Shire

FDA approves Shire’s FIRAZYR

Thursday, August 25, 2011 11:33 AM

The FDA has granted marketing approval for Shire’s FIRAZYR (icatibant injection) for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

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FDA approves LialdaR

Wednesday, July 20, 2011 11:13 AM

Shire, a global biopharmaceutical company, reported the FDA approved LialdaR (mesalamine) Delayed Release Tablets for the maintenance of remission in patients with ulcerative colitis. This approval is based on results from a six-month study demonstrating the safety and effectiveness of Lialda in maintaining endoscopic remission in adult patients. This approval follows the previous indication of Lialda approved by the FDA in 2007 for the induction of remission in patients with active, mild-to-moderate ulcerative colitis.

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Shire to buy Advanced BioHealing

Wednesday, May 18, 2011 12:10 PM

Ireland-based Shire will acquire the U.S.-based Advanced BioHealing for $750 million in cash, according to Pharma Times.

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Shire shows strong profits for Q1

Tuesday, May 3, 2011 01:09 PM

Shire Pharmaceuticals has strong results for the first quarter, with its attention-deficit hyperactivity disorder (ADHD) drugs driving growth, according to Pharma Times.

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Shire reports positive results from investigative use of Vyvanse

Friday, April 29, 2011 11:10 AM

Global biopharmaceutical company Shire reports positive results from a signal-finding study of Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) assessing the drug’s effect in a prospective examination of adults with negative symptom predominant schizophrenia. This study met its pre-defined primary end points.

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FDA approves Intuniv for ADHD

Wednesday, March 9, 2011 10:43 AM

Shire, a global biopharmaceutical company, said the FDA approved the use of once-daily

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Renovo cuts jobs after Shire partnership ends

Thursday, March 3, 2011 02:44 PM

U.K.-based Renovo has halted spending and says it will lay off 100 workers in a broad restructuring that includes the possible sale of virtually all of its clinical assets, according to Fierce Biotech.

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Competition aims to recognize, reward skilled U.S. clinical researchers and raise industry profile

Monday, January 24, 2011 12:06 PM

Clinical research associates, study nurses, trial managers and clinical research teams have a chance to win $1,000 prizes in a competition designed to measure their technical and interpersonal skills in a changing global industry and raise the profile of clinical research in the United States.

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UBC Gets Big Boost with $125 Million Growth Equity Investment

Thursday, October 8, 2009 12:52 PM

Maryland-based contract research organization (CRO) United BioSource Corporation (UBC) received a $125-million growth equity from Berkshire Partners LLC, a Boston-based private equity firm, to support the company’s evidence-based acquisition and service offering expansion strategy. 

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December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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