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The Lead

Phase 1 Results Positive for Tumor Vaccine

April 16, 2014 2:00 pm | News | Comments

Celldex Therapeutics Inc. announced that final data from its Phase 1 study of CDX-1401 (an off-the-shelf vaccine that targets dendritic cells) in solid tumors, including long-term patient follow-up, have been published in Science Translational Medicine. Read more...

Measles Drug Lowers Viral Load

April 16, 2014 2:00 pm | News | Comments

A novel antiviral drug may protect people infected with the measles from getting sick and...

Small Molecule Shows Potential in Advanced Cancers

April 16, 2014 1:34 pm | News | Comments

Cleveland BioLabs Inc. announced the achievement of all objectives in a Phase 1 clinical trial...

Baxter's Orphan Drug Candidate Hits Key Phase 3 Endpoint

April 16, 2014 1:06 pm | News | Comments

Baxter International Inc. announced topline results from a Phase 3 clinical trial evaluating the...

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Researchers ID New Formulation for Cancer Treatment

April 16, 2014 11:20 am | News | Comments

Researchers have discovered a new way to deliver a tricky drug, dichloroacetate, that may one day make it a viable treatment for numerous forms of cancer. Read more...                       

Drug Developers Using New Models, Methods to Boost Clinical Success Rates

April 16, 2014 11:05 am | News | Comments

Drug companies and their development partners who are seeking to increase clinical success rates of new drug candidates are developing tools to help them predict the likelihood of marketing approval and incorporating business planning earlier in clinical development, according to new evidence. Read more...

SSRI Use During Pregnancy Linked to Autism, Developmental Delays

April 16, 2014 10:57 am | News | Comments

In a study of nearly 1,000 mother-child pairs, researchers found that prenatal exposure to selective serotonin reuptake inhibitors (SSRIs) was associated with autism spectrum disorder (ASD) and developmental delays (DD) in boys. Read more...   

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Judge Blocks Zohydro Ban in Massachusetts

April 16, 2014 10:47 am | by Steve LeBlanc | News | Comments

A federal judge has blocked Massachusetts from banning the powerful new painkiller Zohydro after the maker of the drug, Zogenix, argued in a lawsuit that the ban ordered by Gov. Deval Patrick last month is unconstitutional. Read more...    

FDA Approves GSK's Injectable Diabetes Drug

April 16, 2014 10:00 am | News | Comments

The FDA said Tuesday it approved a new injectable drug from GlaxoSmithKline plc for adults with Type 2 diabetes. The agency cleared the company's drug, Tanzeum, to help patients control their blood sugar levels, in combination with diet and exercise. Read more...

New Product Launches Lift J&J in Q1

April 15, 2014 1:05 pm | by Linda Johnson, AP Business Writer | News | Comments

The world's biggest maker of health care products, such as Tylenol, medical devices and prescription drugs, easily beat Wall Street expectations and raised its earnings outlook, driving up its shares to a new high for the year. Read more...

FDA Approves Merck’s Allergy Immunotherapy

April 15, 2014 12:59 pm | News | Comments

Merck announced that the FDA has approved Grastek (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use, an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis. Read more...   

AbbVie’s Lung Cancer Drug Advances to Phase 3

April 15, 2014 12:20 pm | News | Comments

AbbVie announced the initiation of a global Phase 3 clinical trial evaluating the safety and efficacy of its investigational compound, veliparib, in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer. Read more...

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NICE Recommends Firmagon for Special Cases of Advanced Prostate Cancer

April 15, 2014 11:10 am | News | Comments

The National Institute for Health and Care Excellence issued its Final Appraisal Determination (FAD) recommending Firmagon (degarelix) as an option for treating advanced hormone-dependent prostate cancer, only in adults with spinal metastases who present with signs or symptoms of spinal cord compression. Read more...

Potential New Way to Fight Malaria Drug Resistance

April 15, 2014 10:56 am | News | Comments

An anti-malarial treatment that lost its status as the leading weapon against the deadly disease could be given a new lease of life, with new research indicating it simply needs to be administered differently. Read more...        

Mylan, Prosonix Enter Global Deal on Generic Respiratory Meds

April 15, 2014 10:44 am | News | Comments

Prosonix announced that it has entered into a global licensing agreement with Mylan Inc. for its leading inhaled respiratory products, PSX1001 and PSX1050, being developed as generic versions to GlaxoSmithKline’s pressurized metered dose inhalers. Read more...

FDA OKs Trials for Vivolux First-in-Class Cancer Drug

April 15, 2014 10:32 am | News | Comments

Vivolux AB announced that the FDA has granted clearance to proceed with VLX600 into clinical Phase 1/2 trials. The drug candidate kills sleeping cell populations in regions of solid tumors that are metabolically compromised due to poor vascularization. Read more...

