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BioMarin Announces First Quarter 2009 Financial Results

... Results from PEG-PAL Phase I trial 2Q09: initiation of PEG-PAL Phase II trial 3Q09: Decision ... on 6R-BH4 cardiovascular program 1Q10: initiation of Phase I trial for BMN-195 for DMD ... Results from PEG-PAL Phase II trial 2H10: initiation of pivotal Phase III trial for GALNS for MPS IVA ...

Human Genome Sciences Announces First Quarter 2009 Financial Results and Key Developments

... applications planned in fall 2009 - - initiation of Syncria (R) Phase 3 program brings $9 ... a $9 million milestone payment from GSK with the initiation of Phase 3 clinical development of Syncria in ... Milestone Payment Received from GSK Following initiation of Phase 3 Development of Syncria (R) HGS ...

Phase 3 Data Demonstrate Efficacy and Tolerability of Paliperidone Palmitate, an Investigational Long-Acting Therapy for the Treatment of Schizophrenia

... Results of Two Trials Identify Potential initiation Dosing Regimen TITUSVILLE, N.J., Dec. 10 ... when given every 4 weeks with a 150 mg eq. initiation dose. A separate 53-week non-inferiority ... paliperidone palmitate using only a 50 mg eq. initiation dose, and subsequent doses of 25, 50, 75, and 100 ...

Halozyme Therapeutics Reports 2008 Third Quarter Financial Results

... never been stronger and I am pleased with the initiation of our Phase 2 insulin clinical trial. The study ... that target large commercial markets and the initiation of additional human clinical studies should ... alone. These results and other findings support initiation of a Phase 1, dose escalation, intravenous, ...

Sanofi Aventis : New Study Results Support the "Basal Plus" Strategy With LANTUS(R) and APIDRA(R) to Improve Blood Sugar Control in Patients With Type 2 Diabetes

... blood glucose monitoring can be used for initiation and titration of the "basal/basal plus" strategy. ... than or equal to5.5 mmol/L. At LANTUS(R) initiation (baseline), patients were randomised to either ... p<0.0001) with no further change after APIDRA(R) initiation (6.4 plus or minus 1.6 versus 6.3 plus or minus ....

WaferGen Announces Second Quarter 2008 Financial Results

... Corporate Developments and Milestones: -- initiation of alpha testing of WaferGen's SmartChip(TM) ... Real-Time PCR System as evidenced by the initiation of alpha testing by Dr. Steven Shapiro and his ... University of Pittsburgh Medical School -- initiation of SmartChip(TM) beta testing and collaboration ...

Nuvelo Reports Second Quarter 2008 Financial Results

... with NU172 within the next several weeks; -- initiation of a Phase 2 trial with NU172 in CABG procedures ... quarter of 2008 or first quarter of 2009; -- initiation of a Phase 1 single ascending dose (SAD) trial ... volunteers in the second half of 2008; -- initiation of a Phase 1b multiple ascending dose (MAD) trial ...

Lorus Therapeutics Reports Fourth Quarter Results for Fiscal Year 2008

... in Canadian dollars. 2008 HIGHLIGHTS - initiation of GLP toxicology studies for Lorus' lead ... development program in this indication, with initiation of a more advanced Phase II clinical trial. ... achieved during fiscal 2008 including the initiation of GLP-toxicology studies for LOR-253; ...

SemBioSys announces first quarter 2008 financial and operational results

... human clinical trials - Upon FDA approval, initiation of a 30 patient Phase I/II clinical trial of ... by studies of plaque regression - initiation of a formal partnering process for Apo AI and ... scale-up of High GLA Safflower Oil - initiation of pond trials for the Company's shrimp feed ...

Nuvelo Reports First Quarter 2008 Financial Results and Updated Outlook for 2008

... the following near-term milestones: -- initiation of a Phase 1b bolus plus infusion trial with ... with NU172 in the third quarter of 2008; -- initiation of a Phase 2 trial with NU172 in medical or ... quarter of 2008 or first quarter of 2009; -- initiation of a Phase 1 trial with NU206 in mucositis in the ...

SemBioSys announces 2007 financial and operational results

... an IND to the FDA in the second half of 2008 - initiation of a 30 patient Phase I/II clinical trial of ... with safflower-produced Apo AI(Milano) - initiation of formal partnering process for Apo AI and Apo ... the initial in vivo efficacy results - initiation of the preparatory work in order to submit an IND ...

Pharmion Corporation Announces 2007 Operating Results

... across our product portfolio, including the initiation of clinical studies for Amrubicin, MGCD0103 ... to development expenses incurred for the initiation of Phase 2 and 3 studies in small cell lung cancer (SCLC) for Amrubicin, the initiation of Phase 1 and 2 studies in solid tumors and ...

Ardea Biosciences, Inc. Reports Third Quarter 2007 Operating and Financial Results

... few months," added Dr. Quart. These include: -- initiation of a Phase 2a proof-of-concept trial with our ... in a first-in-human micro-dosing study; -- initiation of a Phase 1 advanced cancer clinical study of our lead MEK inhibitor, RDEA119; -- initiation of a program to evaluate RDEA119 in inflammatory ...

