Jul21Thu

Member News from Almac Group

Almac LogoAlmac Group’s Rapid Launch Services Support U.S. Approval of Intercept Pharmaceutical’s First Commercial Orphan Drug Product

Craigavon, 14 July 2016 – Almac Group, the global contract development and manufacturing organisation, wishes to congratulate its long-term client partner Intercept Pharmaceuticals, Inc. on the U.S. Food and Drug Administration (FDA) approval of their first orphan drug product obeticholic acid, marketed in the US as Ocaliva®.  Ocaliva has been granted accelerated approval for the treatment of primary biliary cholangitis (PBC), previously known as primary biliary cirrhosis, in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.The partnership between Intercept and Almac commenced in 2013, with Almac’s Pharmaceutical Development teams supporting the early phase development of various dosage forms of Ocaliva.  Building on this partnership, Almac’s commercial teams have worked with Intercept for the commercial packaging including packaging design & artwork of the now FDA approved drug product Ocaliva. Read More
Jul14Thu

Member News from Almac Group

Almac LogoAlmac Group’s Rapid Launch Services Support U.S. Approval of Intercept Pharmaceutical’s First Commercial Orphan Drug Product
Craigavon, 14 July 2016 – Almac Group, the global contract development and manufacturing organisation, wishes to congratulate its long-term client partner Intercept Pharmaceuticals, Inc. on the U.S. Food and Drug Administration (FDA) approval of their first orphan drug product obeticholic acid, marketed in the US as Ocaliva®.  Ocaliva has been granted accelerated approval for the treatment of primary biliary cholangitis (PBC), previously known as primary biliary cirrhosis, in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.The partnership between Intercept and Almac commenced in 2013, with Almac’s Pharmaceutical Development teams supporting the early phase development of various dosage forms of Ocaliva.  Building on this partnership, Almac’s commercial teams have worked with Intercept for the commercial packaging including packaging design & artwork of the now FDA approved drug product Ocaliva.Intercept received accelerated FDA approval on Friday, 27th May 2016, and utilising Almac’s commercial Rapid Launch program, delivered from its Audubon, Pa. commercial packaging facility, Ocaliva was successfully packed and distributed on Tuesday, 31st May after the Memorial Day holiday to Intercept’s specialty pharmacy network. Read More
Jul07Thu

Ireland has jumped 10 places into the top ten countries in a global innovation ranking

The BDO International Business Compass report examines the capacity for innovation by measuring labour market performance, infrastructure and foreign direct investment.

The study compared 74 countries across all continents.

“Ireland’s ranking of 7th in the BDO International Business Compass is excellent news for our foreign direct investment offering,” said Kevin Doyle, tax partner at BDO Ireland.

Mr Doyle said the ranking reflects “the strong proposition Ireland presents to international organisations and investors”.

Ireland has overtaken the UK, which remains in eighth place.

Hong Kong, Singapore and The Netherlands were the three top-ranking countries, according to the report.

“The results of the 2016 BDO International Business Compass recognise the marked improvements in Ireland’s economic outlook and capacity for innovation in recent years,” he said.

Read More

Jun20Mon

Irish Fans at the Euro 2016

images(CNN)Russian and English fans may have dominated headlines during this month’s Euro 2016 football championships for their boorish, thuggish behavior.

But what about the tens of thousands of Irish fans? They’re out of control.
In the best possible way.
To read more, please click HERE.
May31Tue

Ireland rises to 7th in World Competitiveness ranking

Ireland_(MODIS)Ireland has risen nine places to seventh out of 61 countries in the 2016 IMD World Competitiveness Yearbook.

The IMD survey is a closely watched report published by the Swiss business school since 1989.

It compares countries based on both statistics available from a range of domestic and international sources and a survey of global executives.

It ranked Ireland first for growth in GDP or annual economic output, flexibility and adaptability of people and finance skills.

To read more, please click HERE.