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Vectibix(R) in Combination With Chemotherapy Significantly Improved Progression-Free Survival in First-Line Metastatic Colorectal Cancer

... rest of the world are pending. Important product Safety Information Dermatologic Toxicity: ... we project. Discovery or identification of new product candidates or development of new indications for ... cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no ...

NOVAVAX Achieves Pandemic H1N1 Influenza Production Milestone

... including the Company's ability to progress any product candidates in preclinical or clinical trials; the ... studies or clinical trials is positive, the product may not prove to be safe and efficacious; ... obtain adequate financing in the future through product licensing, public or private equity or debt ...

Nektar Therapeutics Reports Second Quarter 2009 Financial Results

... advance for small molecule therapies. The product is being developed to treat opioid-induced ... but not limited to: (i) the company's proprietary product candidates and those of its collaboration ... applications for its proprietary or partner product candidates may not issue, patents that have ...

Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)

... we project. Discovery or identification of new product candidates or development of new indications for ... cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for ...

Pharmasset Reports Positive Preliminary Antiviral Data With PSI-7851 for the Treatment of Hepatitis C

... We currently have three clinical-stage product candidates. RG7128, a nucleoside analog for ... clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ...

European Division of Global Top 20 Pharmaceutical Company Awards Phase III Trial to DATATRAK

... in addition to its Electronic Data Capture (EDC) product to efficiently manage the study. "We are ... in 59 countries. DATATRAK International, Inc.'s product suite has been utilized in some aspect of the ... associated with maintaining and/or developing two product suites; and general economic conditions such as ...

NeurogesX Announces Preliminary Results of FDA-Requested Qutenza(TM) Study

... diabetic neuropathy (PDN). NeurogesX' late stage product portfolio is led by its product candidate Qutenza, a dermal patch designed to ... 2009. NeurogesX' second most advanced product candidate, NGX-1998, is a topically applied, ...

R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent

... "Our objective with R788 in RA is to position the product after methotrexate and before biological ... pharmaceutical partners to develop and market our product candidates. Rigel has product development programs in inflammatory/autoimmune ...

Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma

... Please see additional important product information for ASMANEX TWISTHALER. ... Please see additional important product information for FORADIL AEROLIZER. ... including market forces, economic factors, product availability, patent and other intellectual ...

Accent on Aesthetics Plastic Surgery Medical Center Selects Artefill to Meet Growing Patient Demand for a Longer Lasting Dermal Filler

... Dr. Rosenberg commented, "Artefill is a product we have consistently recommended to our patients ... We believe we have had great success with the product over the past few years as it's easy to ... formed in April 2009 to deliver the same great product that physicians and patients have embraced over ...

Idenix Pharmaceuticals Successfully Completes Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV)

... that the company will advance any clinical product candidate or other component of its potential ... to the ongoing clinical trials evaluating its product candidates; the company's ability to obtain ... other intellectual property protection for its product candidates and its discoveries. These and other ...

Prospective Clinical Advantages of Trabecular Metal(TM) Technology Highlighted in Comparative Study

... Act matters announced in October 2007; price and product competition; changes in customer demand for our ... changes or other factors; dependence on new product development, technological advances and innovation; shifts in the product category or regional sales mix of our products ...

Orexigen(R) Therapeutics Schedules July 20, 2009 Teleconference and Webcast Discussion of Contrave(R) Phase 3 Results

... focused on the development of pharmaceutical product candidates for the treatment of obesity. Orexigen's lead combination product candidates targeted for obesity are Contrave(R), ... in the later stages of Phase II development. Both product candidates take advantage of the Company's ...

BioCryst Pharmaceuticals Reports Positive Results of Shionogi & Co. Sponsored Phase 3 Studies of i.v. Peramivir for Influenza

... Phase 3 studies of i.v. peramivir to support product registration. Additionally, i.v. peramivir is ... as well as double digit royalty payments on product sales of peramivir. BioCryst retains its rights ... its scientific foundation and the utility of its product candidates. For more information, please visit ...

