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DDD Update

Daily news and top headlines for drug research professionals

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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FDA: Little Evidence to Support Testosterone Drugs

September 3, 2014 2:56 pm | by Matthew Perrone | News | Comments

The FDA says there is little evidence that testosterone-boosting drugs taken by millions of American men are beneficial, though the agency is also unconvinced by studies suggesting the hormone carries serious risks. Read more...       

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AbbVie, Infinity Team Up to Develop Cancer Drug

September 3, 2014 2:53 pm | News | Comments

Shares of Infinity Pharmaceuticals Inc. soared Wednesday after it said it could receive more than $800 million from a collaboration with fellow drug developer AbbVie on a potential cancer treatment. Read more...            

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Alkermes Wraps Enrollment for Phase 2 Antipsychotic Drug Trial

September 3, 2014 11:19 am | News | Comments

Alkermes plc announced completion of patient enrollment in a Phase 2 study of ALKS 3831, an investigational, novel, oral, broad-spectrum atypical antipsychotic medicine in development for the treatment of schizophrenia. Read more...      

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Prosonix MAA for Generic Asthma Drug Under Assessment in EU

September 3, 2014 11:15 am | News | Comments

Prosonix announced that its Marketing Authorization Application (MAA) for PSX1001 has been validated and is being assessed under the Decentralized Procedure (DCP), in which the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is the Reference Member State. Read more...

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AstraZeneca, Redx Pharma Collaborate on Cancer Drugs

September 3, 2014 10:57 am | News | Comments

AstraZeneca announced that it has entered into a research collaboration with Redx Pharma Limited to discover and develop new molecules targeting a genetic driver of tumor growth and survival. Read more...              

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Amgen Submits Cholesterol Drug for EMA Approval

September 3, 2014 10:44 am | News | Comments

Amgen announced the submission of a Marketing Authorization Application to the European Medicines Agency via the centralized procedure for evolocumab seeking approval for the treatment of high cholesterol. Read more...          

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Actavis' Eluxadoline Granted U.S. Priority Review

September 3, 2014 10:32 am | News | Comments

Actavis plc announced that the FDA has accepted for filing Actavis' New Drug Application (NDA) for eluxadoline and the NDA has been granted priority review status by the FDA. Read more...                  

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