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Intra-Cellular Therapies demonstrates ability of ITI-002 to improve motor and non-motor behaviors in PD

Intra-Cellular Therapies, Inc. today announced results from studies demonstrating the anti-Parkinson and other beneficial effects of ITI-002 (IC200214), the Company's novel and selective phosphodiesterase type I (PDE1) inhibitor.

1 Oct 2010

FDA grants Emergent Fast Track Designation for AVP-21D9 anthrax monoclonal antibody development program

Emergent BioSolutions Inc. announced today that its anthrax monoclonal antibody development program investigating AVP-21D9 for the treatment of inhalational anthrax has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). Emergent recently commenced a Phase I clinical trial for AVP-21D9, which is a fully human monoclonal antibody product candidate being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease.

1 Oct 2010

Global phase IV study confirms efficacy of erlotinib in treatment of non-small cell lung cancer

Featured in the October edition of the Journal of Thoracic Oncology (JTO), data from The Tarceva Lung Cancer Survival Treatment (TRUST) confirms the safety and efficacy profile of erlotinib, a highly potent oral active, reversible inhibitor of epidermal growth factor receptor (EGFR) tyrosine-kinase (TK) activity in a large heterogeneous non-small cell lung cancer (NSCLC) population.

1 Oct 2010

Herpevac Trial for Women finds experimental vaccine ineffective in prevention of genital herpes disease

An experimental vaccine intended to prevent genital herpes disease in women, although generally safe and well-tolerated, proved ineffective when tested in the recently concluded clinical study known as the Herpevac Trial for Women.

1 Oct 2010

Achillion initiates ACH-1625 Phase II dosing for HCV infection

Achillion Pharmaceuticals, Inc., a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that the Company has initiated patient dosing in a Phase II clinical trial of ACH-1625 for the treatment of hepatitis C virus (HCV) infection. ACH-1625 is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication. The drug candidate was discovered and is being advanced by Achillion.

1 Oct 2010

NIH awards Polymedix $986,000 to develop defensin mimetic antimicrobial compounds for oral candidiasis

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has received a Phase 2 grant in the amount of $986,000 from the National Institute of Health (NIH) to support the development of defensin mimetic antimicrobial compounds for the treatment of oral candidiasis. This grant will fund this research project through August 31, 2012. This award represents the 14th grant or research contract received to date by PolyMedix.

30 Sep 2010

Avila commences AVL-292 Phase 1 clinical study for B cell cancers and autoimmune diseases

Avila Therapeutics™, Inc., a biotechnology company developing targeted covalent drugs, announced today that it has initiated a phase 1 clinical trial to assess the safety, tolerability and pharmacokinetic profile of AVL-292, a novel, orally available, covalent drug that targets Bruton's tyrosine kinase (Btk). AVL-292 is the first product candidate to enter clinical evaluation from Avila's proprietary covalent drug platform, Avilomics™.

30 Sep 2010

Repligen Corporation completes patient enrollment in RG2417 Phase 2b clinical trial

Repligen Corporation reported today that it has completed enrollment of patients in its Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression.

30 Sep 2010

sanofi-aventis announces top-line results from lixisenatide Phase III GETGOAL-L-ASIA trial for Type-2 Diabetes

Zealand Pharma A/S, the biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs, is pleased to note that its partner, sanofi-aventis, has today announced positive top-line results of the Phase III GETGOAL-L-ASIA trial which assessed the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist discovered by Zealand Pharma, in combination with basal insulin.

30 Sep 2010

Teva Pharmaceuticals, OncoGenex initiate SYNERGY Phase 3 trial to evaluate custirsen

Teva Pharmaceuticals Industries Ltd. and OncoGenex Pharmaceuticals, Inc. announced today the initiation of SYNERGY, a global Phase 3 trial evaluating custirsen (also known as OGX-011/TV-1011) as first line therapy for the treatment of castrate-resistant prostate cancer (CRPC).

30 Sep 2010

AVEO regains global rights for development, commercialization of AV-299 anti-HGF antibody candidate

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that AVEO has regained worldwide rights from Merck (through its subsidiary, Schering Corporation) to develop and commercialize AV-299 (also known as SCH 900105), its anti-hepatocyte growth factor (HGF) antibody candidate.

30 Sep 2010

FDA grants Type B meeting to review Phase III pivotal efficacy protocols for Androxal

Repros Therapeutics Inc. today announced that the Company has been granted a Type B meeting to be held on November 8, 2010 with the Division of Reproductive and Urologic Products to review the Company's Phase III pivotal efficacy protocols for Androxal in the treatment of secondary hypogonadism. Androxal is an oral drug that normalizes both testosterone and sperm levels.

