Author Archive

EXAS pivotal data due March. SNSS pivotal trial update. AEGR offering

Jan 10, 2013 No Comments

Exact Sciences Corp. (Nasdaq: EXAS) noted that it continues to expect topline results from its DeeP-C pivotal trial for colorectal cancer screening, in March 2013. Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced an update of its VALOR Phase 3 trial of vosaroxin plus cytarabine in patients with first relapsed or refractory acute myeloid leukemia (AML). Target enrollment of 675 patients […]

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IDIX expects clinical hold response this quarter + CTIC INO THRX VPHM updates

Jan 09, 2013 No Comments

Idenix Pharmaceuticals Inc (NASDAQ: IDIX) noted today that it expects a  response from the FDA regarding the clinical hold of IDX184, during 1Q 2013. Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC) today announced that it has initiated a Phase 3 trial, known as PERSIST-1 or PAC325, for pacritinib, for the treatment of patients with myelofibrosis. GlaxoSmithKline plc (LSE: GSK) […]

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TTNP expects March Adcom meeting + updates for MDCO IPXL SVNT THRX

Jan 08, 2013 No Comments

Titan Pharmaceuticals, Inc. (OTCBB:TTNP) announced that it expects an Advisory Committee meeting for Probuphine to be convened during the second half of March 2013. The PDUFA date is April 30, 2013. Impax Pharmaceuticals (NASDAQ: IPXL)  announced that it expects to release Phase 2b data of  IPX159 in patients with Restless Legs, during 1Q 2013. The Medicines Company […]

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DCTH expects May Adcom meeting. EDIT – BLRX + Pipeline updates for ALNY CLVS INFI OREX FOLD ICPT

Jan 07, 2013 No Comments

BioLineRx (NASDAQ: BLRX) announced today that the results of the interim analysis of its Phase 2/3 CLARITY trial of BL-1020, for the treatment of schizophrenia, are expected during the week beginning March 18, 2013. EDIT: DMC will provide estimate of the total number of patients required in the study in order to achieve statistical significance in the Phase 2/3 data […]

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Jan 03, 2013 No Comments

Synageva BioPharma Corp. (NASDAQ:GEVA) announced that offered 2,150,000 shares at $47.53 per share, for proceeds of $80 million in a public offering. Titan Pharmaceuticals, Inc. (OTCBB:TTNP)  announced that the New Drug Application (NDA) for Probuphine, for the maintenance treatment of opioid dependence in adult patients, has been granted Priority Review. The PDUFA date is April 30, 2013. InterMune, Inc. (NASDAQ: ITMN) […]

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Holiday News from AEGR AUXL SGYP OMER and a Happy New Year!

Jan 01, 2013 2 Comments

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), announced that the FDA has set a PDUFA date of September 6, 2013, for its supplemental Biologics License Application (sBLA) for XIAFLEX (collagenase clostridium histolyticum or CCH), for the potential treatment of Peyronie’s disease (PD). Aegerion Pharmaceuticals, Inc. (NASDAQ:AEGR) announced that the FDA approved JUXTAPID (lomitapide) capsules,to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol […]

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RPTP PDUFA date extension. NPSP receives early approval. TSPT fails Phase 2 trial. ALXA approval + SPPI news

Dec 23, 2012 No Comments

Raptor Pharmaceutical Corp. (Nasdaq:RPTP) announced that FDA will require additional time to complete its review of the New Drug Application for RP103 (PROCYSBI), for the potential treatment of nephropathic cystinosis. The new PDUFA date has been extended from January 30, 2013 to April 30, 2013. NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), announced that FDA approved Gattex for subcutaneous use for the treatment of […]

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HEB negative AdCom vote. FOLD disappoints with Phase 3 data + OGXI ANX CEMP ICPT ONTY MDCO AMRN VPHM HALO FOLD

Dec 20, 2012 No Comments

Hemispherx Biopharma (AMEX: HEB) – The FDA Arthritis Advisory Committee voted 5-8 against recommending approval for Ampligen, for the treatment of Chronic Fatigue Syndrome. Amicus Therapeutics (Nasdaq:FOLD) and GlaxoSmithKline plc (GSK)  announced that 6-month primary treatment period results from the first Phase 3 trial (Study 011) of oral migalastat HCl monotherapy in males and females with Fabry disease, […]

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OREX obesity update. VNDA Phase 3 Tasimelteon data. NBIX GALE GENT BIOD PRAN THRX

Dec 19, 2012 No Comments

Orexigen Therapeutics, Inc. (Nasdaq: OREX) said it remains on target to conduct an interim analysis of the Light Study for its obesity candidate, Contrave in 2013, with a possible NDA resubmission in 2Q 2013. Galena Biopharma (Nasdaq:GALE) announced the pricing of its offering of 15,156,250 units at a price of $1.60 per unit, or total gross proceeds of […]

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ATRS files NDA. TSYM discontinues TZP-102 enrolment + GALE GTXI CEMP OMER ITMN CYCC ARIA news

Dec 18, 2012 No Comments

Antares Pharma, Inc. (NASDAQ: ATRS) today announced it has submitted its New Drug Application (NDA) for OTREXUP,  for the delivery of methotrexate (MTX) using Medi-Jet technology to enhance the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and moderate to severe psoriasis. GTx, Inc. (Nasdaq: GTXI) announced that it has attained its enrollment goal for both of its pivotal Phase 3 […]

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CHMP issues negative opinion for VNDA. LGND PDUFA date set + news from CYTX INFI SRPT SNTA AUXL CERS THRX YMI SCMP ACAD SOMX

Dec 14, 2012 No Comments

Vanda Pharmaceuticals Inc.(NASDAQ: VNDA), announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Product for Human Use (CHMP) has issued a negative opinion recommending against approval of Fanaptum (oral iloperidone tablets) for the treatment of schizophrenia in adult patients in the European Union. Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that it intends to […]

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