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Daily news and top headlines for drug research professionals

Manzo Pharmaceuticals' Probiotic Will Not Need FDA Approval

October 7, 2014 3:05 pm | News | Comments

Manzo Pharmaceuticals Inc. announced that after discussions with the FDA, it has been determined that its long lasting lactose digestive aid, Lacto-Freedom, will not need FDA approval to be released to the public. Read more...           

BMS Won't Pursue FDA Approval for HCV Treatment

October 7, 2014 2:56 pm | News | Comments

Given the rapidly evolving hepatitis C (HCV) treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue U.S. Food and Drug Administration (FDA) approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application (NDA) for asunaprevir. Read more...

FDA Grants Fast Track Designation to NurOwn for the Treatment of ALS

October 7, 2014 2:45 pm | News | Comments

BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell technologies for neurodegenerative diseases, announced that the United States Food and Drug Administration (FDA) has designated NurOwn as a Fast Track product for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease). Read more...

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A New Pathway Discovered Regulating Autoimmune Diseases

October 7, 2014 2:32 pm | News | Comments

The main function of the immune system is to protect against diseases and infections. For unknown reasons our immune system attacks healthy cells, tissues and organs in a process called autoimmunity, which can result in diseases such as multiple sclerosis, type 1 diabetes, lupus or rheumatoid arthritis. There are currently no existing cures for these diseases. Read more...

Vivolux Cancer Drug Receives FDA Clearance for Clinical Study

October 7, 2014 2:21 pm | News | Comments

Vivolux, a pharmaceutical company specialized in cancer treatment, announced that the FDA has granted clearance to proceed with VLX1570 to clinical phase 1/2 for treatment against relapsed and/or refractory multiple myeloma. Read more...        

Experimental Drug Provided to Dallas Ebola Patient

October 7, 2014 10:57 am | by Matthew Perrone, AP Health Writer | News | Comments

A North Carolina drugmaker is providing its experimental antiviral drug to a Dallas patient being treated for Ebola, an emergency step authorized by the Food and Drug Administration. Read more...                                    

Acacia Pharma Gets Positive Results for PONV Treatment

October 7, 2014 10:36 am | News | Comments

 Acacia Pharma announces positive Phase 3 results with APD421 for the management of post-operative nausea & vomiting (PONV). Read more...                                   

Stratophase Announces Results From Collaboration with GSK

October 7, 2014 10:21 am | News | Comments

Stratophase, a world-leading provider of automated feeding systems for the biomanufacturing industry, announced the availability of data from a collaboration with the Biopharm Process Research Group at the GSK Medicine Research Centre, applying the Ranger system for Automated Closed Loop Feeding Control (AFC) to a CHO cell culture. Read more...

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Researchers Develop Personalized Ovarian Cancer Vaccines

October 7, 2014 10:02 am | News | Comments

Researchers at the University of Connecticut have found a new way to identify protein mutations in cancer cells. The novel method is being used to develop personalized vaccines to treat patients with ovarian cancer. Read more...         

Spain Quarantines Three More After Nurse Gets Ebola

October 7, 2014 9:48 am | by Ciaran Giles and Mike Stobbe | News | Comments

Three more people were placed under quarantine for Ebola at a Madrid hospital where a Spanish nurse became infected, authorities said. More than 50 other possible contacts were being monitored. Read more...

Advances in Protein Detection and Quantitation Methods

October 7, 2014 8:30 am | by Nuno Goncalves, Manager of Novel Biomolecular Detection, EMD Millipore | Articles | Comments

Protein detection and quantitation is required daily in thousands of laboratories worldwide for activities ranging from protein characterization to clinical diagnostic testing to drug dosing. Read more...                

Icon Bioscience Reports Last Patient Out in Phase 3 Cataract Study

October 6, 2014 3:30 pm | News | Comments

Icon Bioscience Inc., a specialty biopharmaceutical company focused on utilizing its Verisome drug-delivery platform to develop unique intraocular eye-care therapeutics, announced that the last patient has completed treatment in its pivotal Phase 3 study of IBI-10090. Read more...

Mylan Launches Generic HIV-1 Treatment

October 6, 2014 3:21 pm | News | Comments

Mylan Inc. announced the U.S. launch of its Lamivudine and Zidovudine Tablets USP, 150 mg/300 mg, which is the generic version of Viiv's Combivir. Read more...                                

