Shire

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).

More... »


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.

More... »


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.

More... »

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.

More... »

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.

More... »

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.

More... »

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

More... »

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.

More... »

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).

More... »

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.

More... »

CenterWatch Data Library
CWWeekly

January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs