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Sinovac submits clinical trial application for 13-valent pneumococcal conjugate vaccine to China SFDA

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today it submitted the application to commence clinical trials for its 13-valent pneumococcal conjugate vaccine (PCV) to China's State Food and Drug Administration (SFDA) on March 3, 2011.

3 Mar 2011

Clinical trials in Australia take too long– need uniform standards: Report

A government report says that clinical trials for new medicines are taking too long and should be sped up so patients can access urgently needed treatment. The states and territories have been urged to adopt uniform rules on approving trials so the scientific experiments can be conducted more efficiently and effectively.

3 Mar 2011

Glenmark Generics granted final FDA approval for generic Xyzal ANDA

Glenmark Generics Inc., USA (GGI), the United States subsidiary of Glenmark Generics Limited (GGL), announced they have been granted final approval for their Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (U.S. FDA) for Levocetirizine Dihydrochloride 5 mg tablets, the generic version of UCB Inc.'s Xyzal(R) tablets.

3 Mar 2011

Protalex initiates enrollment in 3rd cohort of PRTX-100 Phase 1b dose escalation clinical study in RA

Protalex, Inc, a clinical stage biopharmaceutical company which is engaged in developing a class of drugs for treating autoimmune and inflammatory diseases, today announced enrollment of the first patients in the 3rd cohort of its ongoing multicenter Phase 1b dose escalation clinical study of PRTX-100 in adult patients with active Rheumatoid Arthritis (RA) being conducted in South Africa. The dose was increased by a factor of two from the 2nd cohort.

3 Mar 2011

Infinity commences IPI-926 Phase 2 clinical trial in rare, life-threatening bone cancer

Infinity Pharmaceuticals, Inc. today announced the initiation of a randomized, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of IPI-926 compared to placebo in patients with metastatic or locally advanced, inoperable chondrosarcoma. The trial is expected to enroll over 100 patients worldwide.

3 Mar 2011

Positive outcomes from Argos AGS-004 Phase 2a trial in patients with HIV

Argos Therapeutics announced today that its Arcelis immunotherapy for the treatment of HIV, AGS-004, demonstrated positive outcomes with the primary endpoint of viral load control and a favorable safety and immunogenicity profile in a final analysis of a Phase 2a clinical trial.

3 Mar 2011

Eisai announces publication of Halaven Phase III study results against breast cancer in The Lancet journal

Eisai announced today that results from the global Phase III clinical study "EMBRACE" will be published online in The Lancet.

3 Mar 2011

Depomed completes patient enrollment in Breeze 3 Serada Phase 3 trial to treat menopausal hot flashes

Depomed, Inc. announced today that it has completed enrollment of Breeze 3, the company's pivotal Phase 3 clinical trial evaluating Serada for the non-hormonal treatment of menopausal hot flashes.

3 Mar 2011

Lixte receives $244,479.25 U.S. government grant for QTDP program

Lixte Biotechnology Holdings announced today that the company has received a $244,479.25 grant under the Qualifying Therapeutic Discovery Project.

3 Mar 2011

Vertex announces positive interim results from telaprevir Phase 2 study in patients with HCV, HIV

Vertex Pharmaceuticals Incorporated announced today interim results from an ongoing, two-part, Phase 2 study evaluating telaprevir in combination with pegylated-interferon and ribavirin compared to pegylated-interferon and ribavirin alone in people who are infected with both genotype 1 hepatitis C virus and human immunodeficiency virus, also known as HCV-HIV co-infection.

3 Mar 2011

Vical receives EMA Scientific Advice for Phase 3 trial of TransVax therapeutic CMV vaccine

Vical Incorporated announced today the receipt of Scientific Advice from the European Medicines Agency (EMA) recommending practical efficacy endpoints for a Phase 3 trial of the company's TransVax™ therapeutic cytomegalovirus (CMV) vaccine.

3 Mar 2011

EpiCept: Positive outcome from Ceplene Phase III trial in patients with AML

EpiCept Corporation today announced the Company has identified a statistically significant survival benefit in a subgroup of Acute Myeloid Leukemia patients in its previous Phase III trial with Ceplene administered with low-dose interleukin-2.

3 Mar 2011

Osiris completes patient enrollment in Prochymal Phase 2 trial to treat heart attack

Osiris Therapeutics, Inc., today announced that it has successfully completed enrollment in a Phase 2 clinical trial evaluating Prochymal, an adult mesenchymal stem cell therapy, in patients experiencing their first heart attack.

