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Enrollment for Pharmacyclics' Phase III study using ibrutinib in CLL patients completed

Pharmacyclics, Inc. announced today that the enrollment target of 350 patients for its Phase III study using ibrutinib monotherapy versus ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia / small lymphocytic lymphoma, (RESONATE) was achieved on April 3, 2013.

23 Apr 2013

Alkermes reports topline results from phase 2 study of ALKS 5461 drug for major depressive disorder

Alkermes plc (NASDAQ: ALKS) today announced positive preliminary topline results from a phase 2 study of ALKS 5461, its novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression.

22 Apr 2013

Advaxis completes ADXS-HPV Phase 1/2 dosing in patients with HPV-associated anal cancer

Advaxis, Inc., a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that the first patient has been dosed in a Phase 1/2 study of ADXS-HPV in 25 patients with HPV-associated anal cancer coordinated by the Brown University Oncology Research Group (BrUOG).

22 Apr 2013

Synta completes GALAXY-2 trial evaluating ganetespib inhibitor in non-small cell lung cance

Synta Pharmaceuticals Corp. announced today that the first patients have been treated in the randomized GALAXY-2 Phase 3 trial designed to evaluate docetaxel plus ganetespib, its investigational Hsp90 inhibitor, versus docetaxel alone for the second-line treatment of non-small cell lung adenocarcinoma.

22 Apr 2013

Phase 2 study of VX-661 and ivacaftor shows significant improvements in lung function among CF patients

Vertex Pharmaceuticals Incorporated today announced data from a Phase 2 study of VX-661 and ivacaftor that showed statistically significant improvements in lung function among adults with cystic fibrosis (CF) who have two copies (homozygous) of the most common mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, known as F508del.

22 Apr 2013

Ceregene announces top-line data from CERE-12 Phase 2b clinical study for Parkinson's disease

Ceregene, Inc. today announced the top-line data from its double-blind, randomized, controlled Phase 2b clinical study of CERE-120 (AAV-neurturin), a gene therapy product designed to deliver the neurotrophic factor neurturin, for Parkinson's disease.

20 Apr 2013

Civitas Therapeutics reports positive results from Phase 2 study of CVT-301 for Parkinson's disease

Civitas Therapeutics, Inc., a privately-held pharmaceutical company developing transformative therapeutics using the ARCUS respiratory delivery platform, today announced positive topline results from a Phase 2 clinical trial of CVT-301, an inhaled formulation of levodopa (L-dopa).

20 Apr 2013

GBM brain cancer patient treated with DCVax-L celebrates 10th anniversary of cancer-free survival

Northwest Biotherapeutics, a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, announced today that Brad Silver, an All American swimming and water polo athlete who was diagnosed with Glioblastoma multiforme brain cancer in late 2002, and was treated with DCVax-L in March of 2003, just celebrated the 10th anniversary of his continued cancer-free survival.

19 Apr 2013

SynCon universal H1N1 influenza vaccine generates protective antibody levels in phase 1 study

Inovio Pharmaceuticals, Inc. announced today that its SynCon universal H1N1 influenza vaccine generated protective antibody levels comparable to a current FDA-approved seasonal influenza vaccine against a currently circulating influenza strain.

19 Apr 2013

SironRX completes enrollment in Cohort 1 to study JVS-100 for wound healing, scar prevention

SironRX Therapeutics Inc., a privately-held, clinical-stage biotechnology company developing novel regenerative therapies to prevent scarring and promote dermal wound repair, is pleased to report that it has completed enrollment of patients in Cohort 1 of its placebo-controlled, randomized, dose escalation double-blind clinical study evaluating the safety and efficacy of JVS-100 to reduce scar formation and improve wound healing in patients receiving surgical sternotomy incisions.

19 Apr 2013

FDA agrees to allow ADial to move forward with Phase III trial of AD04 for alcohol use disorder

ADial Pharmaceuticals, LLC, announced today that the U.S. Food and Drug Administration has agreed to allow ADial to move forward with its plan to initiate Phase III trials of AD04 as a treatment for alcohol use disorder in certain targeted genotypes population only.

19 Apr 2013

Romark Laboratories starts NT-300 Phase 3 trial for treatment of acute uncomplicated influenza

Romark Laboratories announced that it has begun enrolling patients in a global Phase 3 clinical trial of NT-300 (nitazoxanide) for treatment of acute uncomplicated influenza.

19 Apr 2013

Clinical data of EV71 vaccine for prevention of HFMD presented at World Vaccine Congress & Expo

Sinovac Biotech Ltd., a leading provider of vaccines in China, announced today that Fengcai Zhu, Deputy Director of the Jiangsu Provincial Center for Disease Prevention and Control, presented data regarding Sinovac's proprietary enterovirus 71 ("EV71") vaccine against hand, foot and mouth disease at the 13th Annual World Vaccine Congress & Expo, taking place from April 16-18, 2013, in Washington D.C.

