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Coadministration of INTUNIV tablets with stimulant reduces ADHD symptoms

Shire plc the global specialty biopharmaceutical company, today presented research results of once-daily INTUNIV (guanfacine) Extended-Release Tablets, coadministered with stimulants in children and adolescents diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) who had suboptimal response to treatment with a long-acting stimulant alone.

29 Oct 2010

Forest, Almirall report topline results from aclidinium bromide comparative Phase III study in COPD

Forest Laboratories, Inc. and Almirall, S.A. today announced top-line results from ACCORD COPD II, a 12-week Phase III study comparing the efficacy and safety of inhaled aclidinium bromide, an investigative bronchodilator, to placebo in 544 patients with moderate to severe COPD.

29 Oct 2010

StemCells initiates HuCNS-SC second clinical trial for Batten disease in children

StemCells, Inc. announced today that it has initiated a second clinical trial of its HuCNS-SC product candidate (purified human neural stem cells) in neuronal ceroid lipofuscinosis (NCL, also often referred to as Batten disease), a fatal neurodegenerative disorder in children.

29 Oct 2010

Geron 2010 third quarter revenue increases from $494,000 to $546,000

Geron Corporation today reported financial results for the three and nine months ended September 30, 2010.

29 Oct 2010

ImmunoGen first quarter net loss increases to $12.9 million

ImmunoGen, Inc., a biotechnology company that develops targeted antibody-based anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced financial results for the three-month period ended September 30, 2010 - the first quarter of the Company's 2011 fiscal year (1QFY11).

29 Oct 2010

Amira initiates AM152 Phase 1 clinical study for fibrotic diseases

Amira Pharmaceuticals, Inc. announced today that it has initiated a Phase 1 clinical study with AM152, a novel LPA1 antagonist, in normal, healthy subjects.

29 Oct 2010

Antigenics third quarter net loss decreases from $10.8 million to $5.9 million

Antigenics Inc. reported today its results for the quarter ended September 30, 2010. The company incurred a net loss attributable to common stockholders of $5.9 million, or $0.06 per share, basic and diluted, for the third quarter of 2010, compared with a net loss attributable to common stockholders of $10.8 million, or $0.13 per share, basic and diluted, in the third quarter of 2009.

28 Oct 2010

Pharmasset's PSI-938 phase I monotherapy trial shows positive result for HCV treatment

Pharmasset, Inc. reported positive preliminary results today from its phase I monotherapy trial of PSI-352938 for the treatment of chronic hepatitis C (HCV). PSI-938 is a guanosine nucleotide analog polymerase inhibitor in development for the treatment of chronic HCV infection.

28 Oct 2010

QLT expands QLT091001 Phase 1b LCA study to include patients with Retinitis Pigmentosa

QLT Inc. today announced expansion of the Phase 1b clinical proof-of-concept study of QLT091001 in the treatment of Leber Congenital Amaurosis (LCA) to include patients with Retinitis Pigmentosa (RP), a set of hereditary retinal diseases demonstrating clinical features similar to LCA.

28 Oct 2010

Octapharma initiates Human-cl rhFVIII clinical study for severe hemophilia A

Octapharma, one of the largest human protein products manufacturers in the world, today announced that patients diagnosed with severe hemophilia A have started treatment with the first recombinant Factor VIII derived from a human cell line (Human-cl rhFVIII). Researchers are investigating pharmacokinetics, efficacy, safety and immunogenicity of Human-cl rhFVIII for previously treated patients with severe hemophilia A.

28 Oct 2010

Pfizer announces publication of crizotinib data for NSCLC patients in New England Journal of Medicine

Pfizer Inc. announced today the publication of data showing that 57 percent of ALK-positive advanced non-small cell lung cancer (NSCLC) patients treated with crizotinib (PF-02341066), an investigational oral anaplastic lymphoma kinase (ALK) inhibitor, had either a complete (one patient) or partial (46 patients) response to treatment. Data from 82 patients in this Part 2 expansion cohort of the Phase 1 study were published in the October 28 issue of the New England Journal of Medicine.

28 Oct 2010

Curemark adds two sites in California for CM-AT Phase III clinical trial program

Curemark, LLC, a drug research and development company focused on the treatment of neurological diseases, announced that it has added two sites in California to its Phase III clinical trial program for CM-AT, the company's autism treatment.

28 Oct 2010

Laureate enters agreement with AVEO to produce AV-203 monoclonal antibody against ErbB3

Laureate Pharma, Inc., a full-service contract development and manufacturing organization, announced today that they have entered into a development and manufacturing agreement to produce AV-203, AVEO Pharmaceutical's (Cambridge, MA) novel monoclonal antibody targeted against ErbB3.

