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The Lancet publishes phase 3 clinical study data on VIVITROL for treatment of opioid dependence

Alkermes, Inc. today announced that results from the phase 3 clinical study of VIVITROL® (naltrexone for extended-release injectable suspension) in opioid dependence have been published by The Lancet. The six-month, phase 3 trial met its primary endpoint and showed significantly greater opioid-free weeks among patients treated with VIVITROL, compared to placebo.

28 Apr 2011

Enrollment complete in Unigene's oral PTH Phase 2 osteoporosis study in postmenopausal women

Unigene Laboratories, Inc. a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced today that the Company has completed patient enrollment of its Phase 2 study with an experimental oral parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women.

28 Apr 2011

FDA Advisory Committee recommends approval of Merck's VICTRELIS for chronic HCV genotype 1 infection

Merck announced today that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously that the available data support approval of Merck's investigational medicine VICTRELIS™ (boceprevir) for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infection in combination with current standard therapy.

28 Apr 2011

CESAR, Saladax begin patient enrollment in paclitaxel CEPAC-TDM trial for NSCLC

In collaboration with Saladax Biomedical, Inc., the Central European Society for Anticancer Drug Research announced today that enrollment has begun in the CEPAC-TDM trial of paclitaxel therapeutic drug management with subsequent pharmacokinetic-guided dose adjustment in patients being treated for advanced non-small cell lung cancer.

27 Apr 2011

Children, adolescents with liver disease may not benefit from vitamin E or metformin

In contrast to previous preliminary data, use of vitamin E or the diabetes drug metformin was not superior to placebo on a measured outcome for treating nonalcoholic fatty liver disease in children and adolescents, according to a study in the April 27 issue of JAMA.

27 Apr 2011

BioInvent, ThromboGenics initiate TB-402 Phase IIb trial for VTE prophylaxis

ThromboGenics NV and co-development partner BioInvent International announce today that the first patient has been dosed in a Phase IIb trial with their novel long-acting anticoagulant TB-402 for the prophylaxis of venous thromboembolism after total hip surgery.

27 Apr 2011

Boehringer Ingelheim initiates enrollment in BI 201335 Phase 3 clinical trial for chronic HCV

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that enrollment has commenced at North American sites in its pivotal Phase 3 clinical trial program for BI 201335, the Company's investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV).

27 Apr 2011

Positive results from Sanofi-aventis and Regeneron ZALTRAP Phase III study in mCRC

Sanofi-aventis and Regeneron Pharmaceuticals, Inc. announced that the Phase III VELOUR trial evaluating the investigational agent ZALTRAP, also known as VEGF Trap, in combination with the FOLFIRI chemotherapy regimen versus a regimen of FOLFIRI plus placebo met its primary endpoint of improving overall survival in the second-line treatment of metastatic colorectal cancer.

27 Apr 2011

IQ Therapeutics completes dosing in IQNLF Phase I trial for anthrax

IQ Therapeutics has completed the dosing of antibody IQNLF in a Phase I clinical trial. A total of 36 healthy volunteers participated in the randomized, placebo controlled, double blind, single dose-escalating study, intended to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of IQNLF.

27 Apr 2011

Tarix begins patient enrollment for TXA127 Phase 1 study in DCBT

Tarix Pharmaceuticals today announced enrollment of the first patient in a Phase 1 clinical study of TXA127, a pharmaceutical grade formulation of a naturally occurring peptide known to stimulate early hematopoietic precursor cells in the bone marrow.

27 Apr 2011

FDA supports new Hepatitis C drug from Vertex Pharmaceuticals

Vertex pharmaceuticals jumped 10 percent in value on the Nasdaq after U.S. regulators FDA said the company’s experimental hepatitis C drug cures more patients than current therapies.

26 Apr 2011

Diabetes and prediabetes are on the rise: New medication in research trials

As the newest statistics from the CDC show, diabetes is an ever increasing problem for Americans. Almost 26 million adults in this country now have diabetes, an increase of 9% since 2008. Ninety to 95% of cases are type 2 diabetes, marked by a gradual inability of the body’s cells to respond to insulin, and eventually an inability to produce enough insulin. In addition, almost 79 million people in this country have prediabetes. The CDC has warned that if diabetes continues on its current course, it could affect a third of all adult Americans by 2050.

