[Please keep these entries up to date! See the updating procedure at the end of this post. Items that are out of date will be removed.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: BMY/PFE (Eliquis approved by FDA for primary VTE prevention—entry removed—but sNDA for VTE treatment/secondary prevention has PDUFA date 8/25/14); EXAS (FDA advisory panel held—entry removed); GILD (S+L MAA submitted and “validated” for review); PRAN (ph2 HD data released and AD data to be released imminently—entries removed).
ABBV – HCV program: see ENTA.
ABT – ABSORB bioresorbable stent: Complete ph3 enrollment in US and China 1H14; ph3 in Japan already enrolled. (Note: ABSORB already launched in all mjor countries except US, China, and Japan.)
BMY – Eliquis: see PFE.
ENTA/ABBV – Submit NDA/MAA for 3-DAA HCV regimen: Apr 2Q14. With priority review, FDA decision expected late 2014. Report ph1 data for ABT-493 and ABT-450 (next-gen 2-DAA regimen) at unspecified venue in 2014. (Individual ph1b trials of ABT-493 and ABT-530 are already underway, which must be completed prior to testing the combination.)
ENTA/NVS – EDP-239 ph1b monotherapy trial started by NVS Jun 2013, expected to complete Jun 2014; DDI study of EDP-239 (presumably with DEB025) started by NVS Jul 2013—further details unavailable.
GILD – Sovaldi + Ledipasvir NDA submission 2/10/14 (with priority review, FDA decision expected 4Q14); EU MAA submission 2/27/14 (“validated for review 3/27/14).
GILD – NDAs for “standalone” elvitegravir and “standalone” cobicstat (component drugs in Stribild): FDA issued CRL on 4/29/13; no further details available. (In the EU, elvitegravir is approved as Vitekta and cobicstat is approved as Tybost.)
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