Tibotec Pharmaceuticals Announces Agreement to Develop and Commercialize a New Fixed-Dose Combination of TMC278 and Truvada(R) With Gilead Sciences

... of a new once-daily fixed-dose antiretroviral product containing Tibotec's investigational ... and look forward to advancing this new fixed-dose product in addition to TMC278 as a single agent." ... represents the first fixed dose combination product collaboration for Tibotec and, when approved, it ...

Schering-Plough Expands Vicriviroc Phase II Study in Treatment-Naive Patients With HIV

... option for first-line therapy. Atazanavir is a product in the protease inhibitor (PI) class of HIV medications. Truvada is a combination product in the nucleoside(tide) reverse transcriptase ... including market forces, economic factors, product availability, patent and other intellectual ...

GNC Unveils Study Results for First and Only Nitric Oxide Product Clinically Proven to Improve Physical Performance at NSCA Conference in Las Vegas

... push past their normal point of exhaustion. This product is designed to increase nitric oxide levels in ... of a truly novel and clinically-validated product to the industry," said Guru Ramanathan, SVP Technology and product Innovation for GNC. "Using advanced technology ...

Bioniche Life Sciences Inc. and Endo Pharmaceuticals Sign Licensing Agreement for Urocidin(TM)

... In addition, Bioniche will manufacture the product and receive a transfer price for supply. ... are met, they will serve as the basis for product approval under a Biologics Licensing Application ... impact of competitive products and pricing, new product development, uncertainties related to the ...

Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial

... pharmaceutical partners to develop and market our product candidates. Rigel has product development programs in inflammatory/autoimmune ... of clinical trials and the commercialization of product candidates, potential problems that may arise in ...

Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases

... we project. Discovery or identification of new product candidates or development of new indications for ... cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for ...

Leading Experts Endorse Bioheart's Muscle Stem Cell MyoCell Therapy

... to finish the pivotal studies to bring this product to FDA approval based on their review. ... of chronic and acute heart damage. Its lead product candidate, MyoCell(R), is an innovative clinical ... The Company's pipeline includes multiple product candidates for the treatment of heart damage, ...

5-Year Study Published in Diabetologia Demonstrated Long-Term Safety of Lantus(R) Compared to NPH

... not historical facts. These statements include product development , product potential projections and estimates and their ... application that may be filed for any such product candidates as well as their decisions regarding ...

ThromboGenics and BioInvent Start Recruitment of Second 100 Patient Cohort in Phase II DVT Prophylaxis Study With TB-402

... ThromboGenics and the exciting potential of this product candidate." About Deep Vein Thrombosis ... vascular disease and cancer. The Company's lead product microplasmin is in Phase III clinical development ... various strategic alliances around these product candidates and is developing them in ...

Acura and King Receive FDA Complete Response Letter Regarding Acurox(R)

... niacin, USP) Tablets CII, an immediate release product intended for the relief of moderate-to-severe ... of Aversion(R) (abuse deterrent) Technology product candidates and other innovative abuse deterrent ... are developing three additional opioid analgesic product candidates utilizing Aversion(R) Technology ...

Sosei and Vectura Announce Start of Phase III Clinical Study With NVA237

... development before market, confidence in the product is at a new high as we anticipate confirmation of ... Novartis in April 2005 for their collaborative product NVA237. Novartis is responsible for developing ... up to $375 million. In addition, royalties on product sales will be paid for the monotherapy and the ...

Sanofi-aventis Stands Behind the Safety of Lantus(R)

... not historical facts. These statements include product development , product potential projections and estimates and their ... application that may be filed for any such product candidates as well as their decisions regarding ...

SIMPONI(TM) (golimumab) Receives Positive Opinion From CHMP for Once-Monthly Subcutaneous Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

... and has exclusive marketing rights to the product in the United States. Following regulatory ... by competitors; challenges inherent in new product development, including obtaining regulatory ... including market forces, economic factors, product availability, patent and other intellectual ...

Alfacell Provides Shareholder Update

... ONCONASE is a first-in-class therapeutic product candidate based on Alfacell's proprietary ... the first company to advance a biopharmaceutical product candidate that works in a manner similar to RNA ... (RNAi) through late-stage clinical trials. The product candidate, ONCONASE, is an RNase that overcomes ...

