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The Lead

Thyroid Cancer Drug Approved for Accelerated Assessment

July 31, 2014 1:59 pm | News | Comments

The European Medicines Agency has approved Eisai's request for accelerated assessment of the investigational oral multiple receptor tyrosine kinase inhibitor lenvatinib, for the treatment of patients with progressive radioiodine-refractory, differentiated thyroid cancer. Read more...

AFFiRiS, MJFF Make Progress on Parkinson's Vaccine

July 31, 2014 1:56 pm | News | Comments

AFFiRiS announced results of a Phase 1 clinical trial of PD01A, a vaccine against Parkinson's...

Kala Initiates Phase 2 Eye Drug Trials

July 31, 2014 1:43 pm | News | Comments

Kala Pharmaceuticals Inc. announced the initiation of two Phase 2 clinical trial to evaluate KP-...

Cannabis Science to Test Multiple Strains for Clinical Development

July 31, 2014 1:36 pm | News | Comments

Cannabis Science Inc. announced that it has commenced production of multiple strains of cannabis...

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Cholesterol Drug Hits Primary Endpoint in Nine Trials

July 31, 2014 9:41 am | News | Comments

Sanofi and Regeneron announced that nine new Phase 3 ODYSSEY trials of alirocumab in people with hypercholesterolemia met their primary efficacy endpoint of a greater percent reduction from baseline in low-density lipoprotein cholesterol at 24 weeks compared to placebo or active comparator. Read more...

Naltrexone May Diminish ICD Symptoms in Parkinson's Patients

July 31, 2014 9:34 am | News | Comments

A team of investigators conducted a pilot study and found that the opioid antagonist naltrexone may be an effective treatment for diminishing symptoms of impulse control disorders (ICDs) in Parkinson's disease patients. Read more...    

AstraZeneca, Almirall Strike Deal on Respiratory Franchise

July 31, 2014 9:17 am | News | Comments

AstraZeneca announced that it has entered an agreement to transfer to the company the rights to Almirall’s respiratory franchise for an initial consideration of $875 million on completion, and up to $1.22 billion in development, launch and sales-related milestones. Read more...

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Illinois Medicaid Restricts Sovaldi Use

July 31, 2014 9:10 am | by Carla L. Johnson, AP Medical Writer | News | Comments

Facing ballooning costs for a $1,000 pill to treat hepatitis C, Illinois' Medicaid program is putting tight restrictions in place, including requiring patients to meet 25 criteria and get prior approval before the government program will pay for the new drug. Read more...

France is 17th Country to Allow Patient Enrollment in Head, Neck Cancer Trial

July 31, 2014 8:44 am | News | Comments

CEL-SCI Corp. announced that the French Agency for the Safety of Health Products has cleared the company to commence patient enrollment for its Phase 3 Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Injection) in France. Read more...

Protein May Prevent Antibody-Mediated Transplant Rejection

July 31, 2014 8:40 am | News | Comments

A study presented at the 2014 World Transplant Congress evaluated the safety and efficacy of CSL Behring's C1 Inhibitor (C1-INH) concentrate in preventing antibody-mediated rejection following kidney transplants in highly sensitized patients. Read more...

CHMP Has More Issues with Weight Loss Drug

July 31, 2014 8:34 am | News | Comments

Orexigen Therapeutics Inc. announced it has received the Day 180 List of Outstanding Issues from the European Medicines Agency's Committee for Medicinal Products for Human Use for the NB32 (naltrexone sustained release (SR) / bupropion SR) Marketing Authorization Application. Read more...

FDA Approves Eylea for Third Indication

July 30, 2014 2:34 pm | News | Comments

Regeneron Pharmaceuticals Inc. announced that the FDA has approved Eylea (aflibercept) Injection for the treatment of Diabetic Macular Edema (DME). Read more...                          

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Treatment Combo Benefits Lung Cancer Patients

July 30, 2014 2:04 pm | News | Comments

A combination of the EGFR-targeted anticancer therapeutics Gilotrif and Erbitux yielded clinical responses in 29% of patients who had lung cancer harboring epidermal growth factor receptor mutations that had stopped responding to other inhibitors, according to new data. Read more...

New Route to ID Bacterial Infection Drugs

July 30, 2014 1:41 pm | News | Comments

About 100 drugs already approved by the FDA for other purposes can also prevent the growth of certain bacterial pathogens inside human cells, including those that cause Legionnaires’ disease, brucellosis, and Mediterranean spotted fever. Read more... 