30 Sep 2010

NIH awards $3.1 million to further fund Inovio's universal SynCon flu vaccine development

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that Inovio Pharmaceuticals and the University of Pennsylvania have received a grant of $3.1 million from the National Institutes of Health (NIH) Director's Office to further fund Inovio's universal SynCon™ flu vaccine development.

30 Sep 2010

Circassia announces advancement in T-cell allergy vaccines development

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced that it has further advanced the clinical development of three of its leading T-cell allergy vaccines.

30 Sep 2010

ThromboGenics enters 10-year supply agreement with MSD Biologics for microplasmin

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, cardiovascular disease and cancer, announces that it has signed a 10-year supply agreement with MSD Biologics (UK) Ltd, part of the Merck BioManufacturing Network, for the production of microplasmin. ThromboGenics anticipates that this deal will meet its long-term commercial needs for bulk drug substance of this novel therapeutic agent.

30 Sep 2010

Zyclara 3.75% more effective than cryotherapy alone in treatment of Actinic Keratoses: Study

Results from a randomized, double-blinded, placebo-controlled, multicentred study just published in the Journal of Drugs in Dermatology shows that treating Actinic Keratoses (AK) with imiquimod 3.75% (Zyclara®) following cryotherapy was more effective than cryotherapy alone in reducing total AK lesion count and achieving complete clearance of AK.

30 Sep 2010

Santarus, Cosmo announce positive results from budesonide MMX Phase III study in ulcerative colitis

Santarus, Inc. and Cosmo Pharmaceuticals S.p.A. today announced positive top-line results from the Phase III clinical study conducted in the U.S. and India to evaluate the safety and efficacy of budesonide MMX® for the induction of remission of mild or moderate active ulcerative colitis. The study results show that budesonide MMX 9 mg taken once daily met the primary endpoint of superiority to placebo.

30 Sep 2010

ACT updates myoblast program for heart failure treatment

Advanced Cell Technology, a leader in the field of regenerative medicine, provided an update today on the status of its myoblast program. The program has successfully and safely completed Phase I human clinical trials in more than forty patients in over four independent studies.

30 Sep 2010

Duke receives approval to initiate NPC-1C Phase I trial for advanced pancreatic and colorectal cancer

Neogenix Oncology, Inc. announced today that researchers at Duke University Medical Center have received approval to move forward with a Phase I trial of the company's lead therapeutic antibody, NPC-1C, in patients with advanced stage pancreatic or colorectal cancer. Duke joins Johns Hopkins Hospital which is already conducting the Phase I trial of NPC-1C. In addition to Johns Hopkins, North Shore - LIJ has also enrolled patients on this multi-center study.

30 Sep 2010

Alnylam Pharmaceuticals publishes ALN-RSV01 Phase IIa study results

Alnylam Pharmaceuticals, Inc. a leading RNAi therapeutics company announced today that it has published results in the American Journal of Respiratory and Critical Care Medicine from its double-blind, placebo-controlled, randomized Phase IIa study of ALN-RSV01 in lung transplant patients naturally infected with respiratory syncytial virus (RSV).

30 Sep 2010

Drug Trial News

Intra-Cellular Therapies demonstrates ability of ITI-002 to improve motor and non-motor behaviors in PD

FDA grants Emergent Fast Track Designation for AVP-21D9 anthrax monoclonal antibody development program

Global phase IV study confirms efficacy of erlotinib in treatment of non-small cell lung cancer

Herpevac Trial for Women finds experimental vaccine ineffective in prevention of genital herpes disease

Achillion initiates ACH-1625 Phase II dosing for HCV infection

NIH awards Polymedix $986,000 to develop defensin mimetic antimicrobial compounds for oral candidiasis

Avila commences AVL-292 Phase 1 clinical study for B cell cancers and autoimmune diseases

Repligen Corporation completes patient enrollment in RG2417 Phase 2b clinical trial

sanofi-aventis announces top-line results from lixisenatide Phase III GETGOAL-L-ASIA trial for Type-2 Diabetes

Teva Pharmaceuticals, OncoGenex initiate SYNERGY Phase 3 trial to evaluate custirsen

AVEO regains global rights for development, commercialization of AV-299 anti-HGF antibody candidate

FDA grants Type B meeting to review Phase III pivotal efficacy protocols for Androxal

NIH awards $3.1 million to further fund Inovio's universal SynCon flu vaccine development

Circassia announces advancement in T-cell allergy vaccines development

ThromboGenics enters 10-year supply agreement with MSD Biologics for microplasmin

Zyclara 3.75% more effective than cryotherapy alone in treatment of Actinic Keratoses: Study

Santarus, Cosmo announce positive results from budesonide MMX Phase III study in ulcerative colitis

ACT updates myoblast program for heart failure treatment

Duke receives approval to initiate NPC-1C Phase I trial for advanced pancreatic and colorectal cancer

Alnylam Pharmaceuticals publishes ALN-RSV01 Phase IIa study results

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

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