International Trade Health

Read need-to-know updates, commentary, and analysis on International Trade issues written by leading professionals.
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DHS Announces Changes to U.S. & Cuba Migration Policies

On January 12, 2017, the U.S. Department of Homeland Security (DHS) announced changes to the policies and regulations affecting Cuban nationals. DHS stated the “changes represent another important step in the normalization of...more

"OFAC Eases Restrictions on the Export of Medical Devices to Iran"

On December 22, 2016, the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) announced amendments to the general license (GL) that authorizes the export or re-export of certain medical devices to Iran....more

EMA on optimising the development of advanced therapies

On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory conference concerning the optimisation of the development of...more

Biosimilars in Europe: 2016 Year in Review and What’s Ahead

Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). 22 biosimilars are approved in eight different product classes...more

OFAC Expands Iran-Related Authorizations for Medicine, Medical Devices and Agricultural Commodities

On December 23, 2016, the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) issued a Final Rule amending the Iranian Transactions and Sanctions Regulations, 31 C.F.R. Part 560 (ITSR) to expand the...more

Year in Review: Top Five Foreign Market Developments of 2016

Here are our picks for the top-five most significant foreign market developments in the world of biosimilars in 2016: Various guidance documents have been published this year further defining regulatory requirements for...more

Happy New Year: OFAC Expands Exports of Medical Devices to Iran

Effective December 23, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) amended the Iranian Transactions and Sanctions Regulations (ITSR) to expand the scope of medical devices that can be exported to...more

Rx IP Update - December 2016

Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions - As reported previously, on October 12, 2016, the Federal Court of Appeal...more

News from Abroad: Antibodies in the European Patent Office

The European Patent Office (EPO) continues to grant many patents relating to antibodies, and in doing so applies the same patentability criteria as to other inventions. However, some commentators have suggested that...more

One Step Up: U.S. Export Controls for Pharma/Device Companies

2016 was an active year for U.S. export control developments impacting U.S. pharma/device companies. We expect 2017 also to be busy, especially with the upcoming change in Administrations. This article briefly will review for...more

Alert: Pfizer and Flynn Pharma Fined £90 Million for Charging “Excessive Prices” for Epilepsy Medicine

The UK Competition and Markets Authority (the CMA) announced on 7 December that it had fined pharmaceutical manufacturer Pfizer and its UK distributor Flynn Pharma a total of £90 million. According to the CMA, the companies...more

Presidential Pulse: 10 Key Ways the Trump Administration May Impact The Way You Do Business in 2017

Today marks just over a month since Donald Trump was elected as the next President of the United States. As each cabinet appointment is announced, we get more clues to help us predict which direction the Trump...more

The Digital Download - Alston & Bird’s Privacy & Data Security Newsletter – November 2016

Updates on the EU: German DPA Publishes First Privacy Shield Guidelines, Requires German-Law Contracts for Transfers. On June 7, 2016, the European Commission adopted the EU-U.S. Privacy Shield. One question that many...more

Stopping The Sale of Gray-Market Medical Devices

On November 3, 2016, the US Court of Appeals for the Second Circuit approved an injunction against about 200 importers and sellers preventing them from importing and selling gray market blood-glucose test strips. The case was...more

International News: Focus on International Dispute Resolution

Overview of the Proposed Reforms of the EU Merger Control Regime - In October 2016, the European Commission launched a public consultation to continue the process of identifying possible areas of the EU Merger Regulation...more

Amgen and Allergan Submit European Application for Avastin® Biosimilar

We recently reported that Amgen and Allergan had submitted an abbreviated Biologics License Application to the FDA for ABP 215, a biosimilar to Avastin® (bevacizumab). Today, the companies announced that they have also...more

Coherus Announces Marketing Authorization Application to the EMA for Pegfilgrastim Biosimilar

Coherus BioSciences, Inc., a global biosimilar company, is currently advancing three late-stage clinical products towards commercialization, namely CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and...more

Rx IP Update - November 2016

Federal Court of Appeal opines on the framework for analyzing obviousness-type double-patenting - On November 4, 2016, the Federal Court of Appeal dismissed Apotex’s appeal in Apotex Inc v Eli Lilly Canada Inc, 2016 FCA...more

Pharmaceutical Product Liability Class Action Filed Relating to Olmetec Drug

Earlier this month a proposed class action was filed in Montreal by the Consumer Law Group alleging that Merck, Shering-Plough and Daiichi Sankyo (the Defendants) provided inadequate warnings about the drugs Olmetec and...more

Highlights from McDermott’s 2016 Pharmaceutical/Medtech Dealmaking Symposium

On October 25, 2016, McDermott Will & Emery held its fifth annual Pharmaceutical/Medtech Dealmaking Symposium in Cambridge, Massachusetts. The day consisted of a series of thought-provoking panels with leading dealmakers in...more

2016 Postelection Regulatory Report

The results of the U.S. presidential election are historic and unanticipated, and they will have significant economic, political, legal and social implications. As we prepare for the Trump presidency, many uncertainties...more

FDA Announces International Draft Guidance for Clinical Evaluation of Software as a Medical Device

The U.S. Food and Drug Administration announced the availability of a draft guidance for the clinical evaluation of software as a medical device (SaMD). The draft guidance was prepared by the SaMD Working Group of the...more

Trump Administration Forecast: Changes to Key Policies Expected

Donald Trump’s election as president of the United States of America was as unexpected in the polls as the United Kingdom’s vote to embrace Brexit. Now Democrats and Republicans alike are trying to assess how Mr. Trump, a...more

U.S. Biosimilars Pathway Under Trump

This week’s election of Donald Trump as the next President of the United States undoubtedly impacts many sectors of the American economy, and the bio/pharmaceutical industry is no exception. Two of Trump’s stated policies...more

"Looking Ahead: The U.S. Legal and Regulatory Environment Under a Trump Administration"

Election Day brought an end to a long period of uncertainty that caused market fluctuations and delayed business planning decisions. As we navigate the post-election landscape, many questions remain regarding the potential...more

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