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FDA clears Insmed IND for ARIKACE Phase 3 clinical trial in nontuberculous mycobacteria lung infections

Insmed Incorporated, a biopharmaceutical company, announced today that the Company's Investigational New Drug Application (IND) to conduct a pivotal Phase 3 clinical trial of ARIKACE™ (liposomal amikacin for inhalation) in nontuberculous mycobacteria (NTM) lung infections has been cleared by the U.S. Food and Drug Administration (FDA).

21 Mar 2011

Nektar initiates dosing in NKTR-181 Phase 1 clinical study for treatment of pain

Nektar Therapeutics today announced that the first subjects were dosed in a new Phase 1 clinical study to evaluate NKTR-181, the company's next-generation opioid analgesic candidate. NKTR-181 is being developed to effectively treat pain while addressing the abuse liability and serious CNS side effects associated with currently available opioid therapies.

21 Mar 2011

NanoViricides reports improved efficacy with optimized FluCide nanoviricide drug candidates for influenza

NanoViricides, Inc. reported dramatically improved antiviral efficacy with its optimized FluCide™ drug candidates in its most recent animal study.

21 Mar 2011

United Therapeutics completes enrollment in FREEDOM-C(2) UT-15C study in pulmonary arterial hypertension

United Therapeutics Corporation announced today that enrollment in its FREEDOM-C(2) registration trial was completed on March 18, 2011.

21 Mar 2011

Advanced Cell Technology reduces 2010 debt to less than $1 million

Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced today 2010 year-end results for the period ended December 31, 2010. The Company utilized $8.8 million in cash for operations during the year, compared to $5.1 million in the year-earlier period.

21 Mar 2011

Medicago launches clinical development of seasonal flu vaccine

Medicago Inc. a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that the first dose of vaccine has been administered thereby initiating the Company's phase I H1N1 influenza VLP vaccine candidate ("H1N1 vaccine") clinical trial in the United States. The primary safety and immunogenicity results for this trial are expected within three months.

21 Mar 2011

Shire announces FDA PDUFA date for FIRAZYR NDA in treatment of acute attacks of hereditary angioedema

Shire plc, the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of August 25, 2011 for the review of the New Drug Application (NDA) for FIRAZYR(R) (icatibant) for the treatment of acute attacks (Types I and II) of hereditary angioedema (HAE). This 6 month review timeline is consistent with review as a Class II resubmission.

21 Mar 2011

XenoPort reports preliminary top-line results from arbaclofen placarbil Phase 2b clinical trial in GERD

XenoPort, Inc. announced today preliminary top-line results from a Phase 2b clinical trial of arbaclofen placarbil (also known as AP) as adjunctive therapy in patients with gastroesophageal reflux disease (GERD) who do not experience complete relief of GERD symptoms while being treated with proton pump inhibitors (PPI).

21 Mar 2011

Positive results from GDC-0449 Phase II clinical trial in advanced basal cell carcinoma

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced a positive outcome from a pivotal Phase II clinical trial conducted by Roche and Genentech, Curis' collaborator and a wholly owned member of the Roche Group, of GDC-0449, a first-in-class hedgehog pathway inhibitor, in patients with advanced basal cell carcinoma (BCC).

21 Mar 2011

$CTI commences pixantrone PIX-R trial in relapsed/refractory diffuse large B-cell lymphoma$

CTI commences pixantrone PIX-R trial in relapsed/refractory diffuse large B-cell lymphoma

Cell Therapeutics, Inc. today announced that it has initiated its randomized pivotal trial of pixantrone for the treatment of relapsed/refractory diffuse large B-cell lymphoma ("DLBCL").

21 Mar 2011

Genentech's vismodegib Phase II clinical study in advanced basal cell carcinoma meets primary endpoint

Genentech, a member of the Roche Group, today announced that a pivotal Phase II clinical study of its investigational Hedgehog Pathway Inhibitor, vismodegib (RG3616/GDC-0449), showed positive results in people with advanced basal cell carcinoma (aBCC), a particularly severe and debilitating form of skin cancer.

21 Mar 2011

BioMarin announces preliminary results from ADAPT in patients suffering from PKU

BioMarin Pharmaceutical Inc. announced today preliminary results from ADAPT (A Diversified Approach for PKU Treatment) in an abstract (Abstract #91, Mental Health Screening in Phenylketoniuria Clinic) presented by Barbara Burton, MD at the 2011 annual American College of Medical Genetics conference in Vancouver, Canada.

