Cadence Pharmaceuticals Reports Second Quarter 2009 Financial Results

... product candidate for the treatment of acute pain and fever. The NDA was subsequently ... background in sales and marketing in the acute care area. His responsibilities include sales, ... product candidate for the treatment of acute pain and fever. For more information about ...

Nile Therapeutics, Inc. Announces Dosing of First Patient in Phase 2 Study of CD-NP for the Treatment of Acute Heart Failure

... of its lead product, CD-NP, for the treatment of acute heart failure. The single-blind, ... when infused for up to 72 hours in patients with acute heart failure and mild to moderate renal ... of CD-NP's ability to relieve symptoms of acute heart failure and its effects on biomarkers of ...

DOR BioPharma Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointestinal GVHD

... and prevention of GVHD, the prevention of acute radiation enteritis and the treatment of Crohn's ... we have already generated in the treatment of acute GI GVHD, we believe that orBec((R) )has the ... and inflammatory cytokines. GVHD presents in both acute and chronic forms. The symptoms of cGVHD ...

Micromet Receives European Orphan Drug Designation for Treatment of Acute Lymphoblastic Leukemia with BiTE Antibody Blinatumomab

... (EMEA) for BiTE antibody blinatumomab (MT103) for acute lymphoblastic leukemia (ALL). Blinatumomab is a ... Berlin, Germany, showing an 81% response rate in acute lymphoblastic leukemia (ALL) patients with ... disease (MRD) in patients with B precursor acute lymphoblastic leukemia (ALL): Update of an ...

United States FDA Clears the REGEN Trial to Test Bioheart's Combination Gene and Stem Cell Therapy in Heart Failure Patients

... cell therapies for the treatment of chronic and acute heart damage. Its lead product candidate, ... the treatment of heart damage, including Bioheart acute Cell Therapy, an autologous, adipose tissue-derived stem cell treatment for acute heart damage, and MyoCell((R)) SDF-1, a therapy ...

Sumavel(TM) DosePro(TM) (sumatriptan injection) Approved by FDA for Acute Migraine and Cluster Headache: First Product Featuring Novel DosePro Needle-Free Delivery System

... injection) needle-free delivery system to treat acute migraine, with or without aura, and cluster ... ) According to the National Headache Foundation, acute migraines affect nearly 30 million Americans. ... needle-free delivery system is indicated for the acute treatment of migraine attacks, with or without ...

Blackrock Microsystems Obtains Expanded 510(k) to Market NeuroPort System

... Neural Signal Processing System enables acute monitoring, signal detection and analysis to ... acquired worldwide rights to the NeuroPort acute monitoring platform technology from Cyberkinetics ... its use at the time was limited exclusively to acute (< 30 days) intracranial monitoring with a ...

IKARIA(R) to In-License BioLineRx's BL-1040

... pathological cardiac remodeling following acute myocardial infarction (AMI). BL-1040, ... and singular focus on therapies for patients in acute care settings makes it an ideal party to further ... Holdings, Inc. is a biotherapeutics company whose acute care products and therapies address the ...

DOR BioPharma Announces Publication of orBec(R) Clinical Pulmonary Data in Bone Marrow Transplantation

... non-infectious inflammation of the lung in acute gastrointestinal Graft-versus-Host disease (GI ... trials evaluating orBec(R), for the treatment of acute GI GVHD. Data from 120 patients (sixty patients ... 3 clinical trial of orBec(R) for the treatment of acute GI GVHD and a Phase 1/2 clinical trial of DOR201 ...

Phase II Trial Demonstrates Elacytarabine May Increase Survival Threefold in Patients With Late-Stage Leukaemia

... in patients with late-stage acute myeloid leukaemia (AML). In the trial, ... difficult-to-treat patient group is late-stage acute myeloid leukaemia (AML) patients who have ... for the most common acute leukaemia type, acute myeloid leukaemia (AML), is in the range of 5-10% ...

