HEALTH & LIFE SCIENCES NEWS
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
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Regulating Medical Devices Post Brexit

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices placed on the market in England, Wales and Scotland after the BREXIT transition period (different rules will apply to Northern Ireland). This On the Subject outlines key dates for implementation of the new rules and certain practical implications of changed regime. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance (the Guidance) on new rules that will govern the regulation of medical devices after the end of the transition period. Whilst some of this guidance is similar to guidance issued as part of the “No deal BREXIT” publications in 2019, the MHRA has also set out proposals to engage and consult on a new medicines and medical devices regulatory framework for the UK. The UK left the European Union (EU) in January 2020 but is...

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What is the Impact of Recent Regulation and Government Measures on Investments in Healthcare and Life Sciences in Europe?

In the fourth installment of McDermott’s HPE Europe Summer Webinar Series 2020: What’s the Impact of Recent Regulation and Government Measures on Investments in Healthcare and Life Sciences in Europe? moderator and McDermott partner Dr. Stephan Rau and industry experts Karthic Jayaraman of TPG Capital, Max Müller of Bayer, Ben Faircloth of L.E.K. Consulting and Dr. Ulrich Wandschneider, former CEO of Asklepios AG, currently at Trilantic Capital Partners and Supervisory Board member of BioNTech SE, the Nasdaq-listed developer of COVID vaccine, headquartered in Germany, discussed the impact that COVID-19 and the government measures to address it have had on investments in healthcare and life sciences in Europe. “I think it's about as interesting a time as any in my last 20 years investing,” said Jayaraman. “People are beginning to focus a lot more on innovation, the speed of innovation and how innovation is brought to market. I think the question is, “How can...

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European Healthcare Innovation & Investment in a Post-Pandemic World

As part of McDermott’s HPE Europe 2020: Where Do the Opportunities Exist for Investment in the Healthcare Sector? webinar, McDermott London Managing Partner Hamid Yunis moderated a panel of industry experts including; Dr. Michelle Tempest of Candesic, Dr. Joanne Hackett of IZY Capital, Dr. Charles Niehaus and Professor Karol Sikora of Rutherford Cancer Centres, who collectively shared their perspectives on healthcare innovation and investment in a post-pandemic world. The panelists agreed that COVID-19 has served as a catalyst for change and which has revealed important prospects for the future. “There has been this zest for change which we’ve been talking about for a long period of time, and this has finally been that breakthrough,” said Dr. Tempest. “Both the professionals and the consumers have suddenly woken up to this new dawn.” “What I’ve actually seen in the past couple of months is a lot of innovation that we were really wanting to accelerate are now...

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Coronavirus Resource Center | Preparedness Planning for Businesses

In our global economy, Coronavirus (COVID-19) raises serious concerns for employers in all industries. Workers may be on the front lines caring for patients and developing vaccines, travelling for business, or in close contact with individuals who travel or may have been affected. At this time, there is no vaccine or medication approved to prevent or treat the COVID-19 disease. Therefore, preparedness and prevention are crucial. Frontline responders must be especially vigilant as they deliver care and anticipate the challenges this uncharted territory presents. McDermott’s Coronavirus Resource Center, brought to you by a multi-disciplinary team, will keep you informed of the latest developments and provide comprehensive insight to help you navigate this crisis with your employees, including: Frequently asked questions for US and multi-national employers Recent news updates Podcasts Upcoming events Click here to access the Resource Center.

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Disrupting Healthcare – Constructively: Considerations for Executing Innovation

The healthcare industry is facing significant disruption from new market entrants and technology innovations that have the potential to improve how care is delivered, to lower healthcare costs, and to improve healthcare outcomes. But not all disruption is built to have a sustained and positive impact—how do you tell which innovative technologies and ventures will change healthcare for the better, and which are just noise? We all hear about disruptive innovation – the power of innovative thinking that sees beyond traditional ways of doing things in favor of new, better methods. When innovators enter the health arena and consider its problems creatively, they seek to break down inefficient aspects that don’t work well for stakeholders and patients. Problems can arise, however, if these innovators simultaneously disrupt processes or protective expectations that serve important functions. Healthcare is a heavily regulated and normative environment—for good...

