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Daily news and top headlines for drug research professionals

Isis Earns $2M from the Advancement of SMA Drug

August 15, 2014 2:07 pm | News | Comments

Isis Pharmaceuticals Inc. announced that it has earned a $2 million milestone payment from Biogen Idec related to the advancement of the ongoing open-label extension study of ISIS-SMNRx in children with spinal muscular atrophy. Read more...    

FDA Accepts BLA for Meningococcal Vaccine

August 15, 2014 10:18 am | News | Comments

Pfizer Inc. announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for bivalent recombinant LP2086, the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds. Read more...

FDA Approves Avastin in Cervical Cancer

August 15, 2014 10:00 am | News | Comments

Roche announced that the U.S. Food and Drug Administration (FDA) approved Avastin (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix. Read more...

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Chikungunya Vaccine Induces Robust Antibody Response

August 15, 2014 9:55 am | News | Comments

An experimental vaccine to prevent the mosquito-borne viral illness chikungunya elicited neutralizing antibodies in all 25 adult volunteers who participated in a recent early-stage clinical trial conducted by researchers at the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Read more...

Amgen Multiple Myeloma Drug Misses Phase 3 Endpoint

August 14, 2014 3:24 pm | News | Comments

Amgen and its subsidiary Onyx Pharmaceuticals Inc. announced that the Phase 3 clinical trial FOCUS did not meet its primary endpoint of improving overall survival (OS). Read more...                   

Breaking News: NewLink Genetics to Test Ebola Vaccine

August 14, 2014 12:48 pm | by Tom Murphy, AP Business Writer | News | Comments

An Iowa drug developer is preparing to test a possible Ebola vaccine in humans, as scientists race to develop ways to prevent or fight a virus that has killed more than 1,000 people in a West African outbreak and for which there is no proven treatment or vaccine. Read more...

Post-EMA Approval Studies for Agitation Drug Progressing

August 14, 2014 11:08 am | News | Comments

Alexza Pharmaceuticals Inc. provided an update on its European Medicines Agency (EMA) post-approval studies for Adasuve inhalation powder, pre-dispensed (loxapine), of which two have been completed and the data submitted to the EMA. Read more...

Severe Asthma Drug Advances to Phase 3

August 14, 2014 10:47 am | News | Comments

AstraZeneca announced the start of the Phase 3 program for tralokinumab, a potential treatment for patients with severe, inadequately controlled asthma, developed by MedImmune, the company’s global biologics research and development arm. Read more...

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NEJM Publishes Positive Data for High-Dose Flu Vaccine

August 14, 2014 10:42 am | News | Comments

Sanofi Pasteur announced that The New England Journal of Medicine published positive results from a large-scale, multi-center efficacy trial, which found that Fluzone High-Dose (Influenza Vaccine) was more efficacious in preventing influenza in adults 65 years of age and older compared to standard-dose Fluzone vaccine. Read more...

Rigel Dry Eye Drug Misses Endpoints in Phase 2

August 13, 2014 2:42 pm | News | Comments

Rigel Pharmaceuticals Inc. announced that R348, its ophthalmic JAK/SYK inhibitor, did not meet the primary or secondary endpoints in a recently completed Phase 2 clinical study in patients with dry eye disease. Read more…         

Cardium's Gene Therapy 'Highly Warranted' for Heart Disease Subset

August 13, 2014 2:37 pm | News | Comments

Cardium Therapeutics announced the publication of a review article that concludes a gene therapy product promoting the growth of blood vessels is "highly warranted" to treat worldwide heart-disease patients. Read more...         

Chagas Disease Drug Candidate Hits Phase 2

August 13, 2014 2:27 pm | Videos | Comments

The Drugs for Neglected Diseases initiative announced the launch of a Phase 2 drug trial to test fexinidazole, a drug shelved in the 1980s and "rediscovered" by DNDi nearly a decade ago, for Chagas disease (American trypanosomiasis) patients. Read more...

Epizyme Presents Early-Phase Data on Cancer Drug

August 13, 2014 11:24 am | News | Comments

Epizyme Inc. reported pre-clinical data and early clinical observations from an ongoing Phase 1 trial, being conducted in collaboration with Eisai, the Institut Gustave Roussy, and the Institut Bergonie, of EZH2 inhibitor EPZ-6438 (E7438) in patients with advanced solid tumors and B-cell lymphomas. Read more...

