"The Orphan Drug Act: 30 years and still going strong" (FDA Law Blog)
Historical context, data, and references regarding FDA Orphan Drug designations and approvals
"The Primary of Statistics: in defense of pivotal phase 3 trials" (Drug Baron)
"Dasatinib fails in prostate cancer #GU13" (Biotech Strategy Blog) re $BMY
"The world according to BIO CEOs" (FasterCures blog)
The "action tank" reports back from New York with the key takeaways from #BIOCEO13
"Prostate Cancer Drug Winners and Losers at ASCO GU" (Xconomy) re $MDVN $BMY Aragon
Compilation of details regarding all major biosimilars / follow-on biologics / FOBs collaborations worldwide (DewDiligence on InvesttorsHub)
"A Biotech Perspective On Why We Shouldn't Cut The NIH" (Forbes / Matthew Herper with ONXX CEO Tony Coles)
"Petition to Delay Biosimilar Game in U.S. Picks up Steam" (BIOWORLD)
No FDA -approved biosimilars in the US until 2022? Color me skeptical, but we will see how long this story lasts.