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Read need-to-know updates, commentary, and analysis on International Trade issues written by leading professionals.

Sandoz Announces Phase I Data For Its Pegfilgrastim Biosimilar

by Goodwin on

On December 8, 2017, Sandoz, a division of Novartis, announced data purportedly showing that its pegfilgrastim biosimilar candidate matches the reference biologic, Neulasta® in terms of pharmacokinetics, pharmacodynamics,...more

Saudi Arabia Update – November and December 2017

by Dentons on

Legal developments - Saudi Arabia anti-corruption drive and protection of corporates - In the wake of Saudi Arabia’s headline-grabbing anti-corruption drive in November, Crown Prince Mohammed bin Salman instructed the...more

What's New In Washington - December 2017

December is often the busiest time in Washington, and this year is no different as Congress races toward the holiday finish line. There is still a multitude of problems to solve before members can head back to their...more

A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar

Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more

Australian Competition & Consumer Law Update - November 2017

by Jones Day on

The Australian competition law environment has undergone some important changes of late. In this Update, we discuss the Australian Competition and Consumer Commission's ("ACCC") increasing focus on the unfair contracts...more

UK publishes paper on Brexit and medicines regulation

by Hogan Lovells on

On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more

Samsung Bioepis Receives EU Marketing Authorization For Trastuzumab Biosimilar

by Goodwin on

Samsung Bioepis announced today that the European Commission (EC) has granted marketing authorization for Ontruzant®, a biosimilar for Herceptin® (trastuzumab), across all 28 European Union member states and the European...more

European Medicines Agency heads for Amsterdam

by Allen & Overy LLP on

Today the 27 member states of the European Union have decided on Amsterdam as the new home of the European Medicines Agency. The decision came after three rounds of voting, with Amsterdam eventually emerging the winner after...more

Compliance into the Weeds-Episode 60, Cardinal Health and Joint GC-CCO Role

by Thomas Fox on

In this episode, Matt Kelly and I take a deep dive into the Cardinal Health corporate governance imbroglio. In it, a disgruntled shareholder, the Teamsters Pension fund brought a motion to have the CEO stripped of his title...more

Italian Regions cannot recommend against use of costly medicines – says highest administrative court

by Allen & Overy LLP on

A recent decision by the Italian Council of State (CS) comes as welcome news for the innovative pharmaceutical industry as it sets important boundaries to the initiatives that regional authorities can take in the attempt to...more

Australia aligns with the European medical device regulatory framework

by Dentons on

In July 2017, the TGA sought comments from interested parties to further align Australian and European medical device regulatory requirements to - - up-classify surgical mesh from Class IIb (medium to high risk) to...more

Big Pharma BI, CBI, and Service Interruption Claims Percolating in Puerto Rico

by Zelle LLP on

As recovery and rebuilding efforts drag on in Puerto Rico, Hurricane Maria’s impact on Big Pharma is radiating across the U.S., and around the globe as the dozens of drugs manufactured in Puerto Rico become scarce. Maria...more

CFDA Issues New Classification Catalogue for Medical Devices In China

by Morgan Lewis on

The new catalogue, which becomes effective on August 1, 2018, is likely to have a significant impact on the registration, manufacturing, operation, and distribution of medical devices in China. ...more

The UK Care Sector | Problem or Opportunity for Investors?

by McDermott Will & Emery on

For investors considering the UK care sector, the Care Quality Commission (CQC) State of Care report released 10 October 2017 again raises alarm bells. Beds in nursing homes declined meaningfully, and funding pressures are...more

EMA senior officer: pharmaceutical companies encouraged to prepare for Brexit

by Hogan Lovells on

Agnès Saint-Raymond, MD, Head of International Affairs at the European Medicines Agency (“EMA”), recently urged pharmaceutical companies to be “proactive” in preparing for Brexit, as there is still uncertainty around a...more

Window On Washington - This Week in the Nation's Capital - Vol. 1, Issue 31

by Clark Hill PLC on

Senate Adopts Budget Resolution Making Way for Tax Reform: The Senate on a party-line vote of 51-49 adopted its FY18 budget resolution that includes $5.1 trillion in spending reductions and instruction for reconciliation for...more

Compulsory Licensing of Biopharmaceutical Inventions

Very few topics in international intellectual property have been as controversial as compulsory licenses. While the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) sets minimum standards for...more

Alert: China Issues New Policy for Drug and Medical Device Approvals

by Cooley LLP on

On October 8, 2017, the General Office of the CPC Central Committee and the General Office of China's State Council jointly issued Opinions of the State Council on Promulgating the Reform of Review and Approval System for...more

Gig Economy Ripples From Across The Pond: An App For Healthcare Workers On Demand?

by Fisher Phillips on

Roughly 3,500 miles on the other side of the Atlantic Ocean, the British government is contemplating an idea which will marry the national healthcare industry with the gig economy. Such an idea could send a ripple toward the...more

IP and healthcare in South East Asia: “Bigger than BRIC”. So why aren’t you filing your patent applications there?

by FPA Patent Attorneys on

The South East Asian healthcare market is emerging as one of great importance, expected to experience faster rates of healthcare spending growth over the next 5 years than the BRIC (Brazil, Russia, India, China) countries...more

What’s New in Washington - October 2017

Congress returned after Labor Day for a busy September and acted quickly to avoid a government shutdown by passing stop gap funding for Fiscal Year (FY) 2018 and raising the debt ceiling. The already crowded congressional...more

EMA publishes external guidance for clinical data publication

by Hogan Lovells on

On 22 September 2017, the European Medicines Agency (“EMA”) published an external guidance document concerning the implementation of Policy 0070 on the publication of clinical data for medicinal products for human use....more

Canada Institutes Certificates of Supplementary Protection for Approved Drug Products

On September 21, 2017, the Comprehensive Economic and Trade Agreement (CETA) signed between the European Union (EU) and Canada provisionally entered into force in Canada.  Among other things, this agreement seeks to harmonize...more

Unintended Consequences: Ex-U.S. Activities Impacting U.S. Federal Health Care Business

by Ropes & Gray LLP on

Given the uptick in global awareness and enforcement of anti-bribery and corruption laws, most health care companies are attuned to the risks associated with legal infractions caused by ex-U.S. activities. However, ex-U.S....more

ArthroCare CEO Reconvicted for Fraud

by Michael Volkov on

The healthcare industry continues to be a frequent target for criminal prosecutions. More importantly, federal prosecutors are ready, willing and able to bring criminal cases against C-Suite actors involved in healthcare...more

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