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Daily news and top headlines for drug research professionals

Insys Updates Timing of NDA for Dronabinol Oral Solution

July 9, 2014 11:18 am | News | Comments

Insys Therapeutics Inc. announced the successful completion of a human abuse study for Dronabinol Oral Solution, its proprietary, orally administered liquid formulation of the synthetic cannabinoid dronabinol in development for the treatment of CINV and anorexia associated with weight loss in patients with AIDS. Read more...


BI Posts Positive Results for Leukemia Drug

July 9, 2014 11:12 am | News | Comments

Results from a Phase 2 study that compared volasertib plus low-dose cytarabine (LDAC), a form of chemotherapy, versus LDAC alone in older patients with untreated acute myeloid leukemia (AML) were published in the American Society of Hematology journal Blood. Read more...


Actavis Confirms Generic Ampyra Patent Challenge

July 9, 2014 11:06 am | News | Comments

Actavis plc confirmed that it has filed an Abbreviated NDA with the U.S. FDA seeking approval to market Dalfampridine Extended-release Tablets, 10 mg, a generic version of Acorda Therapeutics' Ampyra, which is indicated as a treatment to improve walking in patients with multiple sclerosis. Read more...


Glioblastoma Cells Disrupt Blood-Brain Barrier

July 9, 2014 10:59 am | News | Comments

Invading glioblastoma cells may hijack cerebral blood vessels during early stages of disease progression and damage the brain’s protective barrier, a study in mice indicates, a finding that may lead to new ways to bring about the death of the tumor, increasing our ability to treat glioblastoma patients. Read more...


EU Antitrust Fines Drugmakers $580M

July 9, 2014 10:50 am | News | Comments

The European Union's antitrust body is imposing a fine of 428 million euros ($580 million) on France's pharmaceutical company Servier and five producers of generic medicines for distorting competition, by striking a series of deals with the producers of generic medicines to protect Perindopril from price competition. Read more...


CardioCell Launches Phase 2a Chronic Heart Failure Trial

July 8, 2014 3:19 pm | News | Comments

CardioCell LLC announced the start of its Phase 2a clinical trial for chronic heart failure (HF) patients with non-ischemic cardiomyopathy. Read more...                            


FDA Approves NovoSeven for Glanzmann's Thrombasthenia

July 8, 2014 3:12 pm | News | Comments

Novo Nordisk announced the FDA approved NovoSeven RT as the first recombinant treatment for bleeding episodes and perioperative management in patients with Glanzmann's Thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets. Read more...


FDA Grants Priority Review to Purdue’s Abuse-Deterrent Pain Drug

July 8, 2014 3:05 pm | News | Comments

Purdue Pharma L.P. announced that the FDA has granted Priority Review designation for the company’s once-daily, single-entity hydrocodone bitartrate tablet (HYD). Read more...                      


Nanoparticles Can Enhance Cisplatin in Chemotherapy

July 8, 2014 2:19 pm | News | Comments

Researchers have developed a new formulation of cisplatin, a common chemotherapy drug, that significantly increases the drug's ability to target and destroy cancerous cells. Read more...                   


Newly Discovered Compounds Could Affect Circadian Rhythm

July 8, 2014 2:08 pm | News | Comments

Scientists have discovered a surprising new role for a pair of compounds that have the potential to alter circadian rhythm. At least one of these compounds could be developed to uncover new therapeutic approaches to a range of disorders. Read more...


AbbVie Raises Bid for Shire to $51.3B

July 8, 2014 1:51 pm | News | Comments

U.S. drugmaker AbbVie has boosted its offer for Shire by 11 percent to about $51.3 billion, hoping it will be enough to pique the interest of its British counterpart. Read more...                     


AstraZeneca, Max Planck Institute Create Satellite Chemistry Unit

July 8, 2014 10:46 am | News | Comments

AstraZeneca announced an agreement with the Max Planck Institute of Molecular Physiology, Germany, to establish a "satellite unit" in cardiovascular and metabolic disease (CVMD), linked to AstraZeneca’s CVMD Innovative Medicines unit in Mölndal, Sweden, to study new modalities chemistry. Read more...


FDA Accepts NDA for Sanofi's Basal Insulin

July 8, 2014 10:40 am | News | Comments

Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), an investigational basal insulin, formerly abbreviated as "U300." Read more...


Japan Approves First All-Oral, Interferon- and Ribavirin-Free Hep C Treatment

July 8, 2014 10:34 am | News | Comments

Bristol-Myers Squibb announced that the Japanese Ministry of Health, Labor and Welfare has approved Daklinza, a potent, pan-genotypic NS5A replication complex inhibitor, and Sunvepra, a NS3/4A protease inhibitor, providing a new treatment that can lead to cure for many patients in Japan who currently have no treatment options. Read more...


Merck Serono Funds Scientific Innovation

July 8, 2014 10:22 am | News | Comments

Merck Serono, the biopharmaceutical division of Merck, announced the launch of Merck Global Grants – a program that underscores the company’s commitment to funding scientific innovation and independent medical education around the world. Read more...



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