D-Pharm Receives FDA Clearance to Commence a Phase III Trial of DP-b99 in Acute Stroke Patients

... a pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients has been approved by the ... US is $68.9 billion. Only about 2 to 5% of acute stroke patients are eligible for treatment with ... (tPA), the only FDA approved drug treatment for acute stroke. About D-Pharm Ltd. D-Pharm ...

ViroPharma Receives Complete Response Letter for Cinryze(TM) Supplemental Biologics License Application for Acute Treatment of Hereditary Angioedema

... esterase inhibitor [human]) as a treatment for acute attacks of hereditary angioedema (HAE). The FDA ... the FDA cited no safety concerns related to acute treatment with Cinryze in the clinical studies. ... an unmet medical need for patients suffering from acute laryngeal attacks," said Vincent Milano, ...

PeriCor Therapeutics Reports Positive Preclinical Results of GP531 at the European Heart Failure Congress in Nice

... Chronic Advanced Heart Failure" found that an acute intravenous infusion of GP531 at doses ranging ... GP531 as an adjunct therapy for the treatment of acute heart failure syndromes. GP531 represents a novel ... we plan to initiate a Phase II study of GP531 in acute decompensated heart failure during the second ...

Astellas Receives FDA Approval for Use of Prograf(R) (Tacrolimus) in Conjunction With Mycophenolate Mofetil (MMF) in Kidney Transplant Recipients

... rate for the combined endpoint of biopsy proven acute rejection, graft failure, death and/or lost to ... rates (GFR), at 12 months after transplantation. acute rejection, graft survival and overall mortality ... fewer efficacy failures, defined as biopsy proven acute rejection (BPAR), graft loss, death and/or lost ...

Amgen Exercises Option for Exclusive License to Cytokinetics' Cardiac Contractility Program That Includes CK-1827452

... and an increased likelihood of survival following acute myocardial infarctions. The costs to society ... chronic heart failure patients suffer repeated acute episodes. Despite currently available therapies, ... to drugs used to treat each of chronic and acute heart failure. Sales of drugs to treat chronic ...

Multiple Types of Heart Attacks Reduced by Prasugrel in TRITON-TIMI 38 Trial

... of the study and showed that patients with acute coronary syndromes (ACS) undergoing percutaneous ... and fatal bleeding.(5) About acute Coronary Syndromes acute coronary syndromes (ACS), which includes heart ...

Micromet to Present New Clinical Data on Blinatumomab at EHA and on Adecatumumab at ASCO

... clinical trial with blinatumomab in patients with acute lymphoblastic leukemia (ALL) were chosen for an ... disease (MRD) in patients with B precursor acute lymphoblastic leukemia (ALL): Update of an ... clinical trial for the treatment of patients with acute lymphoblastic leukemia and a phase 1 clinical ...

Schering-Plough Announces Changes to its Global Collaboration with Novartis to Develop Combination Therapies for Asthma and COPD

... ASMANEX should not be used to treat acute asthma episodes (including status asthmaticus) ... inhalers. FORADIL AEROLIZER is also for the acute prevention of exercise-induced bronchospasm (EIB) ... FORADIL AEROLIZER should not be used to treat acute ....

ViroPharma Incorporated Honored by the National Organization for Rare Disorders

... Application for Cinryze for the treatment of acute attacks of HAE. If approved, Cinryze may be the first C1 esterase inhibitor available for the acute treatment for this condition. ViroPharma's ... Fee Act (PDUFA) date for the use of Cinryze for acute attacks in patients with HAE is June 3, 2009. ...

Nile Therapeutics CD-NP Clinical Program for Acute Heart Failure Released From Clinical Hold by FDA

... when infused for up to 72 hours in patients with acute heart failure and renal insufficiency. The dosing ... in clinical development for the treatment of acute heart failure. CD-NP was designed to reduce ... for favorable differentiation from other acute heart failure therapies. In addition to an ...

