International Trade Health

Read need-to-know updates, commentary, and analysis on International Trade issues written by leading professionals.
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Ingestible e-Pill Approved For Use in Hospitals

BodyCap, a France-based company said to be dedicated to the development of miniature wireless electronic sensors, recently announced that its e-Celsius® device has earned CE mark approval and is now commercially available for...more

First Biosimilar Monoclonal Antibody in Oncology Granted EU Approval: Implications for the U.S. Market

Recent developments in Europe may augur a new push for oncology biosimilars in the United States. On February 22, 2017, the European Commission approved Celltrion’s Truxima™ for all indications of reference rituximab...more

Pro Te: Solutio - Vol.9 No.3 – Fall 2016

The Fall 2016 issue of Pro Te is about all things regulatory, including a peek at the newly developing issue of crowdfunding for medical devices. In EMA Guidance on Clinical Data Publication, we discuss recent guidance...more

Outsourcing of Services in the Medical Device Industry

As the medical device market continues to grow, the medical device industry has strived to reduce costs through outsourcing. An industry report has found that the global medical device outsourcing market was valued at $33.2...more

Health Company Fined by UK’s Information Commissioner Office

Last week, the UK’s Information Commissioner’s Office (ICO) published a monetary penalty notice which fined a private healthcare company, HCA International, £200,000 for its failure to keep sensitive data secure....more

What’s New in Washington: 10 Things You Need to Know

The Trump administration and Congress continue to take on a new shape. The Presidential Transition Team officially shut its U.S. General Services Administration office on February 28, 2017, and the remaining staff moved to...more

Limiting Extraterritorial Reach of U.S. Patents: "Substantial" Means More than One

Last week, the Supreme Court provided much-needed clarity to U.S. companies concerned about their potential liability for supplying a single component of a multicomponent invention abroad. The Court’s decision in Life...more

President Trump's Address to Congress: The Path Forward for 2017

On Tuesday evening, President Trump addressed a joint session of Congress to outline the path forward for his 2017 policy agenda. The president’s agenda is ambitious, yet Trump signaled the White House’s desire to work with...more

First Biosimilar in Oncology, TRUXIMA, Granted Marketing Approval in European Union

We previously reported that the Committee for Medicinal Products for Human Use (CHMP) had recommended that the European Medicine Agency (EMA) grant marketing approval for Truxima (CT-P10), Celltrion Healthcare’s biosimilar of...more

News from Abroad -- Swiss-style Patent Claims Can Be Very Valuable in Australia

The scope for enforcement of Swiss-style claims may be broader in Australia than for method of medical treatment claims. Second medical use inventions can be claimed in an ever increasing number of claim formats depending on...more

RxIP Update - February 2017

Federal Court of Appeal rules on non-infringing alternatives and apportionment as defences to an accounting of profits from patent infringement - On February 2, 2017, the Federal Court of Appeal released a significant...more

Tokyo Dispute Resolution & Crisis Management Newsletter – February 2017

Product Pricing and Antitrust Law in the United States - A recent US court action by a Japanese company in respect of a competitor’s volume discounts - Introduction - The current position in the US on the rules...more

Restrictions on Advertising with Nutrition and Health Claims Apply to Both Communications Addressed to Consumers and to...

The Court of Justice of the European Union (ECJ) held that the restrictions on promoting foodstuffs with nutrition and health claims not only apply to communications addressed to the general public but also to communications...more

What’s New in Washington: 10 Things You Need to Know

The first four weeks of the Trump administration have brought a flurry of policy and regulatory activity through Executive Orders (EO), proposed new legislation and review of existing regulation. After eight years of the...more

Hurdles for Neulasta Biosimilars

A number of biosimilar makers have tried to obtain approval for proposed biosimilar versions of Amgen’s Neulasta (pegfilgrastim), a long-acting version of Amgen’s Neupogen (filgrastim), but have encountered hurdles so far...more

The GDPR – Possible Impact on the Life Sciences and Healthcare Sectors

Regulation (EU) 2016/679 of the European Parliament and the Council of 27 April 2016, (the “GDPR”) came into force in May 2016 and introduced a number of changes to European data protection law. Such changes will impact upon...more

Borderline products: Marketing food supplements in the UK following the glucosamine case

In late December 2016, the Supreme Court rejected the Medicines and Healthcare Products Regulatory Agency's (MHRA) application for permission to appeal against the decision of the Court of Appeal in R. (on the application of...more

As patients sue over insulin’s skyrocketing costs, Trump thunders, confuses

Just under a century ago, a team of Canadian scientists made the breakthrough that led to widely available insulin as an effective treatment for diabetes, which then was a deadly disease. The researchers, who won the Nobel...more

Update on Ireland’s Framework Agreement

Last fall, we reported on Pfizer’s 30% price cut to Enbrel® (etanercept) to comply with Ireland’s Framework Agreement on the Supply and Pricing of Medicines, which requires price reductions for off-patent branded biologic...more

Privacy and Data Security: 2017 Year in Preview

Few issues keep executives awake at night more than Privacy and Data Security. New regulations and threats alike are plentiful, varied, and evolving. The rate of change for cybersecurity and information governance continues...more

Ringing in the Change

The UAE legal system has always adopted globally accepted best practices when it comes to the issue of drug abuse. This approach is again witnessed in the newly effected Federal Law No. 8 of 2016, the new drug law, amending...more

An Increased Cooperation in Enforcement Activity: The Italian Competition Authority and the Italian Medicines Agency Sign a...

On 19 January 2017, the Italian Competition Authority (AGCM) and the Italian Medicines Agency (AIFA) signed a memorandum of understanding in order to increase enforcement in the pharmaceutical sector by strengthening their...more

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

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