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European Phase III clinical trial of budesonide MMX completes patient enrollment

Santarus, Inc., a specialty biopharmaceutical company, today announced that its collaboration partner, Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA (SIX: COPN), has completed enrollment of 514 patients in the European Phase III clinical trial to evaluate budesonide MMX® administered over eight weeks for the induction of remission of mild or moderate active ulcerative colitis.

3 Dec 2009

Favorable initial results from Novavax' 2009 H1N1 VLP pandemic influenza vaccine Phase II study

Novavax, Inc. today reported favorable initial results from the first stage of a two-stage pivotal Phase II study evaluating the safety and immunogenicity of the company's 2009 H1N1 virus-like particle (VLP) pandemic influenza vaccine. Novavax is conducting this study in collaboration with Avimex Laboratories of Mexico to support registration of the vaccine in Mexico and potentially other countries.

2 Dec 2009

FDA grants Fast Track designation for AEterna Zentaris' perifosine

AEterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company's PI3K/Akt pathway inhibitor compound, perifosine (KRX-0401), for the treatment of relapsed/refractory multiple myeloma.

2 Dec 2009

Genta to supply Ganite for new CF clinical trial

Genta Incorporated announced that the Company will supply Ganite® (gallium nitrate injection) for a new clinical trial that will be initiated in patients with cystic fibrosis (CF) who may develop serious infections.

2 Dec 2009

Sepracor to present clinical study data of STEDESA at the 2009 AES meeting

Sepracor Inc. today announced that clinical study data for STEDESA™ (eslicarbazepine acetate) will be presented at the 2009 annual meeting of the American Epilepsy Society (AES) in Boston. Seven posters describing new safety analyses will be presented at the Hynes Convention Center during the formal poster session on Saturday, December 5, 2009 between 1:00 pm and 8:00 pm EST.

2 Dec 2009

New data demonstrating the strength of Novartis' hematology portfolio to be presented

Novartis announced today that new data, including a late-breaking presentation on Tasigna® (nilotinib) 200 mg capsules in a form of chronic myeloid leukemia, demonstrate the strength of the company's hematology portfolio in advancing the care of patients.

2 Dec 2009

University of Texas M.D. Anderson Cancer Center and Stemline Therapeutics enter into research collaboration

Stemline Therapeutics, Inc., a private clinical stage biopharmaceutical company and leading developer of oncology compounds directed to cancer stem cells, today announced that The University of Texas M.D. Anderson Cancer Center (Houston, TX) and Stemline have entered into a research collaboration.

2 Dec 2009

Updated results from MYTHOS clinical trial of RenalGuard presented at AHA meeting

PLC Systems Inc., a company focused on innovative cardiac and vascular medical device-based technologies, today announced that updated results from the MYTHOS investigator-sponsored clinical trial of RenalGuard(®) were presented at the American Heart Association (AHA) Scientific Sessions 2009, on Sunday, November 15 in Orlando, Florida.

2 Dec 2009

Roche announces results of phase III taspoglutide study in diabetes patients

Ipsen, an innovation-driven global specialty pharmaceutical group, today announced that its partner Roche has disclosed the results of the second and third of eight T-emerge phase III studies in patients with diabetes for taspoglutide, the first human once weekly glucagon-like peptide-1 (GLP-1) analogue originating from Ipsen’s research and developed by Roche.

2 Dec 2009

Results from second Phase III placebo controlled study of EXPAREL announced

Pacira Pharmaceuticals, Inc., announced today that its second Phase III placebo controlled study of EXPAREL(TM) (DepoBupivacaine) met its primary endpoint.

2 Dec 2009

Data from brentuximab vedotin and dacetuzumab programs to be presented by Seattle Genetics

Seattle Genetics, Inc. today announced that data from its brentuximab vedotin (SGN-35) and dacetuzumab (SGN-40) programs will be reported at the upcoming 51st American Society of Hematology (ASH) 2009 Meeting and Exposition being held December 5-8, 2009 in New Orleans, Louisiana.

2 Dec 2009

New data on pixantrone Phase III trial in non-Hodgkin's lymphoma to be presented

Cell Therapeutics, Inc. (CTI) announced today that Ruth Pettengell, M.D. of St. George's Hospital, University of London, the lead investigator for the PIX 301 EXTEND trial will present new data on the pixantrone phase III trial in relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL) at the 51st Annual Meeting of the American Society of Hematology on Saturday, December 5, 2009 in New Orleans, Louisiana.

2 Dec 2009

Results from ongoing clinical trial of ISF35 to be presented at ASH annual meeting

Memgen announced today that results from its ongoing, Leukemia & Lymphoma Society co-sponsored clinical trial in chronic lymphocytic leukemia (CLL) have been selected for an oral presentation at the 51st Annual Meeting of the American Society of Hematology (ASH) in New Orleans, Louisiana.

