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Data Protection Prescription Drugs

A&O Shearman

China advances pharmaceutical data protection regime with new Draft Measures

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On March 19, 2025, China’s National Medical Products Administration (NMPA) released the Draft Measures for the Protection of Drug Trial Data (the “Draft Measures”), along with its accompanying implementation guidelines, the...more

Ropes & Gray LLP

China Formalizes Regulatory Data Protection Mechanism

Ropes & Gray LLP on

Recently, the National Medical Products Administration (NMPA) issued the draft version of 'Implementation Measures for Drug Trial Data Protection (hereinafter referred to as the 'Draft for Comments'), aiming to clarify the...more

Sheppard Mullin Richter & Hampton LLP

Reminder: FDA Does, In Fact, Review DOF

When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the...more

Smart & Biggar

2024 highlights in Canadian life sciences IP and regulatory law

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In 2024, the Rx IP Update team at Smart & Biggar reported on a number of developments in Canadian life sciences IP and regulatory law. Highlights from 2024 are below; see also our top ten Rx IP Update reads of 2024....more

Jones Day

Vital Signs: Digital Health Law Update | Fall-Winter 2024

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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more

Robinson+Cole Data Privacy + Security Insider

Privacy Tip #418 – New Phishing Scheme Uses Scarce Weight Loss Drugs as Hook

Scammers are always looking for new ways to dupe victims. If you battle your weight, you think about it a lot and are always looking for easier ways to lose some pounds. There is no easy way, but we are always looking for an...more

Goodwin

The European Parliament Adopts Position on the European Commission’s Proposal for the First Major Overhaul of the EU Medicines...

Goodwin on

In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more

ArentFox Schiff

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

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Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

ArentFox Schiff

Legal Implications of AI in the Life Sciences Industry

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Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more

Foley & Lardner LLP

IP Toolbox Is Crucial In AI-Powered Drug Discovery

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Navigating the complex landscape of drug discovery requires innovative strategies and interdisciplinary collaborations spanning biotechnology, pharmacology, medicine and engineering. As the cost of developing new drugs...more

McDermott+

McDermottPlus Check-Up: May 19, 2023

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The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more

Smart & Biggar

Federal Court of Appeal restores Minister of Health’s decision to grant RUZURGI NOC despite FIRDAPSE data protection

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As previously reported, the Federal Court quashed a second decision by the Minister of Health (Minister) to issue a Notice of Compliance (NOC) to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, following the...more

Proskauer on Privacy

“A Full Plate”: FTC’s Open Meeting on PBMs, AI, Privacy and Online Harms

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During a much anticipated Open Commission Meeting announced by Commission Chair Lina M. Khan, the Federal Trade Commission (“FTC”) voted in favor of issuing one new policy statement and one new report to Congress. First,...more

Jones Day

Covid-19 Key EU Developments, Policy & Regulatory Update No. 81

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COMPETITION & STATE AID - Competition- European Commission ramps up home searches of employees of companies suspected of potential competition breaches - On 5 April 2022, Maria Jaspers (Director of Cartel Directorate, DG...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No.75

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COMPETITION & STATE AID - State Aid- Fit for Future Platform pursues simplification of EU law, including Opinion on State aid - On 28 January 2022, the Fit for Future Platform, a high-level expert group to assist the...more

Smart & Biggar

2021 Highlights in Canadian Life Sciences IP and Regulatory Law

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In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 66

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Competition - European Commission comments on the future of competition policy - On 29 October 2021, Executive Vice-President and Competition Commissioner Margrethe Vestager provided remarks on the future of competition...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 64

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European Commission adopts Communication on Energy Prices to tackle exceptional rise in energy prices - On 13 October 2021, the Commission adopted a Communication on Tackling Rising Energy Prices: a Toolbox for Action and...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 63

Jones Day on

State Aid - European Commission consults on proposed amendments to General Block Exemption Regulation - On 6 October 2021, the Commission opened its consultation with Member States and interested parties to comment on...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 61

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European Commission releases State of the Union 2021 report, including on COVID-related State aid - On 15 September 2021, the Commission published the State of the Union 2021 report on the Commission’s work and...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 58

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This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. LATEST KEY DEVELOPMENTS...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 57

Jones Day on

This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. LATEST KEY DEVELOPMENTS...more

Smart & Biggar

Federal Court of Appeal confirms Janssen’s SPRAVATO not eligible for data protection

Smart & Biggar on

Update: On November 10, 2021, the Minister rejected Janssen’s second request for data protection for SPRAVATO, which was submitted following the coming into force of the Canada-United States-Mexico Agreement (CUSMA). The...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 56

Jones Day on

This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. LATEST KEY DEVELOPMENTS...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - June 2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

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