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DDD Update

Daily news and top headlines for drug research professionals

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...

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iBio, Kanematsu Chemicals Partner on Biologics Development, Production

August 14, 2014 11:02 am | News | Comments

iBio Inc. and Kanematsu Chemicals Corp., part of Kanematsu Corp., have entered into a collaboration agreement under which Kanematsu Chemicals Corp. will market the novel iBioLaunch platform in Japan, which commands 9% of global biologics sales (led only by the U.S. and the EU). Read more...

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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...

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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...

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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...

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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...

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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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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...         

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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...

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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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Debate Continues Over Experimental Ebola Drugs

August 13, 2014 2:06 pm | by Sarah Dilorenzo and Maria Cheng, Associated Press | News | Comments

Doctors treating a leading Sierra Leone physician who became sick with Ebola considered giving him an experimental drug but feared it could trigger a dangerous immune response and did not administer it, Doctors Without Borders said Wednesday. Read more...

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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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TNI BioTech, Hubei Qianjiang Agree to Collaborate

August 13, 2014 11:17 am | News | Comments

TNI BioTech Inc. a biotechnology company pioneering the manufacturing and marketing of innovative therapies for autoimmune diseases in emerging nations, announced the signing of a supplemental agreement with Hubei Qianjiang Pharmaceutical Co. Ltd, China, on behalf of Cytocom, TNI BioTech's wholly owned subsidiary. 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...

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