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M&A Activity in the Life Sciences Sector in 2023
While the Irish M&A market slowed this year in line with global trends, dealmaking activity conti...
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The Importance of ESG for Employers within the Life Sciences Sector
Employers not complying with their ESG obligations face regulatory, capital, and talent retention...
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Article and Insights
M&A Review 2022 through the Life Sciences Lens
We took a look at how the Irish economy fared last year from a Life Sciences perspective.
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Reality Bites as Industry Forces Postponement of MDR Implementation
European Parliament votes to extend MDR transition periods to avoid supply shortages of medical d...
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Article and Insights
Legal News – January 2022
Here is a selection of our recent publications on subjects that may affect you or your business.
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The Unified Patent Court – An Idea Worth Protecting?
Following the German Federal Constitutional Court's finding that German legislation ratifying the...
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Stamp Duty Battle: Abbvie Wins Appeal Against €587m Irish Stamp Duty
A recent decision of the Tax Appeals Commission will peak the interests of Pharma, Healthcare and...
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New Government Legislation Programme: Industry & Sector Breakdown Summer 2022
The Summer legislation programme has been published by the government. The programme includes 34...
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New Government Legislation Programme Spring Session 2019 Published
No-deal Brexit legislation to dominate Oireachtas schedule over coming months
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Medical Devices Regulation – Applicable from Today
Amidst much anticipation, the Medical Devices Regulation becomes fully applicable across the EU f...
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Medical Devices – New Classification Rules – Is your Business Ready?
A guide to the classification of devices under the new Medical Devices Regulation
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Medical & In Vitro Diagnostic Devices and the AI Act: Proposed Regulatory Requirements
Artificial Intelligence (AI) is becoming an increasingly pervasive general-purpose technology, wi...
Partner
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MDR Countdown – 1 Month. European Commission Updates its Rolling Plan
With the Medical Devices Regulation (MDR) set to become fully applicable next month the European ...
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Life Sciences Deals of the Year
A look at the major pharmaceutical, medtech, and healthcare deals William Fry has advised on in 2...
Managing Partner
Stephen Keogh
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Article and Insights
Launch of our Medical Device Publication
William Fry are delighted to launch our MDR/IVDR publication. To assist medical device companies ...
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IVDR Crunch Time – Where does Ireland Stand?
The In Vitro Diagnostic Medical Device Regulation, (EU) 2017/746, is fully applicable as of Thurs...
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Ireland Launches Intellectual Property and Technology Court and Reforms IP Disputes Procedures
Under new Court Rules which come into operation on 22 October 2021, Intellectual Property cases a...
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IPHA’s Revised Self-Care Advertising Code
Effective from 1 March 2021, the revised IPHA Code introduces new rules for advertising non-presc...
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Article and Insights
Guidance Published on Appropriate Surveillance under Article 120 of the MDR
The Medical Device Coordination Group has published guidance on the activities to be performed by...
Partner
Charleen O’Keeffe
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European Commission Proposes a Unitary SPC and/or a Unified Procedure for Granting National SPCs
The European Commission has proposed a unified procedure for granting Supplementary Protection Ce...
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Article and Insights
EUDAMED – A Work in Progress!
New rules for the operation of Eudamed will enter into force on 19 December 2021. In this brief a...
Partner
Charleen O’Keeffe
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ECJ issues Decision on SPCs for Medical Devices
ECJ rules on the availability of SPC protection for medical devices incorporating a pharmaceutica...
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Article and Insights
Drug-Device Combination Products: Where do they fall within the new MDR Regime?
Continuing our series of publications, in this briefing we examine the key changes to the regulat...
Partner
Charleen O’Keeffe
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Cutting Costs in Personal Injuries Litigation
New legislative changes aimed at cost savings in personal injuries to commence
Consultant
Margaret Muldowney
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Court of Appeal Upholds Invalidity of a Combination Product SPC Applying the CJEU Test
The Court of Appeal has upheld a finding by the High Court that Merck Sharp & Dohme's Inegy SPC w...
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Compulsory Licences on the Horizon for Drugs and Equipment?
As concerns grow globally about the availability of certain drugs and equipment in the midst of t...
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Clinical Trials Regulation to Take Effect from 31 January 2022
The European Commission has announced that the long-awaited Clinical Trials Regulation (EU) No 53...
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A Progressive Roll Out of the IVDR
The European Commission proposes a progressive roll-out of the In Vitro Medical Devices Regulatio...
Partner
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A Stricter Regime is Beckoning for Manufacturers of Popular Beauty Devices
The European Commission has proposed reclassifying certain beauty and brain stimulation devices w...
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A Further Update on the Unified Patent Court
The requisite number of Member States have now joined the protocol on a European Unified Patent C...
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Third Strike for Warner-Lambert’s Lyrica® patent
The lengthy Lyrica® patent dispute between Warner-Lambert and Mylan and Actavis is over. Last wee...
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Progressive Roll Out of the IVDR Confirmed by EU Parliament and Council
The European Parliament and European Council recently approved the progressive roll-out of the In...
Partner
Charleen O’Keeffe
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Article and Insights
Is Change on the Horizon for the Disclosure Regime Under Order 39, Rule 46 RSC?
In a recent decision, the Court of Appeal (CoA) considered the interpretation and application of ...
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Article and Insights
What Regulatory Challenges are Facing the Life Sciences Sector?
Charleen O’Keeffe discusses some of the regulatory trends and challenges she sees coming down the...
Partner
Charleen O’Keeffe
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Article and Insights
The European Unified Patent Court – is it Finally within Reach?
The German Federal Constitutional Court has rejected the latest constitutional challenge to the G...
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Article and Insights
IPHA’s Revised Code of Practice for the Pharmaceutical Industry
Taking effect on 1 March 2021, the IPHA have revised their Code of Practice for the Pharmaceutica...
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Managing Partner
Stephen Keogh
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Article and Insights
Improved Access to Affordable Medicines – EU Proposes Radical Action
EU Commission releases its Pharmaceutical Strategy for Europe, marking the first step in its prop...
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Article and Insights
