Phase III
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.
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.
The company is conducting analyses to understand safety data that had been gathered prior to the pausing of the three studies, NCT04605159, NCT04980391 and NCT05229068.
The FDA said that the shared NDA documents did not show ample proof that bardoxolone methyl effectively slows down kidney function loss in patients with Alport syndrome.
With nipocalimab, Janssen is hoping to take one big swing and knock the power right out of these autoantibodies.
The FDA places holds, companies receive clearance for new studies and Pharma giants release new data in last week’s clinical trial news.
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