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Roche’s GALLIUM Results Draw Skepticism about Changing Practice in First-Line Follicular Lymphoma
Roche’s (VTX:ROG) Phase III GALLIUM study of Gazyva (obinutuzumab) in first-line follicular lymphoma (FL) has low probability of changing...
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the Market Before 2020"
Humira Biosimilar Unlikely to Reach the Market Before 2020
The numerous biosimilars for AbbVie’s (NYSE:ABBV) Humira (adalimumab) are unlikely to reach the market prior to Amgen’s...
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Politicizing Science
POLITICIZING SCIENCE BY STEVE USDIN, WASHINGTON EDITOR While the FDA reform provisions in the 21st Century Cures Act give the agency...
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NY-ESO-1 Therapy Renewed Enthusiasm Underscored by New Checkpoint Inhibitors
NY-ESO-1 targeting immunotherapies are seeing renewed clinical development interest as the antigen is widely expressed in certain solid...
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Democratizing Antibodies
“Will it be mammalian cells forever? Or is there an opportunity to get even better and to get to the next step change in productivity?” -...
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FDA Review Policies for PD-1/PD-L1 Inhibitors Spark Expert Debate
The potential for changes to FDA oncology drug application review and approval policies has drawn contrasting expert opinions following...
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PCSK9 Inhibitor Competition: Amgen, Scanofi, and Regeneron Show Equally Decent CVOT Outlooks
• Comparable CV effect expected across PCSK9 inhibitor class • Post-hoc MACE results in previous trials viewed with some restraint • 50%...
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South Korea Trials Drive Further Opportunities for Global Pharma and CROs
• Goals to improve regulation and site standards • Korean data used in Japanese approvals • Big pharma interest in earlier...
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Changing the Channel, Overcoming Crisis : Reproducibility Initiatives
--Strategy-- CHANGING THE CHANNEL By Mark Zipkin, Staff Writer Having helped expose the reproducibility crisis about five years ago,...
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Early CAR-T Multiple Myeloma Data Promising, Though Efficacy, Safety Remain Unclear
• Source of anti-CD19 CAR-Ts’ benefit obscure • Targeting multiple antigens may be necessary, says expert • Cytokine release...
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