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Daily news and top headlines for drug research professionals

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...

Eisai Seeks Marketing Approvals for Anticancer Drug in Europe, U.S.

August 18, 2014 10:56 am | News | Comments

Eisai Co. Ltd. announced that it has submitted applications to regulatory authorities in the U.S. and Europe for marketing approval of its novel in-house developed anticancer agent lenvatinib mesylate as a treatment for progressive radioiodine-refractory differentiated thyroid cancer. 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...   

FDA Committee Backs BI's COPD Drug

August 15, 2014 2:22 pm | News | Comments

Boehringer Ingelheim announced that the FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted that existing data supports approval of investigational tiotropium bromide inhalation spray for long-term, once-daily maintenance treatment of bronchospasm associated with COPD. 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...    

New Focus on Drugs Made in Tobacco Plants

August 15, 2014 1:47 pm | by Malcolm Ritter, AP Science Writer | News | Comments

It's an eye-catching angle in the story of an experimental treatment for Ebola: The drug comes from tobacco plants that were turned into living pharmaceutical factories. Using plants this way- sometimes called "pharming"- can produce complex and valuable proteins for medicines. Read more...

Mallinckrodt Acquires Questcor Pharmaceuticals

August 15, 2014 10:27 am | News | Comments

Mallinckrodt plc, a leading global specialty pharmaceutical company, announced that it has completed its acquisition of Questcor Pharmaceuticals Inc. in a cash and stock transaction valued at approximately $5.8 billion following strong approval by both Mallinckrodt and Questcor shareholders. Read more...

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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...

NSAIDs May Lower Breast Cancer Recurrence Rate

August 14, 2014 3:30 pm | News | Comments

Recurrence of hormone-related breast cancer was cut by half in overweight and obese women who regularly used aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), according to new data. 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...                   

Allergan Buys Bladder Treatment Program from TARIS Biomedical

August 14, 2014 3:17 pm | News | Comments

Allergan and TARIS Holdings announced that Allergan has closed a transaction to acquire worldwide rights to TARIS Biomedical's lead program, LiRIS, which is currently in Phase 2 trials for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). Read more...

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Potential Drug Therapy for Kidney Stones Identified

August 14, 2014 3:10 pm | News | Comments

Anyone who has suffered from kidney stones is keenly aware of the lack of drugs to treat the condition, which often causes excruciating pain. Now, a new mouse study suggests that a class of drugs approved to treat leukemia and epilepsy also may be effective against kidney stones, researchers report. Read more...

Liberia Gets ZMapp, Ponders Who Should Get It

August 14, 2014 2:50 pm | by Jonathan Paye-Layleh and Sarah DiLorenzo | News | Comments

Liberian officials faced a difficult choice Thursday: deciding which handful of Ebola patients will receive an experimental drug that could prove life-saving, ineffective or even harmful. 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...

FDA Approves Merck’s Insomnia Drug

August 14, 2014 10:35 am | by Matthew Perrone, AP Health Writer | News | Comments

Merck & Co. Inc. has won federal approval for a new type of sleeping pill designed to help people with insomnia stay asleep by temporarily blocking chemicals known as orexins that control the sleep cycle and can keep people awake at night. Read more...

Study Reveals How Ebola Blocks Immune System

August 14, 2014 10:28 am | News | Comments

The Ebola virus, in the midst of its biggest outbreak on record, is a master at evading the body’s immune system, but researchers at Washington University School of Medicine in St. Louis and elsewhere have learned one way the virus dodges the body’s antiviral defenses, providing important insight that could lead to new therapies. Read more...

BDSI, Endo Pursue Pain Drug after FDA Meeting

August 13, 2014 2:50 pm | News | Comments

BioDelivery Sciences International and Endo Pharmaceuticals engaged in a positive pre-New Drug Application (NDA) meeting with the FDA regarding BEMA Buprenorphine for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. 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...

Heart Attack Drug Reduces Tissue Damage, Minimizes Bleeding Risk

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

An investigational drug studied in animals significantly reduced damage to heart muscle from a heart attack and minimized the risk of bleeding during follow-up treatments, according to a new study. Read more...           

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