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
COMPETITION - Action brought on 5 February 2024 - Coöperatieve Rabobank Vs. Commission - Case T-57/24 Re: annulment of Commission Decision C(2023) 7811 of 22 November 2023 relating to proceedings under Article 101 TFEU and...more
Proposed federal legislation known as the BIOSECURE Act is being considered in both the U.S. House of Representatives and the U.S. Senate....more
Among other things, on May 19, 2023, the U.S. Department of Commerce’s Bureau of Industry and Security (“BIS”) issued a sweeping new set of restrictions that collectively operate to deter the Putin Regime from acquiring...more
RUSSIA RESPONDS TO WESTERN SANCTIONS WITH PATENT RETALIATION - On March 6, 2022, the Russian government retaliated against the West’s imposition of sanctions by issuing a decree permitting patented innovations to be used...more
In an open letter posted on February 26, six life sciences business leaders called on other members of their industry "to cease all business involvement in Russia." The authors of the open letter included Meg Alexander,...more
1. BIS Eliminates Reporting Requirements for Certain Encryption Items Effective March 29, 2021, BIS eliminated or reduced reporting requirements for certain encryption items. For encryption source code and beta test...more
On March 1, 2021, the Eurasian Patent Office (EAPO) launched the EAPO Pharmaceutical Register (the 'Register'). The Register lists Eurasian patents that relate to the active pharmaceutical ingredients of the drugs according...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. ...more
In Washington - Negotiations between Democrats and Republicans on a deal for the next coronavirus package remain far apart. The caucuses remain divided over unemployment benefits and state and local aid while the enhanced...more
Last week, authorities from the United States, United Kingdom and Canada accused a well-known hacker group tied to the Russian government, APT29 a/k/a Cozy Bear of using malware to exploit security vulnerabilities to enable...more
Nowadays the sphere of healthcare is becoming one of the mostly discussed because of a mass spread of the coronavirus pandemic (also COVID-19). Confirmed cases of COVID-19 around the world have passed more than a 2.4 million....more
The COVID-19 pandemic has impacted every industry, causing global economic changes and, consequently, extensive legislative amendments. There are no doubts that the pharmaceutical industry is the most affected. Since the...more
On March 30, 2020, Russian pharmaceutical company, Biocad, announced that it and its partner, ICM d.o.o., recently obtained European registration certification in Bosnia and Herzegovina for two cancer treatment biosimilars: ...more
Last month, the Russian government passed a decree (the Decree) amending the rules on state regulation of ceiling prices for drugs included in the Vital and Essential Drugs List (Essential Drugs), which is approved annually....more
In a record year, there are bound to be numerous interesting enforcement actions and principles. I picked out a few to highlight....more
On December 20, 2019, President Trump signed into law the National Defense Authorization Act for Fiscal Year 2020 (“NDAA 2020”), which includes numerous sanctions-related provisions. The law includes the previously introduced...more
Russian law currently prohibits the online sale of pharmaceuticals and requires that pharmaceuticals must be sold only in stationary pharmacies operated by a person holding a pharmaceutical licence....more
Under the Federal Law “On drugs circulation” (Law), information on state registration of drugs in Russia shall be publicly available. Pursuant to Art. 37(1) of the Law, MoH-s obligation is to disclose information regarding...more
Led by partner Natalia Gulyaeva, the Hogan Lovells Moscow team represented Novartis in a precedent case for pharma business proving that one can obtain an injunction using patent rights against a generic in Russia before the...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
HSBC’s making good on its plans to shift to a focus on Asia by naming John Flint—who spent his first 14 years at the bank in Asia—as its new CEO. Flint will take over from Stuart Gulliver in February....more
U.S.-based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions. In this series, members of our European Life Sciences Transactions...more
Donald Trump’s election has the potential to significantly reshape U.S.-Russia relations, but whether any change occurs will depend largely on his willingness to offer Russia a clean slate and whether the U.S. Congress...more
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