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DDD Update

Daily news and top headlines for drug research professionals

Allergan, Pershing Square Settle Lawsuit

June 30, 2014 10:57 am | News | Comments

Pershing Square, the investment firm run by activist investor Bill Ackman, said Friday it settled a lawsuit with Allergan, the maker of Botox, related to Allergan's poison pill plan and Pershing's $53 billion offer for the company. Read more...  

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Scientists Reconstruct Life History of a Single Cell

June 30, 2014 10:50 am | News | Comments

Researchers have developed new methods to trace the life history of individual cells back to their origins in the fertilized egg by looking at the copy of the human genome present in healthy cells and building a picture of each cell's development from the early embryo to part of an adult organ. Read more...

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FDA Approves Inhalable Diabetes Drug Afrezza

June 30, 2014 10:40 am | News | Comments

The Food and Drug Administration on Friday approved a long-delayed inhalable diabetes medication - Afrezza, an insulin powder, that comes in a single-use cartridge - to help patients control their blood sugar levels during meals. Read more...

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Curing Diabetes Takes Guts

June 30, 2014 10:30 am | News | Comments

By switching off a single gene, scientists at Columbia University’s Naomi Berrie Diabetes Center have converted human gastrointestinal cells into insulin-producing cells, demonstrating in principle that a drug could retrain cells inside a person’s GI tract to produce insulin. Read more...

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DVT/PE Drug Receives Positive CHMP Opinion

June 27, 2014 2:11 pm | News | Comments

Pfizer and Bristol-Myers Squibb announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending that Eliquis be granted marketing authorization for the treatment of DVT and PE, and the prevention of recurrent DVT and PE, in adults. Read more...

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Researchers Block Key Enzyme to Minimize Stroke Injury

June 27, 2014 2:05 pm | News | Comments

A drug that blocks the action of the enzyme Cdk5 could substantially reduce brain damage if administered shortly after a stroke, UT Southwestern Medical Center research suggests, because aberrant Cdk5 activity causes nerve cell death during stroke. Read more...

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CHMP Recommends EU Approval of CF Drug

June 27, 2014 1:59 pm | News | Comments

Vertex Pharmaceuticals Inc. announced that the European CHMP has issued a positive opinion recommending the approval of Kalydeco for people with cystic fibrosis ages six and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Read more...

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Essentialis Doses First Patient in Prader-Willi Study

June 27, 2014 1:46 pm | News | Comments

Essentialis announced the dosing of the first patient in clinical study PC025, which is designed to evaluate the safety and efficacy of diazoxide choline controlled release tablets (DCCR) in obese Prader-Willi syndrome patients. Read more...   

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BMS Hep C Drug Gets Positive CHMP Opinion

June 27, 2014 1:41 pm | News | Comments

BMS announced that CHMP of the EMA has adopted a positive opinion recommending that Daklinza, an investigational, potent pan-genotypic NS5A complex inhibitor, be granted approval for use in combination with other medicinal products for the treatment of chronic HCV infection in adults. Read more...

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Scientists Use Cancer Drug in Gene Therapy

June 27, 2014 1:28 pm | News | Comments

Scientists working to make gene therapy a reality have solved a major hurdle - how to bypass a blood stem cell’s natural defenses and efficiently insert disease-fighting genes into the cell’s genome - with rapamycin, which is commonly used to slow cancer growth and prevent organ rejection. Read more...

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EU Panel OKs Expanded Use of Roche Cancer Drug

June 27, 2014 11:10 am | News | Comments

Roche announced that the EU Committee for Medicinal Products for Human Use recommended that the European Commission approve the use of Avastin in combination with chemotherapy as a treatment for women with ovarian cancer that is resistant to platinum-containing chemotherapy. Read more...

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Gilead Submits Sofosbuvir NDA in Japan

June 27, 2014 11:01 am | News | Comments

Gilead announced that the company has submitted a New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for approval of sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection. Read more...       

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CHMP Recommends Bayer Drug for Gastrointestinal Stromal Tumors

June 27, 2014 10:54 am | News | Comments

The oncology compound regorafenib (Stivarga) from Bayer has been recommended for approval by the European Committee for Medicinal Products for Human Use for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors. Read more...

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Lilly-BI Compound is First Biosimilar Insulin Backed by CHMP

June 27, 2014 10:41 am | News | Comments

The investigational compound LY2963016, a new insulin glargine product from Eli Lilly and Co. and Boehringer Ingelheim for the treatment of type 1 and type 2 diabetes, is the first biosimilar insulin recommended for approval in the EU. Read more...

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Prosensa Snags $200,000 Research Grant from PPMD

June 27, 2014 10:26 am | News | Comments

Prosensa announced that the company's vice president of drug discovery, Dr. Judith van Deutekom, has been awarded a $200,000 research grant from Parent Project Muscular Dystrophy to fund the development of a multi exon-skipping strategy for exons 10-30 of the dystrophin gene. Read more...

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