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Hackers Post Athletes’ Medical and Drug Testing Records Online

Hacking group Fancy Bear, reportedly a Russian group, who allegedly hacked into the Democratic National Committee emails which made headlines, has posted U.S. Olympians’ medical and drug testing records online. Although it...more

Samsung Bioepis Biosimilars Update

According to Business Wire, on September 12, 2016, Samsung Bioepis announced that it has added Canada to its growing list of jurisdictions in which it has received regulatory approval for its biosimilar of Amgen’s Enbrel®...more

Put the Candle Back: the AstraZeneca FCPA Enforcement Action

I am back from a two-week summer study program at Oxford, run by Michigan State University through its Odyssey to Oxford program. It was a great experience. My class was on The Tudors in film and print so not only did I...more

Lessons Learned from AstraZeneca’s $5.5 Million SEC FCPA Settlement

Last week, the SEC added another pharmaceutical company to its list of FCPA violators when AstraZeneca agreed to a $5.5 million settlement with the SEC. AZ is now the 25th drug or medical device company to pay an FCPA penalty...more

Corporate Investigations and White Collar Defense - August 2016

Spotlight on the False Claims Act - Why it matters: This month, we review a recent Ninth Circuit case that allowed a qui tam relator’s action against various Medicare Advantage organizations to proceed, holding that the...more

Review Published of Nanomaterials for Products and Application in Agriculture, Feed, and Food in the European Union

The European Food Safety Authority (EFSA) requested a review of the already marketed and in-development applications of nanomaterials in the agri/feed/food sectors. The results of the review are published in the August 2016...more

InSeal Medical Receives CE Mark for Vascular Closure Device

InSeal Medical recently announced that it has received CE Mark approval for its InClosure large bore vascular closure device (VCD). The InSeal VCD provides an internal biodegradable membrane for sealing large cuts in blood...more

Duty Savings Opportunity on Imported Scientific Instruments for Research Institutions

In Depth - US research hospitals and other research institutions that import scientific instruments should take advantage of a US customs procedure that allows foreign instruments to enter duty-free if imported by such...more

Letter to Colombian President Encourages Grant of Compulsory License for Imatinib

Last month, we reported on letters sent by two Senators and fifteen Representatives to the U.S. Trade Representative, seeking clarification regarding the Administration's position on compulsory licenses. The letters were...more

Headlines from Mid-Year FCPA Enforcement Review

Just to add my voice to the cottage industry surrounding FCPA enforcement and compliance, I wanted to take a deep breath and offer some observations on FCPA enforcement in 2016. There are a few significant headlines...more

Hudson Institute Report Refutes UN Panel Stance on Impact of Patents on Access to Medicines

In June, the Hudson Institute released a research report that analyzes several positions taken by the United Nations (UN) High Level Panel on Access to Medicines (HLP) on the impact of patents on global access to medicines. ...more

Your daily dose of financial news - The Brief – 7.22.16

EU financial watchdog ESMA has fined rating agency Fitch Ratings Ltd. $1.5 million for reportedly violating the EU’s rules for rating agencies relating to the 12-hour requirement, internal controls, and unauthorized...more

FDA Deep Dive: Real Life Implications of FDA NEST Program Explored

In our Israel Connect Summer 2016 edition we summarized the FDA’s post-market surveillance data programs, including the NEST program designed to consolidate and analyze real-world device data once a device is legally...more

European Life Sciences Review: Issue 3

Welcome to the third issue of our European Life Sciences Review that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

New EU Rules for Medical Devices

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies...more

China Issues Guidance Clarifying Core Tasks and Deadlines for Application of the Country’s Telemedicine System

The Chinese government has been in the process of modernizing its telemedicine law and policy and associated infrastructure for nearly 2 years now, to support broad, domestic application of telemedicine. We outline one of the...more

Privacy & Cybersecurity Newsletter: July 2016

General Data Protection Regulation Update - As reported in the April Locke Lord Privacy & Cybersecurity Newsletter, the European Parliament gave the final approval to the General Data Protection Regulation (GDPR) on...more

28 Organizations Seek Clarification from President Obama Regarding Colombian Compulsory License -- U.S. Chamber of Commerce...

On July 5, 2016, we reported on two letters sent by two Senators and fifteen Representatives to Michael Froman, the U.S. Trade Representative ("USTR"), seeking clarification regarding the Administration's position on...more

Will the USPTO’s “Patents 4 Patients” Program Even Make It Off the "Cancer Moonshot" Launch Pad?

The White House recently announced the Cancer Moonshot Task Force, an effort to “focus on making the most of Federal investments, targeted incentives, private sector efforts from industry and philanthropy, patient engagement...more

EMA’s New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine

Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated...more

Cuba an Untapped Market for Medical Device Exports

The United States is the world’s largest medical device exporter, according to reports accounting for $45 billion of over $140 billion in global exports in 2014. This is not surprising since it also produced the largest...more

Colombian Organizations Send Letter to CEWG Regarding Imatinib Compulsory License

In letter from three Colombian organizations to the Chairman of the World Health Organization (WHO) 2016 Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) (posted on the...more

European General Data Protection Regulation to Apply from May 2018

In Depth - On 4 May 2016, the General Data Protection Regulation (GDPR), was published in the Official Journal of the European Union (L 119/1). It will apply from 25 May 2018, at which point it replaces the current legal...more

EU Reaches Deal on New Medical Device Regulations

The European Parliament and European Council recently jointly announced an agreement regarding new rules on medical devices and in vitro diagnostic medical devices. The process that lead to the agreement began in 2012. ...more

China Competition Authority Initiates Drug Pricing Investigation

On May 22, 2015, the National Development and Reform Commission (the NDRC) of China promulgated a notice (the Pricing Investigation Notice) announcing that it would carry out a nationwide drug pricing investigation on...more

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