Archive for November, 2011

TSPT marketing deal. MRNA reverse split likely soon + NBY news

Nov 30, 2011 No Comments by

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced today that Purdue has exercised its option to commercialize Intermezzo in the United States. Purdue plans to launch Intermezzo in 2Q 2012 and to invest approximately $100 million to support sales and marketing during the first year of commercialization. Purdue has the right to negotiate for the commercialization of […]

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HZNP PDUFA date announced. OMER CYTK ALNY trial updates + INFI

Nov 30, 2011 No Comments by

Horizon Pharma, Inc. (NASDAQ: HZNP) today announced that the FDA has accepted for filing and review its New Drug Application (NDA) for LODOTRA, a proprietary modified (delayed)-release formulation of low-dose prednisone, for the treatment of rheumatoid arthritis (RA) in adults, and set a PDUFA date of July 26, 2012, based on the standard 10 month […]

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AMRN PDUFA date set for AMR101 for patients with very high triglycerides

Nov 29, 2011 No Comments by

Amarin Corporation plc (Nasdaq:AMRN)  announced earlier that its New Drug Application (NDA) for AMR101 has been accepted for filing by the FDA, seeking approval to market and sell AMR101 in the United States for the indication studied in the MARINE trial—the treatment of patients with very high triglycerides (≥500mg/dL). The application will be subject to […]

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CLSN Phase 3 to continue to final analysis+ MITI OXGN news

Nov 29, 2011 No Comments

Celsion Corporation (NASDAQ: CLSN)  announced today that the independent Data Monitoring Committee (DMC) for Celsion’s Phase III HEAT Study, a multinational, double-blind, placebo-controlled, pivotal study of ThermoDox in combination with radio frequency ablation (RFA) for hepatocellular carcinoma (HCC) or primary liver cancer, has completed a planned interim analysis for safety, efficacy and futility and unanimously […]

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POZN sells royalty rights. TSPT FDA Approval. Shelf filings for ARRY and SQNM

Nov 24, 2011 No Comments

POZEN Inc. (NASDAQ:POZN) said in a 8-k filing today that it had entered into a Purchase and Sale Agreement with CPPIB Credit Investments Inc. where it sold its right to receive future royalty payments arising from U.S. sales of MT 400, including Treximet. It received a purchase price of $75 million and will receive a […]

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PARD reverse split coming Wednesday. SPPI FDA Approval. EXEL initiates Ph2 breast cancer

Nov 21, 2011 No Comments

Poniard Pharmaceuticals, Inc. (NASDAQ: PARD) announced today that its shareholders have approved proposals to complete the previously announced merger with ALLOZYNE, Inc. As a result a 1-for-40 reverse stock split of Poniard common stock will be effective at 5:00 PM, Pacific Time, on November 22, 2011, and Poniard common stock is expected to begin to […]

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PATH to resubmit NDA. NGSX March PDUFA date. CADX offering. Updates for DYAX CYCC GERN PCYC

Nov 15, 2011 No Comments

NuPathe Inc. (NASDAQ: PATH) announced that it intends to resubmit its NDA in 1H 2012 for its migraine patch that was issued a CRL in August 2011. NeurogesX, Inc. (Nasdaq:NGSX) announced that the FDA has accepted for review the its supplemental new drug application (sNDA) for Qutenza (capsaicin) 8 percent, for the management of neuropathic […]

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CRL for PSDV ALIM. FDA Approval for IGXT. ANX offering. BNVI short of cash. ZGNX NDA filing soon.

Nov 11, 2011 No Comments

pSivida Corp. (NASDAQ: PSDV) today reported that its licensee Alimera Sciences, Inc. (ALIM) received a complete response letter (CRL) from the FDA for ILUVIEN for the treatment of diabetic macular edema (DME) associated with diabetic retinopathy. The FDA stated in the CRL that it was unable to approve the ILUVIEN NDA because the NDA did […]

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CLSN Phase 3 interim analysis due this year. ARQL Phase 2 HCC data due early 2012.

Nov 10, 2011 No Comments

ArQule, Inc. (NASDAQ: ARQL) noted that in the last quarter patient recruitment in the Phase 2 trial with tivantinib, an oral, selective inhibitor of the c-MET receptor tyrosine kinase, in hepatocellular carcinoma (HCC), had been completed and expects to have data available very early in 2012. Celsion Corporation (NASDAQ: CLSN) maintained today that it interim […]

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Shelf filed by ARNA and ZIOP. NGSX Phase 2 data. Pipeline updates from ACHN OREX OMER CYTR ASTM LGND HALO ISIS

Nov 08, 2011 No Comments

Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) filed a $50m shelf today. Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) said today it is on track to release interim early virologic response (EVR) results by the end of 2011. Orexigen Therapeutics, Inc. (Nasdaq: OREX) maintained previous guidance that it intends to initiate a cardiovascular outcomes trial (CVOT) in 1H 2012 for its […]

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NPSP positive Phase 3 data. APPA to refile NDA 1H 2012. NABI fails second Phase 3 trial

Nov 07, 2011 No Comments

A.P. Pharma, Inc. (OTCQB: APPA.PK) today maintained previous guidance of resubmitting its NDA for APF530 in 1H 2012 for the prevention of both acute-onset and delayed-onset chemotherapy-induced nausea and vomiting (CINV). Data from a QT study designed to support the resubmission is due 1Q 2012. NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) today announced positive top-line results […]

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