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Mitotech releases positive phase II data of SkQ1 for dry eye

Friday, April 24, 2015 02:11 PM

Mitotech, a Luxembourg-based clinical-stage biotechnology company developing novel antioxidant molecules targeting mitochondria, has achieved significant positive results in its U.S. phase II clinical trial of SkQ1 compound in patients with moderate to severe dry eye syndrome. SkQ1 is a small molecule engineered specifically for reducing oxidative stress inside mitochondria, which proved to be effective in a topical ophthalmic formulation for treatment of dry eye syndrome.

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Quest Diagnostics

Biohaven to begin phase I study in 3Q2015, readying for phase III study start by 1Q2016

Friday, April 24, 2015 01:58 PM

Biohaven Pharmaceutical Holding is on schedule to initiate a phase I pharmacokinetic and biomarker study with its lead drug development candidate BHV-0223. Biohaven plans to initiate the trial no later than 3Q2015. After confirming projected drug exposure levels in the phase I study, Biohaven will move directly into a phase III registrational trial in affective disorders.

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Juniper Pharmaceuticals formation scientific advisory board

Friday, April 24, 2015 01:52 PM

Juniper Pharmaceuticals, a specialty pharmaceutical company focused on developing therapeutics that address unmet medical needs in women's health, has created a scientific advisory board (SAB) comprised of international physicians and scientists whose mission will be to provide scientific and clinical advice on the identification and advancement of product candidates for Juniper's women's health portfolio.

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Parexel wins 2015 Clinical Innovator of the Year Award

Friday, April 24, 2015 01:43 PM

Partnerships in Clinical Trials has named Parexel's Drew Garty, senior director, product management, the 2015 Clinical Innovator of the Year. The award recognizes Garty's leadership of the product development team for the company's Perceptive MyTrials Data-Driven Monitoring solution.

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BioClinica names Mukhtar Ahmed as eClinical president

Friday, April 24, 2015 01:38 PM

BioClinica, a specialty clinical trials services and technology provider, has announced that Mukhtar Ahmed, a recognized business leader within the life sciences, healthcare and technology sectors, has joined BioClinica as president of its Global eClinical Business Unit.

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John Castellani wins clinical trial diversity leadership award from National Minority Quality Forum

Friday, April 24, 2015 01:35 PM

Gary A. Puckrein, Ph.D., president and CEO of the National Minority Quality Forum (NMQF), has presented an award to John Castellani, president of the Pharmaceutical Research and Manufacturers of America (PhRMA), for his demonstrated leadership to increase diversity in clinical trials. On behalf of PhRMA, and in conjunction with NMQF, Castellani spearheaded the "I'm In" campaign to build awareness, start conversations, and increase diversity in clinical trials, especially among African Americans, Asian Americans and Hispanic populations.

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WuXi NextCODE Genomics, DNAnexus partner

Friday, April 24, 2015 01:27 PM

WuXi NextCODE Genomics, a subsidiary of WuXi PharmaTech, an open-access R&D capability and technology platform company, and DNAnexus, an cloud-based genome informatics and data management company, have formed a strategic alliance that aims to accelerate the use of genomics to benefit patients worldwide.

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Synchrogenix, CISCRP partner on clinical data transparency requirements

Friday, April 24, 2015 01:24 PM

Synchrogenix, the regulatory writing consultancy of Certara, a global biosimulation technology-enabled drug development consultancy, and the nonprofit Center for Information and Study of Clinical Research Participation (CISCRP) have partnered to provide lay language clinical trial results to clinical trial volunteers.

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INC Research, DrugDev collaborate on cloud-based solutions

Friday, April 24, 2015 01:23 PM

Global CRO INC Research Holdings has announced a strategic collaboration with DrugDev to drive increased efficiencies in clinical trials through enhanced access to and management of critical investigator and site data. INC Research becomes the first CRO to complete integration with and implementation of DrugDev’s SiteCloud platform, the same technology used by TransCelerate’s Investigator Registry (launching later this year) and the Investigator Databank, to facilitate more efficient feasibility, site selection and study start-up processes.

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Mylan to commence formal offer to acquire Perrigo

Friday, April 24, 2015 01:21 PM

On April 8, Mylan issued a Rule 2.4 announcement under the Irish Takeover Rules stating that it had made a non-binding proposal to acquire Perrigo for $205 in a combination of cash and Mylan stock for each Perrigo share. The Rule 2.4 announcement followed the delivery of that proposal to Perrigo's chairman on April 6.

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April 20

Christie Clinic, PMG Research's 12th clinical research site, expands its geographic reach north to Illinois

Clinipace acquires Accovion to expand European presence, following an infusion of equity that could lead to more deals

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PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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