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Pfizer releases Phase III study results comparing VFEND-ERAXIS combination to VFEND for IA

Pfizer Inc. today reported the top-line results of an international Phase III clinical trial which compared the combination of VFEND (voriconazole) and ERAXISTM (anidulafungin) to VFEND monotherapy for primary therapy of invasive aspergillosis, a life-threatening invasive fungal infection that can develop as a complication in patients with compromised immune systems.

1 Oct 2011

New analyses from Phase III studies of VICTRELIS to be presented at AASLD 2011

Merck, known as MSD outside of the United States and Canada, announced today that several new analyses from Phase III studies of VICTRELIS (boceprevir), the company's first-in-class, oral hepatitis C virus NS3/4A protease inhibitor will be presented at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases.

1 Oct 2011

Vertex announces abstracts from hepatitis C program to be presented at The Liver Meeting

Vertex Pharmaceuticals Incorporated today announced that abstracts from its hepatitis C program, including two late-breaking posters from studies of INCIVEK (telaprevir) tablets and VX-222, were accepted for presentation at The Liver Meeting, the 62nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, November 4-8, 2011.

1 Oct 2011

Circadian subsidiary submits IND application to FDA to initiate VGX-100 study against cancer

Circadian Technologies Limited is extremely proud to announce that its 100% owned subsidiary, Vegenics Pty Ltd, has submitted an investigational new drug application to the U.S. Food and Drug Administration to initiate clinical studies of VGX-100.

1 Oct 2011

Baxter seeks European marketing authorization for HyQ to treat PI

Baxter International Inc. announced today that it has submitted an application to the European Medicines Agency's Committee for Human Medicinal Products seeking marketing authorization for HyQ. HyQ is Baxter's investigational immunoglobulin (IG) therapy administered subcutaneously and facilitated by recombinant human hyaluronidase, a dispersion and permeation enhancer, for use in patients with primary immunodeficiencies.

From Baxter International Inc. 1 Oct 2011

Roche inaugurates new clinical supply manufacturing facility in Nutley, N.J.

Roche announced today the opening of a new state-of-the-art clinical supply manufacturing facility on its campus in Nutley, N.J. The Roche Center of Excellence produces dosage forms of highly potent compounds for preclinical safety studies, and Phase 1 and 2 clinical studies.

30 Sep 2011

Cincinnati Children's to conduct first medication clinical trial for pediatric migraine

Cincinnati Children's Hospital Medical Center has received a $12 million grant from the National Institutes of Health to conduct the first clinical trial to determine the medication of choice for preventing migraines in children and teens.

30 Sep 2011

Array announces results from selumetinib Phase 2 combination study on KRAS-mutant NSCLC

Array BioPharma Inc. today announced results from a randomized Phase 2 placebo-controlled study conducted by AstraZeneca comparing the efficacy of selumetinib in combination with docetaxel with docetaxel alone in the second-line treatment of 87 patients prospectively selected with KRAS-mutant, locally advanced or metastatic non-small cell lung cancer.

30 Sep 2011

Small Phase I trial shows HIV vaccine candidate is most powerful to date

Researchers at the Spanish Superior Scientific Research Council (CSIC) have successfully completed a small Phase I human clinical trial of an HIV vaccine candidate that granted 90 percent of 30 study participants an immunological response against the virus, Gizmag reports.

30 Sep 2011

Microbicide Trials Network stops tenofovir arm of study after findings show drug less effective than anticipated

"The Microbicide Trials Network (MTN), which is funded by the U.S. National Institutes of Health, on Wednesday announced that it decided to stop one arm of a study involving more than 5,000 women in South Africa, Zimbabwe, and Uganda" after "an interim review of the ongoing trial by an independent monitoring board found that the drug tenofovir when used as pre-exposure prophylaxis (PrEP) had less effect in protecting women than anticipated," Science Magazine's "Science Insider" blog reports.

30 Sep 2011

Circadian files IND with FDA for VGX-100 for the treatment of cancer patients with solid tumors

Circadian Technologies Limited (ASX: CIR, OTCQX:CKDXY) is extremely proud to announce that its 100% owned subsidiary, Vegenics Pty Ltd, has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate clinical studies of VGX-100. The first trial (Phase I) will involve the treatment of a variety of different cancer types in patients with late stage cancer.

