ALKS PDUFA date set. RLYP files NDA for hyperkalemia

Oct 22, 2014 No Comments by

Alkermes plc (NASDAQ: ALKS) announced that the FDA has set a PDUFA date of August. 22, 2015 for aripiprazole lauroxil, for the treatment of schizophrenia. Relypsa, Inc. (Nasdaq:RLYP) announced that they have submitted a New Drug Application (NDA) to the FDA seeking approval for Patiromer for Oral Suspension (Patiromer FOS) for the treatment of hyperkalemia.  

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KERX FDA Approval + updates for ALKS FLXN BLRX

Sep 06, 2014 No Comments by

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) announced that the FDA has approved Ferric Citrate (formerly known as Zerenex) for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. Alkermes plc (NASDAQ: ALKS) announced completion of patient enrollment in a Phase 2 trial of ALKS 3831, for the treatment of schizophrenia. Top-line data are […]

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ITMN to be acquired by Roche. RGDO halts Phase 3 trial. ALKS files NDA. IMMU lupus data due 1H 2015

Aug 26, 2014 No Comments by

Regado Biosciences, Inc. (NASDAQ: RGDO) announced the permanent termination of enrollment in its REGULATE-PCI Phase 3 trial following a recommendation from the trial’s Data and Safety Monitoring Board (DSMB) following their analysis of serious allergic adverse events. Roche (SIX: RO, ROG; OTCQX: RHHBY) and InterMune, Inc. (NASDAQ: ITMN) announced they have entered into a definitive merger agreement […]

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Pipeline updates and news over the previous week from 20 companies.

Aug 03, 2014 No Comments

Pacira Pharmaceuticals, Inc.(NASDAQ: PCRX) noted that the FDA has set a PDUFA date of March 5, 2015 for the supplemental New Drug Application (sNDA) for a nerve block indication for EXPAREL. NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY) said that their BAYnovation trial for viral conjunctivitis has been completed and top-line results are due in mid-August 2014. Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) maintained guidance that the pre-planned […]

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

Jun 11, 2014 No Comments

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

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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May 01, 2014 No Comments

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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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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