Archive for Daily News

NPSP PDUFA delay. Pipeline updates for BMRN and IMGN

Oct 24, 2014 No Comments by

NPS Pharmaceuticals, Inc. (NASDAQ:NPSP) announced that their PDUFA date for its Natpara Biologics License Application (BLA) has been extended by three months from October 24, 2014 to January 24, 2015. The company cited the need for the the FDA to review a major amendment, and also requested the company to submit a Risk Evaluation and […]

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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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GEVA starts rolling NDA. OMER trial halt. VRTX gets Adcom thumbs up + AGIO news

Oct 22, 2014 No Comments by

Synageva BioPharma Corp. (Synageva) (NASDAQ: GEVA) announced the start of a rolling submission of a Biologics License Application (BLA) to the FDA for sebelipase alfa as a treatment for patients with lysosomal acid lipase deficiency (LAL Deficiency). The company anticipates completing the rolling submission of the BLA to the FDA and submitting the Marketing Authorization Application (MAA) […]

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NBIX initiates Phase 3 tardive dyskinesia trial. NLNK license deal with Genentech. CVM offering.

Oct 21, 2014 No Comments

NewLink Genetics Corporation (NASDAQ: NLNK), announced that they have entered into a license agreement with Genentech for the development of NLG919, an IDO pathway inhibitor. NewLink will receive an upfront payment of $150m and will be eligible to receive in excess of $1 billion in milestone payments based on achievement of certain predetermined milestones as well […]

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GWPH pipeline update. ESPR offering. BLUE sickle cell disease data due 2015 + OHRP update

Oct 15, 2014 No Comments

bluebird bio, Inc. (Nasdaq: BLUE) announced that the first patient has undergone infusion in a Phase 1/2 trial of LentiGlobin gene therapy in patients with severe sickle cell disease. Initial clinical data on LentiGlobin in sickle cell disease patients are due in 2015. GW Pharmaceuticals plc (Nasdaq: GWPH) provided an update that a Phase 2/3 trial […]

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SGEN Phase 3 AETHERA data due Monday. ALIM PSDV FDA Approval. ACRX NDA update + GLYC delay

Sep 27, 2014 No Comments

Seattle Genetics, Inc. (Nasdaq:SGEN) will host a conference call and webcast on Monday, September 29, 2014, at 8:30 a.m. Eastern Time (ET) regarding top-line results from its ADCETRIS Phase 3 AETHERA clinical trial for Hodgkin lymphoma patients at risk of relapse following autologous stem cell transplant. Alimera Sciences, Inc. (NASDAQ: ALIM) and pSivida Corp. (NASDAQ: […]

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CEMP Phase 3 data due 1Q 2015 + updates for AKBA ZFGN

Sep 25, 2014 No Comments

Akebia Therapeutics, Inc. (NASDAQ:AKBA) announced that the first patient has been dosed in a Phase 2 clinical study of AKB-6548 in patients with anemia related to chronic kidney disease (CKD) who are undergoing dialysis. Data are due in 3Q 2015. Data from their separate Phase 2b trial of AKB-6548 for the treatment of anemia related to CKD […]

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Additional trials required for EGLT. ACOR acquires Phase 3 Parkinson’s candidate + LCPN MDGN MNOV updates

Sep 24, 2014 No Comments

Acorda Therapeutics, Inc. (Nasdaq:ACOR) announced that it will acquire Civitas Therapeutics, a privately-held biopharmaceutical company, for $525 million in cash. Acorda will obtain worldwide rights to CVT-301, for OFF episodes of Parkinson’s disease (PD).  The Phase 3 trial is expected to commence in early 2015. Egalet Corporation (Nasdaq: EGLT) (Egalet) announced that they will need […]

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LPCN Phase 3 data due Wednesday. ATOS Breast Aspirator NOT cleared + OPK TTNP ZSPH updates

Sep 23, 2014 No Comments

Lipocine Inc. (Nasdaq:LPCN) announced that they will host a conference call on Wednesday September 24, 2014 at 8:45 a.m. Eastern time to discuss top-line results from its Study of Oral Androgen Replacement (“SOAR”) pivotal Phase 3 clinical trial. A press release will be released prior to the call. Atossa Genetics Inc. (NASDAQ: ATOS) announced that […]

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AVNR offering. THLD trial to continue through to completion + TKMR DVAX AUXL updates

Sep 22, 2014 No Comments

Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced that it is offering to sell $200 million of its common stock in an underwritten public offering. Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) has reviewed the merger proposal from Endo International plc and has unanimously determined it is not a superior proposal under the terms of its existing merger agreement with QLT […]

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ADHD Phase 3 data due in about 2 weeks. LTPN offering + updates for HTBX ARGS

Sep 20, 2014 No Comments

Alcobra Ltd. (Nasdaq:ADHD) announced that data from their Phase 3 trial of Metadoxine Extended Release (MDX) in adult Attention Deficit Hyperactivity Disorder (ADHD) patients are due in about two weeks. Argos Therapeutics, Inc. (Nasdaq:ARGS) noted that they are on target to complete enrolment in their pivotal Phase 3 ADAPT trial of AGS-003 for the treatment of metastatic renal cell […]

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