IGXT receives CRL. FURX Phase 3 eluxadoline meets endpoints. AGEN offering + ARRY update

Feb 05, 2014 No Comments by

IntelGenx Corp. (TSXV: IGX) (OTCQX: IGXT) and RedHill Biopharma Ltd. (NASDAQ: RDHL) announced that they received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for their VersaFilm Oral Film Product for the treatment of acute migraines. According to the company, the concerns raised in the CRL “primarily relate to […]

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Pipeline and news updates for INCY ARRY CLVS VICL BMRN SGYP ACOR GENT ENMD DSCO MACK ARIA

Nov 02, 2013 No Comments by

Incyte Corporation(Nasdaq: INCY $40.40) provided a pipeline update noting that Phase 3 data of Jakafi (ruxolitinib) in patients with polycythemia vera (PV), are expected in early 2014, with a potential NDA filing in 1H 2014. Data from their Phase 3 trial measuring disease-related symptoms in patients with PV (RELIEF) are due in mid-2014. In addition, Phase 2 data from […]

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CSII receives PMA Approval. PFE to continue Remoxy development + updates for ZIOP AMRN CBST QCOR HALO ARRY

Oct 23, 2013 No Comments by

Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII $26.75) announced that it has received PMA approval from the FDA for their Diamondback 360 Coronary Orbital Atherectomy System (OAS) as a treatment for severely calcified coronary arteries. Pain Therapeutics, Inc. (Nasdaq:PTIE $3.77) and DURECT Corporation(Nasdaq: DRRX $1.56) reported Pfizer Inc. will continue the development program for REMOXY (oxycodone) Extended-Release Capsules CII, with new […]

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CHTP PDUFA delay. VNDA PDUFA date assigned. ANAC submits NDA + SNSS VRTX ARRY news

Jul 30, 2013 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that the FDA has requested further information regarding the resubmitted New Drug Application (NDA) for NORTHERA (droxidopa). As a result the original PDUFA date will be extended from January 3, 2014, to a date to be confirmed later. The FDA noted deficiencies that relate to the formatting of certain submitted […]

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SRPT NDA due 1H 2014. ARRY positive data. CYTK ALS data now due early 2014 + INSV TSRO IMMY updates

Jul 24, 2013 No Comments

Array BioPharma Inc. (NASDAQ: ARRY) announced that it met its primary and secondary endpoints in its Phase 2 trial of ARRY-502 in patients with mild to moderate persistent allergic asthma and will now seek a partner to further develop ARRY-502. Sarepta Therapeutics, Inc. (NASDAQ: SRPT) announced it will plans on submitting an NDA for eteplirsen in the first half of 2014 for […]

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ARRY Phase 2 asthma date due Tuesday. RMTI PRAN XOMA data due Sept/Oct + ISIS BCRX MACK IGXT updates

Jul 22, 2013 No Comments

Array BioPharma Inc. (Nasdaq:  ARRY) will report top-line results from its Phase 2 trial in mild to moderate persistent allergic asthma for ARRY-502, on Tuesday, July 23, 2013. Rockwell Medical (NASDAQ: RMTI) announced that it has completed dosing in its second Phase 3 trial SFP (Soluble Ferric Pyrophosphate), called CRUISE-2, for the treatment of iron deficiency in chronic […]

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Biotech news from MDCO CLDX and ARRY

Jul 03, 2013 No Comments

The Medicines Company (NASDAQ: MDCO) announced results for its Phase 3 SOLO II trial of oritavancin, for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria. In SOLO II, all protocol-specified primary and secondary efficacy endpoints were met. The company anticipates submitting an NDA in 4Q 2013 and a European MAA […]

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PSTI Phase 2 trial placed on clinical hold. AVEO restructuring + updates from THRX BMY AZN GENT ARRY PBTH

Jun 05, 2013 No Comments

AVEO Oncology (NASDAQ: AVEO) announced a strategic restructuring where it intends not to pursue tivozanib development in RCC, and will instead focus on its BATON Phase 2 clinical trials of tivozanib in breast and colorectal cancer. The BATON-CRC study of tivozanib in patients with colorectal cancer completed patient enrollment earlier this year and results are expected […]

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News for ARRY ISIS ALNY ENTA CELG CYTR

May 07, 2013 No Comments

Array BioPharma Inc. (NASDAQ: ARRY) announced that it will initiate a Phase 3 trial called MILO (MEK Inhibitor in Low Grade Serous Ovarian Cancer) of MEK162 compared to standard chemotherapy, in patients with recurrent low-grade serous ovarian cancer (LGSOC) during the summer of 2013. Isis Pharmaceuticals, Inc.(NASDAQ: ISIS) announced the initiation of a Phase 1b/2a trial of ISIS-STAT3Rx in patients with advanced […]

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HEB issued CRL for Ampligen. IDIX discontinues IDX184 trial + CLDX offering

Feb 04, 2013 No Comments

Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX) announced that it will cease development of IDX184, in phase 2b testing for the treatment of hepatitis C virus (HCV) infection. IDX184 was placed on partial clinical hold in August 2014 due to cardiac adverse events seen in a competitor’s phase 2 clinical trial of BMS-986094. In February 2013, the FDA communicated that the IDX184 […]

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HPTX SLXP PDUFA dates delayed. ACAD Phase 3 data due November. RPRX ARRY ZLCS TGTX NPSP RIGL OREX AVNR BPAX SRPT MNOV news

Sep 06, 2012 No Comments

Hyperion Therapeutics, Inc. (Nasdaq:HPTX) announced that the PDUFA date for Ravicti (glycerol phenylbutyrate) has been extended by three months to January 23, 2013 following the submission of additional information by the company. ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD)  announced the completion of enrollment in its pivotal Phase 3 trial with pimavanserin in patients with Parkinson’s disease psychosis (PDP). Top-line […]

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