Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 205: Novant Health’s Carolinas Expansion with Senior Vice President Jason Bernd
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
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 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 200: Athlete Mental Health and Physical Conditioning With Dawn Staley
False Claims Act Insights - Assessing the Fallout from a Thermonuclear FCA Verdict
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 199: Bringing Awareness to Organ and Tissue Donation with Dave DeStefano of We Are Sharing Hope
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 198: Artificial Intelligence in Healthcare and Life Sciences with hosts Matthew Roberts and Lauren DeMoss, Maynard Nexsen Health Care Attorneys
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 196: Regulation Trends in Healthcare and Certificate of Need with Rebecca Thornhill of Maynard Nexsen
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 193: Federally Qualified Health Centers and Rural Health with Dr. Jeniqua Duncan of CareSouth Carolina
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 192: Business Issues for Healthcare with Ira Bedenbaugh and Randi Branham of Elliott Davis
Introduction to The Good Bot: Decoding AI and Its Integration Into Health Care — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 191: South Carolina Lowcountry Healthcare with Walter Bennet, MUSC Orangeburg CEO
To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more
On 3 September 2024, the European Court of Justice (ECJ) ruled that the European Commission (Commission) cannot encourage or accept referrals for below-threshold deals from national competition authorities if those...more
The European Union’s Court of Justice (ECJ) has rendered its two long-awaited judgments in the European Commission’s (EC’s) perindopril case. The 27 June 2024 judgments concern: - The EC’s appeal of the General Court’s...more
Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
The European Union (EU) is leading the global charge with AI regulations. U.S. companies are not beyond their regulatory reach, however, and should be preparing their AI risk mitigation efforts accordingly....more
The European Commission (EC ) has approved the first Important Project of Common European Interest (IPCEI) in the health sector— IPCEI Med4Cure. Under the IPCEI, six EU member states will provide up to EUR1bn of state aid...more
On March 26, 2024, Skadden hosted a discussion on key developments in antitrust enforcement in the pharmaceuticals and life sciences sectors. ...more
The European Commission (EC) has opened a formal antitrust investigation into whether animal health company Zoetis has breached EU antitrust law by preventing the market launch of a competing novel biologic medicine used to...more
On 31 January 2025 the Clinical Trials Regulation will become fully applicable to all ongoing clinical trials with medicinal products in the EU. All clinical trials that have been authorized under the Clinical Trials...more
This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
Bayer’s aflibercept 8 mg recommended for approval in Europe: On November 10, 2023, Bayer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive...more
European Commission Orders Unprecedented Unwinding Of Illumina’s Acquisition of GRAIL. For the first time, the European Commission has ordered reversal of a consummated transaction, Illumina Inc.’s 2021 acquisition of GRAIL...more
The Foreign Subsidies Regulation (FSR) establishes a new regime, enforced by the European Commission (EC), to regulate subsidies granted by non-EU countries to businesses active in the EU that could distort competition in EU...more
The European Commission (EC) has fined five pharmaceutical companies a total of EUR13.4 million for participating in a cartel concerning N-Butylbromide Scopolamine/Hyoscine (SNBB) – an active pharmaceutical ingredient (API)...more
In its two Confédération Paysanne decisions (cases C-528/161 and C-688/21), the Court of Justice of the European Union limited the exclusion of plants and products obtained by new genomic techniques (NGTs) from the...more
We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Zurich, where co-head of Hogan Lovells Life Sciences and Health Care sector Jane Summerfield, and partners Melissa K. Bianchi,...more
The European Commission (EC) has imposed a fine of around EUR432 million on genomics company Illumina for closing its acquisition of blood-based cancer test developer GRAIL before the conclusion of the EC’s merger control...more
We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the...more
The European Commission (EC) has just published its draft proposals to overhaul the European Union (EU) general pharmaceutical legislation. Tackling the problem of antimicrobial resistance was a key priority in the 2020...more
Yesterday, the European Commission published two legislative proposals concerning the regulation of medicinal products in the European Union. The proposals seek to consolidate existing legislation into two instruments, a...more
A medicinal product containing only one of two active substances contained in an earlier product is not part of the global marketing authorisation and is, therefore, entitled to its own data protection period....more
The European Commission and the United Kingdom government announced on Monday that they have come to agreement on measures to alleviate the remaining practical difficulties in the supply of medicines to Northern Ireland that...more
In Short - The Situation: The transition to the new so-called Medical Device Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR"), which establish new rules for the placing on the market of medical devices...more