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Sunesis Pharma Shares Sink

October 6, 2014 3:13 pm | News | Comments

Shares of Sunesis Pharmaceuticals tanked Monday, wiping out all their gains for 2014 and then some, after the drug developer said its treatment for an aggressive form of blood cancer missed its main goal in late-stage testing. Read more...       

AbbVie's Humira Receives FDA Approval for JIA

October 6, 2014 3:04 pm | News | Comments

AbbVie announced that the FDA has approved the extension of the Humira indication for moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) to reducing signs and symptoms in patients ages 2 and older. Read more...

Ariad and Bellicum Announce Revised License Agreement

October 6, 2014 2:52 pm | News | Comments

Ariad Pharmaceuticals Inc. and Bellicum Pharmaceuticals Inc. announced a restructuring of their license agreement for Ariad’s cell-signaling technology. Ariad will receive $50 million in exchange for a fully paid up license to this technology and return of its equity stake in closely held Bellicum. Read more... 

BMS to Study Opdivo in Combination with Novartis' Lung Cancer Drugs

October 6, 2014 2:42 pm | News | Comments

 Bristol-Myers Squibb Company announced the establishment of a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of combining Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) with three molecularly targeted oncology therapies (Zykadia (ceritinib), INC280 and EGF816) from Novartis. Read more...

Actavis Buying Durata Therapeutics for $616.4

October 6, 2014 10:39 am | News | Comments

Specialty pharmaceutical company Actavis is buying Durata Therapeutics Inc. for about $616.4 million to help bolster its infectious disease portfolio. Read more...                                    

Teva Announces Results of Review of Core Specialty Therapeutic Areas

October 6, 2014 10:32 am | News | Comments

Teva Pharmaceutical announced results of its strategic review of core therapeutic areas for the company. The review included an extensive evaluation of Teva’s current and future capabilities to address unmet patient needs, the competitive landscape, barriers to entry and profitability with the purpose of creating a winning strategy to achieve global leadership in each of the company's core therapeutic areas. Read more...

Alcobra Gets Positive Results for Adult ADHD Drug

October 6, 2014 10:22 am | News | Comments

Alcobra Ltd., an emerging pharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced topline results from a Phase 3 study of Metadoxine Extended Release (MDX) in adults with ADHD. Read more...

‘Programmable’ Antibiotic Harnesses Enzyme to Attack Drug-Resistant Microbes

October 6, 2014 10:12 am | News | Comments

The multitude of microbes scientists have found populating the human body have good, bad and mostly mysterious implications for our health. But when something goes wrong, we defend ourselves with the undiscriminating brute force of traditional antibiotics, which wipe out everything at once, regardless of the consequences. Read more...

Journalist with Ebola Arrives at Nebraska Hospital

October 6, 2014 9:57 am | by Josh Funk | News | Comments

An American video journalist who contracted Ebola while working in Liberia has arrived at a Nebraska hospital, where he will be treated for the deadly disease. Ashoka Mukpo, 33, arrived by ambulance Monday at the Nebraska Medical Center, where he will be kept in a specialized biocontainment unit built specifically to handle this type of illness. Read more...

Sanofi Signs 15-Year Supply Agreement for Wearable Injectors with Unilife

October 6, 2014 9:47 am | News | Comments

Unilife Corporation, a developer and supplier of injectable drug delivery systems, announced the signing of a worldwide Master Services and Commercial Supply Agreement with Sanofi to be the sole provider of cartridge based wearable injectors for all of Sanofi's applicable large dose volume drugs, excluding insulins, for a minimum 15 years. Read more...

CEL-SCI Enrolls 16 New Patients in Phase 3 Cancer Trial

October 3, 2014 3:33 pm | News | Comments

CEL-SCI Corp. announced that during the month of September the company enrolled 16 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase 3 trial. Read more...             

New Technology Isolates Tumor Cells from Blood to Optimize Cancer Therapy

October 3, 2014 3:29 pm | News | Comments

A team of bioengineers, molecular biologists, and clinicians used a novel rare cell-sorter to isolate breast cancer cells from the blood of patients, with the aim of identifying the most effective drugs to treat each individual tumor. Read more...

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