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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +
A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous thirty days. less -
White & Case LLP

Healthy returns: European life sciences M&A heats up as sector faces demographic reckoning

White & Case LLP on

Dealmaking in Europe’s life sciences sector has been relatively muted in recent years, but the first half of 2025 has shown signs of strength as companies respond to the stark realities of an aging population - Earlier this...more

Hogan Lovells

Pharmaceutical and cosmetic companies targeted by revised urban wastewater treatment directive – A critical moment to assess legal...

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The European Commission has revised the Urban Wastewater Treatment Directive (“UWWTD”), which is instrumental in mitigating urban wastewater pollution across EU. This revision, prompted by emerging environmental challenges,...more

Goodwin

Antitrust and Competition Life Sciences Year in Review 2024

Goodwin on

The last year (and particularly the last few months) of the Biden Administration brought a flurry of activity from the Federal Trade Commission (FTC) in the life sciences space, continuing a yearslong pattern of close...more

Goodwin

Regulatory Updates on Samsung’s Denosumab Biosimilars

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On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing Amgen’s PROLIA® and XGEVA®,...more

Goodwin

Antitrust and Competition Life Sciences Quarterly Update Q2 2024

Goodwin on

To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more

Wilson Sonsini Goodrich & Rosati

European Antitrust Bimonthly Bulletin – July/August 2024

Wilson Sonsini Goodrich & Rosati on

The "European Antitrust Bimonthly Bulletin” breaks down the major antitrust developments in Europe during the past two months into concise and actionable takeaways. ...more

Jones Day

EU Parliament Adopts SPC Reform Proposals: Clarifying the Protection Scope for Biologics

Jones Day on

On February 28, 2024, following the European Commission's four 2023 proposals, the European Parliament adopted a legislative resolution on the amended proposal to create a Unitary Supplementary Protection Certificate ("USPC")...more

Hogan Lovells

Reduction of EU regulatory data protection, but not as short as the European Commission proposed - European Parliament’s position...

Hogan Lovells on

On 10 April 2024 the European Parliament adopted its position on the draft text on the revision of the European Union’s (EU) general pharmaceutical legislation, also referred to as the (proposed) “EU Pharmaceutical Law...more

Hogan Lovells

The European Commission report on competition enforcement in the pharmaceutical sector

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On 26 January 2024, the European Commission published a report on competition enforcement in the pharmaceutical sector, highlighting the role of EU competition law in safeguarding market participants and consumers,...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

A&O Shearman

European Commission sanctions first ever pharmaceuticals cartel and scores victory in pay-for-delay appeal

A&O Shearman on

The European Commission (EC) has fined five pharmaceutical companies a total of EUR13.4 million for participating in a cartel concerning N-Butylbromide Scopolamine/Hyoscine (SNBB) – an active pharmaceutical ingredient (API)...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 98

Jones Day on

This regular update (no. 98 | 1 March 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more

A&O Shearman

European Commission investigation into Teva’s potential abuse of dominance – misuse of patent procedures and disparagement

A&O Shearman on

On 10 October 2022, the European Commission (EC) sent a Statement of Objections to Teva Pharmaceutical Industries Limited and Teva Pharmaceuticals Europe BV (Teva). The EC has provisionally found that Teva abused its dominant...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No.69

Jones Day on

COMPETITION & STATE AID - State Aid - European Commission publishes revised Communication on State aid rules for Important Projects of Common European Interest (IPCEI). On 25 November 2021, the Commission published a...more

A&O Shearman

Antitrust in focus - July 2021

A&O Shearman on

This newsletter is a summary of the antitrust developments we think are most interesting to your business. Please note that this is our final edition before we take a break over the summer, returning in September. Tjarda van...more

A&O Shearman

Beyond “pay-for-delay” – the EU-Commission’s investigation into patent filing practices and communication measures

A&O Shearman on

On 4 March 2021, the European Commission (Commission) opened a formal investigation into alleged anti-competitive conduct by the pharmaceutical company Teva. The Commission suspects Teva of having deployed a strategy with the...more

K&L Gates LLP

Brussels Regulatory Brief: March 2021

K&L Gates LLP on

ANTITRUST AND COMPETITION - The European Commission Opens a New Investigation in the Pharma Sector - On 4 March 2021, the European Commission (Commission) has opened a formal investigation into alleged misuses of patent...more

A&O Shearman

European Commission completes current cycle of pay-for-delay probes with fines imposed on Teva and Cephalon

A&O Shearman on

On 26 November 2020, the European Commission (Commission) issued a decision fining pharmaceutical companies Teva and Cephalon EUR60.5 million for infringing Article 101 TFEU by agreeing to delay the entry of a cheaper generic...more

K&L Gates LLP

Brussels Regulatory Brief: February 2020

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ANTITRUST AND COMPETITION - The Court Of Justice Of The EU Rules Provides Clarity On The Assessment Of Pay-For-Delay Agreements - The Court of Justice of the EU (CJEU) has backed the UK Competition and Markets Authority...more

Hogan Lovells

The European Commission releases an updated Borderline Manual for medical devices

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The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is intended to assist manufacturers in...more

Morrison & Foerster LLP

The EU General Court’s Ruling on Pay for Delay - Why Patent Settlement Agreements May Violate EU Antitrust Laws

Morrison & Foerster LLP on

The EU General Court (“Court”) reduced the fines imposed on Servier SAS and its subsidiaries (“Servier”) from a total of €428 million to €315 million (see press release no. 194/18), thereby partially annulling a European...more

Goodwin

European Commission Grants Marketing Authorization for Adalimumab and Trastuzumab Biosimilars

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Last week the European Commission granted marketing authorization for two biosimilars. First, Sandoz, a division of Novartis, announced on July 27 that it had received marketing authorization for Hyrimoz, its adalimumab...more

A&O Shearman

EU Regulatory Data Protection for Life Sciences Companies

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This note discusses regulatory data protection (or data exclusivity) and market protection (marketing exclusivity). It identifies their legal bases, defines relevant legal terms and case law, and explains why these forms of...more

McDermott Will & Schulte

Brexit Update: What’s Next for the Global Marketplace

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In Depth - UK Withdrawal Process - The United Kingdom will continue to be an EU member until procedures are completed for exiting the European Union, which is likely to be a long process. Under EU Treaty rules,...more

McGuireWoods LLP

More on Patent Settlements Including Litigation at the European Courts

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Last week I posted on the European Commission’s (EC) latest report into patent settlement agreements between originator and generic companies in the European Union (EU). The EC says each time it produces these reports that...more

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