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DDD Update

Daily news and top headlines for drug research professionals

Mallinckrodt's Pain Drug Shows Efficacy in Phase 3

September 4, 2014 2:52 pm | News | Comments

Mallinckrodt reported that a Phase 3 efficacy trial of investigational MNK-155 met the study’s primary endpoint of improved pain scores vs. placebo over the first 48 hours following bunionectomy. Read more...            

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HIV Antibody Binds to Novel Target on Virus

September 4, 2014 2:46 pm | News | Comments

A team of scientists has discovered a new vulnerability in the armor of HIV that a vaccine, other preventive regimen or treatment, could exploit. Read more...                           

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J&J to Accelerate Ebola Vaccine Development

September 4, 2014 2:40 pm | News | Comments

J&J announced it will fast-track the development of a promising new combination vaccine regimen against Ebola and broadly collaborate with its partners in global health to deliver immediate relief aid to address the current Ebola outbreak. Read more...

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Google's Health Startup Forges Venture with AbbVie

September 4, 2014 2:34 pm | News | Comments

Google's ambitious health startup is teaming up with biotechnology drugmaker AbbVie in a $500 million joint venture that will try to develop new ways to treat cancer and other diseases such as Alzheimer's. Read more...          

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Lilly's Insulin Fares Well in Late-Stage Tests

September 4, 2014 11:31 am | News | Comments

Eli Lilly and Co. plans to seek approval early next year for a new insulin it developed after the diabetes treatment fared better than the competition in two late-stage clinical studies. Read more...               

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Flexion Advances OA Drug Development Plan by One Year

September 4, 2014 11:16 am | News | Comments

Based on a recent meeting with the U.S. Food and Drug Administration (FDA) to review the clinical development program for Flexion’s lead drug candidate FX006, the company announced it will initiate a Phase 3 clinical trial for FX006 in late 2014. Read more...

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Bayer Submits App in Japan for New Eylea Indication

September 4, 2014 11:05 am | News | Comments

Bayer HealthCare announced that Bayer Yakuhin Ltd. has submitted an application for marketing authorization for aflibercept solution for injection into the eye for patients with macular edema secondary to branch retinal vein occlusion (BRVO). Read more...

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Debiopharm's Antibiotic Named QIDP by FDA

September 4, 2014 10:44 am | News | Comments

Debiopharm Group announced that the FDA has designated its anti-infectious agent Debio 1450 as a Qualified Infectious Disease Product for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Read more...       

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How Outsourcing Can Accelerate the Drug Development Process

September 4, 2014 10:36 am | by Matthew Weinberg, CEO, The Weinberg Group | Articles | Comments

Outsourcing is an old concept in the healthcare industry that has recently been applied to a new area: regulatory affairs. Traditionally conducted in-house, regulatory affairs is extremely critical to a product’s success. For certain companies, this entire function can and should be outsourced in its entirety, not just for discrete projects. Read more...

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Blood from Ebola Survivors May Help Treat Patients

September 4, 2014 10:32 am | by Maria Cheng, AP Health Writer | News | Comments

As West Africa struggles to contain the biggest ever outbreak of Ebola, some experts say an unusual but simple treatment might help: the blood of survivors. Read more...                       

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Takeda Ordered to Pay $6B in Diabetes Drug Case

September 4, 2014 10:26 am | News | Comments

Takeda Pharmaceutical Co. said Thursday it has been ordered by a U.S. district court to pay $6 billion in punitive damages over a lawsuit filed by a man who claimed his bladder cancer was caused by Takeda's diabetes medicine Actos. Read more...  

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Chimerix's Brincidofovir Shows Activity Against Ebola

September 3, 2014 3:18 pm | News | Comments

Chimerix Inc. announced in vitro activity of its investigational antiviral brincidofovir (BCV) against the Ebola virus, following testing at the CDC the NIH. Read more...                       

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Eisai Sells U.S. Rights to Zonegran

September 3, 2014 3:13 pm | News | Comments

Eisai Inc. announced it has entered into an agreement with Concordia Pharmaceuticals Inc. to purchase Eisai's U.S. and Puerto Rican commercialization and distribution rights to Zonegran. Read more...                

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Actinium Eyes Orphan Drug Designation for AML Treatment

September 3, 2014 3:09 pm | News | Comments

Actinium Pharmaceuticals Inc. announced it has filed an Application for Orphan Drug Designation with the FDA for Actimab-A, a radiolabeled antibody being developed for newly diagnosed AML in patients over 60. Read more...         

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Exelixis to Cut 70% of Staff After Disappointing Trial Results

September 3, 2014 3:02 pm | News | Comments

Exelixis Inc. announced that COMET-1, the Phase 3 pivotal trial of cabozantinib in men with metastatic castration-resistant prostate cancer, did not meet its primary endpoint. As a result, Exelixis will initiate a significant workforce reduction. Read more...

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