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FDA Fast Tracks OncoGenex Drug for Prostate Cancer

April 23, 2014 | 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...

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Daily news and top headlines for drug research professionals

AMSBIO Expands U.S. Operations

April 23, 2014 12:58 pm | Comments

AMSBIO has announced the opening of a new North American headquarters with executive management facilities in Cambridge, Mass., for its U.S. subsidiary, AMSBIO LLC, recognized  as a leading company contributing to the acceleration of discovery. Read more...

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FDA Clears IND Amendment for Hematologic Cancer Drug

April 23, 2014 12:40 pm | 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...

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Glaucoma Adjunct Restores Vision in Blinding Disorder

April 23, 2014 12:25 pm | Comments

An inexpensive glaucoma drug, acetazolamide, when added to a weight loss plan, can improve vision for women with a disorder called idiopathic intracranial hypertension (IIH), according to a study funded by the National Institutes of Health. Read more...

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Drug Firm Exec Jailed for Insider Trading

April 23, 2014 11:58 am | Comments

A former pharmaceutical executive (John Lazorchak, past director of financial reporting at Celgene Corp.) has been sentenced in federal court, Newark, N.J., to 15 months in prison for his role in an insider trading scheme. Read more...

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Bayer's Ciprofloxacin DPI Gets Orphan Drug Status

April 23, 2014 11:41 am | Comments

Bayer HealthCare announced that the U.S. Food and Drug Administration's Office of Orphan Products Development has granted orphan drug designation for its investigational Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) for the treatment of non-cystic fibrosis bronchiectasis. Read more...

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Lpath, Walter Reed Collaborate on Brain Injury Drug

April 23, 2014 11:23 am | Comments

Lpath Inc., the industry leader in bioactive lipid-targeted therapeutics, and scientists from the Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research (WRAIR), have initiated a study that is the focus of a collaborative research agreement. Read more...

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Sales of Controversial Hep C Drug Total $2.27B

April 23, 2014 11:08 am | Comments

Gilead Sciences said Tuesday that sales of its hepatitis C pill Sovaldi - launched in the United States during December and approved in Europe in January - totaled more than $2 billion in its first full quarter on the market, and it said quarterly net income tripled. Read more...

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Glioblastoma Vaccine Hits Primary Endpoints in Phase 1

April 23, 2014 11:03 am | Comments

Immatics Biotechnologies GmbH, Cancer Research UK and Cancer Research Technology announced that they have entered a license agreement to continue developing its cancer vaccine IMA950 for glioblastoma after positive results from a Phase 1 trial. Read more...

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Alexion's Soliris Gets EC Orphan Status for New Treatment

April 23, 2014 10:30 am | Comments

Alexion Pharmaceuticals Inc. announced that the European Commission has granted an orphan drug designation to Soliris (eculizumab) for the prevention of graft rejection following solid organ transplantation. Read more...          

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Molecules Discovered for Neurodegenerative Diseases

April 22, 2014 1:02 pm | Comments

Researchers from NeuroPhage Pharmaceuticals Inc. have engineered a series of molecules with the potential to treat most neurodegenerative diseases that are characterized by misfolded proteins, such as Alzheimer's, Parkinson's and Huntington's diseases. Read more...

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NIH, Broadview Ventures Fund Stroke Study

April 22, 2014 12:33 pm | 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...

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Sentinel, Oncothyreon Collaborate on Cancer Drugs

April 22, 2014 12:13 pm | Comments

Sentinel Oncology Ltd., the small molecule drug discovery company, announced it has signed a collaboration agreement with Oncothyreon Inc. for development of Sentinel’s Checkpoint Kinase 1 (Chk1) program, under which Sentinel is eligible to receive milestone payments. Read more...

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AbbVie Submits NDA for Hep C Regimen

April 22, 2014 11:54 am | Comments

AbbVie submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the company's investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. Read more...

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Pfizer Reports Positive Phase 3 Results for Psoriasis Drug

April 22, 2014 11:46 am | 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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FDA Accepts Gilead NDAs for HIV Drugs

April 22, 2014 11:34 am | Comments

Gilead Sciences Inc. announced that the FDA has accepted the company’s refiling of two New Drug Applications (NDA) for cobicistat, a pharmacoenhancing or “boosting” agent, and elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults. Read more...

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