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How to Engage in Constructive Disruption

The healthcare industry is facing significant disruption from new market entrants and technology innovations that have the potential to improve how healthcare is delivered. But how do you tell which innovative technologies and ventures will have a sustained and positive impact, and which are just noise? In this episode of the Collaborative Transformation podcast series, Lucia Savage, chief privacy and regulatory officer at Omada Health, joins McDermott partner Jennifer S. Geetter to discuss: What it takes for disruption to be truly constructive in today’s dynamic market The rise of mobile healthcare delivery and patient engagement, driven by technological advances and consumer expectations The limits of the HIPAA regulatory framework and current reimbursement rules as they relate to digital health technologies Tips for tapping into the growing digital health innovation community through strategic investment Click here to listen to the episode....

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Five Questions with a Health Lawyer: Marshall E. Jackson, Jr.

Marshall E. Jackson, Jr. Associate Office: Washington, DC Year at Firm: 4 What is your favorite part about practicing healthcare law at McDermott?  My favorite part of practicing healthcare law at McDermott is working with clients that are out in front tackling very interesting and unique issues. The healthcare industry continues to evolve, and our clients are at the forefront. The changes in the industry have required clients to navigate areas of uncertainty, and our clients look to us to help them navigate that uncertainty. I have been blessed to sit shoulder to shoulder with a dynamic McDermott team helping our clients tackle new and unprecedented issues. No day is a dull day. What is the biggest opportunity and greatest challenge facing clients in your area of focus today?  Many of our clients face the challenge of balancing the need to deliver affordable, quality healthcare to people when and where they need it, while maximizing return on investment for...

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Proactive Due Diligence Considerations for Life Sciences Dealmakers

In today’s competitive and fast-paced life sciences dealmaking environment, buyers and investors are often unable to spend as much time on due diligence as they might like. Market players are often highly focused on the science itself and, as a result, may pay less attention to issues such as supply chain, intellectual property components and reimbursement. However, addressing these topics at the due diligence stage is critical—they can cause a deal to unravel if left unexamined, regardless of the strength of the science. Due diligence standards and considerations vary significantly across life sciences subsectors— pharma, medical devices, digital health and AI are each governed by unique regulatory structures and operate in very different deal landscapes. Buyers and investors are well advised to consider end-game issues such as reimbursement options, protection for valuable IP and pathways to commercialization early in the planning process. Framing the areas...

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Pursuing Progress: Collaborative Transformation in Action

It's the industry disruptors, the unusual partnerships, and the cross-border and cross-sector relationships that are driving Collaborative Transformation in the health care and life sciences organizations. But a Collaborative Transformation takes more than signing paperwork and shaking hands. A successful Collaborative Transformation takes cultural integration between non-traditional partners, incorporating new technologies into health care regulatory compliance structures, and so much more. At McDermott, we've recently had the opportunity to help our clients pursue their own Collaborative Transformations, and are proud to showcase their achievements. Innate Pharma Expands its Collaboration with AstraZeneca McDermott Will & Emery advised Innate Pharma, a French oncology-focused biotech company, in signing a multi-term agreement with AstraZeneca and MedImmune – AstraZeneca's global biologics research and development arm. This agreement broadens the...

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Collaborative Transformation: Shaping the Future of Health Care, Together

As the health care and life sciences fields experience ever-increasing levels of disruption, diverse entities across the industry are teaming up to embrace and foster innovation. These new pairings are shaping the future of health care, as organizations come together to tackle the industry’s most pressing issues with redoubled agility and pooled resources. In an environment of change and uncertainty, this trend of Collaborative Transformation is yielding improved financial outcomes, increased operational efficiencies, and a fresh infusion of diverse talent and perspectives—all of which result in enhanced quality of care. This is where the McDermott Health and Life Sciences team comes in. As a top-ranked US health law practice and a leader in life sciences with decades of experience advising the leading players in US and cross-border health and life sciences, we have the skill, market insight and ingenuity to partner with you wherever your innovation takes...

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