The filing of a Biologics License Application for a subcutaneous version of Biogen and Eisai’s Leqembi (lecanemab) has been delayed due to procedural reasons, the companies announced Monday.
Tag Archive for: Biologics License Application
Johnson & Johnson’s anti-BCMA antibody can now be dosed once every two weeks in relapsed or refractory multiple myeloma patients who have achieved and maintained complete response for at least six months.
An FDA advisory committee will meet to review J&J and Legend Biotech’s supplemental BLA for Carvykti for the treatment of relapsed or refractory multiple myeloma patients who have undergone at least one prior line of therapy.
The FDA was on a roll in the first half of 2023, approving more than two dozen novel treatments. And if the first six months is any indication, the biopharma industry should expect several more novel therapies to be greenlit, including a few more first-in-class treatments.
If approved, crovalimab would be the first monthly subcutaneous treatment for patients with PNH, with the option to self-administer outside of a supervised healthcare setting.
The regulator informed bluebird bio that it will not convene an advisory committee meeting to discuss the company’s application for the gene therapy being developed for sickle cell disease.
Following the regulator’s request for more data beyond the scope of its Phase III TIDES trial, Takeda decided to voluntarily withdraw the Biologics License Application for its TAK-003 dengue vaccine.
Vedanta Biosciences closed a $106.5 million funding round on Tuesday to support a pivotal Phase III study of its candidate VE303 for Clostridioides difficile (C.diff) infection.
The FDA has approved Gamida Cell’s omidubicel-onlv, now to be marketed as Omisirge, in patients over 12 years of age with blood cancers, the company announced Monday.
In an earnings call, bluebird bio revealed it is unlikely to meet its first-quarter goal to submit a Biologics License Application for sickle cell disease (SCD) gene therapy lovo-cel.
