News | June 03, 2022
GSK to acquire clinical-stage biopharmaceutical company Affinivax for US$ 3.3 billion
GSK to pay $2.1 billion upfront and up to $1.2 billion in potential development milestones
GSK to pay $2.1 billion upfront and up to $1.2 billion in potential development milestones
The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023
CLNK is a biotechnology research and development company that utilizes umbilical cord blood as the raw material to develop innovative, allogeneic, off-the-shelf, cell based therapeutic products
R&D investment up 11.7% to 4.1 billion EUR in 2021 (20.0% of net sales)
Clinical improvements were consistent across patient subgroups including age, gender, ethnicity, and IL-36 gene mutation status
The NMPA Breakthrough Therapy Designation was based on results from the Phase 2 TRUST trial of ROS1 fusion-positive NSCLC patients treated with taletrectinib, a new generation of potent ROS1 inhibitors
The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China
The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022
Alzheimer's disease is a serious, progressive and devastating disease with few treatment options
The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology
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