International Trade Health

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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

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

Post-Election Outlook: A New, Unpredictable World

In a shock to investors and political analysts around the world, Donald J. Trump won the 2016 Presidential election, putting the Republican Party in charge of the White House and Congress for the first time in a decade. Even...more

Update: Obamacare and TPP

While Donald Trump’s victory has made world headlines, what may be less well known to our readers is that the election also gave Trump’s Republican Party majority control of both the House and the Senate. For the first time...more

CETA Implementation in Canada - Implications of Bill C-30 on the Pharmaceutical Industry

Bill C-30 presents significant changes to Canada’s pharmaceutical landscape by introducing supplementary protection for pharmaceutical products and proposing substantial modifications to the Patented Medicines (Notice of...more

Investing in Cuban Health Care Biotech Industries

The Obama Administration made significant new regulatory changes to allow certain investment opportunities in the Cuban health care and biotech industries. While many barriers remain, US firms in the health care industry...more

Celltrion’s Herceptin Biosimilar Submitted For Approval in Europe

According to The Korea Herald, the South Korean biopharma company Celltrion submitted their Herceptin biosimilar, Herzuma, to the European Medicine Agency for approval. Herzuma, a biosimilar to Roche’s breast cancer drug...more

Antitrust M&A Snapshot - October 2016

UNITED STATES: Continuing an active first half of 2016, the Federal Trade Commission (FTC) and US Department of Justice (DOJ) have challenged several large mergers and acquisitions. In fact, trials for the two...more

Pfizer to Lower Price of Enbrel in Ireland

The Irish Times reports that Pfizer will be cutting the price of Enbrel® (etanercept) on November 1st. Pfizer is cutting its price to comply with Ireland’s Framework Agreement on the Supply and Pricing of Medicines (the...more

"OFAC and BIS Implement Additional Amendments in Support of Cuba Policy Shift"

On October 14, 2016, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) and the Department of Commerce’s Bureau of Industry and Security (BIS) announced further amendments to ease U.S. sanctions and...more

Top Ten International Anti-Corruption Developments for September 2016

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

Price fixing not justified to protect pharmacies in rural areas

On 19 October 2016, the Court of Justice of the European Union (CJEU) issued an important judgment concerning the German law on fixing prices of retail prescription drugs. In the case before the Higher Regional Court of...more

Member States cannot impose uniform retail prices for prescription-only medicinal products, highest EU Court says

EU law precludes national legislation setting fixed retail prices for prescription medicinal products, as it unreasonably restricts imports - On 19 October 2016, the European Court of Justice issued a ruling concluding...more

Update on Life Sciences Exports to Iran and Sudan

On September 28, the Office of Foreign Assets Control (OFAC) at the U.S. Department of the Treasury issued its Biennial Report of Licensing Activities Pursuant to the Trade Sanctions Reform and Export Enhancement Act of 2000,...more

U.S. Authorities Amend Cuba Sanctions Regulations

On October 17, 2016, the U.S. Treasury Department’s Office of Foreign Assets Control (OFAC) and the Commerce Department’s Bureau of Industry and Security (BIS) issued new amendments to the Cuban Assets Control Regulations (31...more

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