False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
On Wednesday, President Donald Trump signed the United States-Mexico-Canada Agreement (USMCA) into law. The USMCA contains a number of key and last-minute revisions that implicate biologic medicines and patent obligations. ...more
While there’s plenty of other business afoot in D.C. these days, it also happens to have been a pretty big week for trade deals. A day after Phase One with China was inked, the Senate overwhelmingly approved a revised...more
On December 10, 2019, an agreement was reached between the United States, Mexico, and Canada on amendments to the U.S.-Mexico-Canada Agreement (“USMCA”). The USMCA, if ratified by each respective country, would replace the...more
On December 10, 2019, the House Democrats and Trump administration reached an agreement on the United States-Mexico-Canada Agreement (USMCA), which would replace the North American Free Trade Agreement (NAFTA) of 1994....more
Some remembrances upon the passing of influential former Fed Chair Paul Volcker, a force in American economic policy for nearly 60 years who led “the Federal Reserve’s brute-force campaign to subdue inflation in the late...more
On Monday, December 2, 2019, The Wall Street Journal reported that the Trump administration is considering reducing the 12-year data exclusivity period for biologic drugs set forth in the Biologics Price Competition and...more
On 30 September, after an intensive, last-minute flurry of negotiations, Canada joined the United States and Mexico in a new trilateral agreement to replace the original North American Free Trade Agreement (NAFTA 1.0). ...more
After more than a year of negotiations, the U.S., Mexico, and Canada recently concluded the United States-Mexico-Canada Agreement (USMCA). The USMCA, when it takes effect, will replace the North American Free Trade Agreement...more
On October 1, the Trump administration announced that it had secured a new trade agreement with Canada and Mexico. The United States-Mexico-Canada Agreement (USMCA) would replace the North American Free Trade Agreement...more
Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more
Late on September 30, an agreement (USMCA) was reached between the United States, Mexico and Canada which modernizes the 24 year old North American Free Trade Agreement (NAFTA)....more
Outlook for This Week in the Nation's Capital - Kavanaugh Vote. The Senate was previously planning to tee up the final vote on Kavanaugh over the weekend, but the vote on the floor has been delayed a week to accommodate a...more
To no one’s surprise, the Fed followed through with its months of promises and raised its benchmark interest rate by 25 basis points yesterday. The FOMC also indicated that it’s planning to raise rates again in December....more
Theranos founder and ex-CEO Elizabeth Holmes has been indicted on federal fraud charges along with former company president Ramesh Balwani. The charges come three months after Holmes settled civil charges with the SEC....more
Lawmakers have returned from the Memorial Day recess and are facing a packed legislative agenda over the summer. With the announcement this week of a shortened August recess, the Senate will have more time to address...more
Congress returned from its spring recess with a host of issues to address—trade, Trump administration nominations and opioid legislation sitting atop the priority list. Given the ongoing data scandal at Facebook, privacy...more
On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more
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
Tribunal dismisses Eli Lilly’s NAFTA challenge on promise utility doctrine - As previously reported, Eli Lilly submitted claims to international arbitration under the North American Free Trade Agreement (NAFTA) seeking...more
On Monday, President Trump made good on one of his signature campaign promises and notified the other twelve countries (Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam)...more
International investment arbitration – also known as investment treaty arbitration or investor-State arbitration – is a procedure whereby foreign investors may seek a binding adjudication of claims against host States that...more
The United States and 11 other Pacific Rim trading partners recently announced that they have come to a provisional agreement on the wide-ranging trade agreement known as the Trans-Pacific Partnership (“TPP”), which, over...more
While the United States and Canada share a border, common values and a strong commitment to international trade and security issues, many are surprised to learn that protection of intellectual property (IP) is a source of...more