Politicizing Science
Biopharmaceutical Report I Issue12_December 2016 POLITICIZING SCIENCE BY STEVE USDIN, WASHINGTON EDITOR While the FDA reform provisions...
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NY-ESO-1 therapy renewed enthusiasm underscored by new checkpoint inhibitors
Biopharmaceutical Report III Issue11_September 2016 NY-ESO-1 targeting immunotherapies are seeing renewed clinical development interest...
Democratizing Antibodies
Biopharmaceutical Report II Issue11_September 2016 “Will it be mammalian cells forever? Or is there an opportunity to get even better and...
FDA Review Policies for PD-1/PD-L1 Inhibitors Spark Expert Debate
Biopharmaceutical Report I Issue11_September 2016 The potential for changes to FDA oncology drug application review and approval policies...
PCSK9 Inhibitor Competition: Amgen, Scanofi, and Regeneron Show Equally Decent CVOT Outlooks
Biopharmaceutical Report II Issue10_July 2016 • Comparable CV effect expected across PCSK9 inhibitor class • Post-hoc MACE results in...
South Korea Trials Drive Further Opportunities for Global Pharma and CROs
Biopharmaceutical Report I Issue10_July 2016 • Goals to improve regulation and site standards • Korean data used in Japanese...
Changing the Channel
Overcoming Crisis : Reproducibility Initiatives Biopharmaceutical Report III Issue9_April 2016 --Strategy-- CHANGING THE CHANNEL By Mark...
Early CAR-T multiple myeloma data promising, though efficacy, safety remain unclear
Biopharmaceutical Report II Issue9_April 2016 • Source of anti-CD19 CAR-Ts’ benefit obscure • Targeting multiple antigens may be...
Samsung RA biosimilar EU uptake tied to perceived cost despite physician concerns
Biopharmaceutical Report I Issue9_April 2016 • Reference companies may lower drug prices too • Payers may mandate biosimilar use in...
Controlling Drug Prices
Biopharmaceutical Report III Issue8_Novemver 2015 Goodwill Hunting Martin Shkreli and Hillary Clinton last week provided the flint and...