ThromboGenics - Business Update and Interim Results for the Seven Month Period Ending 30 June 2007

... Injection) in the United States, as well as the initiation of two Phase IIa clinical trials of microplasmin ... without the need for mechanical intervention. - initiation of MIVI III (microplasmin in vitrectomy) clinical ... expected to start in the second half of 2008. - initiation of two Phase IIa trials microplasmin for ...

InterMune Reports Second Quarter 2009 Financial Results and Business Highlights

... ------- ITMN-191 (R7227) --------------- Phase 2b initiation by Roche ($20 million payment to InterMune) ... includes an expected $20 million milestone payment from Roche upon initiation of the Phase 2b study of ITMN-191, expected in August. Operating ...

MacroGenics Announces the Initiation of a Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Monoclonal Antibody MGAWN1 in Subjects with Suspected Central Nervous System Infection Due to West Nile Virus

... Md. , July 13 /PRNewswire/ -- MacroGenics, Inc. today announced the initiation of the PARADIGM trial, a Phase 2 clinical study evaluating MGAWN1, a ... well tolerated at all doses tested. "We are delighted with the initiation of the PARADIGM trial as well as the completion of the Phase 1 trial," ...

Intarcia Therapeutics, Inc. Presents ITCA 650 Phase 1b Study Results as a Late-Breaker at the American Diabetes Association 69th Scientific Sessions

... receive the benefits of an optimized dose of exenatide immediately upon initiation of treatment, and it continuously provides consistent, round-the-clock ... treatment. Decreases in FPG were evident within 24 hours of the initiation of treatment suggesting a rapid and consistent achievement of desired ...

Raptor Pharmaceuticals Doses First Patient in Phase 2b Clinical Trial of DR Cysteamine for Cystinosis

... principal investigator for the cystinosis clinical trial, commented, "The initiation of this cystinosis trial offers us an opportunity to evaluate the ... affect 2-5% of the U.S. population. In October, 2008 Raptor announced the initiation of a Phase 2a clinical study of cysteamine bitartrate in NASH patients, in ...

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

... spending of $968,996 in research and development in preparation for the initiation of the confirmatory Phase 3 clinical trial of orBec(R) for the treatment ... President and CEO of DOR. "We continue to work diligently towards the initiation of our confirmatory Phase 3 clinical trial of orBec(R) in GI GVHD under a ...

Novavax Reports First Quarter 2009 Financial Results

... a highly pathogenic H5N1 avian influenza strain. Announced the initiation of enrollment in the second Phase II study of its trivalent seasonal ... the joint venture with Cadila Pharmaceuticals Ltd in India; and, initiation of a Phase II clinical study of our trivalent seasonal flu vaccine in ...

SENOMYX ANNOUNCES FIRST QUARTER 2009 FINANCIAL RESULTS

... research and license agreement with Campbell Soup Company - initiation of development activities to support regulatory filings for Bitter ... determines that a new flavor ingredient has met their requirements for initiation of development activities and evaluation of commercial potential," Snyder ...

Aegera Initiates Phase 2 Clinical Trial Of AEG33773 - A Small Molecule Targeting Neuropathic Pain

... May 6 /PRNewswire/ - Aegera Therapeutics is pleased to announce the initiation of a Phase 2a, proof-of-concept, clinical trial for AEG33773, a novel, ... successful conclusion of the Phase 1 safety studies for AEG33773 and the initiation of the first Phase 2a trial in diabetic patients suffering from ...

Health Canada Approves SIMPONI(TM) (golimumab) for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

... for the risk of tuberculosis, including latent tuberculosis, prior to initiation of SIMPONI. Treatment of latent tuberculosis infection should be initiated ... hepatitis B should be appropriately evaluated and monitored prior to the initiation of, during treatment with, and for several months ...

Medivation Reports Fourth Quarter and Year-End 2008 Financial Results and Provides Corporate Update

... are already well on our way with the ongoing CONNECTION study, the recent initiation of a large safety trial designed to support a potential earlier NDA filing ... forward-looking statements, including statements regarding the timing of: initiation of clinical studies, filing of an NDA for Dimebon, seeking approval to ...

Financial Results for Full Year 2008: NicOx in a Unique Position to Deliver Significant Shareholder Value

... in the collaboration with Merck & Co., Inc., following the initiation of a series of phase 1b studies in mild to moderate hypertensive ... seek advice regarding naproxcinod data from many leading advisors. initiation of a series of phase 1b studies by Merck & Co., Inc. in ...

BioMarin Announces Fourth Quarter and Full Year 2008 Financial Results

... C study -- 1Q09: Results from Phase 2 PAH trial -- 1Q09/2Q09: initiation of Phase 1 trial for GALNS for MPS IVA -- 2Q09: Results from ... trial -- 2Q09: Results from PEG-PAL Phase 1 trial -- 2Q09: initiation of PEG-PAL Phase 2 trial Upcoming Investor Conferences and Events ...

