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FDA Clears IND Amendment for Hematologic Cancer Drug

April 23, 2014 12:40 pm | News | Comments

Fate Therapeutics Inc., a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators, announced that the FDA has cleared its IND amendment to evaluate Prohema in pediatric patients undergoing hematopoietic stem cell transplantation for hematologic malignancies. Read more...

Bayer's Ciprofloxacin DPI Gets Orphan Drug Status

April 23, 2014 11:41 am | News | Comments

Bayer HealthCare announced that the U.S. Food and Drug Administration's Office of Orphan...

New Drugs Offer Hope for Migraine Prevention

April 23, 2014 11:11 am | News | Comments

Two new studies may offer hope for people with migraine. ...

Glioblastoma Vaccine Hits Primary Endpoints in Phase 1

April 23, 2014 11:03 am | News | Comments

Immatics Biotechnologies GmbH, Cancer Research UK and Cancer Research Technology announced that...

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FDA Fast Tracks OncoGenex Drug for Prostate Cancer

April 23, 2014 10:38 am | News | Comments

OncoGenex Pharmaceuticals Inc. announced that the FDA has granted Fast Track designation to the investigation of custirsen when administered in combination with cabazitaxel/prednisone for the treatment of men with metastatic castrate-resistant prostate cancer. Read more...

NIH, Broadview Ventures Fund Stroke Study

April 22, 2014 12:33 pm | News | Comments

ZZ Biotech announced that the National Institutes of Health will support a multicenter Phase 2 clinical trial evaluating the safety, tolerability and activity of its experimental drug, 3K3A-APC, in patients suffering from acute ischemic stroke. Read more...

Pfizer Reports Positive Phase 3 Results for Psoriasis Drug

April 22, 2014 11:46 am | News | Comments

Pfizer announced top-line results from two pivotal Phase 3 trials from the Oral treatment Psoriasis Trials (OPT) Program evaluating the efficacy and safety of tofacitinib, the first in a new class of medicines being investigated for the treatment of moderate-to-severe plaque psoriasis. Read more...

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Zonegran Shows Promise in Children with Partial Epilepsy

April 22, 2014 10:26 am | News | Comments

Zonegran (zonisamide) is well tolerated and efficacious when used as an adjunctive (add-on) treatment for partial epilepsy, with or without secondary generalization, in children aged between six and 17 years for at least one year. Read more...  

GSK, Theravance Launch Phase 3 COPD Trial

April 22, 2014 10:15 am | News | Comments

GlaxoSmithKline and Theravance Inc. announced the start of a Phase 3 efficacy and safety study of a combination treatment of the inhaled corticosteroid (ICS), fluticasone furoate and long-acting beta-2 agonist (LABA), vilanterol (FF/VI). Read more...

Breaking News: Gastric Cancer Drug Approved

April 22, 2014 8:56 am | News | Comments

Lilly announced that the FDA has approved Cyramza for advanced/metastatic gastric cancer or gastroesophageal junction adenocarcinoma with disease progression on/after prior fluoropyrimidine- or platinum-containing chemotherapy. Read more...

Questcor Reports Positive Results for Kidney Disease Drug

April 21, 2014 1:18 pm | News | Comments

Questcor Pharmaceuticals Inc. announced that results from an investigator-initiated clinical study of H.P. Acthar Gel in 20 patients with nephrotic syndrome due to idiopathic membranous nephropathy (iMN) have been published in the journal Nephrology Dialysis Transplantation. Read more...

Cubist Submits Ceftolozane/Tazobactam NDA

April 21, 2014 12:27 pm | News | Comments

Cubist Pharmaceuticals Inc. announced that it has submitted a New Drug Application (NDA) to the FDA for approval of its investigational antibiotic ceftolozane/tazobactam for the treatment of complicated urinary tract infections and complicated intra-abdominal infections. Read more...

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FDA Guides Sarepta on Muscular Dystrophy Drug NDA

April 21, 2014 12:20 pm | News | Comments

Sarepta Therapeutics Inc., a developer of innovative RNA-based therapeutics, announced it plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the end of 2014 for the approval of eteplirsen for the treatment of Duchenne muscular dystrophy (DMD). Read more...

Phase 1/2 Results Positive for Cancer Drug

April 18, 2014 12:20 pm | News | Comments

XBiotech is announcing that results from its Phase 1/2 oncology study conducted at MD Anderson Cancer Center in Houston, TX were published in Lancet Oncology, which describes the outcome in 52 advanced cancer patients treated with Xilonix, XBiotech’s anti-tumor therapy. Read more...

Ivabradine Fast Tracked for Chronic HF

April 18, 2014 12:13 pm | News | Comments

The U.S. Food and Drug Administration (FDA) has granted fast track designation for investigational ivabradine - an oral drug that inhibits the If current (“funny” current) in the sinoatrial node, the body’s cardiac pacemaker - for patients with chronic heart failure (HF). Read more...

