Legend Biotech and Johnson & Johnson have to wait three more months for an FDA decision on their CAR-T medicine. BeiGene's Brukinsa posts competitive frontline leukemia data as key BTK showdown nears. Samsung Biologics' newly minted CEO talks about the CDMO's rapid expansion. And more.
As Bayer looks to ramp up its R&D work in the gene therapy space amid a host of biotech tie-ups, the German pharma is tapping Christoph Koenen as its new global head of clinical development and operations in its R&D unit.
Otsuka and Lundbeck have announced FDA acceptance of a supplemental new drug application for Rexulti for the treatment of schizophrenia in adolescents. Rexulti (brexpiprazole, Otsuka/Lundbeck) is currently approved in the U.S. as a treatment for adults with schizophrenia and as an adjunctive treatment for adults with major depressive disorder. The application submission occurred 1 year earlier
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