Shire

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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Quest Diagnostics

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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Inversion rule change prompts AbbVie to halt Shire takeover

Thursday, October 16, 2014 02:21 PM

In what could have been a major pharmaceutical acquisition and one of the biggest tax inversion deals, Chicago-based AbbVie has recommended its shareholders vote against its proposed $54 billion takeover of Shire, a Dublin-headquartered pharmaceutical company specializing in medications to treat attention deficit disorder and rare diseases

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Shire to pay $56.5M to U.S. government

Thursday, September 25, 2014 12:43 PM

Shire has reached a final agreement with the U.S. Attorney’s Office to resolve a civil investigation of its sales and marketing practices for a period ending in 2010 relating to Adderall XR, Vyvanse, Daytrana, Lialda and Pentasa. Shire will pay $56.5 million, plus interest, fees and costs.

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Shire, ArmaGen ink agreement

Monday, July 28, 2014 02:55 PM

Shire, a global specialty biopharmaceutical company, and ArmaGen, a U.S. privately held biotechnology company, have announced a worldwide licensing and collaboration agreement for AGT-182, an investigational enzyme replacement therapy (ERT) for the potential treatment of both the central nervous system (CNS) and somatic manifestations in patients with Hunter syndrome (MPS II).

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AbbVie to acquire Shire in $54.6 billion deal

Friday, July 18, 2014 10:24 AM

The boards of AbbVie and Shire have reached agreement on the terms of a recommended combination of Shire with AbbVie that values Shire at approximately $54.61 billion.

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Shire willing to discuss AbbVie’s 5th revised proposal

Monday, July 14, 2014 12:48 PM

Following discussions with AbbVie, Shirerequested and has received a further revised proposal from AbbVie on July 13 for a total offering of $53 billion.

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AbbVie outlines revised $51.3B Shire offer

Wednesday, July 9, 2014 12:08 PM

AbbVie has outlined its revised proposal for Shire of $38.38 in cash and 0.8568 ordinary shares of New AbbVie for each Shire share (the Fourth Proposal). The Fourth Proposal represents an indicative value of $87.49 as of July 7, for a total of approximately $51.3 billion.

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AbbVie outlines rationale for Shire offer

Wednesday, June 25, 2014 02:14 PM

Following Shire’s confirmed rejection of Abbvie’s offer on June 20, AbbVie has outlined its strategic rationale for, and background to, its proposal to the board of Shire of $34.74 in cash and 0.7988 ordinary shares of New AbbVie for each Shire share. The proposal represented an indicative value of $78.63 on May 29 (the latest practicable date before the proposal was made). While this cash and share mix is valued at $77.57 per share as of June 24, any firm offer made by AbbVie under Rule 2.7 of the Code will need to be equivalent to $78.63 per share.

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CWWeekly

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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The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
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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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