Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
Biologics manufacturing to expand the Aragen platform by offering “gene to GMP” solution
The companies will spread the adoption of the latest HOS and Mass Spec technologies to help scientists improve the safety, stability, and effectiveness of biotherapeutics
Amgen will be prohibited from leveraging its drug portfolio to disadvantage rivals and will be required to seek prior approval before acquiring related products
Investigational cellular therapy, bemdaneprocel (BRT-DA01), was well tolerated with no major safety issues in all 12 participants in low dose and high dose cohorts through one year / At one-year
UTD2 is the world's first oral epothilone microtubule inhibitor
The primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52
The judicial response to industry lawsuits on drug pricing regulations have been mixed in the past
Agilent respectfully disagrees with the PTAB’s opinion of unpatentability in view of prior art previously considered by the USPTO during its primary examination
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