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DDD Update

Daily news and top headlines for drug research professionals

FDA Committee Rejects Novartis Heart Drug

March 28, 2014 10:47 am | News | Comments

Novartis announced today that the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted against approval for RLX030 (serelaxin) for the treatment of acute heart failure (AHF). Read more...      

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pSivida Resubmits Iluvien Application

March 27, 2014 3:35 pm | News | Comments

pSivida Corp. announced that the New Drug Application for Iluvien for the treatment of chronic Diabetic Macular Edema has been resubmitted to the U.S. Food and Drug Administration (FDA). Read more...                

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FDA Approves Revised Use for Genzyme Thyroid Drug

March 27, 2014 3:28 pm | News | Comments

Genzyme announced the FDA approved revised prescribing information for the use of Thyrogen (thyrotropin alfa for injection) to widen the dose range of radioiodine (RAI) when used for thyroid remnant ablation. Read more...         

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Merck Replacing CFO with Baxter Exec

March 27, 2014 3:27 pm | News | Comments

Drugmaker Merck & Co. has named a new chief financial officer to succeed Peter N. Kellogg, who's held the post for seven years. Merck, based in Whitehouse Station, said Thursday that Robert M. Davis will become CFO on April 23. Read more... 

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Pfizer Cholesterol Drug Hits Main Trial Goal

March 27, 2014 3:22 pm | News | Comments

Pfizer Inc. announced the Phase 2b results of a study of investigational bococizumab, the proposed generic name for RN316. The study met its primary endpoint across all doses, showing that bococizumab significantly reduced low density lipoprotein cholesterol (LDL-C). Read more...

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Mylan Wins $106.7M Breach of Contract Case

March 27, 2014 3:11 pm | News | Comments

Mylan Inc. announced that, after a trial, a jury returned a verdict in favor of Mylan in its breach of contract lawsuit against GlaxoSmithKline (GSK) relating to Paroxetine Hydrochloride Extended-release (ER) Tablets. Read more...      

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Baxter Split Spawns New Biopharmaceutical Company

March 27, 2014 2:59 pm | by Linda A. Johnson, AP Business Writer | News | Comments

Following a rival's lead, Baxter International Inc. said it's planning a breakup into two health care companies, a biopharmaceutical company and a medical products business, as it tries to boost innovation and profitability and reward shareholders. Read more...

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Drug Companies to Phase Out Animal Antibiotics

March 27, 2014 2:53 pm | by Mary Clare Jalonick | News | Comments

Twenty-five pharmaceutical companies are voluntarily phasing out the use of antibiotics for growth promotion in animals processed for meat, the Food and Drug Administration said Wednesday. Read more...              

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GSK Pulls EMA App for Cancer Treatment Combo

March 27, 2014 11:11 am | News | Comments

GlaxoSmithKline announced that it has withdrawn its Marketing Authorization Application to the European Medicines Agency for the use of Mekinist (trametinib) in combination with Tafinlar (dabrafenib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Read more...

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Tampering Forces Massive Alli Recall

March 27, 2014 11:04 am | News | Comments

GlaxoSmithKline Consumer Healthcare is voluntarily recalling all Alli weight loss products from U.S. and Puerto Rico retailers as the company believes that some packages of the product were tampered with and may contain product that is not authentic Alli. Read more...

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Novartis Treatment Promising Against Drug-Resistant Lung Cancer

March 27, 2014 10:48 am | News | Comments

Novartis published clinical trial results showing the investigational compound LDK378 (ceritinib) achieved an overall response rate of 58% and a median progression-free survival of seven months in adults with advanced anaplastic lymphoma kinase positive non-small cell lung cancer. Read more...

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Germany's Merck Launches Phase 3 Fertility Study

March 27, 2014 10:35 am | News | Comments

Merck announced the enrollment of the first patient into a new Phase 3 study in the area of fertility, marking another step in its efforts to explore innovative solutions in areas of unmet medical need.  Read more...          

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New Cancer Drug Targets CEA Protein

March 27, 2014 10:17 am | News | Comments

A new cancer drug, based on further development of a discovery originally made by Cancer Research UK, has entered a clinical trial to target a wide range of cancers. Read more...                      

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Takeda, Otsuka to Co-Promote Gastrointestinal Drug in Japan

March 27, 2014 5:26 am | by Takeda | News | Comments

Otsuka Pharmaceutical Co. Ltd. and Takeda Pharmaceutical Co. Ltd. announced that the two firms have entered into a co-promotion agreement in Japan for TAK-438, a drug discovered by Takeda for the treatment of acid-related diseases. Read more...

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Stimulant Drugs Can Impair Neuronal Activity

March 26, 2014 2:38 pm | News | Comments

Researchers have discovered impaired neuronal activity in the parts of the brain associated with anticipatory functioning among occasional 18- to 24-year-old users of stimulant drugs. Read more...                

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