ECYT Phase 3 trial halted + pipeline updates for ACOR MACK TRVN ITMN NBY VTL

May 04, 2014 No Comments by

Merck (NYSE:MRK) and Endocyte, Inc. (NASDAQ:ECYT) announced that the Data Safety Monitoring Board (DSMB) of the PROCEED trial has recommended that the trial be stopped because vintafolide did not demonstrate efficacy on the pre-specified outcome of Progression-Free Survival (PFS) in patients with platinum-resistant ovarian cancer. Acorda Therapeutics, Inc. (Nasdaq:ACOR) announced that the FDA has issued […]

Daily News Read more

ICPT wows the biotech world. ITMN Ph3 data due early 2Q. IMMU initiates Ph3 pancreatic trial + SNTA AEGR BOTA XLRN news

Jan 10, 2014 No Comments by

Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT $257.87) announced that the Phase 2 FLINT trial of obeticholic acid (OCA) for the treatment of nonalcoholic steatohepatitis (NASH) has been stopped early for efficacy based on a planned interim analysis showing that the primary endpoint of the trial has been met. They also noted that data from their Phase 3 POISE trial of obeticholic […]

Daily News Read more

CPRX receives Breakthrough Designation. RIGL fails Phase 2 trial. OREX NDA due end of 2013 + updates for SGMO QRXPY OGXI ONXX AMGN IMMU

Aug 28, 2013 No Comments by

Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX $2.01)  announced that Firdapse, currently in Phase 3 development, has received “Breakthrough Therapy Designation” by the FDA for the treatment of patients with Lambert-Eaton Myasthenic Syndrome (LEMS). Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL $3.11) announced that R343, for patients with allergic asthma, did not meet the primary or secondary endpoints in a Phase 2 […]

Daily News Read more

Pipeline updates for YMI OREX IMMU BDSI FOLD

May 11, 2012 No Comments

YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM) provided an update today on CYT387 for the treatment of myelofibrosis. It intends to initiate its Phase 3 trial during 2H 2012. By the end of 2012 both final data from its Phase 1/2 Core trial and interim data from the Phase 1/2 Extension trial are expected to be reported. Interim […]

Read more

NBIX VICL EXEL IMMU CRIS pipeline updates + numerous companies raising cash

Feb 09, 2012 No Comments

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) gave a pipeline update today noting that it expects to initiate its Phase 3 trial of elagolix for endometriosis during 1H 2012. It also expects data from its second Phase 2 trial of NBI-98854 in tardive dyskinesia patients during March 2012. A larger Phase 2b program is planned to be initiated during 2012. Topline data […]

Read more

ALXA panel vote.YMI CYT387 data + PCYC CYTR IMMU GERN NKTR OPTR news

Dec 12, 2011 No Comments

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) appeared before the Psychopharmacologic Drugs Advisory Committee (PDAC) today where the committee was divided on whether Adasuve should be approved as a single dose when used with FDA proposed REMS, with 9 votes FOR, 8 votes AGAINST and one abstention. It had earlier voted that Adasuve had been shown to be effective […]

Read more

VVUS PDUFA announced. MELA approval + INHX MDVN IMMU AVNR LGND RGRX

Nov 05, 2011 No Comments

Inhibitex, Inc. (NASDAQ:INHX) today reported top-line safety and antiviral data from the first cohort of its ongoing clinical trial of INX-189, for HCV. In this study, 200 mg INX-189, dosed once-daily for seven days, continued to demonstrate potent and dose-dependent antiviral activity with a median HCV RNA reduction from baseline of -4.25 log10 IU-mL. Further, […]

Read more

YMI pipeline update. OPTR positive CHMP opinion. IMMU clinical hold + RGRX CYCC

Sep 09, 2011 No Comments

Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for DIFICLIR (fidaxomicin) tablets for the treatment of adults suffering with a Clostridium difficile infection (CDI), also known as C. difficile-associated diarrhea (CDAD). RegeneRx Biopharmaceuticals, Inc. (OTC […]

Read more

IMMU pipeline update. PPHM Ph2 breast cancer data. ZGNX to raise cash

Aug 24, 2011 No Comments

Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), today announced 20.7 month median overall survival (OS) from a prior single-arm Phase 2 trial evaluating bavituximab in combination with docetaxel in patients with locally advanced or metastatic breast cancer. Immunomedics, Inc. (Nasdaq:IMMU) gave a pipeline update today saying that it intends to initiate a Phase 3 trial in 2012 […]

Read more

IMMU pipeline update. PPHM Ph2 breast cancer data. ZGNX to raise cash

Aug 24, 2011 No Comments

Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), today announced 20.7 month median overall survival (OS) from a prior single-arm Phase 2 trial evaluating bavituximab in combination with docetaxel in patients with locally advanced or metastatic breast cancer. Immunomedics, Inc. (Nasdaq:IMMU) gave a pipeline update today saying that it intends to initiate a Phase 3 trial in 2012 […]

Read more

Latest updates for EPCT SGEN CBRX PTIE IMMU ICGN

Jun 27, 2011 No Comments

EpiCept Corporation (Nasdaq: EPCT) today announced that it has received initial written responses from the FDA regarding the its application for a Special Protocol Assessment (SPA) for Ceplene. Ceplene, which is administered in conjunction with low-dose interleukin-2 (IL-2), is its maintenance therapy for patients with acute myeloid leukemia (AML) in first remission. Among those responses, […]

Read more