19 Mar 2011

The Lancet publishes Oceana's Solesta injectable gel study results against fecal incontinence

Oceana Therapeutics, a global company focused on acquiring, developing and commercializing best-in-class specialty therapeutics, today announced the publication of results from a randomized-controlled clinical trial of the bulking agent, NASHA DX, a dextranomer suspended in stabilized, which was injected into the submucosa of the anal canal in patients with fecal incontinence.

19 Mar 2011

Quark Pharmaceuticals receives results from Phase 2 trial of PF-04523655 in patients with DME

Quark Pharmaceuticals, Inc., a pharmaceutical company engaged in the discovery and development of RNAi-based therapeutics, today announced that it has received results from a prospective randomized Phase 2 trial, the DEGAS study.

19 Mar 2011

Polaris initiates ADI-PEG 20 Phase 2 trial in patients with malignant mesothelioma

Polaris Group announced today the enrollment of the first patient in a Phase 2 clinical trial of ADI-PEG 20, the company's novel enzyme-based treatment for malignant mesothelioma.

19 Mar 2011

Science journal publishes CYTK preclinical cardiac myosin activation research results

Cytokinetics, Incorporated announced today the publication of preclinical research in the March 18, 2011 issue of the journal Science regarding the activation of cardiac myosin by an investigational drug candidate, omecamtiv mecarbil, and the potential therapeutic role that this novel mechanism may play for patients with systolic heart failure.

18 Mar 2011

KYTHERA presents additional data from third ATX-101 Phase II clinical study in submental fat reduction

KYTHERA Biopharmaceuticals, Inc. today presented additional efficacy data from a third Phase II clinical study with ATX-101, a first-in-class adipolytic agent that is under investigation for the reduction of submental ('under the chin') fat. The expanded analysis focused on additional patient reported outcome measures, including instruments measuring submental fat impact, subject global assessments and subject self-ratings of chin attractiveness.

18 Mar 2011

Individualized dentritic cell vaccine may increase survival time in patients with glioblastoma

A dendritic cell vaccine personalized for each individual based on the patient's own tumor may increase median survival time in those with a deadly form of brain cancer called glioblastoma, an early phase study at UCLA's Jonsson Comprehensive Cancer Center has found.

18 Mar 2011

FibroGen, Astellas advance FG-4592 to phase 2b development for treatment of anemia in chronic kidney disease

FibroGen, Inc., today announced that FibroGen and partner Astellas Pharma Inc. advanced FG-4592 (Astellas designation ASP1517), an investigational anemia therapy, to phase 2b development for treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis.

18 Mar 2011

CytRx commences INNO-206 Phase 1b trial in advanced solid tumors

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that it has initiated an open-label Phase 1b safety and dose escalation clinical trial with INNO-206 at the Sarcoma Oncology Center in Santa Monica, California. The clinical trial will include up to 24 patients with advanced solid tumors who have failed standard therapies.

17 Mar 2011

Drug Trial News

FDA clears Insmed IND for ARIKACE Phase 3 clinical trial in nontuberculous mycobacteria lung infections

Nektar initiates dosing in NKTR-181 Phase 1 clinical study for treatment of pain

NanoViricides reports improved efficacy with optimized FluCide nanoviricide drug candidates for influenza

United Therapeutics completes enrollment in FREEDOM-C(2) UT-15C study in pulmonary arterial hypertension

Advanced Cell Technology reduces 2010 debt to less than $1 million

Medicago launches clinical development of seasonal flu vaccine

Shire announces FDA PDUFA date for FIRAZYR NDA in treatment of acute attacks of hereditary angioedema

XenoPort reports preliminary top-line results from arbaclofen placarbil Phase 2b clinical trial in GERD

Positive results from GDC-0449 Phase II clinical trial in advanced basal cell carcinoma

CTI commences pixantrone PIX-R trial in relapsed/refractory diffuse large B-cell lymphoma

Genentech's vismodegib Phase II clinical study in advanced basal cell carcinoma meets primary endpoint

BioMarin announces preliminary results from ADAPT in patients suffering from PKU

The Lancet publishes Oceana's Solesta injectable gel study results against fecal incontinence

Quark Pharmaceuticals receives results from Phase 2 trial of PF-04523655 in patients with DME

Polaris initiates ADI-PEG 20 Phase 2 trial in patients with malignant mesothelioma

Science journal publishes CYTK preclinical cardiac myosin activation research results

KYTHERA presents additional data from third ATX-101 Phase II clinical study in submental fat reduction

Individualized dentritic cell vaccine may increase survival time in patients with glioblastoma

FibroGen, Astellas advance FG-4592 to phase 2b development for treatment of anemia in chronic kidney disease

CytRx commences INNO-206 Phase 1b trial in advanced solid tumors

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