19 Apr 2013

Targacept moving forward with Phase 2b study of TC-5619 for treatment of schizophrenia

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics, today announced that it has completed recruitment of patients in the Phase 2b study of TC-5619 as a treatment for negative symptoms and cognitive dysfunction in schizophrenia.

19 Apr 2013

FDA approval paves way for U-M to conduct Phase II trial of stem cell injections in ALS patients

For nearly two years, University of Michigan neurologist Eva Feldman , M.D., Ph.D. has led the nation's first clinical trial of stem cell injections in patients with the deadly degenerative disease known as amyotrophic lateral sclerosis, often called ALS or Lou Gehrig 's disease.

19 Apr 2013

Patient enrollment underway in Phase III trial program to evaluate amikacin inhalation solution

Bayer HealthCare Pharmaceuticals Inc. announced today that patient enrollment is underway in its global Phase III trial program to evaluate the efficacy and safety of adjunctive aerosolized BAY41-6551 versus aerosolized placebo in the treatment of intubated and mechanically ventilated patients with Gram-negative pneumonia receiving standard of care intravenous antibiotics.

19 Apr 2013

ARMGO Pharma gets $1 million to support ARM210 preclinical work for DMD treatment

ARMGO Pharma and the Muscular Dystrophy Association today announced that $1 Million has been awarded for preclinical work in support of an Investigational New Drug application with the U.S. Food and Drug Administration for ARM210, a novel, orally available, small-molecule Rycal drug that has potential as a treatment for Duchenne muscular dystrophy.

18 Apr 2013

Two abstracts related to Advaxis' ADXS-HPV selected for poster presentation at ASCO meeting

Advaxis, Inc., a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that two abstracts related to ADXS-HPV (ADXS11-001), the Company's lead clinical stage product candidate, have been selected for poster presentation at the 2013 American Society of Clinical Oncology Annual Meeting in Chicago, IL, from May 31 - June 4, 2013, at the McCormick Place Convention Center.

18 Apr 2013

Eli Lilly reports positive results from Phase III AWARD trials of type 2 diabetes drug, dulaglutide

Eli Lilly and Company today announced positive top-line results of two additional Phase III AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) receptor agonist being studied as a once-weekly treatment for type 2 diabetes.

18 Apr 2013

Mast Therapeutics' data show that MST-188 reduces aggregation of both older and younger RBC

Mast Therapeutics, Inc. today announced that two posters for its lead product candidate, MST-188, were presented at the 7th Annual Sickle Cell Disease Research & Educational Symposium, currently underway in Miami.

18 Apr 2013

Drug Trial News

Enrollment for Pharmacyclics' Phase III study using ibrutinib in CLL patients completed

Alkermes reports topline results from phase 2 study of ALKS 5461 drug for major depressive disorder

Advaxis completes ADXS-HPV Phase 1/2 dosing in patients with HPV-associated anal cancer

Synta completes GALAXY-2 trial evaluating ganetespib inhibitor in non-small cell lung cance

Phase 2 study of VX-661 and ivacaftor shows significant improvements in lung function among CF patients

Ceregene announces top-line data from CERE-12 Phase 2b clinical study for Parkinson's disease

Civitas Therapeutics reports positive results from Phase 2 study of CVT-301 for Parkinson's disease

GBM brain cancer patient treated with DCVax-L celebrates 10th anniversary of cancer-free survival

SynCon universal H1N1 influenza vaccine generates protective antibody levels in phase 1 study

SironRX completes enrollment in Cohort 1 to study JVS-100 for wound healing, scar prevention

FDA agrees to allow ADial to move forward with Phase III trial of AD04 for alcohol use disorder

Romark Laboratories starts NT-300 Phase 3 trial for treatment of acute uncomplicated influenza

Clinical data of EV71 vaccine for prevention of HFMD presented at World Vaccine Congress & Expo

Targacept moving forward with Phase 2b study of TC-5619 for treatment of schizophrenia

FDA approval paves way for U-M to conduct Phase II trial of stem cell injections in ALS patients

Patient enrollment underway in Phase III trial program to evaluate amikacin inhalation solution

ARMGO Pharma gets $1 million to support ARM210 preclinical work for DMD treatment

Two abstracts related to Advaxis' ADXS-HPV selected for poster presentation at ASCO meeting

Eli Lilly reports positive results from Phase III AWARD trials of type 2 diabetes drug, dulaglutide

Mast Therapeutics' data show that MST-188 reduces aggregation of both older and younger RBC

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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