Author Archive

SCMP PDUFA date extension. BCRX terminates merger

Dec 01, 2012 No Comments

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) announced today that the FDA has extended the PDUFA date for its priority review of the supplemental new drug application (sNDA) for lubiprostone for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain. The delay is due to the submission of FDA-requested supportive analyses which is seen as a major amendment to the […]

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SUPN prices offering. EXEL FDA Approval + updates for AMRN CYTK XOMA CRIS THRX INSV

Nov 30, 2012 No Comments

Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) announced the pricing of its public offering of 6m shares of its common stock at a price to the public of $8.00 per share with an option to issue 900,000 additional shares to cover over-allotments. Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) announced that it will offer 11m shares of its common stock at a price of $2.00 per […]

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AVEO PDUFA date set. PGNX offering + IRWD TTHI PRAN ECYT news

Nov 29, 2012 No Comments

AVEO Oncology(NASDAQ: AVEO) and Astellas Pharma Inc announced that the FDA has accepted for filing the New Drug Application (NDA) for tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC). The expected PDUFA date is July 28, 2013 Ironwood Pharmaceuticals, Inc.(NASDAQ: IRWD) announced that the European Commission has granted marketing authorization to Constella (linaclotide 290mcg) for the symptomatic […]

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ACAD Phase 3 pimavanserin data to be released Tuesday morning

Nov 27, 2012 No Comments

ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) announced that it will host a conference call and webcast at 8:00 a.m. Eastern Time on Tuesday, November 27, 2012 to present the top-line results from its pivotal Phase 3 trial with pimavanserin in patients with Parkinson’s disease psychosis (PDP).

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MAPP PDUFA date set. SPPI files mixed shelf

Nov 21, 2012 No Comments

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that its New Drug Application (NDA) resubmission for LEVADEX orally inhaled migraine drug for the potential acute treatment of migraine in adults has been accepted for filing by the FDA.  The PDUFA date is April 15, 2013. Spectrum Pharmaceuticals, Inc.s (NASDAQ: SPPI) announced it filed a mixed shelf where it may, from […]

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NBIX files shelf. SUPN and XOMA release data. MNOV initiates Phase 2 trial in opioid or heroin abusers

Nov 21, 2012 No Comments

NEUROCRINE BIOSCIENCES INC (NASDAQ: NBIX) filed a shelf allowing it to issue common stock to the value of $150m from time to time. Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) released topline results from its Phase 2b study on SPN-810 for the treatment of impulsive aggression in ADHD patients. The primary endpoints were the effect in reducing impulsive aggression as […]

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LGND FDA Approval. ALXA MAA decision due Dec 14. OXGN reverse split vote Dec 21

Nov 19, 2012 No Comments

OXiGENE, Inc. (NASDAQ: OXGN), confirmed a special meeting of stockholders will be held on December 21, 2012 at 10:00 a.m., to seek approval of a reverse stock split of its common stock, at a ratio in the range of 1:5 to 1:20. Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) and partner GlaxoSmithKline (NYSE: GSK) announced it received approval from the FDA for PROMACTA […]

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POZN NDA due April. TSYM files Phase 2b trial + updates for DVAX ZIOP PRAN KYTH ACRX MACK RDUS MNOV

Nov 16, 2012 No Comments

POZEN Inc. (NASDAQ: POZN) announced that it plans to file its PA32540/PA8140 New Drug Application (NDA) by the end of April 2013. Radius Health, Inc. (RDUS) withdrew its proposed initial public offering due to general market conditions. Tranzyme Pharma (Nasdaq:TZYM) said that it failed to meet its primary endpoint following the release of top-line results of the preliminary […]

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NAVB PDUFA date set + pipeline updates for SGYP INSM AEZS CLVS NKTR ICPT

Nov 14, 2012 No Comments

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) announced today that the FDA has set a PDUFA goal date of April 30, 2013 for the Class 2 resubmission of its New Drug Application (NDA) for Lymphoseek Injection. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor. Synergy Pharmaceuticals, Inc. (Nasdaq:SGYP) announced that it expects to release top-line data from […]

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ZGNX Advisory Committee date set + pipeline updates for CLSN TZYM OGXI OGXN SNSS CPRX GTXI IGXT SCMP POZN ZCLS NPSP ZIOP CEMP CYTR CUR + ARRY MYRX SPEX news

Nov 10, 2012 No Comments

Celsion Corporation (NASDAQ: CLSN) announced that it projects that it has reached its target of 380 events in its Phase 3 HEAT Study, of ThermoDox in combination with radiofrequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), also known as primary liver cancer. Top line results are expected to be released in January 2013. Zogenix, […]

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Pipeline updates for SNTS BCRX ANAC VNDA ATRS AUXL ITMN ALIM NKTR CHTP VICL

Nov 08, 2012 No Comments

Vical Incorporated (Nasdaq:VICL) said that it has revised  its projection for reaching the target number of death events in its Phase 3 Allovectin melanoma trial, to mid-2013. The company also noted that Astellas is planning to initiate a multinational pivotal Phase 3 trial of TransVax in hematopoietic cell transplant (HCT) recipients and a Phase 2 trial of TransVax for solid organ […]

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