[Please keep entries up to date! See updating procedure at the end of this post.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: PPHM - bavituximab cancer, bavituximab HCV
ACHN – See GILD
ADLR – Approvable letter for Entereg issued 11/6/06 requesting safety data due in 2Q07.
AMGN – Vectibix: final OS from ‘408’ study: schedule unknown (low chance of hitting endpoint).
AMLN – Phase-3 LAR results: 2H07; Byetta monotherapy results: 2H07.
ANDS – ANA975 for HCV placed on hold 6/26/06 due to preclinical safety issue; human trials expected to resume at end of 2007 following FDA analysis of animal tox study.
ANDS – ANA380 in HBV: phase-2b to begin “sometime in 2007” (don’t hold your breath).
ANOR / AOM.TO – pivotal AMD3100 results any day.
ASPM – Interim data from BRITE trial in depression: scientific conference in 2Q07.
BMY – Plavix litigation: trial began 1/22/07.
CEPH – Nuvigil approvable letter with minor issues received 3/30/07; response pending.
CLSC - Two phase 3 Trials 1600-2000 patients to complete in calendar Q4 with public " top line data" on results anticipated for calendar Q1 07. This is a 10 week trial.
COLY – Phase-3 PF-3512676 in NSCLC (by PFE): late 2007 or, more likely, 2008 (2 trials).
COR – CX-717 additional tox data report to be submitted to FDA in early April 2007. (FDA clinical hold was partially lifted 10/9/06.)
CRME - IV RSD1235 NDA refiled, FDA decision likely 4th qtr/07.
CYT.TO - Initiated pivotal A-fib trial Oct/06. Results timing, will update when company provides timeline.
CYPB – Phase-3 Milnacipran in fibromyalgia, second phase-3 results: mid 2007 (#msg-9132392).
DDSS (formerly LBPFF) – Response to and appeal of Tramadol approvable letter submitted 12/20/06.
DNA – Avastin in breast cancer: FDA requested additional data confirmation on 9/11/06; resubmission by DNA pending.
GPCB – Satraplatin SPARC trial: final overall survival: fall 2007. (The trial hit the primary PFS endpoint on 9/24/06; interim OS look announced on 6/8/06 failed to meet threshold for unblinding.) NDA submitted 2/16/07.
GTCB – ATryn EU launch for HD: July 2007.
GTCB – ATryn DIC program in EU: start of ph-2 (by Leo Pharma) any day.
GTCB – ATryn ph-3 for HD in U.S.: complete enrollment 1H07, report data 2H07, submit BLA end 2007.
GTCB – Merrimack MM-093 phase-2b in RA, phase-2 in psoriasis to be presented at EULAR in June 2007.
GTOP – Final MyVax results Dec 07.
IDIX – Sebivo in EU: endorsed by CHMP 2/23/07; approval expected April-May. (Approved in U.S. 10/06 and in China 3/07.)
IDIX – NM283+ribavirin drug-interaction study: top-line data by PR late June 2007; full data at medical conference in fall 2007 (probably AASLD).
IDIX – Tyzeka phase-3 in decompensated liver disease: enrollment complete in 1Q07 (75% complete as of 9/27/06).
IMCL – (See #msg-9218093 for selected Erbitux trials): 1) CRYSTAL trial in first-line CRC hit its PFS endpoint (announced 1/10/07); full data release at ASCO in June, 2007. 2) Erbitux in NSCLC. OS in 1st-line FLEX study: 2H07. 3) Erbitux in pancreatic cancer, SWOG trial. Missed Primary Goal. Full Data release at Asco 2007. 4) Erbitux in 3rd line mCRC. NCIC trial. Primary Goal (OS) met. Full Data at AACR April 2007. 5) Erbitux in 2nd line mCRC. Epic trial. Primary Goal (OS) missed. Possible secondary goals (PFS)(RR) met. Full Data at AACR April 2007. 6) Erbitux with Chemo in H/N. Extreme trial. Primary Goal (OS) met. Full Data at Asco 2007. 7) Critical Trials in 1st line mCRC upcoming OPUS (cet/Folfox) and CAIRO2 (capox/bev/cet) top line results 2H07
ITMN – Phase-1 PK data for ITMN-191: 2H07.
JNJ: CoStar (CONR) data from U.S. pivotal trial: March 2007 at ACC
LBPFF – see DDSS
MCU/MPH.to - Medicure - MC-1 Lead drug candidate for cardiovascular reperfusion is in PH 3 trial /w 3000 patients. Expect full enrollment Nov/07 with Data by August /08. This drug has zero side effects, zero competition, and No Partnership yet with Big Pharma as of 3/31/07.
Merrimack: see GTCB
MS.TO - Complete enrollment in pivotal Secondary Progressive MS trial this year, possible interim results 2007, trial results in 2008.
Novocell – see SRDX
NRMX, NRM.TO – North American Alzhemed trial complete Jan 07, results to follow. European Alzhemed trial complete 1H08 (?). Kiacta (Fibrillex) received an approvable letter on 8/11/06.
PPHM - Bavituximab 1B, adv. metastatic breast, lung or ovarian that failed prior chemo. 3/22/07 enrollment closed. top line data ~ May 07.
PPHM - Bavituximab 1B HCV 14 day monotherapy in non-responders/relapsers. 2/14/07 top-line info released. details at an upcoming conf.
RPRX Proellex *Uterine Fibroids Phase 2 (U.S.) Full Phase 2 data (mid-2007) *One year extension data (4Q2007) *Initiate pivotal trials (YE2007) *Endometriosis Phase 1/2 (Europe) Full Phase 1/2 data (3Q2007) *Initiate U.S. Phase 2 (mid-2007)
Androxal *Male Secondary Hypogonadism Non-pivotal Phase 3 (U.S.) Full non-pivotal Phase 3 data (3Q2007) *Initiate first pivotal Phase 3 (around YE2007)
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