Actavis Agrees to Generess FE Patent Settlement

April 15, 2014 10:22 am | News | Comments

Actavis plc announced that it has entered into an agreement with Mylan Inc. and Famy Care Ltd. to settle all outstanding patent litigation related to Mylan's generic version of Generess FE. Read more...             

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Ex Vivo Data Supports Mast's Sickle Cell Treatment

April 14, 2014 2:19 pm | News | Comments

Mast Therapeutics Inc. announced that, in an ex vivo study, MST-188 reduced the mean erythrocyte sedimentation rate (ESR) by 50% relative to control in blood collected from individuals with sickle cell disease. Read more...         

Lexicon’s Type 1 Diabetes Trial Gets Positive Results

April 14, 2014 1:53 pm | News | Comments

Lexicon Pharmaceuticals Inc. announced positive, top-line results in a Phase 2 clinical trial of LX4211 in type 1 diabetes, which achieved the primary endpoint of reducing mealtime insulin use as well as several secondary endpoints, including improved glycemic control. Read more...

FDA Accepts BI, Lilly NDA for Type 2 Diabetes Combo Tablet

April 14, 2014 1:39 pm | News | Comments

Boehringer Ingelheim and Eli Lilly and Co. announced that the FDA accepted the filing of the New Drug Application (NDA) for the investigational combination tablet of empagliflozin and linagliptin for the treatment of adults with type 2 diabetes. Read more...

BMS Files NDA for HIV Combo Treatment

April 14, 2014 12:59 pm | News | Comments

Bristol-Myers Squibb announced the submission of a new drug application (NDA) to the FDA for a fixed-dose combination of atazanavir sulfate and cobicistat that can increase the level of certain HIV-1 medicines in the blood and make them more effective. Read more...

Ipsen's Dysport Helps Upper Limb Spasticity in Phase 3 Trial

April 14, 2014 11:04 am | News | Comments

Ipsen announced that a first set of results on Phase 3 clinical study of Dysport in the treatment of adults suffering from Upper Limb Spasticity was presented on Saturday at the World Congress for NeuroRehabilitation in Istanbul. Read more...   

Janssen Posts Final Data from Phase 2 COSMOS Study

April 14, 2014 10:44 am | News | Comments

Janssen announced new results from cohort 2 of the Phase 2 COSMOS study demonstrating that 93% of patients with the hepatitis C virus (HCV) and advanced liver fibrosis who were treated with simeprevir and Gilead's sofosbuvir achieved sustained virologic response 12 weeks after the end of treatment (SVR12). Read more...

Abbvie’s Ribavirin Promising for Hep C Patients with Liver Cirrhosis

April 14, 2014 10:13 am | News | Comments

AbbVie announced results from the Phase 3 TURQUOISE-II, which evaluated the efficacy and safety of 12 weeks or 24 weeks of treatment with AbbVie's regimen with ribavirin (RBV) in adult patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection with compensated liver cirrhosis. Read more...

Collaboration Advances Use of Antibody Drug Conjugates

April 11, 2014 1:23 pm | News | Comments

PolyTherics Ltd. announced an extension to its ThioBridge antibody drug conjugate (ADC) collaboration with MacroGenics Inc., a U.S. biotechnology company developing innovative medicines utilizing its next generation antibody technologies. Read more...

After Setback, Impax Resubmits Parkinson’s NDA

April 11, 2014 12:36 pm | News | Comments

Impax Pharmaceuticals, a division of Impax Laboratories Inc., announced today the resubmission of Impax's NDA for Rytary (IPX066) to the FDA. IPX066 is a patented extended- release capsule formulation of carbidopa and levodopa, an investigational drug for the symptomatic treatment of Parkinson's disease. Read more...

AbbVie's Hep C Regimen Posts Promising Phase 3 Results

April 11, 2014 10:36 am | News | Comments

AbbVie announced that in two Phase 3 studies, adult, non-cirrhotic patients with chronic genotype 1 hepatitis C virus infection receiving the investigational regimen with ribavirin (RBV) for 12 weeks achieved sustained virologic response rates 12 weeks post-treatment of about 96%. Read more...

Judge Enforces Generic Frova Settlement in Favor of Mylan

April 11, 2014 10:12 am | News | Comments

Mylan Inc. confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan, settling patent litigation in connection with Mylan's generic version of Frova. Read more...   

Sovaldi Continues to Excel in Trials with Hep C, Advanced Liver Disease

April 11, 2014 10:01 am | News | Comments

Gilead Sciences Inc. announced data from two Phase 2 studies and a compassionate access study in which a regimen containing once-daily Sovaldi was administered for the treatment of chronic hepatitis C virus infection in patients with advanced liver disease. Read more...

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