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Shire

Showing 15 posts of 170 posts found.

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Shire given permission for $400 million biologics manufacturing facility

December 6, 2016
Manufacturing and Production, Research and Development Co Meat, Ireland, Shire

Shire has received planning permission for a new state-of-the-art biologics manufacturing facility in Co Meath, Ireland. The plant will be …

News
nice_reception

NICE rules Shire’s Onivyde not cost effective

November 17, 2016
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing NHS, NICE, Onivyde, Shire

Shire’s Onivyde has been determined by NICE as not cost effective, in draft guidance, despite adding on average two months …

News
shire_image

Shire Q2 results outpace forecasts with 56% revenue growth

August 2, 2016
Research and Development, Sales and Marketing Baxalta, Shire, financial report

Shire has announced its fiscal results for Q2 2016, reporting a strong quarter with a 56% growth in total revenues …

News

FDA approves Shire’s haemophilia A treatment system

August 1, 2016
Manufacturing and Production, Research and Development FDA, Shire, adynovate, baxject, haemophilia

Shire has announced that the Food and Drug Administration (FDA) has approved the baxject III reconstitution system for adynovate [antihemophilic …

News
antiviralresearch

FDA fast tracks Shire’s SHP626 nonalcoholic steatohepatitis drug

July 29, 2016
Research and Development FDA, SHP626, Shire, liver fibrosis, nash, volixibat, volxibat

The Food and Drug Administration (FDA) has granted Fast Track designation to Shire’s SHP626 (volixibat) treatment for patients suffering from …

News

Shire and BMS secure NICE recommendations for oncology drugs

July 27, 2016
Research and Development, Sales and Marketing BMS, Baxalta, NICE, Oncaspar, Shire, Yervoy, opdivo

The National Institute for Health and Care Excellence (NICE) has issued final guidance recommending Shire’s Oncaspar (pegaspargase) and Bristol-Myers Squibb’s …

News
shire_image

Shire receives positive EU opinion for pancreatic cancer drug

July 25, 2016
Research and Development, Sales and Marketing CHMP, EU, Pancreatic cancer, Shire

Shire has announced that the EU regulator’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion …

News
shire_image_4

Shire dry eye treatment gets FDA approval

July 12, 2016
Manufacturing and Production, Sales and Marketing FDA, Shire, dry eye, xiidra

Shire (LSE: SHP) has announced that the US Food and Drug Administration has approved its twice-daily eye drop solution, Xiidra …

News
shire_image_4

Shire gets extended market authorization in Europe for drug to treat children with a rare gastrointestinal condition

July 7, 2016
Research and Development, Sales and Marketing European Commission, Revestive, Shire, market authorisation, short bowel syndrome

UK drugmaker Shire (LSE: SHP) said the European Commission has granted extension of Market Authorization for Revestive (teduglutide) to treat …

News
shire_image

Shire says Phase II trial for rare eye condition in premature infants fails

July 1, 2016
Medical Communications, Research and Development Shire, US FDA, drug trial, rare eye condition in infants

Shire plc (LSE: SHP) said its drug compound to treat a rare eye condition in infants failed mid-stage trials. The …

News
shire_image_4

Shire says trial drug for ADHD shows positive results

June 30, 2016
Research and Development, Sales and Marketing ADHD, Shire, US FDA, drug trial, regulation

UK drugmaker Shire plc (LSE: SHP) said its trial drug to treat Attention-Deficit/Hyperactivity Disorder (ADHD) showed positive topline results.  Philip …

News
shirelabsus

Shire adds to gastrointestinal portfolio with Pfizer compound acquisition

June 14, 2016
Research and Development, Sales and Marketing Pfizer, Shire, acquisition, compound

Shire (LSE: SHP) has announced that it has acquired an investigational biologic for the treatment inflammatory bowel disease from Pfizer …

News
shire_image_4

Shire gets FDA breakthrough therapy designation for two rare disease drugs

June 13, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Breakthrough Therapy Designation, Shire, US FDA, rare disease, rare disease drugs

Ireland headquartered Shire (LSE: SHP) on Monday said the US Food and Drug Administration (FDA) has granted breakthrough therapy designation …

News
shire_image_4

Shire completes Baxalta takeover

June 3, 2016
Medical Communications, Research and Development, Sales and Marketing Baxalta, Shire, deal, merger and acquisition, revenue, sales

UK drugmaker Shire (LSE: SHP) on Friday announced the completion of merger with rare disease specialist Baxalta (NYSE: BXLT).  The …

News
shire_image_4

Shire gets positive opinion from EMA on rare gastrointestinal disease treatment

May 27, 2016
Medical Communications, Research and Development, Sales and Marketing CHMP, EMA, Revestive, Shire, gastrointestinal, paediatric, short bowel syndrome, treatment

Shire (LSE: SHP) has announced that it has received a positive opinion from the European Medicines Agency’s (EMA) Committee for …

News
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