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NEWS ROUNDUP: Pharma Invests In Patients, More Trials Use FitBit Trackers

Clinical Leader news roundup for the week of April 11, 2016, with articles on pharma’s investment in patients, FitBit activity trackers in clinical trials, new Hep C combination treatment tested in Malaysia and Thailand, prostate and pancreatic cancer trials, the need for clinical trial participants, and making the most of clinical trial data.

How Do I Get My Compound Into Phase I?
The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. By Dr. Scott E. Boley and Greg Ruppert
Will Protagonist Be The Hero In Making Stable Oral Peptides To Replace Injectables?
Protagonist Therapeutics has created a technology for making stable oral peptides capable of replacing injectable-only drugs and is developing entirely new oral-peptide therapeutics or GI patients. Its initial development areas are irritable bowel diseases (IBD) and irritable bowel syndrome (IBS). Two compounds, one an injectable peptide to block IL-6, and another, an oral peptide to block integrins, will enter clinical trials in 2015.
Can Rapid Mobile Diagnostics Speed Up Clinical Trials And Regulatory Reviews?
As a new technological space containing all the alternatives, the most practical and immediate application for Rapid Mobile Diagnostics (RMDx) may be in clinical trials.

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Strategic Clinical Outsourcing Considerations: The Interdependency Of Clinical Drivers
A solid outsourcing strategy is critical to leading your organization to a successful outsourcing experience. Of course every organization in need of outsourced services must consider their priorities: Is it cost? Timelines? Team experience? Some combination? Inevitably the salient considerations are a combination of each of these factors, yet some will be weighed more heavily than others. By Kevin Boos, RDP Clinical Outsourcing, Scott Connor, Acurian, and Meenal Patel, RDP Clinical Outsourcing
Leveraging Investigator Grant Payment Practices To Enhance Sponsor-Site Relationships
One of the world’s leading pharmaceutical companies, AstraZeneca, has over 67,000 employees. Among those are about 13,000 at 17 principal research and development centers in eight countries — including the United States.
Optimizing Clinical Trial Enrollment: Same Day Turnaround Of Blood Chemistry For Eligibility
Potential clinical trial participants and sponsors typically wait 2-3 days for lab results to determine eligibility. For the would-be participant every day that elapses could contribute to the loss of interest and increase the risk of losing a potential study subject for many reasons. By Paul S. Savuto, MS, MBA Blinded Diagnostics
Point Of Care Lactate Testing Predicts Mortality Of Severe Sepsis In A Predominantly HIV Type 1-Infected Patient Population In Uganda To evaluate the ability of a handheld portable whole-blood lactate (PWBL) analyzer to predict mortality in patients who are admitted to the hospital with severe sepsis.