DOR BioPharma Reports 1st Quarter 2009 Financial Results and Reviews Recent Accomplishments

... 3 clinical trial of orBec(R) for the treatment of acute gastrointestinal Graft-versus-Host disease (GI ... dipropionate (oral BDP) for the prevention of acute radiation enteritis. On January 20, 2009, ... its lead product orBec(R) for the treatment of acute GI GVHD. The agreement was made under the FDA's ...

New Study Funded By the National Institutes of Health (NIH) Finds Masimo SpCO(R) May Provide a Noninvasive Measure of Acute Asthma Severity in Children

... (SpCO) may help clinicians better assess acute asthma severity during and after treatment. The ... "We have limited measures to assess severity of acute asthma exacerbations and the finding of an ... and inflammation in pediatric patients with acute asthma exacerbations." Dr. Arnold and ...

Alexza to Announce 2009 First Quarter Financial Results and Update Its Clinical Pipeline Status on Thursday, May 7, 2009

... of novel, proprietary products for the acute treatment of central nervous system conditions. ... loxapine) and is being developed for the acute treatment of agitation in schizophrenic or ... product candidates are being developed for the acute treatment of migraine headache. AZ-002 ( ...

ViroPharma Incorporated Reports First Quarter 2009 Financial Results

... and await our June 3, 2009 PDUFA date for the acute indication for Cinryze." GAAP net loss in ... review of our regulatory submission related to an acute treatment indication for Cinryze. Our 2009 ... approval for the use of Cinryze for the acute treatment of HAE; the availability of ...

Kiadis Pharma Reports ATIR(TM) Clinical Data, Further Supporting its Potential in Mismatched Bone Marrow Transplantations

... T-cells, is under development to prevent acute Graft versus Host Disease (GvHD) and allow for ... Nevertheless, no cases of severe grade III/IV acute GvHD occurred after ATIR(TM) ... in combination with the prevention of acute GvHD in bone marrow transplantations using a ...

Frost & Sullivan Applauds SHL Telemedicine for Excellence in Product Innovation

... reduce morbidity and mortality rates following an acute MI or other severe cardiac incidents." SHL Telemedicine performed an extended six-month acute Coronary Syndrome Israel Survey (ACSIS) in 2004 ... who survived hospitalisation after sustaining an acute MI. Results showed that in spite of having more ...

DOR BioPharma Reports Year-End 2008 Financial Results and Reviews Recent Accomplishments

... 3 clinical trial of orBec(R) for the treatment of acute GI GVHD. This, in part, has enabled us to shore ... dipropionate (oral BDP) for the prevention of acute radiation enteritis. On January 20, 2009, ... its lead product orBec(R) for the treatment of acute GI GVHD. The agreement was made under the FDA's ...

Amorcyte Reports Phase I Results of AMR-001 to Improve Recovery From Severe Heart Attack at ACC Annual Scientific Session

... the treatment of damaged heart muscle following acute myocardial infarction (AMI), that showed a ... there are approximately 1.1 million instances of acute myocardial infarction (AMI). 160,000 AMIs are ... heart failure, significant arrhythmias and acute coronary syndrome. Amorcyte's therapy aims to ...

Nile Therapeutics Provides Update on Phase II CD-NP Clinical Trial for Acute Heart Failure

... clinical trial with CD-NP for the treatment of acute heart failure, the FDA has placed CD-NP on ... data from the Phase IIa clinical trial in acute heart failure patients. About CD-NP ... in clinical development for the treatment of acute heart failure. CD-NP was designed to have direct ...

Alexza's Corporate Presentation to be Webcast at the Future Leaders in the Biotech Industry Conference

... novel, proprietary products for the treatment of acute and intermittent conditions. The Company's ... loxapine) and is being developed for the acute treatment of agitation in schizophrenic or ... both product candidates being developed for the acute treatment of migraine headache. AZ-002 ( ...

