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Nplate reduces treatment failure and splenectomies in adults with chronic immune thrombocytopenia

Amgen Inc. today announced the publication of results from the first open-label study to compare Nplate® (romiplostim) treatment to standard of care therapies (SOC) in non-splenectomized adult patients with chronic immune thrombocytopenia (ITP). The study results, which were published today in the New England Journal of Medicine (NEJM), show that both the incidence of treatment failure and need for splenectomy were reduced among the Nplate-treated patients.

11 Nov 2010

Watson’s Uracyst pilot study for interstitial cystitis fails to demonstrate efficacy endpoints

Watson Pharmaceuticals, Inc. today announced that the U.S. pilot study evaluating Uracyst (sodium chondroitin sulfate solution 2.0%) for the treatment of interstitial cystitis did not meet predefined efficacy endpoints.

11 Nov 2010

Vertex to enroll additional treatment arm in telaprevir/VX-222 Phase 2 clinical trial for HCV

Vertex Pharmaceuticals Incorporated today announced plans to enroll an additional treatment arm as part of its ongoing Phase 2 clinical trial evaluating 12-week regimens of Vertex's lead investigational hepatitis C virus (HCV) protease inhibitor, telaprevir, in combination with its lead investigational HCV polymerase inhibitor, VX-222.

10 Nov 2010

Amarin reports $31.4 million cash balance for third quarter 2010

Amarin Corporation plc, a clinical-stage biopharmaceutical company focused on cardiovascular disease, today reported its financial and operational results for the three-month period ended September 30, 2010.

10 Nov 2010

Positive results from XOMA 052 study in patients with uveitis of Behcet's disease

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, announced additional positive results from an open-label pilot study of XOMA 052 in patients with uveitis of Behcet's disease who were suffering from vision-threatening exacerbations despite maximal doses of immunosuppressive medicines.

10 Nov 2010

Zalicus third quarter total revenue decreases to $1.2 million

"We made solid product development progress this quarter," commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. "We finalized our development plans for Synavive, and also related to Synavive, we were awarded a Therapeutic Discovery Project grant to help fund Synavive development going forward.

10 Nov 2010

Abbott presents results of 2 pivotal HUMIRA studies at American College of Rheumatology meeting

Today, Abbott presents results from a pooled analysis of two pivotal HUMIRA® (adalimumab) studies, which look at patients with early and long-standing moderate to severe rheumatoid arthritis (RA), at the American College of Rheumatology meeting in Atlanta.

10 Nov 2010

Data from AVEO's tivozanib-FOLFOX6 combination Phase 1b trial presented at 22nd EORTC-NCI-AACR

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that new clinical data from a Phase 1b trial evaluating the company's lead product candidate, tivozanib, a highly potent and selective inhibitor of VEGF receptors 1, 2, and 3, in combination with FOLFOX6, a standard chemotherapy regimen, will be presented during the 22nd Annual Symposium of EORTC-NCI-AACR being held November 16-19, 2010 in Berlin, Germany.

10 Nov 2010

TRU-016 abstracts to be presented at ASH meeting

Emergent BioSolutions Inc. today announced the acceptance of four abstracts for presentation at the 52nd Annual Meeting of the American Society of Hematology to be held from December 4 to 7 in Orlando, Florida. The presentations include an oral presentation on the results of a Phase I dose escalation, monotherapy study of TRU-016 for patients with chronic lymphocytic leukemia.

10 Nov 2010

Myrexis presents key preclinical findings of MPI-0485520 at ACR/ARHP meeting

Myrexis, Inc., a biotechnology company focused on discovering, developing, and commercializing novel treatments for cancer, today presented key preclinical findings of the Company's novel oral anti-interferon, MPI-0485520, at the 74th Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals, in Atlanta, Georgia.

10 Nov 2010

Epratuzumab reduces SLE disease activity in phase IIB EMBLEM study

UCB and U.S. based partner Immunomedics Inc. announced that results from the phase IIB study, EMBLEM, showed that certain doses of epratuzumab were associated with a meaningful and statistically significant reduction in disease activity in adult patients with moderate to severe active SLE.

10 Nov 2010

Synageva's SBC-102 enzyme replacement therapy for LAL deficiency granted European orphan product designation

Synageva BioPharma Corp., a privately held biopharmaceutical company, announced that the European Medicines Agency (EMA) granted orphan product designation for SBC-102 (Recombinant Human Lysosomal Acid Lipase), the Company's enzyme replacement therapy in development to treat Lysosomal Acid Lipase (LAL) Deficiency.

10 Nov 2010

BioInvent receives FDA IND clearance for BI-204 Phase II trial in cardiovascular disease

BioInvent International AB today announces IND clearance from the U.S. Food & Drug Administration (FDA) to initiate a Phase II study for BI-204. BI-204 is a human monoclonal antibody that specifically targets oxidized forms of a low-density lipoprotein (LDL) which has been linked to increased inflammatory processes leading to plaque formation in the blood vessel walls. BI-204 is being co-developed with Genentech for secondary prevention of cardiovascular events in patients with acute coronary syndrome (ACS).

