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DDD Update

Daily news and top headlines for drug research professionals

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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ZMapp: Best Anti-Ebola Drug Yet

September 3, 2014 10:15 am | by Cynthia Fox, Science Editor | Articles | Comments

ZMapp, the experimental drug that may have already have saved a few patients in Africa, is the most effective anti-Ebola therapy yet, according to a recent Nature paper on rhesus macaques monkeys. Read more...           

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AstraZeneca Releases Phase 4 Brilinta Data

September 2, 2014 3:35 pm | News | Comments

AstraZeneca announced the results of the Phase 4 ATLANTIC study, which indicates that the profile of Brilinta/Brilique (ticagrelor) is comparable whether administered in a pre-hospital or in-hospital setting to ST segment elevation myocardial infarction (STEMI) patients. Read more...

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FDA Names Myelofibrosis Treatment an Orphan Drug

September 2, 2014 3:25 pm | News | Comments

Promedior Inc. announced that the FDA has granted an orphan drug designation for PRM-151, for the treatment of myelofibrosis, a serious, life-limiting cancer characterized by fibrosis of the bone marrow. Read more...         

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Ipsen's Somatuline Gets Priority Review

September 2, 2014 3:16 pm | News | Comments

Ipsen N.A. announced that the FDA has accepted and granted priority review of its supplemental New Drug Application for Somatuline Depot 120mg injection in the treatment of gastroenteropancreatic neuroendocrine tumors. Read more...      

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Scientists Make Diseased Cells Synthesize Their Own Drug

September 2, 2014 3:08 pm | News | Comments

In a new study that could ultimately lead to many new medicines, scientists have adapted a chemical approach to turn diseased cells into unique manufacturing sites for molecules that can treat a form of muscular dystrophy. Read more...     

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Amgen Submits MAA for Melanoma Treatment

September 2, 2014 2:59 pm | News | Comments

Amgen announced the submission of a Marketing Authorization Application to the European Medicines Agency via the centralized procedure for talimogene laherparepvec seeking approval for the treatment of adults with melanoma that is regionally or distantly metastatic. Read more...

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