It was RCB's third win — and second in a row — in 10 matches so far this season, keeping their slim hopes of reaching the playoffs alive
cricket2 hours ago
The US health regulator has approved a therapy developed by Johnson & Johnson and its China-focused partner Legend Biotech Corp to treat a type of white blood cell cancer, the US healthcare company said on Monday.
The Food and Drug Administration's decision paves the way for Legend's first approved product in the United States, at a time when the regulator has stepped up its scrutiny of drug trials conducted in China. The Legend-J&J therapy was tested initially in China, and then in the United States and Japan.
"This is the first of many cell therapies we plan to bring to patients as we continue advancing our pipeline across disease states," said Ying Huang, Legend's chief executive officer and chief financial officer.
The treatment, Carvykti/Cilta-cel, belongs to a class of drugs known as CAR-T therapies, or chimeric antigen receptor T-cell therapies.
CAR-T drugs work by harvesting a patient's own disease-fighting T-cells, genetically engineering them to target specific proteins on cancer cells, and replacing them to seek out and attack cancer.
Legend and J&J will sell the drug in Greater China at 70-30 split in profit, and in all other countries in a 50-50 split in profit.
A decision on the CAR-T therapy was initially expected to come by the end of November after it was given priority review six months earlier, but this was extended by three months to allow sufficient time to review information submitted by J&J following an FDA request.
ALSO READ:
Legend, which initiated the development, signed an agreement with Janssen Biotech Inc, an arm of J&J, in 2017, to jointly develop and commercialize the drug, with Legend getting $350 million in upfront payment.
Besides the United States, Carvykti/Cilta-cel is also being reviewed by health authorities in Japan and Europe. A Marketing Authorisation Application (MAA) for the therapy in China is yet to be filed.
It was RCB's third win — and second in a row — in 10 matches so far this season, keeping their slim hopes of reaching the playoffs alive
cricket2 hours ago
Offshoring business operations to captive centres has proven to be a cost-effective and efficient strategy
realty2 hours ago
Tourism minister Ahmed Al Khateeb says all the kingdom's projects are far away from the conflict
mena2 hours ago
A wave of exceptionally hot weather has blasted the region over the past week, sending the mercury as high as 45 degrees Celsius
asia2 hours ago
This was following a Reuters report that some senior US officials did not find Israel's assurances credible
world2 hours ago
Chinese Premier Li Qiang promises to Musk that the country will always be open to foreign firms
auto2 hours ago
Prevailing market trends, investment opportunities and growth strategies instilling confidence in stakeholders navigating Dubai's dynamic landscape
realty2 hours ago
Both parties must be taxable; or become taxable as a result of the transfer
business2 hours ago