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The Lead

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...

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...

AbbVie Submits NDA for Hep C Regimen

April 22, 2014 11:54 am | News | Comments

AbbVie submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)...

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...

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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...

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...

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...  

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...

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...           

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...

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...

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...

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...

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...

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...

Biogen in License Agreement with Amunix for XTENylated Factor VIII

April 21, 2014 10:42 am | News | Comments

Amunix Operating Inc. announced that Biogen Idec has exercised its option to enter into an exclusive, worldwide license agreement to research and develop novel, fully-recombinant Factor VIII products with improved therapeutic properties. Read more...

$14M Awarded in Suit Linking Yasmin, Stroke

April 21, 2014 10:01 am | News | Comments

A jury has awarded $14 million to a suburban Chicago woman who sued her doctor over a debilitating stroke she suffered after taking Bayer's birth control drug Yasmin. Read more...                 

Court Declines to Block Ruling in Teva Patent Case

April 21, 2014 8:30 am | by Sam Hananel | News | Comments

Supreme Court Chief Justice John Roberts on Friday declined to temporarily block a lower court ruling that opens the world's best-selling multiple sclerosis drug to competition from generic rivals next month. Read more...         

Breaking News: Cubist Recalls Cubicin Lot

April 18, 2014 2:02 pm | News | Comments

Cubist Pharmaceuticals Inc. announced it is voluntarily recalling one lot of Cubicin (daptomycin for injection) to the user level due to the presence of particulate matter, reported via customer complaint and identified as glass particles. 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...

Anti-Seizure Drug Could Reduce Alcohol Consumption

April 18, 2014 10:34 am | News | Comments

Researchers have discovered that the anti-seizure drug ezogabine, reduced alcohol consumption in an experimental model. The findings may lead to more effective treatments for alcoholism. Read more...               

Actavis to Acquire New Products from Akorn

April 18, 2014 10:19 am | News | Comments

Actavis plc announced that it has entered into agreements with Akorn Inc. and Hi-Tech Pharmacal Co. Inc. to purchase four currently marketed products and one product under development for cash consideration. 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...     

Canada is First to Approve GSK's New COPD Drug

April 18, 2014 9:43 am | News | Comments

GlaxoSmithKline announced that Incruse Ellipta has received world-first market authorization in Canada for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD. Read more...       

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