[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 Items that are out of date will be removed.]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: GILD (Truvada approved for HIV prevention—entry deleted).
ABT – Bioresorbable DES: EU launch 2H12 (following reimbursement negotiations—product already approved); US launch possible in 2013 (pending clinical results).
BMY – Yervoy in melanoma brain mets: OS data from phase-2 ‘042’ trial 2012 (?) (RR data reported at 2010 ASCO). BMY – Yervoy in NSCLC/SCLC: OS data from phase-2 ‘041’ trial 2012 (?) (PFS data for NSCLC reported at 2010 ASCO). Decision has been made to advance to phase-3 in NSCLC. ).
GILD – PSI-7977: numerous data reports due in 2012 (too numerous to list here). . GILD – 4-drug phase-2 all-oral HCV trial: SVR data early 2013. GILD – Quad PDUFA date 8/27/12 (positive FDA panel 5/11/12). GILD – “Standalone” Evitegravir: NDA submitted 6/27/12, awaiting decision on priority review. GILD – “Standalone” Cobicstat NDA submitted 6/28/12; MAA submitted 5/23/12. GILD – GS-7340 (Viread enhancement): Data from phase-1b dose-ranging and phase-1 combo w Emtriva: 2Q11. (Phase-2 started 1/24/12.)
IDIX – IDX184: start of unspecified all-oral combination studies promised in PR of 6/20/12. IDIX – IDX719 (NS5A inhibitor): 3-day PoC phase-1b monotherapy data reported 6/20/12; NVS now has exclusive option to license IDX719 with a decision expected in about 3 months.
ITMN – Pirfenidone: No specific timeline for response to FDA’s CRL of 5/4/10 requesting a new trial.
JNJ – Xarelto NDA for VTE treatment/secondary prevention: on or about 11/2/12; (Xarelto NDA in PCI/ACS withdrawn on 7/10/12). JNJ – Bapineuzumab: ‘301’/‘302’ (N. American) phase-3 trials conducted by JNJ: data 10/8/12 at American Neurological Assocation; (ex-US) phase-3 trials conducted by PFE: data in 2014.
LGND - Promacta NDA/MAA for HCV reviews pending (submissions made 5/30/12). LGND - SCH527123 (MRK) CXCR2 antagonist p2 COPD is enrolled, data early 2012
PFE – Tofacitinib PDUFA date Aug 2012 (positive FDA panel 5/9/12). PFE – Xalkori (crizotinib) in NSCLC: EU decision mid 2012 (MAA accepted for review 8/17/11). Approved by FDA 8/26/11. PFE – Bosutinib in CML: PDUFA date Oct 2012; EU decision mid 2012 (MAA accepted for review 8/17/11). PFE – Eliquis: see BMY. PFE – Bapineuzumab: see JNJ.
REGN – Zaltrap BLA in mCRC PDUFA date 8/4/12 (priority review).
SNTA – phase 2b ganetespib + docetaxel in NSCLC: 2Q12.
SNY – Aubagio for RRMS: PDUFA date Jun 2012; in EU, MAA accepted for review 2/23/12.
SPPI - Belinostat phase-3 data: 2012 (according to PR of 3/1/12).
TEVA – Copaxone litigation: see MNTA. TEVA – Thrice-weekly formulation of Copaxone: timing of NDA unclear according to 6/14/12 PR announcing positive top-line results from GALA study.
VRTX – Phase-2b testing multiple (non-response-guided) protocols for Incivek + VX-222 + ribavirin in treatment-naïve genotype-1 to start 3Q12. (Data on no-IFN arms of ZENITH study reported 2/23/12.) VRTX – Initial data on studies with ALS-2200 and ALS-2158: 2Q12.
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