News | January 25, 2022
USFDA rejects Merck’s gefapixant; gain approval in Japan
Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant
Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
It is the first CAR T Therapy approved for the treatment of multiple myeloma in Japan
The brand is now available pan-India through their distribution partner
The drug will be marketed under the brand name Molnaflu
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In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2020
Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)
It is anticipated to be safe and efficacious by targeting the receptor-binding domain (RBD) of the new coronavirus
This strategic collaboration will enable continued innovation in cancer care
Takeda is establishing the capability to manufacture TAK-019 (known outside Japan as NVX-CoV2373) at its facilities in Japan and aims to begin distribution in the early calendar year 2022
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