstrated a mean serum TTR reduction of 93% at the highest dose level of 1.0 mg/kg by day 28.
The FDA declined approval for Amryt Pharma’s therapeutic oleogel-S10. The topical gel is intended to treat a group of rare skin diseases called epidermolysis bullosa.
Acrotech is looking to launch drugs with either improved efficacy and/or safety over currently available treatments in the oncology, dermatology, neuroscience and rare disease spaces.
The FDA lifts its clinical hold on Ocugen’s COVID-19 vaccine, and Ocugen announces a clinical trial for the treatment of inherited retinal diseases.
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