Complete in Biological Technology

Catalyst Pharmaceutical Partners Reports Second Quarter 2009 Financial Results

... debt. "We have sufficient cash to complete the analysis of the results from our cocaine ... of factors, including our ability to successfully complete the clinical trials required for us to file a new drug application for CPP-109, our ability to complete such trials on a timely basis within the budgets ...

Shire plc: Core Portfolio of Products Delivers 20% Sales Growth

... encouraging recent news. With the receipt of a complete Response Letter from the US Food and ... was July 27, 2009. Shire has received a complete Response Letter from the FDA for INTUNIV. ... clinical data or additional analyses in the complete Response Letter. Shire and the FDA will ...

King and Pain Therapeutics Announce REMOXY(R) NDA Update

... Food and Drug Administration (FDA) to discuss the complete Response Letter regarding the New Drug ... NDA and to address all FDA comments in the complete Response Letter. King now anticipates the ... In December 2008, Pain Therapeutics received a complete Response Letter from the FDA. Subsequent to the ...

Clavis Pharma Raises NOK 129 Million (USD 20 Million) in a Private Placement to Fund Further Development of its Pipeline of Novel Anticancer Drug Candidates

... clinical studies for lead products a. complete first part of a Phase II/III registration study ... elacytarabine in leukaemia (AML) b. complete a randomised Phase II study with IV CP-4126 in pancreatic cancer c. complete Phase I study for Oral CP-4126 in various solid ...

MasterControl and Datafarm Launch GxP2eCTD at the DIA 45th Annual Meeting

... sciences companies the ability to implement a complete solution for the eCTD submission lifecycle. ... companies that want to simultaneously implement a complete document management and eSubmissions ... MasterControl provides our customers with a complete information management solution across the entire ...

Spherix Announces Full-Scale Production of Pharmaceutical Tagatose

... Continuing Supplies Will Be Used For NDA and to complete Current Phase 3 Trial of Naturlose(R) for Type 2 ... FDA approval. The Company has enough drug to complete all of its clinical trials involving Naturlose as ... manufactured, we may lack financial resources to complete development of Naturlose, the FDA may interpret ...

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

... to elacytarabine with a complete remission or complete remission without full recovery of platelet ... to p<0.0001). If only patients whose complete remission has been confirmed by histology are ... treatment, including some patients in complete remission and others with a more modest level of ...

Anadys Pharmaceuticals, Inc. Announces Strategic Restructuring to Focus Operations on Continuing the Advancement of ANA598

... Ph.D., President and CEO of Anadys. "As we complete preparations for the first Phase II study of ... measures which we expect to ensure our ability to complete the Phase II study with our expected cash ... all treatment at 24 weeks. All patients who complete 24 or 48 weeks of treatment will be assessed for ...

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

... VPHM ) today announced that it has received a complete Response letter from the U.S. Food and Drug ... in support of the sBLA lacked robustness. In the complete Response letter, the FDA cited no safety concerns ... and uncertainties. The Company is evaluating the complete response letter from the FDA and there can be no ...

Pixantrone Significantly Increases Complete Remissions, Overall Response Rates, Frequency of Durable Remissions and Progression Free Survival in Patients with Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

... Plan Significant Increase in complete Remission Rates 20% vs. 5.7%; p=0.021 ... first time since the top-line data were released, complete pivotal phase III results of CTI's EXTEND (PIX ... or refractory aggressive NHL. CTI expects to complete the submission this month and will request ...

Low Occurrence of Severe Cardiac Side Effects Despite Extensive Prior Doxorubicin Treatment Reported in Pixantrone Pivotal Trial

... higher rate of confirmed (CR) and unconfirmed complete remissions (CRu) compared to patients treated ... standard chemotherapy arm achieving a confirmed complete remission. Pixantrone recipients had a low ... non-Hodgkin's lymphoma (NHL). CTI expects to complete the submission this quarter and will request ...

Angiotech Pharmaceuticals, Inc. announces financial results for the first quarter ended March 31, 2009

... There can be no assurance that we will be able to complete any transaction, or that any transaction could be ... if at all. In addition, we may not be able to complete any restructuring, reorganization or strategic ... our ability to secure interim financing or to complete any of the activities as described on favorable ...

BioVex Commences OncoVEX (GM-CSF) Phase 3 Trial in Metastatic Melanoma

... overall objective response, which is defined as a complete response (CR), where disease is completely ... with all stages of disease, including the complete resolution of un-injected visceral deposits. ... genital herpes, ImmunoVEX (HSV2), which provides complete protection in animal models of the disease. The ...