DOR BioPharma Appoints Brian L. Hamilton, MD, PhD as Chief Medical Officer

... dipropionate or BDP) in the treatment of acute GI GVHD. Dr. Hamilton earned his MD and PhD ... 3 clinical trial of orBec(R) for the treatment of acute GI GVHD and a Phase 1/2 clinical trial of DOR201 ... placebo-controlled trial in the prevention of acute GVHD. Oral BDP may also have application in ...

Micromet, Inc. To Regain Rights to Blinatumomab in North America; Reports Financial Results for the Fourth Quarter and Full Year ended December 31, 2008

... blinatumomab for the treatment of patients with acute lymphoblastic leukemia and a phase 1 clinical ... trial of blinatumomab in adult patients with acute lymphoblastic leukemia. In September, ... the phase 2 clinical trial with blinatumomab in acute lymphoblastic leukemia (ALL) patients at the 14th ...

Nile Therapeutics Reports 2008 Fourth Quarter and Full Year Financial Results and Announces Conference Call on March 10, 2009

... of CD-NP for the treatment of patients with acute heart failure. Nile executed a focused clinical ... assess hemodynamic and renal effects of CD-NP in acute heart failure patients. Nile believes that the ... at doses of up to 20 ng/kg/min in stable and acute heart failure patients; CD-NP blood ...

Cerimon Pharmaceuticals Initiates Phase III Clinical Studies to Evaluate Its Topical Diclofenac Sodium Patch for Mild-to-Moderate Pain

... patch compared to placebo for the treatment of acute pain caused by mild-to-moderate ankle sprains, ... a ratio of 1:1. "Results from our Phase II acute ankle sprain study have demonstrated our topical diclofenac patch can deliver effective relief of acute pain due to mild-to-moderate musculoskeletal ...

Implicit Licenses Clinical Stage Antibody Program From Lilly

... intend to develop this promising drug to treat acute lung injury (ALI) caused by a dysregulated immune ... and commercialisation. About acute Lung Injury acute lung injury (ALI) is a severe inflammatory ...

ViroPharma Incorporated Reports Fourth Quarter and Full Year 2008 Financial Results

... Application (sBLA) for Cinryze for treatment of acute attacks of HAE; Granted priority review ... Administration for Cinryze sBLA for treatment of acute attacks of HAE, with a Prescription Drug User Fee ... including the ongoing commercial launch and our acute indication sBLA with a June PDUFA date; continued ...

European Commission Approves EFIENT(R) (prasugrel) for Patients with Acute Coronary Syndrome Undergoing PCI

... 23 /PRNewswire-FirstCall/ -- Heart patients with acute coronary syndrome (ACS) undergoing an ... United States for the treatment of patients with acute coronary syndromes (ACS) managed with ... as a treatment initially for patients with acute coronary syndromes who are undergoing PCI. ...

Zogenix Reports FDA Provides New PDUFA Date for Sumavel(TM) DosePro(TM)

... marketing approval of Sumavel DosePro for the acute treatment of migraine attacks with or without aura, and the acute treatment of cluster headache episodes. In ... delivery of sumatriptan for the treatment of acute migraine and cluster headache. Zogenix submitted ...

Vion Pharmaceuticals Submits New Drug Application for Onrigin(TM)

... years of age or older with de novo poor-risk acute myeloid leukemia (AML). The Company has ... for the Onrigin clinical development program. acute myeloid leukemia is a devastating disease, and ... in patients with brain tumors. About acute Myeloid Leukemia (AML) The American Cancer ...

First Multiple Dose Clinical Trial of TorreyPines Therapeutics' Oral Compound NGX426 Demonstrates Compound Is Safe and Well-Tolerated

... about the potential for NGX426 to treat both acute and chronic pain conditions." The Phase I ... candidates each capable of treating a number of acute and chronic diseases and disorders such as ... NGX426 as a treatment for neuropathic pain and acute migraine, and the ability for TorreyPines to ...