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Daily news and top headlines for drug research professionals

Celgene's Abraxane Approved for Pancreatic Cancer in Australia

March 18, 2014 10:53 am | News | Comments

Australian biopharmaceutical company Specialized Therapeutics Australia announced that Abraxane, in combination with gemcitabine, is now approved by Australia's Therapeutic Goods Administration for the treatment of metastatic pancreatic cancer. Read more...

Amgen Drug Hits Endpoint of Cholesterol Reduction

March 18, 2014 10:44 am | News | Comments

Amgen announced that the Phase 3 TESLA trial evaluating evolocumab met its primary endpoint of the percent reduction from baseline at week 12 in low-density lipoprotein cholesterol (LDL-C). Read more...              

FDA OKs Phase 2 Trial in Orphan Mitochondrial Disease

March 18, 2014 10:38 am | News | Comments

Edison Pharmaceuticals announced that the company's Investigative New Drug (IND) application to initiate "A Phase 2 Safety and Efficacy Study of EPI-743 (Vincerinone) in Children with Pearson Syndrome," was approved by the FDA. Read more... 

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New Imaging Approach Speeds Prostate Cancer Drug Testing

March 18, 2014 10:26 am | News | Comments

Scientists have developed a new way to test the effectiveness of a drug for prostate cancer that has spread to the bone, which is currently incurable, according to new research. Read more...                 

Astellas, Medivation Want New Cancer Indication for Xtandi

March 18, 2014 8:22 am | News | Comments

Astellas Pharma and Medivation announced the submission of a supplemental New Drug Application to the FDA seeking approval of Xtandi capsules for the treatment of men with metastatic castration-resistant prostate cancer who have not received chemotherapy. Read more...

AstraZeneca Makes Progress on Global Brilinta Trial

March 17, 2014 3:13 pm | News | Comments

AstraZeneca announced it has completed patient enrollment approximately four months ahead of plan in the Phase 3 clinical trial EUCLID studying Brilinta (ticagrelor) tablets. Read more...                 

Cirrhosis Drug Hits Primary Endpoints in Phase 3

March 17, 2014 2:52 pm | News | Comments

Intercept Pharmaceuticals Inc. announced that its international Phase 3 POISE trial of obeticholic acid (OCA) for the treatment of primary biliary cirrhosis (PBC) hit the primary endpoint of achieving a reduction in serum alkaline phosphatase. Read more...

Amgen's Cancer Drug Shrinks Melanoma Tumors

March 17, 2014 2:21 pm | News | Comments

Amgen announced findings from a pre-specified retrospective analysis of patients with metastatic melanoma that showed talimogene laherparepvec reduced the size of melanoma tumors. Read more...                 

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BMS in $50.5M Deal with Five Prime

March 17, 2014 12:25 pm | News | Comments

Drugmakers Bristol-Myers Squibb and Five Prime Therapeutics said Monday they will work together on experimental immune therapies for cancer. The companies say they will study therapies that affect two targets in immune checkpoint pathways identified by Five Prime. Read more...

First Patients Enrolled into European CKD-Associated Anemia Trial

March 17, 2014 11:05 am | News | Comments

Astellas Pharma Europe Ltd. announced that the first European patients have been enrolled into the global ALPINE program being conducted in collaboration with FibroGen Inc. to investigate the safety and efficacy of roxadustat, a potential new treatment for anemia in people with chronic kidney disease. Read more...

FDA Fast Tracks Edison's New Friedreich's Ataxia Drug

March 17, 2014 10:53 am | News | Comments

Edison Pharmaceuticals announced that the FDA granted Fast Track designation to EPI-743, the company's lead drug, for the treatment of Friedreich's ataxia. Read more...                       

Medivir Presents New Phase 3 Simeprevir Data

March 17, 2014 10:39 am | News | Comments

Medivir AB announced that new Phase 3 data for the once-daily protease inhibitor simeprevir have been presented at the Conference of the Asian Pacific Association for the Study of the Liver (APASL) in Brisbane, Australia. Read more...      

