Shire

WCG encourages its global research network to use ACTA as clinical trial contract solution

Monday, April 20, 2015 06:00 AM

Global IRB WIRB-Copernicus Group (WCG) today said it will encourage the 1,200 members of its global research network to accept and use the Accelerated Clinical Trial Agreement (ACTA) as their default agreement for industry-sponsored, multicenter clinical trials.

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Quest Diagnostics

FDA grants Priority Review to lifitegrast NDA for dry eye disease in adults

Thursday, April 9, 2015 02:20 PM

The FDA has accepted for filing Shire's NDA for lifitegrast and granted a Priority Review designation. Lifitegrast is an investigational treatment for dry eye disease in adults and, if approved, has the potential to be the first treatment indicated to address both signs and symptoms of the disease. The FDA is expected to provide a decision on October 25, based on the Prescription Drug User Fee Act V action date.

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Shire, Cincinnati Children's establish rare disease research collaboration

Thursday, March 26, 2015 02:37 PM

Shire and Cincinnati Children's Hospital Medical Center have announced a three-year, broad research collaboration for rare diseases. The goal of the collaboration is to discover and develop novel therapies to treat rare diseases with high unmet medical need combining Shire's development and commercialization capabilities with Cincinnati Children's research experience.

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Shire acquires Meritage Pharma

Wednesday, February 25, 2015 11:27 AM

Shire has acquired Meritage Pharma, a global, privately held company, for $70 million upfront and additional contingent payments based on development and regulatory milestones.

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Pharming appoints Dr. Perry Calias chief scientific officer

Thursday, February 19, 2015 02:17 PM

Pharming Group has appointed Dr. Perry Calias chief scientific officer. Calias will have overall responsibility for the company's new enzyme replacement therapy (ERT) programs, achieving the scientific milestones set in the business plan, enhancing the IP portfolio, overseeing new product development and contributing to the overall strategic direction of the company.

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PharmaTimes clinical research awards to be presented Feb. 26

Thursday, February 12, 2015 03:33 PM

The 2015’s PharmaTimes Clinical Researcher of the Year—The Americas awards will be presented Feb. 26 in North Carolina.

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Vyvanse is FDA-approved for moderate to severe binge eating disorder

Thursday, February 5, 2015 01:29 PM

The FDA has approved Shire’s Vyvanse (lisdexamfetamine dimesylate) Capsules (CII), the first and only medication for the treatment of moderate to severe binge eating disorder (BED) in adults, shown to significantly reduce the mean number of binge days per week. Vyvanse is not indicated or recommended for weight loss or the treatment of obesity. Other sympathomimetic drugs used for weight loss have been associated with serious cardiovascular reactions.

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Shire's SHP609 receives FDA Fast Track designation

Thursday, January 29, 2015 01:27 PM

The FDA has granted Fast Track designation for Shire’s SHP609 (idursulfase-IT; also known as HGT-2310) for the treatment of neurocognitive decline associated with Hunter syndrome (mucopolysaccharidosis II or MPSII).

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Shire to acquire NPS Pharma for $5.2 billion

Monday, January 12, 2015 02:38 PM

Dublin, Ireland-based Shire and NPS Pharmaceuticals have entered into a merger agreement, under which Shire will acquire all outstanding shares of NPS Pharma for $46 per share in cash, for a total consideration of approximately $5.2 billion.

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Shire to relocate 500 jobs, U.S. headquarters, to Massachusetts

Thursday, November 20, 2014 01:43 PM

Shire plans to relocate over 500 positions to Massachusetts from its Chesterbrook, Pa., site and establish Lexington, Mass., as the company’s U.S. operational headquarters. The transition is a continuation of the company’s “One Shire” efficiency program and will streamline business globally through two principal locations—Massachusetts and Switzerland—with support from a limited number of regional and country-based offices around the world.

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CWWeekly

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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The CenterWatch Monthly

April

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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March

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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