FDA Approves Arzerra for Chronic Lymphocytic Leukemia

April 18, 2014 12:03 pm | News | Comments

GlaxoSmithKline and Genmab announced that the FDA has approved a supplemental BLA for the use of Arzerra, a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia. Read more...

Multi-Target TB Drug May Treat Other Diseases, Evade Resistance

April 18, 2014 9:53 am | News | Comments

A drug under clinical trials to treat tuberculosis could be the basis for a class of broad-spectrum drugs that act against various bacteria, fungal infections and parasites, yet evade resistance, according to a new study. Read more...     

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VentiRx Completes Enrollment in Study of Orphan Cancer Drug

April 17, 2014 11:47 am | News | Comments

VentiRx Pharmaceuticals Inc. announced that enrollment has been completed in a Phase 2 trial of VTX-2337 in combination with pegylated liposomal doxorubicin in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer who have failed prior platinum-based chemotherapy. Read more...

'Matrix' Trial Will Advance Personalized Medicine for Lung Cancers

April 17, 2014 10:52 am | Videos | Comments

The "National Lung Matrix" trial, a partnership between Cancer Research UK, AstraZeneca and Pfizer, will give researchers unprecedented access to libraries of drugs developed by the companies, allowing several to be tested at the same time, within one trial. Read more...

Cancer Drugs Block Dementia-Linked Brain Inflammation

April 17, 2014 10:40 am | News | Comments

A class of drugs developed to treat immune-related conditions and cancer– including one currently in clinical trials- eliminates neural inflammation associated with dementia-linked diseases and brain injuries, according to researchers. Read more...

Vaccine Offers Survival Hope for Melanoma Patients

April 17, 2014 10:29 am | News | Comments

Researchers have discovered that a new trial vaccine offers the most promising treatment to date for melanoma that has spread, with increased patient survival rates and improved ability to stop or reverse the cancer. Read more...      

HPV Vaccine Works in HIV+ Women

April 16, 2014 2:00 pm | News | Comments

HIV-positive women respond well to a vaccine against the human papillomavirus (HPV), even when their immune system is struggling, according to newly published results of an international clinical trial, countering doubts about whether the vaccine would be helpful. Read more...

Phase 1 Results Positive for Tumor Vaccine

April 16, 2014 2:00 pm | News | Comments

Celldex Therapeutics Inc. announced that final data from its Phase 1 study of CDX-1401 (an off-the-shelf vaccine that targets dendritic cells) in solid tumors, including long-term patient follow-up, have been published in Science Translational Medicine. Read more...

Small Molecule Shows Potential in Advanced Cancers

April 16, 2014 1:34 pm | News | Comments

Cleveland BioLabs Inc. announced the achievement of all objectives in a Phase 1 clinical trial of CBL0102, or quinacrine, an orally administered small molecule in patients with advanced cancers for which no standard care exists or which had become resistant to conventional therapies. Read more...

Baxter's Orphan Drug Candidate Hits Key Phase 3 Endpoint

April 16, 2014 1:06 pm | News | Comments

Baxter International Inc. announced topline results from a Phase 3 clinical trial evaluating the safety, efficacy and pharmacokinetics of BAX 111, a recombinant von Willebrand factor under investigation for the treatment of bleeding episodes in patients with von Willebrand disease. Read more...

Drug Developers Using New Models, Methods to Boost Clinical Success Rates

April 16, 2014 11:05 am | News | Comments

Drug companies and their development partners who are seeking to increase clinical success rates of new drug candidates are developing tools to help them predict the likelihood of marketing approval and incorporating business planning earlier in clinical development, according to new evidence. Read more...

CBR Starts Cerebral Palsy Stem Cell Study

April 15, 2014 12:45 pm | News | Comments

Cord Blood Registry (CBR) announced the launch of an FDA-regulated clinical trial being conducted at The University of Texas Health Science Center at Houston to investigate two forms of stem cell therapy in children diagnosed with cerebral palsy. Read more...

AbbVie’s Lung Cancer Drug Advances to Phase 3

April 15, 2014 12:20 pm | News | Comments

AbbVie announced the initiation of a global Phase 3 clinical trial evaluating the safety and efficacy of its investigational compound, veliparib, in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer. Read more...

FDA OKs Trials for Vivolux First-in-Class Cancer Drug

April 15, 2014 10:32 am | News | Comments

Vivolux AB announced that the FDA has granted clearance to proceed with VLX600 into clinical Phase 1/2 trials. The drug candidate kills sleeping cell populations in regions of solid tumors that are metabolically compromised due to poor vascularization. Read more...

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