Novartis previously signed an agreement with CellforCure in July to produce CAR-T cell therapies including Kymriah (tisagenlecleucel) – which was the first CAR-T cell therapy approved by the FDA ...
Developer Autolus set a list price of $525,000 for its new cell therapy, which it will sell for a type of leukemia under the ...
Novartis’ CAR-T therapy Kymriah will be available in the US to adults with relapsed large B-cell lymphoma – bringing the cell therapy into direct competition with Gilead’s rival at exactly ...
While Gilead’s Tecartus and Novartis’ Kymriah also boast approvals in ALL, Autolus’ new med boasts a unique edge as the only CAR-T that doesn’t come with an FDA requirement for a Risk Evaluation ...
Senator asks Novartis to explain its payments to Cohen, noting FDA approval of cancer drug Novartis made $1.2 million in payments to Cohen's firm during the time that the FDA was deciding whether ...
An FDA announcement last year of an investigation into the risk of patients developing secondary cancers following the ...
Swiss pharmaceuticals group Novartis has said it will charge $475,000 ... the drug, known as Kymriah, is the most expensive to go on sale. Strigini pointed out the price tag was below the ...
LEGN)), and Novartis’ Kymriah. These therapies are individually approved for multiple myeloma, large B-cell lymphoma, and other blood cancers. The FDA specifically instructs the companies to ...
He also oversaw U.S. manufacturing operations at Novartis, scaling production and supporting regulatory approval for Kymriah ®, the first FDA-approved CAR-T cell therapy. Eissa's expertise in ...
With the AveXis and Endocyte deals - as well as Novartis's ongoing work with Kymriah - Novartis has managed to extend its reach into a number of buzzy new areas of biotech, from gene therapies to ...
The US regulatory body’s decision was based on the results of a Novartis-sponsored clinical trial, in which 52 of 63 patients (83%) who received the Kymriah treatment achieved remission from ...
The United States Food and Drug Administration (USFDA) on Monday said that companies will be required to add a serious warning on the prescribing information for cancer therapies known as CAR-T ...