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FDA Accepts Gilead NDAs for HIV Drugs

April 22, 2014 11:34 am | News | 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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DDD Update

Daily news and top headlines for drug research professionals

Molecules Discovered for Neurodegenerative Diseases

April 22, 2014 1:02 pm | News | 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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Sentinel, Oncothyreon Collaborate on Cancer Drugs

April 22, 2014 12:13 pm | News | 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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On the Hunt for Safer Alternatives to NSAIDs

April 22, 2014 10:54 am | News | Comments

Nonsteroidal antinflamatory drugs (NSAIDs) that block an enzyme called COX-2 relieve pain and inflammation but can cause heart attacks, stroke, heart failure or sudden cardiac death. This has prompted a decade-plus search for safer, but still effective, alternatives to these drugs. Read more...

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Sanofi Selling Cell Therapy, Regenerative Medicine Businesses

April 22, 2014 10:43 am | News | Comments

Aastrom Biosciences Inc. announced that it has entered into a definitive agreement to acquire Sanofi's Cell Therapy and Regenerative Medicine (CTRM) business for a purchase price of $6.5 million. 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...  

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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...

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Valeant, Ackman Make $45.6B Allergan Bid

April 22, 2014 9:28 am | News | Comments

Valeant Pharmaceuticals and activist investor Bill Ackman have unveiled details of their offer to buy Botox maker Allergan, proposing a cash-and-stock deal that could be worth about $45.6 billion. Read more...           

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Novartis Reshapes Business with GSK, Lilly Deals

April 22, 2014 9:28 am | by John Heilprin | News | Comments

Swiss pharmaceutical firm Novartis AG launched a major overhaul of its business Tuesday, unveiling a series of multibillion-dollar deals with Britain's GlaxoSmithKline PLC and the U.S.'s Eli Lilly & Co. that heralds more restructuring in the fast-changing industry. Read more...

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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...

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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...

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MSU Physicists Push Parkinson’s Drug Toward Clinical Trials

April 21, 2014 12:56 pm | News | Comments

The most effective way to tackle debilitating diseases is to punch them at the start and keep them from growing, as shown in research by physicists at Michigan State University, published in the Journal of Biological Chemistry. Read more...

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Inhaled Pirfenidone Shows Promise in Lung Fibrosis

April 21, 2014 12:35 pm | News | Comments

Genoa Pharmaceuticals, the leader in inhaled medicines for pulmonary fibrosis, and collaborators Drs. Martin Kolb and Kjetil Ask at McMaster University announced additional measured advantages of inhaled GP-101 (aerosol pirfenidone) in the treatment of idiopathic pulmonary fibrosis (IPF). Read more...

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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...

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Emergent’s BioThrax Granted Orphan Drug Status

April 21, 2014 12:10 pm | News | Comments

Emergent BioSolutions Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BioThrax (Anthrax Vaccine Adsorbed) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis. Read more...

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