Archive for March, 2012

AVII data due Monday. RPTP ISIS NDA filings. TELK reverse split + ONTY XOMA EXEL RIGL CYCC CUR DEPO STEM IMGN news

Mar 31, 2012 No Comments by

AVI BioPharma, Inc. (NASDAQ: AVII) announced it will hold a conference call at 8:00 a.m. EDT (5:00 a.m. PDT) on Monday, April 2, 2012 to discuss top-line results from its Phase 2b study evaluating eteplirsen for the treatment of Duchenne Muscular Dystrophy (DMD). Raptor Pharmaceutical Corp.  (Nasdaq:RPTP) submitted its New Drug Application (NDA) seeking approval […]

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CHTP receives CRL for Northera. TELK holds reverse split vote

Mar 29, 2012 No Comments by

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced today it received a  complete response letter for Northera for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). The FDA requested that the company submit data from an additional trial demonstrating efficacy over a 2- to 3-month period. The company said that this data could possibly come from its ongoing […]

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AFFY OMONTYS approved. BNVI reverse split vote May + NBIX ALIM PSDV GENT AEZS RPRX NBY DVAX TRGT updates

Mar 28, 2012 No Comments by

Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Company Limited announced that the FDA approved OMONTYS (peginesatide) Injection for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. OMONTYS is the only once-monthly erythropoiesis-stimulating agent (ESA) for anemia to be made available to the dialysis patient population in the United States. Bionovo, Inc. (OTCQB: […]

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MAPP receives CRL. ISTA buyout. RPTP NDA filing this week. APPA NDA mid-2012 + ASTX VVUS ARNA CLVS NBIX news

Mar 26, 2012 No Comments

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced it received a Complete Response letter for LEVADEX. The FDA noted that the company will need to address issues relating to chemistry, manufacturing and controls (CMC) and observations from a recent facility inspection of a third party manufacturer. The FDA also noted that it had requested the company to provide information of […]

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RGEN Advisory Committee meeting date set. POZN NDA filing due 3Q. CLVS CYCC raise cash

Mar 23, 2012 No Comments

Repligen Corporation (NASDAQ:RGEN) – The Gastrointestinal Drugs Advisory Committee will meet on May 31, 2012 to discuss the new drug application (NDA) 200-436, synthetic human secretin, proposed for use with magnetic resonance imaging (MRI) to improve pancreatic duct visualization for the detection of duct abnormalities to enhance clinical decision making in patients with known or suspected pancreatitis. POZEN Inc. (NASDAQ: POZN) announced […]

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TLON receives positive ODAC vote. AVII files shelf. CYTR reverse split vote date set + MNOV news

Mar 22, 2012 No Comments

Talon Therapeutics, Inc., (OTCBB:TLON), announced the Oncologic Drugs Advisory Committee voted 7 yes, 4 no, and 2 abstain for a  favorable benefit/risk assessment for use of Marqibo for the treatment of adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or that has progressed following two or more lines of anti-leukemia therapy. The PDUFA date for […]

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FDA Adcom votes against ridaforolimus. TRGT Phase 3 fail. PATH NDA update + CXM AEGR news

Mar 21, 2012 No Comments

NuPathe Inc. (NASDAQ: PATH) gave an update noting that it intends to submit its New Drug Application for its migraine patch (NP101) during 1H 2012. Merck (NYSE: MRK) and ARIAD Pharmaceuticals, Inc., (NASDAQ:ARIA), announced today that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 13 to 1 against the use of ridaforolimus for patients with metastatic soft-tissue sarcoma or bone sarcoma […]

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ARNA Advisory Committee date set – May 10 2012

Mar 17, 2012 No Comments

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA – The Endocrinologic and Metabolic Drugs Advisory Committee will meet on May 10, 2012, to discuss the safety and efficacy of new drug application (NDA) 22-529 (lorcaserin hydrochloride) tablets. The meeting will be held on May 10, 2012, from 8 a.m. to 5 p.m.

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DSCO OGXI price offerings.

Mar 16, 2012 No Comments

Discovery Laboratories, Inc. (Nasdaq: DSCO) today announced the pricing of its public offering of 16,071,429 shares at a price of $2.80 per share for gross proceeds of $45m and net proceeds of $42.1m, with an option to issue an additional 2,410,714 shares. OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced the pricing of its public offering of […]

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MNKD AFREZZA update. SCLN files mixed shelf. DSCO and OGXI offerings. OMER update

Mar 15, 2012 No Comments

MannKind Corporation (Nasdaq: MNKD) said in its annual filing that it has commenced recruitment in its two clinical trials of  AFREZZA as requested by the FDA following its CRL. It expects to complete both of these studies by or near the end of 2012, and would expect to submit the results to the FDA as an amendment to its […]

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Pipeline updates and news for SNSS IDRA THLD SYN BIOD XOMA

Mar 15, 2012 No Comments

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) gave a pipeline update noting that it expects an interim analysis of its Phase 3 VALOR trial analysing vosaroxin in patients with first relapsed or refractory AML, during 3Q 2012. Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) gave a pipeline update noting the following: Phase 2 initiation of IMO-3100 in patients with psoriasis during 2Q 2012. Phase […]

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