Threshold Pharmaceuticals Announces Agreement With U.S. FDA on a Special Protocol Assessment for Planned Phase 3 Trial of TH-302 in Combination With Gemcitabine in Advanced Pancreatic Cancer

Threshold Pharmaceuticals, Inc. ( NASDAQ : THLD ) today announced that the U.S. Food and Drug Administration (FDA) has reached agreement with the U.S. affiliate of Merck KGaA, Darmstadt, Germany, Threshold's partner for the development and commercialization of TH-302, covering a Special Protocol Assessment (SPA) for a Phase 3 randomized trial of TH-302 in patients with metastatic or locally advanced unresectable pancreatic cancer. The trial is designed to evaluate the efficacy and safety of TH-302 in combination with gemcitabine compared with gemcitabine therapy alone. Pursuant to Threshold's license and co-development agreement with Merck, Merck will be responsible for conducting the Phase 3 study under the SPA.

Published: 16 October 2012
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Cyclacel's Sapacitabine Nearly Doubles Expected Survival of Elderly Patients With MDS After Front-Line Therapy Failure

Conference Call Today at 3:30 PM ET With Leading Physicians to Review Results

Cyclacel Pharmaceuticals, Inc. (CYCC) (CYCCP) (Cyclacel or the Company), will host a conference call today to discuss updated data from an ongoing, multicenter, Phase 2 randomized trial of oral sapacitabine capsules, the Company's lead product candidate, in older patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) after treatment failure of front-line hypomethylating agents, such as azacitidine (Vidaza(R)) and/or decitabine (Dacogen(R)).

Published: 15 October 2012
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FDA Posts Briefing Documents for Advisory Committee Meeting Reviewing Gattex® (teduglutide) for Adult Short Bowel Syndrome

Gastrointestinal Drugs Advisory Committee Meeting Scheduled for October 16, 2012

NPS Pharmaceuticals, Inc. (NPSP), a biopharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, announced today that the U.S. Food and Drug Administration (FDA) has posted briefing materials for the October 16, 2012 Gastrointestinal Drugs Advisory Committee meeting to review Gattex® (teduglutide). Gattex is a novel, recombinant analog of human glucagon-like peptide 2 (a protein involved in the rehabilitation of the intestinal lining) being developed for the treatment of adults with short bowel syndrome.

Published: 12 October 2012
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KYTHERA Biopharmaceuticals Announces Pricing of Initial Public Offering

KYTHERA Biopharmaceuticals, Inc. (“KYTHERA”) today announced the pricing of its initial public offering of 4,400,000 shares of its common stock at a price to the public of $16.00 per share. The shares of KYTHERA's common stock will trade on the NASDAQ Global Select Market under the symbol "KYTH." All of the shares of common stock are being offered by KYTHERA. In addition, KYTHERA has granted the underwriters a 30-day option to purchase up to an additional 660,000 shares of common stock to cover over-allotments, if any.

The offering is expected to close on October 16, 2012, subject to customary closing conditions.

Published: 11 October 2012
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BioLineRx Announces New Analysis of EAGLE Phase IIb Study Showing a Significantly Greater Beneficial Effect of BL-1020 on Cognitive Function in Schizophrenia Patients

–BL-1020 is currently undergoing the CLARITY Phase II/III clinical trial with results expected in H2 2013–

BioLineRx (BLRX) (BLRX.TA), a biopharmaceutical development company, announced today that a recent analysis of the results from the Phase IIb EAGLE trial for BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia, indicates that BL-1020 demonstrated a significant increase in efficacy at improving cognitive impairment associated with this condition, as compared to the original analysis of the study.

Published: 09 October 2012
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