ISIS PDUFA date set. LGND/GSK file Promacta sNDA. EXEL files NDA + initiates second Phase 3 mCRPC + CLSN ALNY INSM ACRX news

May 30, 2012 No Comments

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), and Isis Pharmaceuticals Inc. (ISIS), announced yesterday that the FDA has set a PDUFA date of of January 29, 2013 for  KYNAMRO (mipomersen sodium) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The NDA filing with the FDA triggers a $25 million milestone payment to Isis from Genzyme. […]

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IRWD PDUFA extended. CYTR reverse split likely mid-May. NABI merger + KERX news

Apr 24, 2012 No Comments

Nabi Biopharmaceuticals (Nasdaq:NABI) announced plans to merge with Biota Holdings Limited (ASX:BTA), a Melbourne, Australia company to form a combined company to be named Biota Pharmaceuticals, Inc. CytRx Corporation (Nasdaq: CYTR) announced it has been informed by NASDAQ that its bid price needs to be above $1.00 for a minimum of 10 consecutive business days by the close of […]

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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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NPSP files NDA short bowel syndrome + CLDX CLSN AVEO ANTH IDRA ANX

Dec 02, 2011 No Comments

Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that it has launched a pivotal, randomized, double-blind, controlled Phase 3 trial of rindopepimut in patients with surgically resected epidermal growth factor variant III (EGFRvIII)-positive glioblastoma, the “ACT IV Study.” Celsion Corporation (NASDAQ: CLSN) today announced that it has received commitments from investors to purchase an aggregate of […]

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CLSN Phase 3 to continue to final analysis+ MITI OXGN news

Nov 29, 2011 No Comments

Celsion Corporation (NASDAQ: CLSN)  announced today that the independent Data Monitoring Committee (DMC) for Celsion’s Phase III HEAT Study, a multinational, double-blind, placebo-controlled, pivotal study of ThermoDox in combination with radio frequency ablation (RFA) for hepatocellular carcinoma (HCC) or primary liver cancer, has completed a planned interim analysis for safety, efficacy and futility and unanimously […]

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CLSN Phase 3 interim analysis due this year. ARQL Phase 2 HCC data due early 2012.

Nov 10, 2011 No Comments

ArQule, Inc. (NASDAQ: ARQL) noted that in the last quarter patient recruitment in the Phase 2 trial with tivantinib, an oral, selective inhibitor of the c-MET receptor tyrosine kinase, in hepatocellular carcinoma (HCC), had been completed and expects to have data available very early in 2012. Celsion Corporation (NASDAQ: CLSN) maintained today that it interim […]

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RGEN NDA filing possibly delayed. CLSN raises cash + PLX MHAN

Jul 21, 2011 No Comments

Repligen Corporation (NASDAQ: RGEN) today it intends to file its NDA of RG1068 for MRI Imaging of the Pancreas LATER THIS YEAR. In a previous press release it noted that the NDA would be filed LATER THIS SUMMER. This subtle change in wording may suggest that it will not submit its NDA this summer, rather […]

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Jul 12, 2011 No Comments

Poniard Pharmaceuticals, Inc. (NASDAQ: PARD) announced today that it reconvened its annual meeting of shareholders on July 8, 2011 for a second time and adjourned the meeting until 9:00 a.m. Pacific Time, on July 22, 2011 due to insufficient votes cast for its reverse split proposal. Votes representing approximately 2.2 million more shares are needed […]

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Clinical and company updates for CLSN ACUR ZGNX APPA CADX AVNR STEM CYCC

Jul 01, 2011 No Comments

Celsion Corporation (NASDAQ: CLSN) today announced that will sell an aggregate of approximately 2.1 million shares of its common stock and warrants, potentially exercisable for up to approximately 630,000 additional shares of its common stock. The securities will be sold in units at a price of $3.1675 per unit, with each unit consisting of one […]

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PARD Reverse Split vote tomorrow + CLSN SOMX NEOP ACHN news

Jun 08, 2011 No Comments

Celsion Corporation (NASDAQ: CLSN) today announced that after reviewing safety data from its recently completed Phase I portion of the DIGNITY Phase I-II study of ThermoDox and hyperthermia in recurrent chest wall (RCW) breast cancer (the DIGNITY Study), an independent Drug Safety Monitoring Board (DSMB) has recommended advancing from Phase I to Phase II at […]

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CLSN Phase 3 HEAT trial enrolment 95 percent complete

Jun 07, 2011 No Comments

Celsion Corporation (NASDAQ: CLSN) said today that patient enrollment in the Phase 3 trial (the HEAT study) in patients with non-resectable primary liver cancertrial has now reached 95%. This compares with 93% on May 13. A pre-planned, unblinded interim efficacy analysis will be performed by the independent Data Monitoring Committee when enrollment in the HEAT […]

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