Savient Pharmaceuticals to Raise $31 Million Through Registered Direct Offering

... publicly announced that the FDA issued its complete response letter. In no event may the exercise ... publicly announces that the FDA issued its complete response letter. If the FDA responds to the BLA ... publicly announces that the FDA issued its complete response letter and the date that is nine months ...

Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2008 Financial Results

... In Schedule A, twelve of 29 patients achieved complete remission (CR) or complete remission without full platelet recovery (CRp) ... dose of 90 mg/m2 of voreloxin, is fully enrolled. complete remissions have been observed in Schedule B in ...

Keynote Panel at Bio-IT World Expo to Feature Five Leaders in the Field of "Personal Genomics"

... immediately following a keynote presentation from complete Genomics CEO, Clifford Reid. Bio-IT World's ... Clifford Reid, Ph.D., Chief Executive Officer, complete Genomics, Inc. Dietrich Stephan, Ph.D., ... Spring Harbor Laboratory, Broad Institute, and complete Genomics. High Performance Computing & ...

IDM Pharma Reports 2008 Financial Results

... and to ensure we have adequate cash to complete our review of strategic options for the Company, ... NDA amendment submission on hold until we complete our strategic review, which will allow us to ... instrumental in the approval of MEPACT. As we complete our evaluation of the strategic options available ...

BioVex Raises $40 Million in First Close of Series F Financing

... "Following the unprecedented number of durable complete remissions generated with our lead cancer ... overall objective response, which is defined as a complete response (CR), where disease is completely ... with all stages of disease, including the complete resolution of un-injected visceral deposits. ...

BioMS Medical Announces 2008 Year End Results

... evaluated the first 200 patients to complete MAESTRO-01 and assessed the likelihood of ... MAESTRO-01 and MINDSET-01 trials as more patients complete these trials; a decrease in drug manufacturing ... trials; and that BioMS Medical Corp. will complete the respective clinical trials within the ...

Cell Therapeutics, Inc. (CTI) Reports 2008 Fourth Quarter and Year End Financial Results

... by approximately 50% in 2009 CTI expects to complete pixantrone NDA submission in Q2 2009 ... a high rate of confirmed and unconfirmed complete remissions compared to patients treated with ... standard chemotherapeutic agents. CTI expects to complete submission of the pixantrone NDA in the second ...

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

... commercialization of blinatumomab. MedImmune will complete the development of the commercial scale ... for relapsed colorectal cancer patients after complete resection of liver metastasis with adecatumumab, ... our partner TRACON Pharmaceuticals, Inc. to complete the ongoing phase 1 clinical trial of MT293, a ...

SCOLR Pharma, Inc. Reports Fourth Quarter 2008 Financial Results

... for review. The FDA subsequently issued a complete Response Letter for our pseudoephedrine ... significant adverse events; Received a complete Response Letter from the FDA for our ANDA for a ... to successfully develop new formulations and complete research and development, our ability to raise ...

Angiotech Pharmaceuticals, Inc. announces financial results for the fourth quarter ended December 31, 2008

... if at all. In addition, we may not be able to complete any restructuring, reorganization or strategic ... our ability to secure interim financing or to complete any of the activities as described on favorable ... qualified personnel; our ability to successfully complete pre-clinical and clinical development of our ...

Schering-Plough Submits Response to FDA for SAPHRIS(TM) (asenapine) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder

... Response submitted within one month of FDA complete response letter KENILWORTH, N.J., Feb. 20 ... to the U.S. Food and Drug Administration (FDA) complete response letter for SAPHRIS(TM) (asenapine) ... "We are pleased to have submitted the SAPHRIS complete response within a month from receipt of the FDA ...

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

... and the ability for TorreyPines to successfully complete a strategic or financing transaction. Such ... release, whether TorreyPines will be able to complete any potential strategic or financing transaction ... environment will affect TorreyPines' efforts to complete a strategic or financing transaction, whether ...

Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2008 Results

... On November 6, 2008, Vanda submitted a complete Response to the not approvable action letter that ... The FDA has indicated that it has accepted the complete Response for review and has set a new target ... overhead, personnel costs, costs to complete an ongoing carcinogenicity study and regulatory ...

Complete Genomics to Release Its DNA Sequencing Data for the First Time at Advances in Genome Biology and Technology Annual Meeting

... VIEW, Calif., Jan. 30 /PRNewswire/ -- complete Genomics Inc., a newly launched, third-generation ... Dr. Clifford Reid, chairman, president and CEO of complete Genomics, will review the analysis results during ... Resort and Spa in Marco Island, Fla. About complete Genomics Founded in ...

