Preventative Medicine: Health Care AI Privacy and Cybersecurity – Part 2 — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 207: Long COVID Research & Treatments with Dr. Kashyap Patel of Carolina Blood & Cancer Care Associates
The CMS Interoperability and Prior Authorization Rules
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 206: Supporting Patient Care with Darra Coleman of Prisma Health
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
The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation for the Great Britain market and an...more
The response includes a considered implementation plan to strengthen the regulation of medical devices and in vitro diagnostics, improve patient safety, and foster innovation post-Brexit. On 26 June 2022, the UK Medicines...more
The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom), recently announced a consultation to change the UK clinical trial...more
The agency’s consultation on the post-Brexit regulatory framework for medical devices and diagnostics aims to support innovation and sustainability, among other goals. A 10-week consultation launched by the UK’s Medicines...more
The agreement provides guidance across several areas for the life sciences sector, though gaps remain. The widely anticipated EU-UK Trade and Cooperation Agreement (the Agreement) came into effect on 1 January 2021 after...more
Nearly one year after its introduction to the House of Commons, the Medicines and Medical Devices Bill 2019‑2021 (the Bill) was granted Royal Assent on 11 February 2021, becoming law as the Medicines and Medical Devices Act...more
On Tuesday, 26 January 2021, Allen&Overy (Belgium) LLP hosted a webinar on the key developments in parallel trade of pharmaceuticals in 2020. In this blog post, we discuss a few key topics and questions raised by the...more
Since our last update in December, the UK and the EU have officially agreed on a Brexit deal. The agreement has brought with it a multitude of legislative changes across various areas of UK law. In support of understanding...more
Drugmaker AstraZeneca agreed on Saturday to buy biopharma company Alexion for $39 billion in cash and stock. In the deal—the “biggest by a health care company this year”—will help AstraZeneca expand into the immunology...more
On 31 January 2020, the UK left the European Union and entered a transition period that is due to end at 11:00 pm GMT on 31 December 2020. At this point, it is still uncertain whether a new EU/UK deal will be reached. To...more
As the most tax advantageous HMRC approved share option scheme available, the Enterprise Management Incentive (EMI) scheme has long been the preferred form of incentive for eligible early and mid-stage UK-based life science...more
As Brexit is finally completed in the UK, from 1 January 2021, the Medicines and Healthcare products Regulatory Agency (“MHRA”) will be the UK’s standalone medicines and medical devices regulator. Transition from the EU...more
The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published a raft of guidance on how various aspects of the UK regulatory regime for medicines will operate in England, Wales and Scotland (together Great...more
The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published new guidance (the "Guidance") on how medical devices will be regulated in Great Britain ("GB") (England, Wales and Scotland) and in Northern...more
In this episode, Akin Gump international competition and trade partner Davina Garrod and corporate partner Gavin Weir discuss M&A in the U.K., EU, U.S., China and more, its state of health and where it might go in 2020....more
Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more
The annual gathering of life sciences executives and investors in San Francisco that many now call “JPM Week” recently concluded, marking the J.P. Morgan Healthcare Conference’s 38th year....more
Fiat Chrysler and rival Peugeot have agreed to binding merger terms that, if approved by US and European regulators, would create a “$50 billion auto giant that would rank among the world’s largest car companies by sales”....more
From disrupting the supply of medical devices to affecting how they are regulated and sold in the United Kingdom (UK), Brexit could carry significant implications for UK healthcare and trade....more
The Queen's Speech, which set out the government's proposed plan for new legislation, included a new "Medicines and Medical Devices Bill". The government's background briefing describes the purpose of the Bill as ensuring...more
Amgen will pay $13.4 billion in cash to buy psoriasis treatment Otezla, a deal that will “pave the way for Bristol-Myers Squibb to complete its acquisition of Celgene” by addressing “regulatory concerns over their union”....more
EU – REGULATORY - Brexit, Notified Bodies, and Medical Devices - The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more
Join us on Thursday 19 September for the Hogan Lovells Privacy and Cybersecurity KnowledgeShare in London. We will share our latest thinking on the key privacy and cybersecurity issues faced by those with data protection...more
The guidance provides helpful clarity on key regulatory changes impacting life sciences companies in the event of a no-deal Brexit. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a...more
The President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued two more Brexit related communiques....more