10 Nov 2010

TONIX Pharmaceuticals announces Phase 2a study results of cyclobenzaprine in Fibromyalgia Syndrome

TONIX Pharmaceuticals (formerly known as Krele Pharmaceuticals), a specialty central nervous system (CNS) pharmaceutical company, announced results of a new analysis of a Phase 2a study, which previously demonstrated reduced pain, fatigue and tenderness in patients with Fibromyalgia Syndrome (FMS) following bedtime administration of very low dosage (VLD) cyclobenzaprine (CBP).

10 Nov 2010

Silence Therapeutics' Atu027 RNAi drug prevents pulmonary metastasis formation

Silence Therapeutics plc announces positive research findings demonstrating the ability of the Company's lead RNA interference (RNAi) drug candidate, Atu027, to prevent the formation of pulmonary metastasis in various animal models of cancer metastasis. Researchers showed that Atu027 inhibited multiple key biological processes that enable and contribute to the dissemination and formation of pulmonary metastases in a murine breast cancer metastasis model.

10 Nov 2010

Diamyd completes patient screening for DiaPrevent Phase III study

Diamyd Medical has completed the screening of patients for the US Phase III study, DiaPrevent, ending the recruitment campaign. More than 310 recently diagnosed type 1 diabetes patients between 10 and 20 years of age have already been enrolled in the study and have received their first injection of the antigen-based therapy Diamyd® or placebo.

10 Nov 2010

New York Times examines HIV prevention products undergoing clinical trials

The New York Times examines several products being studied in clinical trials that researchers hope will one day prevent sexual transmission of HIV. The newspaper describes the ongoing trials of a vaginal microbicide gel containing the antiretroviral tenofovir which was found to reduce the risk of HIV infection in women by 39 percent, writing, "[o]ther clinical trials will report their results in 2011 and 2012 and, if all goes well, researchers hope to have a product or two ready to enter the market by 2013."

10 Nov 2010

Enrollment complete in Nabi's second NicVAX Phase III clinical trial for nicotine addiction

Nabi Biopharmaceuticals announced today that it has completed enrollment in the second Phase III clinical trial of NicVAX® (Nicotine Conjugate Vaccine), the company's innovative and proprietary investigational candidate vaccine being developed to treat nicotine addiction and prevent smoking relapse.

10 Nov 2010

Phytomedics awarded $244,000 QTDP grant for development of RA drug

Phytomedics, Inc., a transformational healthcare company developing a novel portfolio of drugs and consumer products solely derived from plant sources, announced today that it has been awarded a grant in the amount of $244,000 under the Qualifying Therapeutic Discovery Project (QTDP) Program to advance the development of its lead product PMI-001 for Rheumatoid Arthritis. PMI-001 is presently in Phase 2b/3 development.

9 Nov 2010

NeuroDerm commences enrollment in ND0801 Phase 2a clinical study of ADD/ADHD in adults

NeuroDerm, Ltd. announced today that patient enrollment has begun in a Phase 2a clinical study of ND0801, a new product for the treatment of Attention Deficit Disorder/Attention Deficit Hyperactivity Disorder (ADD/ADHD) in adults. ND0801, based on a new, proprietary combination with nicotinic actions, is being developed as a dermal patch and will be evaluated for the treatment of cognitive impairment in several disorders including Alzheimer's disease, schizophrenia and advanced Parkinson's disease, among others.

9 Nov 2010

Drug Trial News

Nplate reduces treatment failure and splenectomies in adults with chronic immune thrombocytopenia

Watson’s Uracyst pilot study for interstitial cystitis fails to demonstrate efficacy endpoints

Vertex to enroll additional treatment arm in telaprevir/VX-222 Phase 2 clinical trial for HCV

Amarin reports $31.4 million cash balance for third quarter 2010

Positive results from XOMA 052 study in patients with uveitis of Behcet's disease

Zalicus third quarter total revenue decreases to $1.2 million

Abbott presents results of 2 pivotal HUMIRA studies at American College of Rheumatology meeting

Data from AVEO's tivozanib-FOLFOX6 combination Phase 1b trial presented at 22nd EORTC-NCI-AACR

TRU-016 abstracts to be presented at ASH meeting

Myrexis presents key preclinical findings of MPI-0485520 at ACR/ARHP meeting

Epratuzumab reduces SLE disease activity in phase IIB EMBLEM study

Synageva's SBC-102 enzyme replacement therapy for LAL deficiency granted European orphan product designation

BioInvent receives FDA IND clearance for BI-204 Phase II trial in cardiovascular disease

TONIX Pharmaceuticals announces Phase 2a study results of cyclobenzaprine in Fibromyalgia Syndrome

Silence Therapeutics' Atu027 RNAi drug prevents pulmonary metastasis formation

Diamyd completes patient screening for DiaPrevent Phase III study

New York Times examines HIV prevention products undergoing clinical trials

Enrollment complete in Nabi's second NicVAX Phase III clinical trial for nicotine addiction

Phytomedics awarded $244,000 QTDP grant for development of RA drug

NeuroDerm commences enrollment in ND0801 Phase 2a clinical study of ADD/ADHD in adults

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Fourier 80: bringing benchtop NMR systems to the laboratory

How industrial hygiene flow calibration supports defensible exposure data

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