Pfizer Buying Two Baxter Vaccines for $635M

July 30, 2014 1:26 pm | News | Comments

Pfizer will spend $635 million on two vaccines owned by Baxter International that are sold in a number of European countries and other locations outside of the U.S. Read more...                     

Diabetes Drugs Get Positive CHMP Opinions for CV Safety Updates

July 30, 2014 10:58 am | News | Comments

Takeda Pharmaceuticals International GmbH announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued positive opinions for updates to the Summary of Product Characteristics for Vipidia and the fixed-dose combination therapies Vipdomet and Incresync. Read more...

AstraZeneca, Kyowa Hakko Kirin Partner on Immuno-Oncology Study

July 30, 2014 10:48 am | News | Comments

AstraZeneca announced that it has entered into a clinical study collaboration with Kyowa Hakko Kirin for a Phase 1/1b immuno-oncology study that will evaluate the safety and efficacy of two separate combinations of three investigational compounds in multiple solid tumors. Read more...

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European Commission Approves Eliquis for DVT, PE

July 30, 2014 10:37 am | News | Comments

Bristol-Myers Squibb Co. and Pfizer Inc. announced that the European Commission has approved Eliquis (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of recurrent DVT and PE in adults. Read more...

Impax Labs Slumps After Problems with FDA Inspection

July 30, 2014 8:28 am | News | Comments

Shares of Impax Labs sank Tuesday after an FDA inspection uncovered potential problems at a facility where the company will make its experimental Parkinson's disease drug Rytary. Read more...                  

Cancer Challenge Attracts Anonymous $100M Gift

July 29, 2014 2:54 pm | News | Comments

Oregon Health & Science University’s Knight Cancer Institute has received a $100 million gift to fuel its ambitious vision to stop cancer in its tracks. Read more...                       

Neurotrope Initiates Phase 2a Alzheimer's Treatment Study

July 29, 2014 2:48 pm | News | Comments

Neurotrope Inc. announced that it has initiated a Phase 2a clinical trial to evaluate bryostatin for the treatment of patients with Alzheimer's disease (AD). Read more...                       

FDA Approves Expanded Use of Imbruvica

July 29, 2014 2:43 pm | News | Comments

The FDA has approved the supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Read more...        

Forced Mutations Doom HIV

July 29, 2014 2:32 pm | News | Comments

Fifteen years ago, researchers thought if they could induce the HIV virus to mutate uncontrollably, they could force it to weaken and eventually die out. But in a 2011 clinical trial, a drug based on this method did not eliminate the virus from patients. Now, researchers are aiming to develop better versions of that drug. Read more...

$1,000 Sovaldi Now Choice Hep C Treatment

July 29, 2014 12:28 pm | by Ricardo Alonso-Zaldivar | News | Comments

The price may be high but so is demand. A new $1,000-per-pill drug has become the treatment of choice for Americans with hepatitis C, a liver-wasting disease that affects more than 3 million. Read more...             

Glaucoma Drug Gets EU Approval

July 29, 2014 11:18 am | News | Comments

Alcon, the global leader in eye care and a division of Novartis, announced that Simbrinza eye drops suspension has been approved by the European Commission to decrease elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, for which monotherapy provides insufficient IOP reduction. Read more...

European Commission Approves Leukemia Drug

July 29, 2014 11:04 am | News | Comments

Roche announced that the European Commission has approved Gazyvaro (obinutuzumab) in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia who have comorbidities making them unsuitable for an intensive therapy (full-dose fludarabine based therapy). Read more...

Merck Serono Kicks Off Study of Merkel Cell Carcinoma Drug

July 29, 2014 10:59 am | News | Comments

Merck Serono, the biopharmaceutical division of Merck, announced the initiation of an international Phase 2 study designed to assess the efficacy and safety of MSB0010718C, an investigational fully human IgG1 monoclonal antibody that binds to programmed death-ligand 1 (PD-L1). Read more...

Merck Profit More Than Doubles in Q2

July 29, 2014 8:28 am | by Linda A. Johnson | News | Comments

A big one-time gain and a tax benefit helped drugmaker Merck & Co. more than double its second-quarter profit, raise the lower end of its profit forecast and easily top analysts' expectations. Read more...           

FDA Rejects Zalviso Pain Treatment System

July 28, 2014 12:45 pm | News | Comments

AcelRx Pharmaceuticals Inc. announced that the FDA has issued a Complete Response Letter (CRL) for the company's NDA for Zalviso. The CRL contains requests for additional information on the system to ensure proper use of the device. Read more... 

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