Health Science, Computers & Technology International Trade

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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

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

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

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

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

"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

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