FDA Issues Complete Response Letter to SCOLR Pharma's Abbreviated New Drug Application for CDT(R) 12-Hour Pseudoephedrine

... Food and Drug Administration (FDA) has issued a complete Response letter for its Abbreviated New Drug ... Delivery Technology (CDT(R)) platform. The complete Response letter requests additional information, ... to successfully develop new formulations and complete research and development, including pre-clinical ...

Sunesis Pharmaceuticals Provides Year-End Clinical Update on Voreloxin

... of Hematology (ASH) show that voreloxin induces complete remissions in these poor risk patients. At ASH, ... weeks, was reported. Eleven patients achieved a complete remission (CR) or complete remission without full platelet recovery (CRp), ...

Houston LASIK Eye Surgery Expert and Pioneer Jack Holladay, M.D. Joins Influential Group of Eye Surgeons Listed at Trusted LASIK Surgeons

... treatments. Holladay LASIK Institute provides complete vision correction options, not just laser eye ... are based on experience (not just in LASIK but complete refractive care), research (including FDA ... surgery, but other procedures to give you a complete range of options in obtaining the best vision for ...

Interim Report for the Period 1 January - 30 September 2008 (Unaudited)

... Revenue and margins To view the complete release including financial tables, please click ... to the first nine months: To view the complete release including financial tables, please click ... generated in North America: To view the complete release including financial tables, please click ...

Complete Genomics Chooses Isilon IQ to Power World's First Complete Human Genome Sequencing Service

... its OneFS(R) operating system software, provides complete Genomics' massive Linux clustered compute farm ... a $5000 genome, dramatically lowering the cost of complete genome sequencing, and providing this powerful ... requiring a full-time storage administrator." complete Genomics will offer large-scale, affordable human ...

Vanda Pharmaceuticals Reports Third Quarter 2008 Results

... iloperidone. The FDA asked Vanda to provide a complete response to the not-approvable ... overhead, personnel costs, costs to complete ongoing carcinogenicity studies, costs to complete stability studies for iloperidone, regulatory ...

Varian, Inc. Reports Strong Fourth Quarter 2008 Results

... GAAP net earnings, in fiscal year 2008. For a complete reconciliation of non-GAAP (adjusted) ... our ability to successfully evaluate, negotiate, complete and integrate acquisitions, in particular given ... and industrial applications. The company provides complete solutions, including instruments, ...

Savient's Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology Conference

... to placebo in attaining a gout tophus complete Response was statistically significant and ... pooled analysis. Moreover, the tophus complete Response was attained for the every 2 weeks ... attained statistical significance for tophus complete Response in the pre-specified pooled ....

Large-scale genetic study sheds new light on lung cancer

... pioneering work has painted the clearest and most complete portrait yet of lung cancer's molecular ... cancer's uncontrolled cell growth. To gain a more complete picture, researchers have joined together to form ... using new tools and technologies to examine the complete set of DNA, or genome, found in various types of ...

Complete Genomics Announces Its First Public Presentation at the 7th Annual BIO Investor Forum

... MOUNTAIN VIEW, Calif., Oct. 22 /PRNewswire/ -- complete Genomics Inc., a newly launched, third-generation ... in downtown San Francisco. He will discuss how complete Genomics' scalable service model and proprietary ... Q2 2009 at a cost of $5,000 per genome. About complete Genomics Founded in ...

Alfacell Reports Fiscal Fourth Quarter and Full Year 2008 Financial Results

... the formal statistical analyses required to complete the final sections of the ONCONASE rolling NDA. ... for ONCONASE in UMM. In fiscal 2009, we plan to complete the NDA submission after receiving input from ... clinical trial results will allow the company to complete submission of a New Drug Application and if a New ...

Nventa Provides Corporate Update and Advancement Plans for HspE7, Hsp 6/11 and Poly-ICR

... treatment for CIN 1 or CIN 2/3; that we will not complete the second protocol for the CIN 1 indication; ... of GW or actinic keratosis; that we will not complete development activities or file an IND application ... a treatment for CIN 1 and CIN 2/3; that we will complete the second protocol for the CIN 1 indication; ...

Complete Genomics Launches, Becomes World's First Large-Scale Human Genome Sequencing Company

... MOUNTAIN VIEW, Calif., Oct. 6 /PRNewswire/ -- complete Genomics Inc., a third-generation human genome ... San Francisco. For the past two and a half years, complete Genomics has been reinventing the process of DNA ... of these fields in Silicon Valley has allowed complete Genomics to sequence its ...