DIA Biosimilars 2013

Shire

Shire partners with Shionogi to develop ADHD medicines

Friday, November 18, 2011 11:48 AM

Shire has entered into an agreement with Shionogi & Co. of Japan to co-develop and co-commercialize certain of Shire's Attention Deficit Hyperactivity Disorder (ADHD) medicines in Japan. Shionogi will pay a one time fee and share costs with Shire in exchange for rights to jointly co-develop and co-commercialize the products upon approval for the Japanese market. Specific terms of the agreement are not being disclosed. 

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Cenduit: Now with Patient Reminders

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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CRF Health – eCOA Forum

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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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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