NPSP Adcom meeting date change. ACHN sovaprevir clinical hold lifted + ALKS news

Jun 11, 2014 No Comments by

NPS Pharmaceuticals, Inc.(NASDAQ:NPSP) announced that the FDA has shifted the tentative date for the Natpara Advisory Committee Meeting from July 24 to September 12, 2014. The PDUFA date remains unchanged at October 24, 2014. Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced that the FDA has removed the clinical hold on their Phase 2 trial of sovaprevir, in […]

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OREX PDUFA date change. HRTX to delay NDA resubmission. OMER FDA Approval + ALKS update.

Jun 03, 2014 No Comments by

Orexigen Therapeutics, Inc. (Nasdaq: OREX) announced that the FDA has delayed the PDUFA date of the NB32 New Drug Application to June 11, 2014, one day beyond the original assignment. The delay is due to a FDA administrative error, miscalculating the correct PDUFA date. Heron Therapeutics, Inc. (NASDAQ: HRTX) provided an update regarding their NDA (new drug application) re-submission of SUSTOL, for the […]

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MDCO issued CRL + updates for NYMX GEVA OHRP IRWD TSRO FLXN KPTI NBIX RXII CEMP ALKS LGND OGXI ACHN

May 01, 2014 No Comments by

The Medicines Company (NASDAQ: MDCO) announced that the FDA has issued a Complete Response Letter for its intravenous antiplatelet agent cangrelor. Nymox Pharmaceutical Corporation (NASDAQ: NYMX) released top-line results from their Phase 2 trial of NX03-0040 for prostate cancer. While the results showed an overall benefit in terms of reduced progression in cancer, the primary efficacy endpoint, the percentage of subjects with […]

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Updates for GALE SCMP BLRX APPA RPTP ACOR RLYP INFI HALO ARNA CLVS SGEN ICPT GILD CUR MRK CYCC CRIS ACHN

Jan 13, 2014 No Comments

Curis, Inc.(NASDAQ:CRIS) provided an update noting that Phase 2 data of everolimus for Operable Nodular BCC (basal cell carcinoma) are due 1Q 2014. Their submission to the FDA regarding the partial clinical hold of CUDC-427 is due shortly. A Phase 2 trial of Debio 0932 is due to be to initiated in 2H 2014. Galena Biopharma (Nasdaq:GALE) announced it has […]

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MDCO and NVS Adcom dates set. AEZS raising more cash. Approvals for BMY AZN GSK + updates for MSTX ALKS

Jan 09, 2014 No Comments

Aeterna Zentaris Inc. (NASDAQ: AEZS $1.46) announced that it has commenced another underwritten public offering of common shares and warrants, their third offering in just over five months. GW Pharmaceuticals plc (Nasdaq: GWPH $38.06) announced the pricing of its follow-on offering of American Depositary Shares, or ADSs, on the NASDAQ Global Market. GW will issue 2,441,110 ADSs […]

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ALXA reverse split. ALKS JNJ initiate Phase 3 schizophrenia. NYMX commences Phase 2 prostate cancer enrolment

Jun 13, 2012 No Comments

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced a 1-for-10 reverse split of its common stock effective immediately. The number of common stock outstanding will correspondingly be reduced from approximately 119.6 million to approximately 12.0 million. Alkermes plc (NASDAQ: ALKS) announced that Janssen Research & Development, LLC has initiated a Phase 3 trial for a three-month formulation of INVEGA SUSTENNA(paliperidone palmitate), an injectable medicine […]

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CHTP and ALKS halt further trials following disappointing trial data + OMER news

May 31, 2012 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that it failed to meet its primary endpoint in its Phase 2 trial of CH-4051 in patients with rheumatoid arthritis (RA). As a result it plans to discontinue development of CH-4051. Alkermes plc (NASDAQ: ALKS) said that it did not meet its “pre-specified criteria for advancing into Phase 3 clinical trials” […]

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AMLN ALKS FDA Approval. INFI Phase 2 fail. BNVI to delist + RPRX RPTP TLON IMGN news

Jan 27, 2012 No Comments

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes plc (Nasdaq: ALKS) today announced the FDA  approved BYDUREON, the first once-weekly treatment for type 2 diabetes. BYDUREON will be available in pharmacies nationwide in February. Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that it is halting development of saridegib (IPI-926) in combination with gemcitabine for pancreatic cancer. Interim data […]

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Upcoming PDUFA dates, Adcom meetings and clinical catalysts as of January 12 2012

Jan 12, 2012 No Comments

Some short and long term potential catalysts as of January 12, 2012 (share prices as at the close of trading Wednesday, January 11, 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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Weekly Summary of key pharma events – week ended January 6 2012

Jan 07, 2012 No Comments

See individual posts made in the last week for more detail. PDUFA/NDA FILINGS/ADVISORY COMMITTEE NEWS AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) said that it intends to file its NDA for tivozanib during 2012 following full data release at ASCO this year. Cornerstone Therapeutics (NASDAQ: CRTX) – NDA for lixivaptan for the treatment of hyponatremia was filed on Dec. 29, […]

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INFI pipeline update + ALKS and CLDX news

Jan 04, 2012 No Comments

Alkermes plc (NASDAQ: ALKS) today announced that it had initiated a Phase 2 trial of ALKS 5461 for major depressive disorder (MDD) following positive data from a Phase 1b trial. Data from the study are expected in the first half of calendar 2013. Celldex Therapeutics, Inc. (NASDAQ: CLDX)  initiated a Phase 2 trial of rindopepimut in combination with Avastin in […]

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