Theorem Clinical Research

Shire

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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Quest Diagnostics

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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Spark Therapeutics receives FDA Breakthrough Therapy designation for SPK-RPE65

Friday, November 7, 2014 01:29 PM

Spark Therapeutics, a late-stage gene therapy company developing treatments for debilitating genetic diseases, has announced that its lead product candidate, SPK-RPE65, has received Breakthrough Therapy designation from the FDA. Breakthrough Therapy designation is intended to expedite the development and review of investigational therapies for serious or life-threatening conditions where initial clinical evidence demonstrates a significant improvement over existing therapies. SPK-RPE65 targets a group of blinding conditions known as inherited retinal dystrophies (IRDs) caused by autosomal recessive mutations in the RPE65 gene, and for which there currently is no pharmacologic treatment available.

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PharmaTimes launches 2015 Clinical Researcher of the Year competition

Wednesday, October 29, 2014 08:21 AM

The 2015 PharmaTimes Clinical Researcher of the Year-The Americas competition is open for entry. All research professionals are encouraged to enter.

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Treasury’s tax inversion changes scuttle some big biopharma mergers, modify others, prompting calls for Congressional corporate tax reform

Thursday, October 23, 2014 03:50 PM

The widely-discussed $54.6 billion acquisition of Dublin-based Shire by AbbVie is officially canceled, having crumbled after a notice by the U.S. Treasury Department to tighten tax rules that deter U.S. companies from moving their legal headquarters to countries with lower business taxes.

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CWWeekly

March 2

Huntingdon Life Sciences-Harlan prepares for rebranding and U.S. expansion to compete with early phase CROs Covance, CRL

Patients' increased sharing of clinical trial experiences through social media can help sponsors improve outcomes, enrollment

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The CenterWatch Monthly

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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The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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