[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 Items that are out of date will be removed.]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: ABBV; ENTA; EXAS; GILD; MNTA; JNJ (second CRL issued for Xarelto in ACS—entry removed); PRAN; SNY (CLR issued for Lemtrada—entry removed); TEVA (thrice-weekly Copaxone approved—entry 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.
EXAS – FDA advisory panel for Cologuard 3/27/14.
GILD – Sovaldi + Ledipasvir NDA submission 2/10/14; with priority review, FDA decision expected 4Q14. EU MAA submission 1Q14.
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.)
PFE – Eliquis sNDA in primary VTE prevention: PDUFA date 3/15/14; Eliquis sNDA in VTE treatment & secondary prevention: FDA submission 3Q13. (Eliquis was approved for VTE prevention in EU in 2011.)
PRAN - Reach2HD Phase-2 for Huntington's disease: Results Mar 2014? PRAN - IMAGINE: Phase-2 imaging trial for Alzheimer's disease. Plaque positive prodromal and mild AD. Results?
-- Procedure for Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old calendar.
2. Make your additions or modifications, inserting new items in alphabetical order.
3. Near the top of the message, list the ticker symbols of the entries you changed (e.g. “Edits: GILD MNTA”).
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