CRi Oosight(TM) Instrument Crucial in IVF Breakthrough Demonstrating a Correlation Between Non-Invasive Egg Metrics and Pregnancy

... with multiple births," said Cathy Boutin, product Manager at CRi. CRi's Oosight systems based ... Cleveland Clinic and a 2009 Frost and Sullivan product Line Strategy award. Learn more at ... or contact: Cathy Boutin CRi product Manager 35-B Cabot Road, Woburn, MA 01801 USA ...

MacroGenics and Lilly Achieve Targeted Patient Enrollment in PROTEGE, a Global Phase 2/3 Clinical Trial of Teplizumab in Type 1 Diabetes

... set of capabilities in monoclonal antibody product development. The company's product development efforts leverage three proprietary ... to build a proprietary pipeline of innovative product candidates. The company's lead program, ...

Osteotech Completes Enrollment for DuraTech(TM) BioRegeneration Matrix Clinical Trial

... underlying tissue." DuraTech is the leading product in Osteotech's HCT platform, which is based on ... quarter of 2009 and anticipate clearance of the product before the end of the year," said Sam ... The DuraTech BioRegeneration Matrix is the lead product in Osteotech's collagen platform and is designed ...

New Analysis Shows Efficacy of SIMPONI(TM) (golimumab) in Anti-TNF Experienced Rheumatoid Arthritis Patients

... SIMPONI and has exclusive marketing rights to the product in the United States. Following regulatory ... by competitors; challenges inherent in new product development, including obtaining regulatory ... including market forces, economic factors, product availability, patent and other intellectual ...

Two-Year Data Show Patients Receiving SIMPONI(TM) (golimumab) Experienced Sustained Improvement in Signs and Symptoms of Psoriatic Arthritis and Ankylosing Spondylitis

... SIMPONI and has exclusive marketing rights to the product in the United States. Following regulatory ... by competitors; challenges inherent in new product development, including obtaining regulatory ... including market forces, economic factors, product availability, patent and other intellectual ...

DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD

... Phase 3 clinical trial evaluating its lead product orBec(R) for the treatment of acute ... is formulated for oral administration as a single product consisting of two tablets; one tablet is intended ... will not exceed projected levels, that product development and commercialization efforts will ...

ISTA Pharmaceuticals Announces Positive Results for Phase 2 Study of Low-Dose Bromfenac in Dry Eye Disease

... the data from both programs to determine which product candidate or candidates to move into further ... pharmaceutical company. ISTA's products and product candidates addressing the $5.1 billion U.S. ... markets three products and is developing a strong product pipeline to fuel future growth and market share, ...

Micromet's Blinatumomab Achieves Primary Endpoint in Phase 2 Study with Acute Lymphoblastic Leukemia Patients

... cancer, inflammation and autoimmune diseases. Its product development pipeline includes novel antibodies ... solid tumor target. Micromet's preclinical product pipeline includes several novel BiTE antibodies ... intended utilization of blinatumomab and other product candidates, the conduct, timing and results of ...

Micromet Presents Update on Blinatumomab's Response Rate and Duration in a Phase 1 Study in Non-Hodgkin's Lymphoma Patients

... cancer, inflammation and autoimmune diseases. Its product development pipeline includes novel antibodies ... solid tumor target. Micromet's preclinical product pipeline includes several novel BiTE antibodies ... intended utilization of blinatumomab and other product candidates, the conduct, timing and results of ...

Lilly Announces Positive Phase II Data on Investigational Medicine for Patients with Type 2 Diabetes

... beliefs. However, as with any pharmaceutical product under development, there are substantial risks ... review. There is no guarantee that the product will receive regulatory approval, or that the ... the company. There is also no guarantee that the product will prove to be commercially successful. For ...

Peregrine Pharmaceuticals Highlights Promising Early Data From Its Three Phase II Bavituximab Cancer Trials

... and hepatitis C virus infection with its lead product candidates bavituximab and Cotara(R). Peregrine ... ability to obtain regulatory approval for its product candidates include, but are not limited to, ... trials for our technologies; the early stage of product development; the significant costs to develop our ...

Pharmasset to Present at Goldman Sachs and Needham Healthcare Conferences

... We currently have three clinical-stage product candidates: R7128, a nucleoside analog for ... clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ...
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