FDA Approves ULORIC(R) (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout

... or theophylline. An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including ULORIC. If a gout flare occurs ... (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months. A higher rate of ...

Sangamo BioSciences Reports Fourth Quarter and Full Year 2008 Financial Results

... are resistant to the virus in an animal model of HIV infection. initiation of Phase 2 clinical trial (SB-509-801) of SB-509 in amyotrophic lateral ... of ZFP Therapeutic development, uncertainties related to the timing of initiation and completion of clinical trials, whether clinical trial results will ...

Genomic Health Announces Commencement of QUASAR Clinical Validation Study for Oncotype DX(R) Colon Cancer Assay

... the tens of thousands of patients with stage II colon cancer and the initiation of this study brings us one step closer to delivering a tool that may do ... reporting results of the validation study, the company's belief that the initiation of the clinical validation study brings it closer to delivering a tool ...

SemBioSys announces senior management changes

... and initiate new programs to build the Company's pipeline." "With the initiation of our clinical trial for plant-produced insulin and the progress we made ... of a CTA to the appropriate European authorities, the successful initiation and timely and successful completion of clinical studies, the fact that ...

Cylene Pharmaceuticals Initiates Phase II Clinical Trial of Quarfloxin (CX-3543) in Patients With Carcinoid/Neuroendocrine Tumors

... DIEGO, Dec. 15 /PRNewswire/ -- Cylene Pharmaceuticals today announced the initiation of a Phase II clinical trial of quarfloxin (CX-3543) in patients with ... enroll up to 25 patients at several leading cancer centers. "The initiation of this Phase II trial with quarfloxin is a major milestone for Cylene, ...

SemBioSys begins phase I/II trial of insulin produced in plant seeds

... commercially available insulin currently used to treat diabetes." "The initiation of the phase I/II clinical trial for plant-produced insulin is a major ... of a CTA to the appropriate European authorities, the successful initiation and timely and successful completion of clinical studies, the fact that ...

Isis Reports Financial Results and Highlights for Third Quarter of 2008

... in our pipeline with many milestones to look forward to, including the initiation of three additional trials studying mipomersen," continued Ms. Parshall. ... franchise with the addition of a new drug targeting PCSK9 and the initiation of clinical trials on our CRP inhibitor. This year we and our partners ...

SENOMYX ANNOUNCES THIRD QUARTER 2008 FINANCIAL RESULTS

... - New collaboration with Firmenich SA for commercialization of S2383 - initiation of safety studies to support regulatory filings for Sucrose ... full sweet taste with no off-tastes. Recent progress with S6973 includes initiation of safety studies and demonstrations of efficacy in additional types of ...

Sangamo BioSciences Reports Third Quarter 2008 Financial Results

... personnel costs and lab supply expenses. Recent Highlights * initiation of a Phase 2 clinical trial (SB-509-801) to evaluate SB-509 in ... of ZFP Therapeutic development, uncertainties related to the timing of initiation and completion of clinical trials, whether clinical trial results will ...

BioMarin Announces Third Quarter 2008 Financial Results

... 1Q09: Results from proteinuria in chronic kidney disease trial -- 1Q09: initiation of Phase 1 trial for GALNS for MPS IVA -- 1Q09/2Q09: Results from PEG-PAL Phase 1 trial -- 1Q09/2Q09: initiation of PEG-PAL Phase 2 trial Upcoming Investor Conferences and Events -- ...

Orexigen(R) Therapeutics Initiates First Clinical Trial of OREX-003 for the Mitigation of Antipsychotic-Associated Weight Gain

... and other central nervous system-related disorders, today announced the initiation of its first clinical trial with OREX-003, a proprietary sustained release ... licensed both patents on an exclusive basis from Duke University. "The initiation of the OZ-101 clinical trial and progress in securing comprehensive ...

Bavarian Nordic A/S - Interim Report for the Period 1 January to 30 June 2008

... the $500m contract with the U.S. government. Activities to support the initiation of delivery of the 20 million doses of IMVAMUNE(R) are ongoing and include ... and prostate cancer, was strengthened in the first half of 2008 with the initiation of clinical studies the Company's prostate cancer vaccine candidate. ...

Merrimack Pharmaceuticals Initiates Enrollment in a Phase 1 Study of MM-121, an ErbB3 Antagonist

... family, a pathway that plays a critical role in cancer signaling. With the initiation of the Phase 1 trial, MM-121 becomes the first systems biology product as ... family, a pathway that plays a critical role in cancer signaling. Upon initiation of the Phase 1 trial, MM-121 becomes the first systems biology product as ...

Anadys Pharmaceuticals Reports Second Quarter 2008 Financial Results and Highlights

... for the same period in 2007. Recent Development Program Highlights -- initiation of Phase I Clinical Trial of ANA598. In June, Anadys announced that dosing ... potential can be achieved without adverse toxicology findings. -- initiation of Phase I Clinical Trial of ANA773 in HCV. Following the Company's ...
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