28 Oct 2010

Epigenomics presents data on Septin9 biomarker clinical study for colorectal cancer at UEGW

Epigenomics AG, the cancer diagnostics company, announced that new data obtained in a clinical study with the Company's proprietary Septin9 biomarker for the blood-based detection of colorectal cancer, were presented yesterday at the 18th United European Gastroenterology Week (UEGW) in Barcelona, Spain.

28 Oct 2010

Evotec grants Jingxin Pharma rights to develop, market EVT 201 insomnia drug candidate in China

Evotec AG today announced that it has entered into a license and collaboration agreement with Zhejiang Jingxin Pharmaceutical Co., Ltd for EVT 201, a novel potential treatment for insomnia. The agreement grants Jingxin Pharma exclusive rights to develop and market the drug candidate in China. In return, Evotec will receive a small upfront payment, together with commercial milestones and significant royalties.

28 Oct 2010

ChemoCentryx reports one-year study results of Traficet-EN in Crohn's disease patients

ChemoCentryx, Inc., today announced that it reported one-year results from the Company's PROTECT-1 Study (the Prospective Randomized Oral Therapy Evaluation in Crohn's disease Trial) of Traficet-EN™ (CCX282-B) in patients with moderate-to-severe Crohn's disease. Traficet-EN, an orally bioavailable CCR9-specific chemokine receptor antagonist showed clinical efficacy in a 12-week Induction period, as well as a 36-week Maintenance period.

28 Oct 2010

EpiCept, FDA reach agreement on regulatory path forward for Ceplene

EpiCept Corporation today announced that it has reached an agreement on all outstanding issues with the U.S. Food and Drug Administration (FDA) on a regulatory path forward for Ceplene® (histamine dihydrochloride), the Company's lead product for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first complete remission. Ceplene® is approved in the European Union for this indication and is marketed there by Meda AB.

28 Oct 2010

Nymox updates NX-1207 Phase 3 pivotal trials for benign prostatic hyperplasia

Nymox Pharmaceutical Corporation provided an update today on the Company's Phase 3 pivotal trials for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH).

28 Oct 2010

New oral drug shrinks IMT sarcoma driven by abnormally activated protein

A new oral drug caused dramatic shrinkage of a patient's rare, aggressive form of soft-tissue cancer that was driven by an abnormally activated protein, physician-scientists from Dana-Farber Cancer Institute report in the Oct. 28 issue of the New England Journal of Medicine.

28 Oct 2010

BDSI to initiate BEMA Buprenorphine Phase 3 program following positive End-of-Phase 2 meeting with FDA

BioDelivery Sciences International, Inc. today announced a positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) which took place on September 14, 2010. At that meeting, agreement was reached on the BEMA Buprenorphine development plan for the treatment of chronic pain.

28 Oct 2010

Drug Trial News

Coadministration of INTUNIV tablets with stimulant reduces ADHD symptoms

Forest, Almirall report topline results from aclidinium bromide comparative Phase III study in COPD

StemCells initiates HuCNS-SC second clinical trial for Batten disease in children

Geron 2010 third quarter revenue increases from $494,000 to $546,000

ImmunoGen first quarter net loss increases to $12.9 million

Amira initiates AM152 Phase 1 clinical study for fibrotic diseases

Antigenics third quarter net loss decreases from $10.8 million to $5.9 million

Pharmasset's PSI-938 phase I monotherapy trial shows positive result for HCV treatment

QLT expands QLT091001 Phase 1b LCA study to include patients with Retinitis Pigmentosa

Octapharma initiates Human-cl rhFVIII clinical study for severe hemophilia A

Pfizer announces publication of crizotinib data for NSCLC patients in New England Journal of Medicine

Curemark adds two sites in California for CM-AT Phase III clinical trial program

Laureate enters agreement with AVEO to produce AV-203 monoclonal antibody against ErbB3

Epigenomics presents data on Septin9 biomarker clinical study for colorectal cancer at UEGW

Evotec grants Jingxin Pharma rights to develop, market EVT 201 insomnia drug candidate in China

ChemoCentryx reports one-year study results of Traficet-EN in Crohn's disease patients

EpiCept, FDA reach agreement on regulatory path forward for Ceplene

Nymox updates NX-1207 Phase 3 pivotal trials for benign prostatic hyperplasia

New oral drug shrinks IMT sarcoma driven by abnormally activated protein

BDSI to initiate BEMA Buprenorphine Phase 3 program following positive End-of-Phase 2 meeting with FDA

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