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
The “African Group” in the World Trade Organization (WTO) is pushing for discussions—and potentially renegotiation of international trading rules—on how developing countries do and can acquire technology to build resilience...more
On February 1, the World Health Organization (WHO) released a "zero draft" of a WHO convention, agreement, or other international instrument on pandemic prevention, preparedness, and response (or "WHO CA+") for the...more
On February 1, the USITC formally announced the opening of its investigation into the merits of expanding the TRIPS Waiver to diagnostics and treatments. The investigation was initially requested by USTR, who had been leading...more
On December 16, the Council for Trade-Related Aspects of Intellectual Property Rights of the World Trade Organization (WTO) issued a report recommending that the General Council extend the deadline by which the WTO would...more
Key Points - On December 6, days before a deadline for WTO members to decide whether to expand the TRIPS waiver for COVID-19 vaccines to cover COVID-19 diagnostics and therapeutics as well, the Office of the USTR...more
It is often observed (or asserted) that a fair compromise in a dispute has likely been reached when both sides are not particularly happy about it. This is not always the case, of course, and is more likely not to be the...more
Overview - In March 2020, the world was upended and faced with unimaginable challenges. The COVID-19 pandemic posed threats that had not been experienced in the United States since the smallpox epidemic over 100 years...more
As we previously reported, some members of the World Trade Organization (WTO), including India and South Africa, had called for a waiver of intellectual property enforcement on COVID-19 pandemic-related diagnostic kits,...more
Earlier this month, the U.S. Chamber of Commerce sent a letter to members of Congress indicating that the Chamber "strongly supports" recent House and Senate legislation that the Chamber noted "would prohibit the...more
As posted Monday, BIO (the Biotechnology Innovation Organization) provided a link to the supposed compromise agreement reached recently to permit WTO member states to waive patent protection for "subject matter required for...more
Earlier today, the American Intellectual Property Law Association (AIPLA), Intellectual Property Owners Association (IPO), Licensing Executives Society (LES) International, LES USA & Canada, and New York Intellectual Property...more
A Reuters report published last week indicated that the United States, European Union, India, and South Africa had reached an agreement on a waiver with respect to patents for COVID-19 vaccines. The text of the compromise...more
According to a Reuters report published earlier today, the United States, European Union, India, and South Africa have reached an agreement on a waiver with respect to patents for COVID-19 vaccines...more
Earlier this month, Sen. Thom Tillis (R-NC), the Ranking Member of the Subcommittee on Intellectual Property of the Senate Committee of the Judiciary, wrote to United States Trade Representative Katherine C. Tai to express...more
Last week, United States Trade Representative Katherine C. Tai responded to a series of letters sent by a group of Senators regarding a proposal by India and South Africa to waive certain provisions of the World Trade...more
While over 48% of the U.S. population is fully vaccinated, only about 15% of the world is. Such disparities have caused members of the World Trade Organization (WTO), such as India and South Africa, to call for a waiver of...more
In this new episode of OnAir: Health Care, Akin Gump health care senior policy advisor Matthew Hittle and consultant Dr. Mario Ramirez welcome Akin Gump public law and policy partner Clete Willems and Centrient...more
Pfizer and BioNTech Agree to Vaccine Technology Transfer with South Africa's Biovac Institute - As reported by Reuters* on Wednesday (see "South African firm to help make Pfizer/BioNTech COVID vaccine"), Pfizer and...more
On May 5, 2021, the Biden Administration announced its support for waiving intellectual property protections for COVID-19 vaccines. Understandably, the news made headlines and stirred passionate reactions from the medical...more
On June 8-9, 2021, the World Trade Organization’s (WTO) TRIPS Council will hold their first meeting in the wake of the U.S. Trade Representative (USTR) announcing “the Biden-Harris Administration’s support for waiving...more
On May 26, SBA Administrator Isabella Casillas Guzman began a series of hearings on the Hill that will continue through May 28. On May 26, she testified before the House Committee on Small Business in a hearing titled “An...more
Earlier this month, United States Trade Representative Katherine Tai announced "the Biden-Harris Administration's support for waiving intellectual property protections for COVID-19 vaccines." One day prior to Ambassador...more
The Biden-Harris administration announced on May 5 its intent to support a waiver on intellectual property protections on COVID-19 vaccines. The scope of any potential waiver is subject to further negotiation at the World...more
On 5 May 2021, U.S. Trade Representative Katherine Tai announced that the Biden Administration would support India and South Africa’s request for a World Trade Organization (WTO) waiver of intellectual property (IP) rights...more
And everybody knows that suspending patent rights is necessary to provide sufficient vaccine to stem the global pandemic caused by the SARS-CoV-2 virus known as COVID-19. It is always a sign of intellectual weakness and pack...more