[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 Items that are out of date will be removed.]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: JNJ (Xarelto rejection in ACS).
ABT – Bioresorbable DES: EU launch 2H12 (following reimbursement negotiations—product already approved); US launch possible in 2013 (pending clinical results).
AGN – Latisse for androgenetic alopecia: phase-2 data in men and women late 2012.
AMGN – Xgeva sBLA submission for bone health in non-metastatic cancer: 2012-2013 pending results of phase-3 trial in breast cancer.
AMRN – AMR101 PDUFA date 7/26/12.
BMY – Eliquis in AF: PDUFA date 6/28/12 (extended 3 months on 2/29/12). BMY – Eliquis in VTE prevention: approved in EU (3/18/11); no update on timing of possible FDA submission (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58061618 ). ELN – Bapineuzumab: see JNJ.
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 – Truvada HIV prevention PDUFA date 9/14/12 (positive FDA panel 5/10/12). GILD – Quad PDUFA date 8/27/12 (positive FDA panel 5/11/12). GILD – Evitegravir+Cobicistat *without* Truvada: NDA 2Q12. GILD – “Standalone” Cobicstat as a general replacement for ritonavir: MAA submitted 5/23/12; NDA planned 3Q12. 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 for PCI sub-indication of ACS: NDA submission 5/9/12, FDA notification of acceptance for review pending. Xarelto NDA for ACS per se rejected received CRL on 6/21/12. 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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