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
Life Sciences
Subscribe to Life Sciences's Posts

Top Takeaways: Critical Business Considerations for Life Sciences and Medical Device Companies During COVID-19

Life sciences and medical device companies are dealing with an unprecedented crisis. The industry is not only managing the impact of Coronavirus (COVID-19), they are also a solution provider. Companies are rapidly adapting products, services, facilities and distribution channels to aid in the pandemic response. Simultaneously, they must maintain shareholder value, navigate highly complex regulatory hurdles and compliance obligations while rethinking strategies for growth in a post-COVID-19 world. McDermott Will & Emery and EY co-hosted a webinar to discuss critical COVID-19-related operational, regulatory and legal developments. Below are top takeaways from the program. For a deeper dive into these issues, listen to our webinar recording.  FDA enforcement discretion is a flexible, risk-based approach, not a free pass. Companies operating under FDA’s enforcement policies to provide COVID-19 countermeasures should have a strategy to ensure that products...

Continue Reading

Anticompetitive Conduct in Biologics – An Enforcement Priority with FTC and FDA

This blog was originally published on McDermott’s Antitrust Alert Blog. On February 4, 2020, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) released joint guidance concerning competition for biologics, including biosimilars. The joint guidance seeks to enhance competition for biologics and reduce manufacturers’ use of false or misleading statements or promotional communications concerning the efficacy or safety of biosimilars and other biologics. This guidance appears to be part of the Trump administration’s effort to reduce the cost of medications for consumers, as it is aimed at increasing the level of competition biosimilars can offer and raising awareness of the safety and efficacy of biosimilars. The fast-growing biologics market has become an important sector of the healthcare and pharmaceutical industry. According to the joint guidance, private insurers spent over $125 billion on biologics in 2018 alone. Biologics treat...

Continue Reading

FDA 2019 Year in Review

2019 was a robust year for the US Food and Drug Administration’s (FDA’s) regulatory agenda. The agency continued to implement initiatives and mandates required by the 21st Century Cures Act (Cures Act), and navigated leadership and staffing changes at many levels. Most notably, Commissioner Scott Gottlieb resigned on April 5. Norman Sharpless and Brett Giroir served as acting interim commissioners following Commissioner Gottlieb’s resignation. On December 17, Congress swore in Commissioner Stephen Hahn, a radiation oncologist and former chief executive of MD Anderson Cancer Center. This Special Report reviews notable actions that shaped FDA-regulated industries and products last year, and offers insight into the agency’s 2020 priorities and expected actions in a number of areas, including: Digital health; Streamlined product approvals; Evolving evidentiary thresholds for product approvals; Strategic enforcement; And much more. Click here to read the full...

Continue Reading

Modernizing FDA’s New Drugs Regulatory Program – Reviewing the Guidance Ecosystem and Implications for Life Sciences Companies

In 2016, Congress passed the 21st Century Cures Act (Cures Act), which contained provisions to help accelerate medical product innovation while reducing regulatory burden, as well as to increase efforts for critical research and increase the involvement of patients and their perspectives in research and the product development process. The Cures Act specifically provided the US Food and Drug Administration (FDA) authority to modernize product development and review, and create greater efficiencies and predictability in product development and review. In June 2018, in response to this congressional mandate and corresponding new authorities, as well as reauthorizations of FDA’s user fee agreements, FDA made a series of announcements for a proposal to modernize new drug development. Highlights of FDA’s initial proposal included: Focusing on recruiting talent across disciplines; Building multidisciplinary teams for more efficient collaboration; Prioritizing...

Continue Reading

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...

Continue Reading

Opportunities in Outsourced Pharmaceutical Services

Pharmaceutical outsourcing has emerged as a robust—and rapidly growing—subsector of the life sciences industry. As the push for efficiency continues, more pharmaceutical, biotech and medtech companies are turning to contract research organizations (CROs), contract development organizations, medical affairs outsourcing and other service providers for help bringing products to market, manufacturing and distributing products, and improving quality. This trend is creating exciting new opportunities for investors in this burgeoning space. Several factors are driving this growth in pharmaceutical services outsourcing: Pharma companies are becoming more comfortable with outsourcing. Of outsourced service providers, CROs have the highest penetration, with approximately 50 percent of clinical trials outsourced. Other areas of outsourcing are far less penetrated, however, offering ample opportunity for investment. Consider researching opportunities in health economics...

Continue Reading

Collaborative Transformation: Life Sciences Partnerships – Delivering Deals that Work

The life sciences marketplace has been ripe for collaboration for the past decade, but new players, new technologies and new regulations are changing the space. Traditional life sciences companies are working together in new and exciting ways, bringing a variety of deal structures and new complexities into the landscape. Our Collaborative Transformation podcast episode "Driving the Deal: Life Sciences Partnership Opportunities, Pitfalls and Impact" with Emmanuelle Trombe and Gary Howes explores these issues in depth. Below are key takeaways from the episode, which you can listen to in full here. It's not just new players changing the space—it’s new approaches by traditional players. "It's not only about pharma and biotech," Trombe said. "We are seeing collaboration with health care players such as payers, insurers and providers." Technology companies are also entering the space, bringing financial and philanthropic investments to the table. "People are still...

Continue Reading

Dealmaking in Life Sciences – Valuations and Partnerships that Work

Technology companies are pouring unprecedented capital, time and energy into the health care and life sciences industry, and are reshaping the deal landscape in the process. The top 10 US tech companies have made $4.7 billion in acquisitions in the health care space since 2012, according to CB Insights. Key market factors driving health care joint ventures and mergers and acquisitions include the merger of molecular science and computer technology, a growing focus on patient-centric care, increased mobility of consumer health products and services, and deep capital markets. In this fast-paced, proactive deals environment, traditional health players have exciting—and disruptive—new opportunities to enter into unexpected partnerships and pursue transformative innovation. With Great Disruption Comes Great Opportunity A helpful analogy for understanding the role of tech companies in this rapidly evolving sector is Uber's disruption of the ride-hailing industry....

Continue Reading

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...

Continue Reading

Connecting the Dots: Six Lessons from a Biotech M&A Case Study

For biotechs, success involves a several year hike through mazes of complex, cross-border, business, scientific, financial and regulatory issues. During this year's BIO2018 conference in Boston, McDermott gathered a panel of industry leaders and McDermott practitioners and led a case study assessment of cross-border biotech M&A, linking life sciences hubs in Europe, Asia and North America. I had the opportunity to moderate our panel as we walked through the structuring and closing of an M&A transaction that involved the auction of a fictional US biotech company that has oncology platform IP/technology. While the company described in the case study was fictional as such, the company and its circumstances were a composite of McDermott’s actual deals. Our panel’s examination of this case study yielded valuable insights into the context, cross-border dynamics, practicalities, opportunities and challenges underlying the growing volume of international life...

Continue Reading

STAY CONNECTED

TOPICS

ARCHIVES