Shire Recalls VPRIV Batch for Particulate Matter

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

Shire Pharmaceuticals announced today the initiation of a voluntary recall in the United States of one batch, packaged into three lots, of VPRIV due to the presence of visible particulate matter, identified as stainless steel and barium sulfate. Read more...

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Daiichi Sankyo Files NDA in Japan for Toxic Blood Drug

March 16, 2014 9:21 pm | by Daiichi Sankyo | News | Comments

Daiichi Sankyo Co. Ltd. announced that it has filed an NDA for the manufacture and marketing in Japan of the methaemoglobinaemia injection Methylene Blue (INN: Methylthioninium chloride). Read more...               

Supplements Could Prevent Drug-Induced Hearing Loss

March 14, 2014 3:18 pm | News | Comments

Researchers have discovered that a dietary supplement shows promise for protecting against drug-induced hearing loss when taken during gentamicin treatment for people with bacterial infections. Read more...             

Molecule May Help Fight Cancer Drug Resistance

March 14, 2014 3:04 pm | News | Comments

A group of researchers has discovered that a deubiquitinase complex, USP1-UAF1, may be a key regulator of the DNA damage response and a target for overcoming resistance to platinum-based anticancer drugs. Read more...         

Merck’s Noxafil Approved at New Dose for Intravenous Use

March 14, 2014 2:47 pm | News | Comments

Merck announced that the FDA has approved a new formulation of Noxafil (posaconazole) injection for intravenous (IV) use. Merck now provides an IV formulation and two oral formulations of Noxafil for prophylaxis against invasive Aspergillus and Candida infections. Read more...

FDA Approves New Blood Clot Use for Eliquis

March 14, 2014 2:22 pm | News | Comments

Bristol-Myers Squibb and Pfizer announced that the FDA approved a Supplemental New Drug Application for Eliquis for the prophylaxis of DVT, which may lead to pulmonary embolism, in patients who have undergone hip or knee replacement surgery. Read more...

New Personalized Cancer Treatment Trial Begins in UK

March 14, 2014 11:07 am | News | Comments

The first human trial of a pioneering personalized cancer treatment developed at Oxford University will begin this week, with the potential to tackle a wide range of late-stage cancers. Read more...               

Bayer Kicks Off Phase 3b Riociguat Trial in PAH Patients

March 14, 2014 10:53 am | News | Comments

Bayer HealthCare announced the enrollment of the first patient in a Phase 3b pilot study, RESPITE, designed to evaluate the clinical effects of riociguat in patients with pulmonary arterial hypertension who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors. Read more...

Alexza, Ferrer Launch Adasuve Agitation Drug in Romania

March 14, 2014 10:40 am | News | Comments

Alexza Pharmaceuticals Inc. and Ferrer announced that Adasuve inhalation powder, inhalation therapy for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder, is now available in Romania. Read more...

Novartis Meningitis B Vaccine Gets Recommendation in Australia

March 14, 2014 10:08 am | News | Comments

Novartis announced that Australia has joined the growing number of countries where Bexsero (Meningococcal Group B Vaccine) has received a clinical recommendation for the vaccine's routine use to help protect against meningitis B. Read more...

FDA Accepts NDA for Kidney Transplant Rejection Drug

March 13, 2014 3:21 pm | News | Comments

Veloxis Pharmaceuticals A/S announced the FDA accepted for standard review the company's New Drug Application (NDA) for Envarsus for the prevention of organ rejection in adult kidney transplant patients. Read more...         

FDA Chief Defends Zohydro Approval

March 13, 2014 2:08 pm | News | Comments

The head of the Food and Drug Administration said Thursday that the much-debated painkiller Zohydro fills an "important and unique niche" for treating pain. Read more...                       

Pfizer Will Appeal Celebrex Patent Ruling

March 13, 2014 1:59 pm | News | Comments

A U.S. court on Wednesday invalidated the key patent for one of Pfizer's most lucrative medicines, potentially opening the door for cheaper generic versions 18 months sooner than expected and cutting into the drugmaker's profit. Read more...    

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