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DDD Update

Daily news and top headlines for drug research professionals

Pharma Industry Turns the Corner

June 24, 2014 2:13 pm | News | Comments

Record breaking new drug approvals, a hefty product pipeline and dramatically improved R&D productivity that has kept expenditure growth below sales growth prove that the industry is turning a new corner according to Evaluate's "World Preview 2014, Outlook to 2020" report. Read more...

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FDA Lifts Partial Hold on BRI’s Study of Glioma Drug

June 24, 2014 11:29 am | News | Comments

The Burzynski Research Institute Inc. (BRI) announced that U.S. Food and Drug Administration (FDA) has notified the company that its partial clinical hold on its IND for Antineoplastons A10/AS2-1 Injections has been lifted, and it may initiate its planned Phase 3 study in newly diagnosed diffuse, intrinsic, brainstem glioma. Read more...

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EMD Serono, Mersana to Develop Next-Gen ADCs

June 24, 2014 11:23 am | News | Comments

EMD Serono Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, and Mersana Therapeutics Inc., Cambridge, Mass., U.S., announced an agreement to collaboratively develop next-generation antibody-drug conjugates (ADCs), which are composed of an antibody linked to cytotoxic drugs. Read more...

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Researchers Find Fatal Cellular Malfunction in Huntington’s

June 24, 2014 11:16 am | by Michael C. Purdy | News | Comments

Researchers believe they have learned how mutations in the gene that causes Huntington’s disease kill brain cells, a finding that could open new opportunities for treating the fatal disorder, which affects five to seven people out of every 100,000. Read more...

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Bayer, Dimension Collaborate on Hemophilia Gene Therapy

June 24, 2014 11:05 am | News | Comments

Bayer HealthCare and Dimension Therapeutics, a company focused on developing novel adeno-associated virus (AAV) gene therapy treatments for rare diseases, have entered into a collaboration for the development and commercialization of a novel gene therapy for the treatment of hemophilia A. Read more...

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Abbott to Acquire Russian Pharma Co Veropharm

June 24, 2014 11:00 am | News | Comments

Abbott announced a definitive agreement to acquire Veropharm, a leading Russian pharmaceutical manufacturer, having had a presence in Russia for nearly 40 years and being committed to growing global health care markets and capabilities. Read more...

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UK Guidelines Unfairly Exclude Prisoners from Clinical Research

June 24, 2014 10:52 am | News | Comments

Prisoners are being unfairly excluded from taking part in potentially beneficial clinical research, on the grounds that it would be too difficult and expensive to do so, indicates a study published online in the Journal of Medical Ethics. Read more...

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Regado’s Anticoagulation System Suppresses Thrombin

June 23, 2014 2:30 pm | News | Comments

Regado Biosciences Inc., a biopharmaceutical company focused on the discovery and development of actively controllable aptamer therapeutics for the acute care setting, announced the publication in the Journal of Thrombosis and Thrombolysis of data from a single escalating-dose Phase 1 clinical trial of the REG2 anticoagulation system. Read more...

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Rhythm’s Obesity Drug Increases Energy Expenditure

June 23, 2014 2:25 pm | News | Comments

Rhythm announced the presentation of results from a clinical trial that evaluated the effect of RM-493, the company's novel melanocortin 4 receptor (MC4R) agonist, on resting energy expenditure in obese subjects, indicating that RM-493 increased resting energy expenditure significantly. Read more...

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NW Bio Refutes Latest False Headline and Attack

June 23, 2014 2:18 pm | News | Comments

Northwest Biotherapeutics, a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, refuted Adam Feuerstein's latest false headline and attack on the company, and reaffirmed the company's recent interim data announcements from its Phase 1/2 clinical trial of DCVax-Direct for all inoperable solid tumors. Read more...

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Inovio Kicks Off Study of Cervical Cancer Immunotherapy

June 23, 2014 2:13 pm | News | Comments

Inovio Pharmaceuticals Inc. announced it has initiated a Phase 1/2a clinical trial to evaluate safety, immunogenicity, clinical responses and disease-free survival of its DNA immunotherapy product, INO-3112, in treating human papillomavirus (HPV)-associated cervical cancer. Read more...

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FDA Approves Cubist’s Skin Infection Antibiotic

June 23, 2014 2:08 pm | News | Comments

Cubist Pharmaceuticals Inc. announced the U.S. Food and Drug Administration (FDA) approved Sivextro (tedizolid phosphate) for the treatment of adult acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Read more...

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Shire Rejects AbbVie’s Unsolicited Offer

June 23, 2014 2:02 pm | News | Comments

Takeover target Shire highlighted its potential as a standalone drugmaker, offering investors a rosy projection of its earnings potential that it believes is not reflected in the acquisition proposal made by U.S.-based rival AbbVie. Read more...  

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Pharnext's Neuromuscular Disorder Drug Designated Orphan Drug

June 23, 2014 11:45 am | News | Comments

Pharnext SAS announced that the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have granted orphan drug designation to PXT-3003 for the treatment of Charcot-Marie-Tooth disease type 1A (CMT 1A) in recognition of the value this novel oral therapeutic could bring to these patients. Read more...

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Novo Nordisk Posts Positive Phase 3 Data for Obesity Trial

June 23, 2014 11:39 am | News | Comments

New data from the phase 3a SCALE Obesity and Prediabetes trial were presented at the International Congress of Endocrinology and the Endocrine Society’s meeting, showing that in addition to a greater body-weight loss, significantly fewer people with obesity and normal blood glucose at baseline progressed to prediabetes with liraglutide 3 mg treatment at 56 weeks, compared with placebo. Read more...

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