2 Dec 2009

Ohr Pharmaceutical to present interim data from ongoing Phase II clinical trial of OHR/AVR118

Ohr Pharmaceutical Inc., announced that interim data from the company's ongoing Phase II clinical trial of OHR/AVR118 for the treatment of Cachexia, will be presented at the 5th annual meeting of the Society on Cachexia and Wasting Disorders (SCWD), which will be held in Barcelona December 5 - December 8, 2009.

2 Dec 2009

CRO to run CEL-SCI's upcoming Phase III clinical trial

CEL-SCI Corporation, a late-stage oncology company and a developer of vaccines and therapeutics for the prevention and treatment of infectious diseases, announced today that it has retained the services of an international Contract Research Organization (CRO) to run CEL-SCI's upcoming Phase III clinical trial in advanced primary head and neck cancer with the Company's lead product candidate, Multikine®.

1 Dec 2009

Calistoga Pharmaceuticals to present data on its CAL-101 inhibitor at the 51st ASH meeting

Calistoga Pharmaceuticals, Inc., the leader in the development of isoform-selective phosphatidylinositol 3 kinase (PI3K) inhibitors for the treatment of cancer and inflammatory diseases, today announced that clinical and preclinical data supporting the role of CAL-101, an oral, p110δ(delta) selective PI3K inhibitor in patients with hematologic malignancies, will be featured in two oral presentations at the upcoming 51st American Society of Hematology (ASH) Annual Meeting taking place in New Orleans, LA.

1 Dec 2009

Palatin Technologies issued U.S. patent covering its lead heart failure drug candidate

Palatin Technologies, Inc. today announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,622,440, titled "Cyclic Natriuretic Peptide Constructs." The claims in the issued patent cover a family of cyclic compounds that bind to natriuretic peptide receptor A (NPRA), including PL-3994, Palatin's lead heart failure drug candidate.

1 Dec 2009

Positive results from Ardea Biosciences' ongoing drug-drug interaction study of RDEA594 and febuxostat

Ardea Biosciences, Inc. announced positive results from the first dosing group of an ongoing drug-drug interaction and pharmacodynamic study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, and febuxostat (Uloric®, Takeda Pharmaceutical Company Limited; Adenuric®, Ipsen). This

1 Dec 2009

Bioequivalence and comparable toxicity of ADVENTRX Pharmaceuticals' ANX-514 and Taxotere affirmed

ADVENTRX Pharmaceuticals, Inc. today announced that a new, recently completed preclinical study has affirmed the bioequivalence and comparable toxicity of ANX-514 and Taxotere® (docetaxel). Shin Poong Pharmaceuticals, ADVENTRX's partner for ANX-514 in South Korea, independently conducted the study and data analysis.

1 Dec 2009

Positive data from Provectus Pharmaceuticals' psoriasis and atopic dermatitis trials

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced preliminary data for the company’s PH-10 Phase 2 clinical trial for Psoriasis as well as for its Phase 2 clinical trial for Atopic Dermatitis.

1 Dec 2009

Drug Trial News

European Phase III clinical trial of budesonide MMX completes patient enrollment

Favorable initial results from Novavax' 2009 H1N1 VLP pandemic influenza vaccine Phase II study

FDA grants Fast Track designation for AEterna Zentaris' perifosine

Genta to supply Ganite for new CF clinical trial

Sepracor to present clinical study data of STEDESA at the 2009 AES meeting

New data demonstrating the strength of Novartis' hematology portfolio to be presented

University of Texas M.D. Anderson Cancer Center and Stemline Therapeutics enter into research collaboration

Updated results from MYTHOS clinical trial of RenalGuard presented at AHA meeting

Roche announces results of phase III taspoglutide study in diabetes patients

Results from second Phase III placebo controlled study of EXPAREL announced

Data from brentuximab vedotin and dacetuzumab programs to be presented by Seattle Genetics

New data on pixantrone Phase III trial in non-Hodgkin's lymphoma to be presented

Results from ongoing clinical trial of ISF35 to be presented at ASH annual meeting

Ohr Pharmaceutical to present interim data from ongoing Phase II clinical trial of OHR/AVR118

CRO to run CEL-SCI's upcoming Phase III clinical trial

Calistoga Pharmaceuticals to present data on its CAL-101 inhibitor at the 51st ASH meeting

Palatin Technologies issued U.S. patent covering its lead heart failure drug candidate

Positive results from Ardea Biosciences' ongoing drug-drug interaction study of RDEA594 and febuxostat

Bioequivalence and comparable toxicity of ADVENTRX Pharmaceuticals' ANX-514 and Taxotere affirmed

Positive data from Provectus Pharmaceuticals' psoriasis and atopic dermatitis trials

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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