Sep19Mon

Member News from ICON

ICON Completes the Acquisition of Clinical Research Management, Inc.

Acquisition extends ICON’s presence in the market for government sponsored research and enhances capabilities in Vaccines and Infectious Disease

Dublin, Ireland, 19^th September 2016 – ICON plc, (NASDAQ: ICLR) a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, today announced that it has completed the previously announced acquisition of Clinical Research Management, Inc. (ClinicalRM).

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Aug02Tue

Member News from Almac Group

Almac Group’s Integrated Development to Commercialisation Services Support Amicus Therapeutics’ First Commercial Orphan Drug Product

Craigavon, N.I., UK, – 2 August 2016 – Almac Group, the global contract development and manufacturing organisation, wishes to congratulate its long-term client partner, Amicus Therapeutics on the European approval of its first orphan drug product and precision medicine Galafold™ (migalastat, also referred to as AT1001).  Galafold was approved as a first line therapy for long-term treatment of adults and adolescents (aged 16 years and older) with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation. Read More

Jul26Tue

Member News: ICON Reports Second Quarter 2016 Results

ICON has announced financial results for the second quarter 2016. Please find details below. Full consolidated income statements and summary balance sheet data can be read here.

Some highlights from the quarter include:

• ICON’s acquisition of ClinicalRM which has extended ICON’s presence in the market for government-funded research and has enhanced ICON’s capabilities in vaccines and infectious disease. At the height of the Ebola crisis, ClinicalRM worked on several clinical trials in West Africa and the company is currently supporting the Zika Emergency Response plan.

• A renewal of ICON’s service agreement with Pfizer, where ICON will continue to provide expertise in the planning, execution and management of Pfizer’s clinical trials. ICON first entered into a strategic partnership with Pfizer in 2011.

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Jul21Thu

Member News from Almac Group

Almac 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

Jul19Tue

Call for Irish Legal 100 Nominations

2016  IRISH LEGAL 100 EVENT & AWARD CEREMONY

Thursday, October 27th in Washington, DC

Now accepting NEW nominations for the 2016 program. Click HERE to download the nomination form.

Jul14Thu

Member News from Almac Group

Almac 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