Shire
Shire given permission for $400 million biologics manufacturing facility
December 6, 2016Manufacturing 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 …
NICE rules Shire’s Onivyde not cost effective
November 17, 2016Business 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Shire’s Onivyde has been determined by NICE as not cost effective, in draft guidance, despite adding on average two months …
Shire Q2 results outpace forecasts with 56% revenue growth
August 2, 2016Research 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 …
FDA approves Shire’s haemophilia A treatment system
August 1, 2016Manufacturing 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 …
FDA fast tracks Shire’s SHP626 nonalcoholic steatohepatitis drug
July 29, 2016Research 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 …
Shire and BMS secure NICE recommendations for oncology drugs
July 27, 2016Research 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 …
Shire receives positive EU opinion for pancreatic cancer drug
July 25, 2016Research 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 …
Shire dry eye treatment gets FDA approval
July 12, 2016Manufacturing 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 …
Shire gets extended market authorization in Europe for drug to treat children with a rare gastrointestinal condition
July 7, 2016Research 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 …
Shire says Phase II trial for rare eye condition in premature infants fails
July 1, 2016Medical 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 …
Shire says trial drug for ADHD shows positive results
June 30, 2016Research 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 …
Shire adds to gastrointestinal portfolio with Pfizer compound acquisition
June 14, 2016Research 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 …
Shire gets FDA breakthrough therapy designation for two rare disease drugs
June 13, 2016Manufacturing 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 …
Shire completes Baxalta takeover
June 3, 2016Medical 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 …
Shire gets positive opinion from EMA on rare gastrointestinal disease treatment
May 27, 2016Medical 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 …
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