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Daily news and top headlines for drug research professionals

Bioethicists Say Ebola Drugs Must be Fairly Distributed, Tested Ethically

August 22, 2014 10:42 am | News | Comments

Researchers and health authorities need to ensure that experimental drugs to treat Ebola are distributed fairly, and in the context of randomized controlled trials in collaboration with local communities and other stakeholders, according to a new Viewpoint, published in The Lancet. Read more...

Eisai Submits EU Marketing Authorization for Anti-Epileptic

August 21, 2014 11:34 am | News | Comments

Eisai has submitted a Marketing Authorization Application to the European Commission for its first-in-class anti-epileptic drug (AED) Fycompa (perampanel) as an adjunctive treatment of primary generalized tonic-clonic seizures (PGTC). Read more...

Psoriasis Drug Fares Well in Late-Stage Trial

August 21, 2014 11:25 am | News | Comments

Drugmaker Eli Lilly and Co. said its potential psoriasis treatment fared better than both a fake drug and a competitor's product during late-stage testing on patients with the most common form of the skin disease and plans to submit the product, ixekizumab, to regulators in the first half of next year. Read more...

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CEL-SCI Expands Head, Neck Cancer Trial in North America

August 20, 2014 10:47 am | News | Comments

CEL-SCI Corporation announced its Phase 3 Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine has added Centre Hospitalier Universitaire de Québec’s L’Hotel Dieu de Quebec to its growing number of clinical sites in North America. Read more...

NIH Launches Three Integrated Precision Medicine Trials

August 19, 2014 4:01 pm | News | Comments

The NIH's Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials (ALCHEMIST) was launched Monday to identify early-stage lung cancer patients with tumors that harbor certain uncommon genetic changes and evaluate whether drug treatments targeted against those changes can lead to improved survival. Read more...

Amgen's Thyroid Drug Hits Key Phase 3 Endpoints

August 19, 2014 3:52 pm | News | Comments

Amgen announced that a second placebo-controlled Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis, met its primary and all secondary endpoints. Read more...

DOJ Closes Probe into AstraZeneca Trial

August 19, 2014 3:26 pm | News | Comments

British drugmaker AstraZeneca says the U.S. Department of Justice has closed its investigation into a clinical trial of the company's blood thinner Brilinta, and plans no further action. Read more...               

Gamida Cell, Novartis Sign Option Agreement

August 19, 2014 11:56 am | News | Comments

Gamida Cell, a world leader in stem cell expansion technologies and therapeutic products, announced that it has signed an investment and option agreement with Novartis Pharma AG, under which Novartis will invest $35 million in Gamida Cell. Read more...

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DelMar Pharmaceuticals Amends Glioblastoma Trial

August 19, 2014 11:49 am | News | Comments

DelMar Pharmaceuticals Inc. announced a protocol amendment to allow for expanded dosing in its VAL-083 clinical trial had been filed with the U.S. Food and Drug Administration and that a new cohort of a new 50mg/m2 has been opened at three clinical trial sites in the United States. Read more...

FDA Tentatively Approves Lilly, BI Insulin Glargine

August 19, 2014 11:37 am | News | Comments

The U.S. Food and Drug Administration granted tentative approval for Basaglar (insulin glargine injection), which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes. Read more...

AstraZeneca Posts Positive Antibiotic Combo Results

August 19, 2014 11:30 am | News | Comments

AstraZeneca announced positive top-line results from RECLAIM-1 and RECLAIM-2, the pivotal Phase 3 studies investigating the potential of the antibiotic ceftazidime-avibactam as a treatment for hospitalized adult patients with complicated intra-abdominal infections. Read more...

Ruxolitinib Restores Hair in Alopecia Areata

August 18, 2014 2:28 pm | News | Comments

Researchers have identified the immune cells responsible for destroying hair follicles in people with alopecia areata, a common autoimmune disease that causes hair loss, and have tested an FDA-approved drug that eliminated these immune cells and restored hair growth in a small number of patients. Read more...

Daiichi Sankyo Kicks Off Etanercept Biosimilar Trial

August 18, 2014 11:11 am | News | Comments

Daiichi Sankyo Co. Ltd., in collaboration with the U.S. company Coherus BioSciences Inc., announced the start of the Phase 3 trial of CHS-0214, an investigational etanercept biosimilar, in rheumatoid arthritis (the RApsody trial) in Japan. Read more...

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Pfizer Submits NDA for Breast Cancer Drug

August 18, 2014 11:04 am | News | Comments

Pfizer Inc. announced it has completed the submission of a New Drug Application to the U.S. Food and Drug Administration for palbociclib in combination with letrozole for the treatment of postmenopausal women with ER+/HER2- breast cancer who have not received previous systemic treatment for advanced disease. Read more...

Coherus' Humira Biosimilar Hits Primary Endpoint

August 15, 2014 2:28 pm | News | Comments

Coherus BioSciences Inc. announced that CHS-1420, its proposed biosimilar of adalimumab (Humira), met the primary endpoint in a pivotal clinical pharmacokinetic similarity study that compared CHS-1420 to Humira in healthy subjects. Read more...   

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...

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...

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…         

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