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AstraZeneca’s Gout Drug Achieves Positive Results

August 13, 2014 11:12 am | News | Comments

AstraZeneca announced positive top-line results from CLEAR1, CLEAR2 and CRYSTAL, the pivotal Phase 3 clinical trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor (SURI), as a combination therapy for the treatment of patients with symptomatic gout. Read more...

Pfizer Posts Mixed Results from Chinese Lyrica Studies

August 13, 2014 11:08 am | News | Comments

Pfizer Inc. announced top-line results from two placebo-controlled studies conducted in China with Lyrica (pregabalin) in patients with postherpetic neuralgia (pain after shingles or PHN) and painful diabetic peripheral neuropathy (pDPN), respectively. Read more...

MJFF Highlights Promising Parkinson's Disease Drug Research

August 12, 2014 3:21 pm | News | Comments

Research projects from five groups active in Parkinson's research comprise the 2014 first half (1H 2014) of The Michael J. Fox Foundation for Parkinson's Research (MJFF) Partnering Program. Read more...                

Clinical Trial Evaluates Safety of Stem Cell Transplantation in Spine

August 12, 2014 2:41 pm | Videos | Comments

Researchers have launched a clinical trial to investigate the safety of neural stem cell transplantation in patients with chronic spinal cord injuries. This Phase 1 clinical trial is recruiting eight patients for the five-year study. Read more...

Cortendo Enrolls First Patient into Cushing’s Study

August 12, 2014 11:43 am | News | Comments

Cortendo AB announced that the first patient has been enrolled into the Phase 3 SONICS trial, i.e., “Study of NormoCort in Cushing’s Syndrome,” after successfully completing its European Investigator meeting supporting SONICS. Read more...

Prosensa, CureDuchenne Strengthen Collaboration

August 12, 2014 11:38 am | News | Comments

Prosensa Holding N.V. announced that an affiliate of CureDuchenne will provide Prosensa with up to €5 million by means of convertible promissory notes to support the company and accelerate the development and patient access of much needed DMD therapies. Read more...

Intercept Liver Drug Excels in Trial

August 12, 2014 9:21 am | News | Comments

Shares of Intercept Pharmaceuticals Inc. soared in premarket trading Tuesday, a day after the drug developer said its most advanced candidate performed better than a placebo in a mid-stage study of patients with a form of chronic liver disease. Read more...

Regulators Approve Glioblastoma Study Enhancements

August 11, 2014 2:46 pm | News | Comments

Northwest Biotherapeutics announced that, following a 9-month process of regulatory submissions and reviews by regulators in the US, UK and Germany, it has obtained regulatory approvals to make certain enhancements to its ongoing Phase 3 clinical trial of DCVax-L Glioblastoma multiforme (GBM) brain cancer. Read more...

TPM/Oxymorphone Patch Demonstrates Reproducibility

August 11, 2014 10:53 am | News | Comments

Australian drug delivery company, Phosphagenics Ltd. announced that the first of its additional studies designed to further characterize the TPM/Oxymorphone patch, in support of an Investigational New Drug (IND) application with the FDA has been completed. Read more...

Avillion Doses First Patients in Leukemia Drug Trial

August 11, 2014 10:49 am | News | Comments

Avillion LLP announced that the first patients have been dosed in the United States in a global Phase 3 clinical trial called "BFORE," which is designed to assess the effectiveness and safety of Bosulif as a first-line treatment for patients with chronic phase Philadelphia chromosome positive chronic myelogenous leukemia. Read more...

Genentech Submits sBLA for Diabetic Retinopathy Drug

August 8, 2014 3:21 pm | News | Comments

Genentech, a member of the Roche Group, announced that the company has submitted a supplemental Biologics License Application for Lucentis (ranibizumab injection) to the U.S. Food and Drug Administration for the treatment of diabetic retinopathy. Read more...

Neurovance Completes Enrollment in Abuse Liability Study

August 8, 2014 3:05 pm | News | Comments

Neurovance Inc. announced that it has completed enrollment in a human abuse liability study of centanafadine (formerly EB-1020), a novel non-stimulant being developed for the treatment of adults with attention deficit hyperactivity disorder (ADHD). Read more...

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