3 Mar 2011

FDA accepts Handa's generic DEXILANT ANDA for review

Handa Pharmaceuticals, LLC, a specialty pharmaceutical company based in Fremont, California, today confirmed that its Abbreviated New Drug Application ("ANDA") for Dexlansoprazole Delayed Release Capsules, 60 mg, a generic version of Takeda's DEXILANT®, has been accepted for review by the U.S. Food and Drug Administration.

2 Mar 2011

Virostatics' VS411 Phase 2a trial results against HIV presented at 18th CROI

An analysis of immune markers measured in a sub-study of ViroStatics' proof-of-concept Phase 2a trial showed that VS411 was able to reduce immune activation while producing a median 1.5 log10 reduction in viral load.

2 Mar 2011

Mylan confirms lawsuit relating to Estradiol Transdermal System ANDA

Mylan Inc. today confirmed that the company has been sued by Vivelle Ventures LLC, Noven Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Estradiol Transdermal System, USP (Twice-Weekly), 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day.

2 Mar 2011

Allergan initiates AGN-214868 Phase II trials in post herpetic neuralgia and overactive bladder

Syntaxin, a biotechnology company developing novel biopharmaceuticals to control cell secretion, today announces its partner Allergan, Inc has initiated two Phase II trials to evaluate the safety and efficacy of its re-targeted endopeptidase drug candidate AGN-214868. The Phase II trials will be focused on patients with post herpetic neuralgia (PHN) and overactive bladder.

2 Mar 2011

Neuralstem announces initiation of NSI-189 Phase Ia trial for major depressive disorder

Neuralstem, Inc. announced that the first subject was dosed yesterday in a Phase Ia trial to evaluate the safety of its drug, NSI-189, which is being developed for the treatment of major depressive disorder and other psychiatric indications. NSI-189 is the lead compound in Neuralstem's neurogenerative small molecule drug platform. This phase of the trial is in healthy volunteers and seeks to determine the maximum tolerated single dose.

2 Mar 2011

Scientists at retrovirus conference present findings on microbicide gel, Truvada, male circumcision, ART care by nurses

At the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston on Monday, researchers "suggested the potential" of a gel containing the antiretroviral drug tenofovir to reduce the risk of anal HIV transmission, TIME's "Healthland" blog reports.

2 Mar 2011

Geron's hESC derived GRNCM1 halts remodeling process and preserves cardiac function in acute heart damage

Geron Corporation today announced preclinical study data showing positive effects of GRNCM1, Geron's cardiomyocyte product derived from human embryonic stem cells (hESCs), in a small animal model of acute heart damage. Administering GRNCM1 by injection into the heart resulted in greater resistance to induced arrhythmias, halted adverse cardiac remodeling and preserved mechanical function compared to controls.

2 Mar 2011

Drug Trial News

Sinovac submits clinical trial application for 13-valent pneumococcal conjugate vaccine to China SFDA

Clinical trials in Australia take too long– need uniform standards: Report

Glenmark Generics granted final FDA approval for generic Xyzal ANDA

Protalex initiates enrollment in 3rd cohort of PRTX-100 Phase 1b dose escalation clinical study in RA

Infinity commences IPI-926 Phase 2 clinical trial in rare, life-threatening bone cancer

Positive outcomes from Argos AGS-004 Phase 2a trial in patients with HIV

Eisai announces publication of Halaven Phase III study results against breast cancer in The Lancet journal

Depomed completes patient enrollment in Breeze 3 Serada Phase 3 trial to treat menopausal hot flashes

Lixte receives $244,479.25 U.S. government grant for QTDP program

Vertex announces positive interim results from telaprevir Phase 2 study in patients with HCV, HIV

Vical receives EMA Scientific Advice for Phase 3 trial of TransVax therapeutic CMV vaccine

EpiCept: Positive outcome from Ceplene Phase III trial in patients with AML

Osiris completes patient enrollment in Prochymal Phase 2 trial to treat heart attack

FDA accepts Handa's generic DEXILANT ANDA for review

Virostatics' VS411 Phase 2a trial results against HIV presented at 18th CROI

Mylan confirms lawsuit relating to Estradiol Transdermal System ANDA

Allergan initiates AGN-214868 Phase II trials in post herpetic neuralgia and overactive bladder

Neuralstem announces initiation of NSI-189 Phase Ia trial for major depressive disorder

Scientists at retrovirus conference present findings on microbicide gel, Truvada, male circumcision, ART care by nurses

Geron's hESC derived GRNCM1 halts remodeling process and preserves cardiac function in acute heart damage

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