26 Apr 2011

Millennium submits two VELCADE sNDAs to FDA

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that it has submitted two supplemental new drug applications (sNDAs) for VELCADE® (bortezomib) for Injection to the U.S. Food and Drug Administration. The first application seeks to add a subcutaneous route of administration for VELCADE. The second application is for the use of VELCADE in combination with rituximab in patients with relapsed follicular non-Hodgkin lymphoma (NHL).

26 Apr 2011

USPTO grants Cortex patent for CX1739 AMPAKINE molecule

Cortex Pharmaceuticals, Inc. announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for a patent that protects its lead AMPAKINE® molecule, CX1739.

26 Apr 2011

Pharmacyclics receives Servier's $7 million milestone payment for HDAC inhibitor

Pharmacyclics, Inc. announced today that it has received a $7 million milestone payment for its histone deacetylase inhibitor, PCI-24781 / S 78454 from Les Laboratoires Servier based on an ex-US collaboration agreement signed in April of 2009.

26 Apr 2011

Dactinomycin more effective for low-risk gestational tumor treatment

A clinical trial has sifted out the most effective single-drug chemotherapy regimen for quick-growing but highly curable cancers that arise from the placentas of pregnant women.

26 Apr 2011

HemaQuest initiates HQK-1001 Phase 2 study in sickle cell disease

HemaQuest Pharmaceuticals, Inc., a biotechnology company focused on developing small molecule therapeutics to treat hemoglobin disorders, announced today that clinical investigators have enrolled the first patient in a randomized multi-dose Phase 2 study of HQK-1001 in patients with sickle cell disease.

26 Apr 2011

BMY to present belatacept Phase III new data at American Transplant Congress

New data on belatacept, an investigational selective T cell costimulation blocker being studied for use in renal transplantation by Bristol-Myers Squibb Company, will be presented at the American Transplant Congress April 30 - May 4, 2011 in Philadelphia.

26 Apr 2011

A.P. Pharma targets resubmission of APF530 NDA in 2012

A.P. Pharma, Inc., a specialty pharmaceutical company, today provided an update on its lead product candidate, APF530, for the prevention of chemotherapy-induced nausea and vomiting (CINV).

25 Apr 2011

Curemark CM-182 demonstrates positive results for schizophrenia in transgenic chakragati model of psychosis

Curemark, LLC, a drug research and development company focused on the treatment of neurological diseases, announced today that its compound CM-182 demonstrated positive results for schizophrenia in the transgenic chakragati (ckr) model of psychosis. The mouse model screening was performed by the Contract Research Organization, Cerca Insights.

25 Apr 2011

Drug Trial News

The Lancet publishes phase 3 clinical study data on VIVITROL for treatment of opioid dependence

Enrollment complete in Unigene's oral PTH Phase 2 osteoporosis study in postmenopausal women

FDA Advisory Committee recommends approval of Merck's VICTRELIS for chronic HCV genotype 1 infection

CESAR, Saladax begin patient enrollment in paclitaxel CEPAC-TDM trial for NSCLC

Children, adolescents with liver disease may not benefit from vitamin E or metformin

BioInvent, ThromboGenics initiate TB-402 Phase IIb trial for VTE prophylaxis

Boehringer Ingelheim initiates enrollment in BI 201335 Phase 3 clinical trial for chronic HCV

Positive results from Sanofi-aventis and Regeneron ZALTRAP Phase III study in mCRC

IQ Therapeutics completes dosing in IQNLF Phase I trial for anthrax

Tarix begins patient enrollment for TXA127 Phase 1 study in DCBT

FDA supports new Hepatitis C drug from Vertex Pharmaceuticals

Diabetes and prediabetes are on the rise: New medication in research trials

Millennium submits two VELCADE sNDAs to FDA

USPTO grants Cortex patent for CX1739 AMPAKINE molecule

Pharmacyclics receives Servier's $7 million milestone payment for HDAC inhibitor

Dactinomycin more effective for low-risk gestational tumor treatment

HemaQuest initiates HQK-1001 Phase 2 study in sickle cell disease

BMY to present belatacept Phase III new data at American Transplant Congress

A.P. Pharma targets resubmission of APF530 NDA in 2012

Curemark CM-182 demonstrates positive results for schizophrenia in transgenic chakragati model of psychosis

PhD researcher at LifeArc

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