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Goodwin

Update on Recent International Biosimilar Approvals - September 2024

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Approval of Celltrion’s Ustekinumab Biosimilar in the EU:  On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43, a biosimilar of STELARA...more

Morrison & Foerster LLP

Quarterly Cartel Catch-Up: 2024 Mid-Year Global Review

At the mid-year point, 2024 is shaping up to be an eventful year in cartel enforcement. In the United States, the U.S. Department of Justice (DOJ)’s Antitrust Division (Division) enjoyed two significant victories and finally...more

Morrison & Foerster LLP

Quarterly Cartel Catch-Up: Recent Developments in Criminal Antitrust for Busy Corporate Counsel - Q1 2022

Since the last edition of the QCC, there has been a series of dramatic developments in the criminal antitrust enforcement space in the U.S. from the Department of Justice’s Antitrust Division (Division)....more

Dechert LLP

Increased regulatory scrutiny of foreign direct investments in the healthcare sector

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Key Takeaways - - Foreign Direct Investment (FDI) controls are proliferating around the globe. Since the pandemic, “health” has become a particular focus.  - Several countries have adapted their existing FDI rules, or...more

Goodwin

Biosimilars Approvals: Nepexto Receives European Marketing Authorization, Ziextenzo and Riximyo Receive Health Canada Approval

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Last week, Lupin and Mylan announced that the European Commission had granted marketing authorization for their biosimilar Nepexto (etanercept) for all indications of the reference product. The marketing authorization follows...more

Robins Kaplan LLP

Financial Daily Dose 1.17.2020 | Top Story: Senate Passes USMCA by Wide Margin to Update NAFTA

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While there’s plenty of other business afoot in D.C. these days, it also happens to have been a pretty big week for trade deals. A day after Phase One with China was inked, the Senate overwhelmingly approved a revised...more

Smart & Biggar

2019 Highlights in Canadian Life Sciences IP and Regulatory Law

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In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more

Smart & Biggar

Rx IP Update - April 2018

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Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more

Mintz - Intellectual Property Viewpoints

Canada Institutes Certificates of Supplementary Protection for Approved Drug Products

On September 21, 2017, the Comprehensive Economic and Trade Agreement (CETA) signed between the European Union (EU) and Canada provisionally entered into force in Canada.  Among other things, this agreement seeks to harmonize...more

Morgan Lewis

2016 Global Cartel Enforcement Report

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Authorities launched new criminal probes, obtained guilty pleas from companies and executives and imposed hefty fines as aggressive enforcement continued. Several significant developments occurred in cartel enforcement...more

Morgan Lewis

2016 Mid-Year Global Cartel Enforcement Report

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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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