Politicizing ScienceBiopharmaceutical Report I Issue12_December 2016 POLITICIZING SCIENCE BY STEVE USDIN, WASHINGTON EDITOR While the FDA reform provisions i...
NY-ESO-1 therapy renewed enthusiasm underscored by new checkpoint inhibitorsBiopharmaceutical Report III Issue11_September 2016 NY-ESO-1 targeting immunotherapies are seeing renewed clinical development interest a...
Democratizing AntibodiesBiopharmaceutical 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 DebateBiopharmaceutical 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 OutlooksBiopharmaceutical Report II Issue10_July 2016 • Comparable CV effect expected across PCSK9 inhibitor class • Post-hoc MACE results in pre...
South Korea Trials Drive Further Opportunities for Global Pharma and CROsBiopharmaceutical Report I Issue10_July 2016 • Goals to improve regulation and site standards • Korean data used in Japanese approval...
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 unclearBiopharmaceutical Report II Issue9_April 2016 • Source of anti-CD19 CAR-Ts’ benefit obscure • Targeting multiple antigens may be nece...
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 t...
Controlling Drug Prices Biopharmaceutical Report III Issue8_Novemver 2015 Goodwill Hunting Martin Shkreli and Hillary Clinton last week provided the flint and st...