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Read need-to-know updates, commentary, and analysis on Elections & Politics issues written by leading professionals.

EMA prepares plan to face Brexit

by Hogan Lovells on

European Medicines Agency (EMA) has released a business continuity plan dealing with the potential implications of Brexit. EMA, which is currently established in London, will be required to transfer the Agency’s headquarters...more

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

The exuberance of a November election victory for Republicans has given way to the difficult reality of passing legislation in a closely divided Senate. While the GOP has made significant gains in the area of regulatory...more

A Difficult Decision for EMA

by Hogan Lovells on

The bids to host the EMA are in! We have reviewed all of them and give you our personal impressions on what to expect. After the EMA has announced the development of a business continuity plan to deal with the workload...more

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

On June 30, Congress gaveled out for the July 4 recess after postponing a critical vote to begin debate on an Affordable Care Act (ACA) repeal-and-replace bill. Senate Majority Leader Mitch McConnell (R-KY) and the GOP caucus...more

Ministers Provide Insight on the UK's Position on the Regulation of Medicines post-Brexit

by Hogan Lovells on

With the negotiations for the UK’s withdrawal from the EU formally under way, the UK healthcare sector is calling on the UK Government to make patient safety and access to medicines a priority in negotiations – and it appears...more

New UK Brexit Health Alliance Formed

by Hogan Lovells on

A “Brexit Health Alliance” (BHA) has been formed to bring together a diverse range of UK stakeholders in the healthcare industry and provide a single voice for the sector on Brexit-related issues. Members of the BHA include...more

Senators Urge the Administration to Certify Imports of Prescription Drugs from Canada, Pharmaceutical & Medical Device Update,...

by Jones Day on

On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of...more

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

Despite the headlines coming out of Washington, Congress continues to move forward in regular fashion, discussing and acting upon key issues, such as funding the government, addressing the need to raise the debt ceiling and...more

Window on Washington - This Week in the Nation's Capital - Vol. 1, Issue 9

by Clark Hill PLC on

Agriculture - Lawmakers to Introduce Organic Research Funding Bill: A bipartisan trio of House lawmakers were set to introduce legislation late May 16 that would boost Department of Agriculture funding for research into...more

Washington, D.C. Update – May 2017

by Baker Donelson on

April saw the debate in Congress heat up as Justice Neil Gorsuch was confirmed for a seat on the Supreme Court, House Republicans suspended, restarted and then ultimately succeeded in their effort to repeal and replace the...more

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

Congress returned to session the week of April 24 following a two-week recess. Active discussions and debate surrounding the American Health Care Act (AHCA) and efforts to “repeal-and-replace” the Affordable Care Act resumed...more

Window on Washington - This Week in the Nation's Capital - May 5, 2017 Vol. 1, Issue 7

by Clark Hill PLC on

Spending Bill: The U.S. Senate cleared legislation to fund the government for the rest of the fiscal year, sending it to President Trump for his signature. The vote was 79-18 on H.R. 244, which provides $1.1t in base...more

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

Congress entered into its spring recess on April 7 having delivered regulatory reforms to President Trump’s desk. In the first 75 days of the Trump administration, legislators approved 13 Congressional Review Act resolutions,...more

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

by Bryan Cave on

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

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

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

DHS Announces Changes to U.S. & Cuba Migration Policies

by Cozen O'Connor on

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 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

Presidential Pulse: 10 Key Ways the Trump Administration May Impact The Way You Do Business in 2017

by Seyfarth Shaw LLP on

Today marks just over a month since Donald Trump was elected as the next President of the United States. As each cabinet appointment is announced, we get more clues to help us predict which direction the Trump...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

Trump Administration Forecast: Changes to Key Policies Expected

by Faegre Baker Daniels on

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

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

by DLA Piper on

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

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