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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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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BIOD reverse split. ZIOP initiates Phase 3 SCLC trial. BPAX plans further LibiGel trials + AVNR PLX news

Jun 12, 2012 No Comments

Biodel Inc. (Nasdaq:BIOD) announced that it will effect a one-for-four reverse split prior to the start of trading on June 12, 2012. The number of authorized shares of common stock will be adjusted to 25m. ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) announced that has initiated its Phase 3 MATISSE study (Multicenter Adaptive Trial Investigating Small cell lung cancer Survival Endpoints), of palifosfamide for the […]

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ALXA issued CRL. SGYP offering. Pipeline updates for OGXI NGSX ANTH ZIOP THLD EXEL DRRX

May 04, 2012 No Comments

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has received a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for ADASUVE. In its press release the company said the CRL was issued due to medical device deficiencies and plans to meet with the FDA to resolve the issues. Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) […]

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Upcoming FDA and clinical catalysts as of April 10 2012

Apr 10, 2012 No Comments

Some short and long term potential catalysts as of April 9, 2012 (share prices as at the close of trading Monday, April 9, 2012). See the links in the FDA Calendar for more details about each catalyst. The possible catalysts listed below represent both short and long opportunities. It is NOT a recommendation to take […]

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KERX AEZS trial failure. AVII Phase 2b data. VICL ZIOP CPRX pipeline updates + ONCY THRX SOMX news

Apr 03, 2012 No Comments

Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) and Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) reported today that their Phase 3 trial of perifosine (KRX-0401) + capecitabine (Xeloda) in patients with refractory advanced colorectal cancer did not meet the primary endpoint of improving overall survival. AVI BioPharma, Inc. (NASDAQ: AVII) announced that treatment with eteplirsen met the primary efficacy endpoint […]

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Pipeline updates for KERX ZIOP ISIS SNTA + VVUS prices offering.

Mar 01, 2012 No Comments

Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) gave a pipeline update noting that it intends to complete its Perifosine Phase 3 study in metastatic colorectal cancer in March 2012, and release top-line data release within several weeks thereafter.  It expects to complete its long-term Phase 3 study of Zerenex in 4Q 2012. ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) gave a pipeline update, […]

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News from AMRN CLSN SNTS CHTP ALXA CBRX CHTP SGEN HZNP ALNY CXM ZIOP

Feb 14, 2012 No Comments

Amarin Corporation plc (Nasdaq:AMRN) said that it has been informed by the FDA that no advisory committee meeting will be scheduled for its New Drug Application (NDA) of AMR101 in the treatment of patients with very high triglycerides, currently scheduled for review on July 26, 2012. Celsion Corporation (NASDAQ: CLSN) announced today that the first patient has been […]

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CRIS FDA Approval. CTIC withdraws NDA + ISTA DRRX ZIOP ALTH VICL ARRY news

Jan 30, 2012 No Comments

Roche Holding AG (ROG.VX, RHHBY) and Curis Inc. (CRIS)  – The FDA announced today that it approved vismodegib  for the treatment of adults with metastatic basal cell carcinoma or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. This […]

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ALTH receive negative CHMP opinion. INSM hold lifted + NVS CAPS GALE ZIOP SQNM news

Jan 20, 2012 No Comments

Allos Therapeutics, Inc. (NASDAQ: ALTH) today received a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) for the marketing authorisation for the medicinal product Folotyn, intended for the treatment of peripheral T-cell lymphoma. The Company plans to submit a request for re-examination of the CHMP opinion within two weeks. CHMP made the following comments as to […]

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CTIC EMA decision delay. ZIOP and SQNM offerings. NBIX prices offering

Jan 19, 2012 No Comments

Cell Therapeutics, Inc. (NASDAQ: CTIC) announced that it now expects the Committee for Medicinal Products for Human Use (“CHMP”) to issue an opinion on its Marketing Authorization Application (“MAA”) for Pixuvri in mid-February. It had originally guided of a decision at the end of this week.  The next meeting is scheduled for February 13-16, 2012. It […]

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