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Daily news and top headlines for drug research professionals

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...

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...

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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...

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...

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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...

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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…         

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...

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...                

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