Articles Published in 2015

Perrigo rejects Mylan’s second unsolicited offer

Monday, April 27, 2015 08:56 AM

Dublin-based Perrigo has rejected a second unsolicited offer from Mylan to acquire all outstanding shares of Perrigo for $60 per share in cash and 2.2 Mylan ordinary shares for each ordinary Perrigo share. Mylan is seeking to ward off an unsolicited offer from Israel-based Teva.  

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Quest Diagnostics

CRI and Cancer Immunology

Monday, April 27, 2015 08:00 AM

Since being named “Breakthrough of the Year” by Science magazine less than two years ago, cancer immunology has been taken from the fringe to the forefront. 

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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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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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April 27

Doctors, patients in the U.S. and U.K. agree: Mobile health apps are good for our health

AARP teams with Georgia Tech's HomeLab, Pfizer and UnitedHealthcare to test wearables with consumers 50+

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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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