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Shire - Articles and news items

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Patient trial and appeal board upholds validity of Shire’s patent

Industry news / 6 October 2016 / Niamh Louise Marriott, Digital Content Producer

The Patent Trial and Appeal Board (PTAB) found that the patent was valid in light of the challenges put forward by the petitioner…

epr-logo

FDA approves Shire’s CUVITRU for the treatment of primary immunodeficiency

Industry news / 20 September 2016 / Niamh Louise Marriott, Digital Content Producer

CUVITRU is a treatment for patients with primary immunodeficiency (PI), a group of more than 300 genetic disorders in which part of the body’s immune system is missing or functions improperly…

market-adhd

ADHD market predicted to reach $13.9 billion by 2024

Industry news / 8 September 2016 / Niamh Louise Marriott, Digital Content Producer

The market for attention deficit hyperactivity disorder (ADHD) across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan, is set to experience an increase from approximately $6.1 billion in 2014 to $13.9 billion by 2024, at a compound annual growth rate of 8.5%, according to research and consulting firm GlobalData…

FDA grants fast track for Shire’s NASH investigational treatment

FDA grants fast track for Shire’s NASH investigational treatment

Industry news / 29 July 2016 / Mandy Parrett, Editorial Assistant

Shire Plc has announced today that the United States Food and Drug Administration (FDA) has granted Fast Track designation for SHP626 (volixibat) for an investigational treatment of adults with nonalcoholic steatohepatitis (NASH) with liver fibrosis.

pancreatic cancer

Onivyde receives positive CHMP opinion for pancreatic cancer treatment

Industry news / 25 July 2016 / Niamh Louise Marriott, Digital Content Producer

The positive opinion is based on a pivotal Phase 3 study showing that Onivyde combined with chemotherapy significantly increased overall survival in patients with metastatic pancreatic cancer…

xiidra

FDA approves Shire’s Xiidra for dry eye disease

Industry news / 12 July 2016 / Victoria White, Digital Content Producer

With this approval, Xiidra is the only prescription eye drop indicated for the treatment of both signs and symptoms of this condition…

Revestive

Shire gets extended Marketing Authorisation for Revestive

Industry news / 7 July 2016 / Victoria White, Digital Content Producer

The EC has granted an extension of the Market Authorisation for Revestive for the treatment of patients aged one year and above with Short Bowel Syndrome…

SHP607

Topline results from Phase II study of SHP607 in extremely premature infants

Industry news / 30 June 2016 / Victoria White, Digital Content Producer

While the study did not meet its primary endpoint of reducing severity of ROP, it did produce encouraging secondary endpoints related to lung and brain…

PF-00547659

Shire to license global rights for PF-00547659 from Pfizer

Industry news / 14 June 2016 / Victoria White, Digital Content Producer

PF-00547659 is an investigational biologic being evaluated for the treatment of moderate-to-severe inflammatory bowel disease (IBD)…

baxalta

Shire and Baxalta combine to create a global leader in rare diseases

Industry news / 3 June 2016 / Victoria White, Digital Content Producer

Shire and Baxalta have combined businesses, creating a leading global company focused on rare diseases and other highly specialised conditions…

teduglutide

CHMP positive opinion for teduglutide in paediatric patients

Industry news / 27 May 2016 / Victoria White, Digital Content Producer

The CHMP has adopted a positive opinion of Shire’s Revestive (teduglutide) solution for injection in paediatric patients with short bowel syndrome…

lialda

Shire wins Lialda patent trial against Watson

Industry news / 29 March 2016 / Victoria White

The US District Court for Southern Florida has upheld Shire’s patent for Lialda (mesalamine) delayed release tablets for adults with ulcerative colitis…

 

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