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Pharmaceutical Industry › Italy › European Union

Goodwin

Global Biosimilar Updates - Spring 2025

Goodwin on

Celltrion’s ustekinumab biosimilar, STEQEYMA®, has won its first bid within 2 months of its launch in January of 2025. Since launch, STEQEYMA® has secured contracts in four regions of Italy, including, Piemonte, Valle...more

Morrison & Foerster LLP

Quarterly Cartel Catch-Up: Summer Surge Foreshadows Enforcement Intrigue

Morrison & Foerster LLP on

Despite the summer doldrums, cartel enforcers around the world had several notable enforcement actions and, perhaps more importantly, signaled a busy fall and winter. In the United States, the Department of Justice’s...more

McDermott Will & Schulte

Investing in European Healthcare - What's on the Horizon for 2022? - Regulatory and Legal Changes

McDermott Will & Schulte on

Today’s global healthcare marketplace is marked by unprecedented transformation. The seismic shifts in healthcare delivery and drug development during COVID-19 have, in 2021, continued to demonstrate the power and capacity...more

Hogan Lovells

Combating COVID-19: Government powers for safeguarding supply of critical products and potential conversion of production – Italy,...

Hogan Lovells on

The spread of COVID-19 is causing Europe to experience one of the greatest health crises in decades, the consequences of which are still unpredictable. Faced with this unprecedented situation, the governments of different...more

Hogan Lovells

AIFA provides guidance on critical aspects relating to the management of clinical trials in Italy during the COVID-19 emergency

Hogan Lovells on

Due to the COVID-19 emergency and the consequent lockdown that is affecting non-essential services in Italy, including some health care services, on March 12, 2020 the Italian Medicines Agency ("AIFA") issued a Guidance,...more

Hogan Lovells

New rules for expanded access in Italy

Hogan Lovells on

Fast track for orphan diseases and rare forms of cancers - By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more

Hogan Lovells

Italian time-machine : Limitation of the duration of an SPC may be decided by the Italian Patent Office

Hogan Lovells on

The Board of Appeal of the Italian Patent Office (Commissione dei Ricorsi), by decision published on June 26, 2017, acknowledged the right of the patent holder to ask the Italian Patent Office for the limitation of the...more

Jones Day

European Commission Sets its Sights on Allegedly Excessive Drug Prices

Jones Day on

In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more

Hogan Lovells

Relocation of the EU Medicines Agency: Italy

Hogan Lovells on

The EU Medicines Agency (EMA), the most sought after EU regulator, is looking for a new home. 900 jobs will move from London to an EU Member State when Brexit is complete. In a series of blog posts, our European life science...more

BCLP

January EU Competition Newsletter

BCLP on

Digital and Pharma Merger Cases Raise Worry of Enforcement Gap in EU Merger Control - On 7 October 2016, the EU Commission launched a public consultation ("the Consultation") on the functioning of certain procedural and...more

Morgan Lewis

2016 Mid-Year Global Cartel Enforcement Report

Morgan Lewis on

Cartel enforcement activity promises to remain busy In the coming months and into 2017 Cartel enforcement remains a priority for competition authorities around the world. Global cartel fines totaled more than $6...more

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