29 Sep 2011

Positive new data from Otonomy's OTO-104 Phase 1b study on Meniere's disease

Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that researchers presented positive new data from a Phase 1b study of the company's lead product candidate, OTO-104, in patients with Meniere's disease.

29 Sep 2011

Cubist plans to move CB-183,315 into Phase 3 trial for treatment of CDAD

Cubist Pharmaceuticals, Inc. today announced it plans to move CB-183,315, being studied for the treatment of a severe and sometimes life-threatening diarrhea caused by Clostridium difficile known as C. difficile-associated diarrhea, or CDAD, into late-stage trials.

29 Sep 2011

DSMB authorizes ACT to proceed with next set of patients in stem cell clinical trials

Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced today that the independent Data and Safety Monitoring Board (DSMB) overseeing the Company's two ongoing stem cell clinical trials in the United States authorized ACT to move forward with enrolling and treating the next set of patients in each of the trials.

29 Sep 2011

Cincinnati Children's to conduct first pediatric migraine medicine clinical trial

29 Sep 2011

Almirall submits linaclotide MAA to EMA for treatment of IBS-C

Ironwood Pharmaceuticals, Inc. today announced that its European partner Almirall, S.A. submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for linaclotide, a guanylate cyclase type-C (GC-C) agonist, for the treatment of irritable bowel syndrome with constipation.

29 Sep 2011

VOICE HIV prevention trial to discontinue use of tenofovir tablets

VOICE, an HIV prevention trial evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women - daily use of one of two different ARV tablets or of a vaginal gel - will be dropping one of the oral tablets from the study.

29 Sep 2011

Enrollment complete in Rexahn's Archexin Phase II trial for metastatic pancreatic cancer

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it has completed enrollment for its Phase II clinical trial of Archexin in metastatic pancreatic cancer.

29 Sep 2011

SanBio initiates SB623 Phase 1/2a clinical trial in ischemic stroke

SanBio, Inc. has announced that a patient at Stanford University Medical Center has become the first to be treated with SB623, a novel cell therapy for patients with disability resulting from ischemic stroke.

29 Sep 2011

Halozyme commences HTI-501 clinical trial for cellulite in women

Halozyme Therapeutics, Inc., a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the diabetes, cancer, dermatology and drug delivery markets, today announced the commencement of a Phase 1/2 clinical trial with HTI-501 (rHuCAT-L) in women with moderate to severe edematous fibrosclerotic panniculopathy (also known as cellulite).

28 Sep 2011

Drug Trial News

Pfizer releases Phase III study results comparing VFEND-ERAXIS combination to VFEND for IA

New analyses from Phase III studies of VICTRELIS to be presented at AASLD 2011

Vertex announces abstracts from hepatitis C program to be presented at The Liver Meeting

Circadian subsidiary submits IND application to FDA to initiate VGX-100 study against cancer

Baxter seeks European marketing authorization for HyQ to treat PI

Roche inaugurates new clinical supply manufacturing facility in Nutley, N.J.

Cincinnati Children's to conduct first medication clinical trial for pediatric migraine

Array announces results from selumetinib Phase 2 combination study on KRAS-mutant NSCLC

Small Phase I trial shows HIV vaccine candidate is most powerful to date

Microbicide Trials Network stops tenofovir arm of study after findings show drug less effective than anticipated

Circadian files IND with FDA for VGX-100 for the treatment of cancer patients with solid tumors

Positive new data from Otonomy's OTO-104 Phase 1b study on Meniere's disease

Cubist plans to move CB-183,315 into Phase 3 trial for treatment of CDAD

DSMB authorizes ACT to proceed with next set of patients in stem cell clinical trials

Cincinnati Children's to conduct first pediatric migraine medicine clinical trial

Almirall submits linaclotide MAA to EMA for treatment of IBS-C

VOICE HIV prevention trial to discontinue use of tenofovir tablets

Enrollment complete in Rexahn's Archexin Phase II trial for metastatic pancreatic cancer

SanBio initiates SB623 Phase 1/2a clinical trial in ischemic stroke

Halozyme commences HTI-501 clinical trial for cellulite in women

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