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Aptalis Selects Transperfect’s Trial Interactive Technology As Its Pharmacovigilance System Master File (Psmf) Solution
TransPerfect, a leading provider of solutions for global development and commercialization of products to the life sciences industry, announced that Aptalis Pharma ("Aptalis") has implemented Trial Interactive as its global pharmacovigilance system master file (PSMF) solution.
NeuroDerm Announces Positive Results Of A Phase I Study Of ND0612 For The Treatment Of Parkinson's Disease
NeuroDerm, Ltd. announced today the results of a Phase I safety and pharmacokinetic trial of ND0612, a novel drug formulation for the treatment of Parkinson's disease. ND0612 is a proprietary levodopa/carbidopa liquid formula administered continuously sub-cutaneously through a patch pump. It is designed to provide steady levodopa blood levels for the reduction of motor complications in Parkinson's disease. Results of this study support the continued development of ND0612 for the treatment of Parkinson's disease.
Isis Initates Phase 2/3 Study Of ISIS-TTR Rx And Earns $7.5M Milestone Payment From GlaxoSmithKline
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that it has earned a $7.5 million milestone payment from GlaxoSmithKline (GSK) related to the initiation of a Phase 2/3 clinical study for ISIS-TTR_Rx.
FDA Approves GlaxoSmithKline's Four-Strain Seasonal Influenza Vaccine For Use In The U.S.
GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved FLUARIX® QUADRIVALENT (Influenza Virus Vaccine) for the immunisation of children (three years and older) and adults to help prevent disease caused by seasonal influenza (flu) virus subtypes A and type B contained in the vaccine.
Astrazeneca Announces Top-Line Results Of OSKIRA-4 Phase IIb Study Of Fostamatinib As A Monotherapy For Rheumatoid Arthritis
AstraZeneca recently announced top-line results of OSKIRA-4, a Phase IIb monotherapy study of fostamatinib, the first kinase inhibitor with selectivity for SYK (spleen tyrosine kinase) in development as an oral treatment for rheumatoid arthritis (RA).
Tranzyme Pharma Announces Top-Line Results Of TZP-102 Phase 2b Trial
Tranzyme Pharma (Nasdaq:TZYM), today announced top-line results of the preliminary analysis of the first of two Phase 2b trials assessing the safety and efficacy of its oral ghrelin agonist, TZP-102 in diabetic patients with gastroparesis.
Phase 2b Data Of Boehringer Ingelheim's Interferon-Free Hepatitis C Treatment Show Viral Cure Achieved In Up To 85% Of Treatment-Naive Patients
Final Phase 2b data from Boehringer Ingelheim's interferon (IFN)-free Phase 2b SOUND-C2 study showed that up to 85 percent of genotype 1b (GT1b) hepatitis C (HCV) patients achieved sustained virologic response (SVR or viral cure) 12 and 24 weeks after the end of treatment with the investigational treatment regimen of faldaprevir (BI 201335) and BI 207127, in combination with ribavirin (RBV)
Isis Announces Expedited Development Of ISIS-TTR Rx And Amendment To The Collaboration With GSK To Support Phase 2/3 Study
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that Isis and GlaxoSmithKline (NYSE: GSK) have agreed to amend the clinical development plan and financial terms relating to ISIS-TTR_Rx to reflect the accelerated development plan for the drug. ISIS-TTR_Rx is an antisense drug in development with GSK for the treatment of TTR amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerves and/or heart tissue.
Genelux Corporation Announces Early Results Of A Phase I/II Clinical Trial Of Virotherapeutic GL-ONC1 In Advanced Peritoneal Cavity Cancers
Genelux Corporation, a clinical-stage biopharmaceutical company developing vaccinia virus based oncolytic cancer therapies and companion diagnostics, announced early results of the first patient cohort treated in a Phase I/II clinical trial with GL-ONC1, its leading virotherapeutic product candidate, in patients with advanced peritoneal cavity cancers. As presented at the 8thWorld Congress on Peritoneal Surface Malignancies in Berlin, Germany, GL-ONC1 was found to be clinically well tolerated when applied directly into the peritoneal cavity.
Dynavax To Initiate Phase 1 Studies For TLR-9 Agonist For Asthma
Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it will advance AZD1419, a proprietary second-generation TLR-9 agonist for asthma, into Phase 1 clinical studies.
Phase IIa Laquinimod Trial Results Show Positive Data For Potential Use In Active Crohn's Disease
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced the presentation of Phase IIa clinical data for investigational laquinimod in moderate to severe Crohn's disease (CD).
Lilly Diabetes Announces Positive Results Of Phase III Trials Of Dulaglutide In Type 2 Diabetes
Eli Lilly and Company (NYSE: LLY) today announced positive top-line results of three completed Phase III AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) analog being studied as a once-weekly treatment for type 2 diabetes.
Second Phase 2 Trial Of Telotristat Etiprate Shows Positive Results In Carcinoid Syndrome
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced positive, top-line data from a recently completed Phase 2 study in carcinoid syndrome with telotristat etiprate.
Dr. Reddy’s Custom Pharmaceutical Services (CPS) Business Expands Its Manufacturing Operations In Mirfield, UK
The Custom Pharmaceutical Services (CPS) business of Dr. Reddy’s Laboratories Ltd. recently announced expansion in the areas of activated mPEG manufacturing and in the development and manufacture of NCE (New Chemical Entities) APIs for use in pre-clinical through to commercial development at its manufacturing facility in Mirfield, UK.

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