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ViroPharma initiates Cinryze Phase 2 subcutaneous trial in patients with HAE

ViroPharma Incorporated and Halozyme Therapeutics announced today that ViroPharma has initiated an open-label, multi-dose Phase 2 study to evaluate the safety, and pharmacokinetics and pharmacodynamics of subcutaneous administration of Cinryze in combination with Halozyme's Enhanze technology, a proprietary drug delivery platform using Halozyme's recombinant human hyaluronidase enzyme, in subjects with hereditary angioedema.

14 Sep 2011

Acceleron commences ACE-536 Phase 1 clinical trial in anemia

Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases today announced that it has initiated a Phase 1 clinical study of ACE-536.

14 Sep 2011

Emergent commences TRU-016 Phase 1b/2 combination trial in relapsed indolent NHL

Emergent BioSolutions Inc. today announced the initiation of a Phase 1b/2 study (16011) of TRU-016 in combination with rituximab and bendamustine for patients with relapsed indolent non-Hodgkin's B-cell lymphomas, including follicular lymphoma, small lymphocytic lymphoma and marginal zone lymphoma.

17 Aug 2011

FDA accepts MAP Pharmaceuticals' LEVADEX NDA for filing

MAP Pharmaceuticals, Inc. today announced that its New Drug Application (NDA) for LEVADEX® orally inhaled migraine drug for the potential acute treatment of migraine in adults has been accepted for filing by the U.S. Food and Drug Administration (FDA), with a goal date of March 26, 2012 under the Prescription Drug User Fee Act (PDUFA).

2 Aug 2011

BioMarin commences BMN 673 Phase 1 trial in hematological malignancies

BioMarin Pharmaceutical Inc. today announced the initiation of a Phase 1 trial for BMN 673, a poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with advanced hematological malignancies.

15 Jul 2011

EnVivo initiates EVP-0962 GSM Phase 1 clinical trial for Alzheimer’s disease

EnVivo Pharmaceuticals, a company dedicated to developing a broad range of novel central nervous system (CNS) therapies, announced today that it recently initiated a Phase 1 clinical trial of EVP-0962, its potent and selective gamma secretase modulator (GSM), in healthy volunteers.

27 Jun 2011

Millennium reports results from two MLN9708 ongoing Phase I studies on multiple myeloma

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today reported results from two ongoing Phase I studies with MLN9708, the first oral proteasome inhibitor being studied in patients with relapsed and/or refractory multiple myeloma.

13 Jun 2011

VentiRx presents VTX-2337 Phase 1 trial results against advanced solid tumors at ASCO 2011

VentiRx Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of novel Toll-Like Receptor 8 agonists for the treatment of cancer, respiratory and autoimmune diseases, today announced the presentation of results from a Phase 1 clinical trial of VTX-2337, a selective TLR8 agonist in patients with advanced solid tumors. Data were presented at the American Society of Clinical Oncology Annual Meeting in Chicago, IL.

7 Jun 2011

MAP Pharmaceuticals submits LEVADEX NDA to FDA for treatment of migraine in adults

MAP Pharmaceuticals, Inc. today announced that it has submitted a New Drug Application to the United States Food and Drug Administration for LEVADEX orally inhaled migraine drug for the potential acute treatment of migraine in adults.

27 May 2011

Anavex comments on new Alzheimer’s disease diagnostic guidelines

Anavex Life Sciences Corp. (“Anavex”) (OTCBB: AVXL) today commented on new diagnostic criteria and guidelines for Alzheimer’s disease published recently by the National Institute on Aging (NIA) and the Alzheimer’s Association, which have been updated for the first time in more than 25 years. The new guidelines discuss the importance of new technologies, including brain imaging and biomarker analysis, in research and clinical diagnosis. They describe Alzheimer’s disease at a preclinical stage, Mild Cognitive Impairment (MCI) due to Alzheimer’s disease, and dementia due to Alzheimer’s pathology.

18 May 2011

Roche initiates TB-403 Phase Ib/II study in glioblastoma multiforme

ThromboGenics and co-development partner BioInvent International announce today that their partner Roche has dosed the first patient in a Phase Ib/II study with the novel antibody anti-cancer agent TB-403 (RG7334).

16 May 2011

Santaris Pharma advances SPC4955 into Phase 1 trial for high cholesterol treatment

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the research and development of mRNA and microRNA targeted therapies, today announced that it has advanced a second drug from its cardiometabolic program, SPC4955 into Phase 1 clinical trials, for the treatment of high cholesterol.

11 May 2011

FibroGen announces proof-of-principle for FG-4592 Phase 2 study in hemodialysis patients

FibroGen, Inc., today announced proof-of-principle for oral anemia therapy FG-4592, a hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor, in end-stage renal disease patients receiving hemodialysis.

4 May 2011

IQ Therapeutics completes dosing in IQNLF Phase I trial for anthrax

IQ Therapeutics has completed the dosing of antibody IQNLF in a Phase I clinical trial. A total of 36 healthy volunteers participated in the randomized, placebo controlled, double blind, single dose-escalating study, intended to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of IQNLF.

27 Apr 2011

Anavex: First-in-human dosing cmmenced in ANAVEX 2-73 clinical trial for Alzheimer’s

Anavex Life Sciences Corp. (“Anavex”) (OTCBB: AVXL) today announced that the first healthy human volunteers have been initially dosed in its Phase I clinical trial to evaluate ANAVEX 2-73, the company’s lead compound for Alzheimer’s disease. “We are pleased that the first volunteers have been dosed with the study drug, according to the study protocol, and no adverse events have been recorded post dosing to date," said Dr. Ozkan Yalkinoglou, Medical Director of ABX-CRO.

20 Apr 2011

Results of study evaluating potential inhibitory effects of PPIs on Plavix presented at ACC 2011

Takeda Pharmaceuticals North America, Inc. announced the presentation of new study results, which evaluated the potential inhibitory effects of certain proton pump inhibitors (PPIs) on Plavix (clopidogrel bisulfate). The results showed that in healthy subjects, clopidogrel's active metabolite and inhibition of platelet function were reduced less by the co-administration of clopidogrel with dexlansoprazole or lansoprazole, rather than esomeprazole.

6 Apr 2011

Idera presents IMO-3100 Phase 1 trial data in autoimmune diseases at Keystone Symposia

Idera Pharmaceuticals, Inc. today announced the presentation of data from its multiple-dose Phase 1 clinical trial of IMO-3100 in healthy subjects.

5 Apr 2011

Regado's REG1 system Phase 2b trial results presented at i2 Summit

Regado Biosciences, Inc., a privately held company pioneering the development of antithrombotic aptamers with active control agents, announced today the primary results of the RADAR Phase 2b clinical trial of the company's lead product, the anticoagulation system REG1, at the i2 Summit during the American College of Cardiology 2011 60th Annual Scientific Session & Expo in New Orleans, LA.

4 Apr 2011

Alnylam completes patient enrollment in ALN-VSP Phase I trial against liver cancer

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, today announced that it has completed enrollment in its ALN-VSP Phase I multi-center, multinational, open label, dose escalation clinical trial.

1 Apr 2011

Regado to present REG1 Phase 2b trial results against acute coronary syndromes at i2 Summit

Regado Biosciences, Inc., a privately held company pioneering the development of antithrombotic aptamers with active control agents, announced that Thomas J. Povsic, MD, PhD, Assistant Professor of Medicine at Duke University, will present results of the RADAR Phase 2b clinical trial for the Company's lead product, the REG1 anticoagulation system, at the i2 Summit during the American College of Cardiology 2011 60th Annual Scientific Session & Expo.

29 Mar 2011