News & Analysis as of September 20, 2024

Pharmaceutical Industry

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The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -

Biosimilar Approval Updates in Europe and China

Goodwin on 4/30/2024

On April 25, 2024, the Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion, recommending the granting of marketing authorization for Biogen Netherlands B.V.’s biosimilar TOFIDENCE (tocilizumab),...more

Year in Review: Top Biosimilars-Related Regulatory Developments of 2022

Goodwin on 1/3/2023

As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more

Adalimumab Biosimilar Update: Shanghai Henlius Biotech’s Approval in China and Celltrion’s Positive Opinion in the EU

Goodwin on 12/15/2020

Last week, Shanghai Henlius Biotech announced that China’s National Medical Products Administration has approved its adalimumab biosimilar candidate for the treatment of rheumatoid arthritis, ankylosing spondylitis, and...more

What's New in Washington - September 2020

Akin Gump Strauss Hauer & Feld LLP on 9/15/2020

As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on 8/26/2020

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....more

COVID-19- European Commission's recommendation on conformity assessment and market surveillance procedures

Hogan Lovells on 3/18/2020

On 16 March 2020, the European Commission published Recommendation (EU) 2020/403 of 13 March on conformity assessment and market surveillance procedures within the context of the COVID-19 threat. The objective of the...more

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

Hogan Lovells on 3/16/2020

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

Financial Daily Dose 3.3.2020 | Top Story: Promised Central Bank Action Halts Market Slide (for now)

Robins Kaplan LLP on 3/3/2020

Despite news of additional COVID-19-related deaths and infections in America, central bankers appear to have bought at least one day of peace for US markets, which posted strong gains on a late surge on Monday, breaking a...more

Financial Daily Dose 11.13.2019 | Top Story: Buffeted by Changing Consumer Demands, Dean Foods Declares Bankruptcy

Robins Kaplan LLP on 11/13/2019

Dean Foods, the largest milk company in the U.S., has filed for bankruptcy protection, a “fresh setback to a U.S. dairy industry struggling against declining U.S. milk consumption and rising competition.” Industry experts...more

Financial Daily Dose 10.6.2019 | Top Story: Drug Distributors and Maker in Talks for Multi-billion-dollar Opioid Litigation...

Robins Kaplan LLP on 10/16/2019

A group of three major drug distributors—McKesson, AmerisourceBergen, and Cardinal Health—are in the midst of talks with representatives of state and local governments who have brought more than 2000 opioid-related lawsuits...more

Financial Daily Dose 10.9.2019 | Top Story: Chair Powell says Fed will Expand its Treasury Securities Holdings

Robins Kaplan LLP on 10/9/2019

Fed Chair Powell, speaking at an economics conference in Denver yesterday, made news by indicating that the central bank would “once again begin expanding its portfolio of government-backed securities”—a shift in policy...more

Cross-Border Investigations Update - September 2019

Skadden, Arps, Slate, Meagher & Flom LLP on 10/3/2019

This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including a review of the first year of GDPR enforcement, analysis of...more

Life Sciences International Review - Q2 2019

Morgan Lewis on 8/20/2019

EU – REGULATORY - Brexit, Notified Bodies, and Medical Devices - The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more

Year in Review: Top 5 Foreign Market Developments in 2018

Goodwin on 12/28/2018

Here are our picks for the top-five most significant foreign biosimilar market developments in 2018: 1. Shake-up In Europe’s Adalimumab Market - As a result of litigation and resulting global settlements, several...more

International News Life Sciences - Winter 2018

McDermott Will & Emery on 12/20/2018

Data Inspections in China: Increased Supervision and Compliance - Data protection inspections have become more frequent for companies with operations in China. Many companies are struggling for guidance on how to comply. ...more

Your Daily Dose of Financial News

Robins Kaplan LLP on 10/31/2018

More on yesterday’s news of a split power-generation division at GE, including why fixing the ailing business is such an important task for new CEO Larry Culp and what federal criminal and civil accounting probes mean for the...more

Antitrust, Competition, and Economic Regulation Quarterly Newsletter - Summer 2018

Hogan Lovells on 9/19/2018

Read the latest news on antitrust, competition, and economic regulation in this summer edition of our quarterly ACER newsletter. ...more

Your Daily Dose of Financial News

Robins Kaplan LLP on 6/18/2018

Theranos founder and ex-CEO Elizabeth Holmes has been indicted on federal fraud charges along with former company president Ramesh Balwani. The charges come three months after Holmes settled civil charges with the SEC....more

BioArctic Announces Patent Allowance Entitled Spinal Cord Devices and Methods for Promoting Axonal Regeneration

Knobbe Martens on 2/23/2018

BioArctic AB, a public Swedish biopharma company, recently announced that they received allowance of a patent application directed to a method of promoting axonal regeneration using a biodegradable spinal cord device. The...more

Antitrust, Competition and Economic Regulation Quarterly Newsletter - Autumn 2017

Hogan Lovells on 11/30/2017

First come, first served. That’s not the principle behind the clearance of Bitcoin transactions. Equally for other blockchain technology networks, the relevant factor to get a transaction on the next available block is not...more

Antitrust, Competition and Economic Regulation Quarterly Newsletter - Winter 2017

Hogan Lovells on 2/23/2017

FTC takes another look at merger remedies - On 3 February 2017, the U.S. Federal Trade Commission (“FTC”) released its Merger Remedies Study, which analyzed the success of merger remedies imposed by the FTC from 2006 to...more

Your daily dose of financial news The Brief – 2.23.16

Robins Kaplan LLP on 2/23/2016

It’s a whole new ballgame for Wall Street traders—and one suspects it’s involving a lot fewer actual ballgames and a lot more algorithms, as the advanced-degree coders and their ETF firms take on the old guard – NYTimes...more

Alert: Top 10 Antitrust Developments and Trends to Watch in 2016

Cooley LLP on 1/12/2016

Attention in the US during 2016 will be on the presidential campaign, and the election in November will bring a change in the "antitrust guard" at the top of the DOJ and FTC – even if a Democrat wins – that will drive the...more

Red Notice Newsletter - October 2014

Akin Gump Strauss Hauer & Feld LLP on 11/3/2014

Welcome to the October 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. - This month on the anticorruption front, a Texas company agrees to pay more than $5 million to settle allegations...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter - 3rd Edition

K&L Gates LLP on 10/22/2014

Welcome - We are pleased to provide you with the Fall edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. This newsletter provides updates on important issues and developments across these...more

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