CTIC and CEMP Phase 3 data due 1Q 2015 + pipeline updates for SNTA + CMRX offering

Oct 29, 2014 No Comments by

CTI BioPharma Corp. (CTI) (NASDAQ: CTIC) provided an update, maintaining previous guidance that they continue to expect data from their PERSIST-1 pivotal Phase 3 trial of pacritinib for patients with myelofibrosis in 1Q 2015. Cempra, Inc. (Nasdaq:CEMP) also provided an update noting that data from their Phase 3 trial of oral solithromycin in adult patients with moderate […]

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POZN resubmits NDA. Trial updates for CTIC OGXI THLD RARE

Jul 02, 2014 No Comments by

POZEN Inc. (NASDAQ: POZN) announced that it has resubmitted the NDA for PA8140/PA32540 to the FDA. They expect to hear back from the FDA within 14 days of receipt of the NDA whether or not the submission will be accepted, and if accepted, what the new PDUFA date will be. The FDA will determine whether a two month or six month review […]

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ADMP files NDA. INO reverse split update. CTIC name change. AKBA update.

May 30, 2014 No Comments by

Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) announced the submission of a 505(b)(2) New Drug Application (NDA) to the FDA for its epinephrine pre-filled single dose syringe (PFS) product, for the emergency treatment of allergic reactions (Type I) including anaphylaxis. Akebia Therapeutics, Inc. (NASDAQ:AKBA) maintained guidance that Phase 2b data of AKB-6548, for the treatment of anemia related to chronic kidney disease (CKD) […]

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NYMX trial updates. TSRO ALIM IDIX raising cash + CTIC news

Jan 29, 2014 No Comments

Nymox Pharmaceutical Corporation (Nasdaq:NYMX) provided an update noting that patient participation in the NX02-0017 pivotal Phase 3 benign prostatic hyperplasia (BPH) study is completed. Patient participation in the second pivotal trial, NX02-0018, will be completed in 2Q 2014. Unblinding and data analyses of the two pivotal studies will commence in 2Q 2014 with top line results […]

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CHTP wins at Adcom + updates for MEIP MNOV BMRN CYTR NKTR CTIC NYMX

Jan 15, 2014 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP $2.30) announced that the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 16-1 to recommend approval of NORTHERA for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with primary autonomic failure (Parkinson’s disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic […]

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INSM Phase 3 data to be released Monday. CHMP approvals for HALO DNDN RPTP + CRL for JNJ

Jun 30, 2013 No Comments

Insmed Incorporated (NASDAQ: INSM) announced that it will report top-line results from its European and Canadian Phase 3 study of ARIKACE to treat cystic fibrosis patients with Pseudomonas aeruginosa lung infections on Monday, July 1, 2013 at 7:00 a.m. Eastern time. Cell Therapeutics, Inc. (NASDAQ: CTIC and MTA: CTIC) announced the resignation of Steven E. Benner, M.D., M.H.S., Senior Vice President, Chief Medical […]

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CTIC Tosedostat placed on partial clinical hold. CYTK reverse split. CYTR aldoxorubicin data due 2H 2013 + PBMD ANTH updates

Jun 25, 2013 No Comments

Cell Therapeutics, Inc. (NASDAQ:CTIC) was informed by the FDA that a partial clinical hold has been placed on Tosedostat, for the treatment of blood-related cancers. This follows the death of a patient from myocarditis. The FDA has requested additional data on patients treated with Tosedostat, including additional information about the patient that died. These data will […]

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IDIX expects clinical hold response this quarter + CTIC INO THRX VPHM updates

Jan 09, 2013 No Comments

Idenix Pharmaceuticals Inc (NASDAQ: IDIX) noted today that it expects a  response from the FDA regarding the clinical hold of IDX184, during 1Q 2013. Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC) today announced that it has initiated a Phase 3 trial, known as PERSIST-1 or PAC325, for pacritinib, for the treatment of patients with myelofibrosis. GlaxoSmithKline plc (LSE: GSK) […]

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ONXX receives positive recommendation from ODAC. POZN bio-equivalence of PA32540 not shown. CYTK offering. CTIC President resigns

Jun 21, 2012 No Comments

Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 11-0 [with 1 abstention] in favour of  Kyprolis (carfilzomib) for the treatment of relapsed and refractory multiple myeloma. The PDUFA date  for accelerated approval is July 27, 2012. Cytokinetics, Incorporated (Nasdaq: CYTK) priced two underwritten offerings for total gross proceeds of $60m. […]

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INFI stops Phase 2 trials. RPTP Phase 2/3 Cysteamine data due 1H 2014 + CTIC news

Jun 19, 2012 No Comments

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) announced that following disappointing initial data it will be stopping its Phase 2 trials of saridegib (IPI-926) in patients with metastatic or locally advanced, inoperable chondrosarcoma and in patients with myelofibrosis. Cell Therapeutics, Inc. (NASDAQ and MTA: CTIC) announced that the University of Washington has begun enrolment in a Phase 2 trial of […]

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ANTH fails Phase 3 trial. Pipeline updates for CTIC PPHM BNVI OGXI + ASTM financing

Mar 10, 2012 No Comments

Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) announced that the VISTA-16 Data Safety Monitoring Board (DSMB) has recommended stopping the VISTA-16 clinical study due to a lack efficacy that could not be reasonably overcome in the remainder of the trial.  As a result the company has closed enrollment in the Phase 3 trial. Cell Therapeutics, Inc. (NASDAQ: CTIC) gave […]

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