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DDD Update

Daily news and top headlines for drug research professionals

Takeda, Dainippon Sumitomo Get Schizophrenia Drug Approval Europe

March 28, 2014 11:14 am | News | Comments

Dainippon Sumitomo Pharma and Takeda Pharmaceutical jointly announced that the European Commission has granted Marketing Authorization for once-daily oral Latuda (lurasidone) for the treatment of schizophrenia in adults. Read more...      

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Europe OKs New Formula of Roche Cancer Drug

March 28, 2014 11:10 am | News | Comments

Roche announced that the European Commission (EC) has approved a new subcutaneous (SC) formulation of MabThera (rituximab) for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma. Read more...         

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EMA Validates Gilead’s App for Hep C Combo Therapy

March 28, 2014 11:06 am | News | Comments

Gilead Sciences Inc. announced that the company’s Marketing Authorization Application for a fixed-dose combination of ledipasvir and sofosbuvir for the treatment of chronic hepatitis C virus, genotype 1 infection, has been fully validated and is now under assessment by the EMA. Read more...

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EC Approves GSK's Once-Weekly Diabetes Treatment

March 28, 2014 10:58 am | News | Comments

GlaxoSmithKline plc announced that the European Commission has granted marketing authorization for its once-weekly diabetes treatment, Eperzan (albiglutide). Read more...                       

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Oramed's Oral Insulin Trial Hits Phase 2a

March 28, 2014 10:50 am | News | Comments

Oramed Pharmaceuticals Inc. announced that the first patient has been enrolled in its U.S. Phase 2a trial for its orally ingestible insulin capsule, ORMD-0801, in the treatment of type 1 diabetes (T1DM).  Read more...         

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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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