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
The Biosecure Act, introduced in January 2024 (H.R. 7085), has garnered significant bipartisan support and is increasingly poised to become law, heightening its impact on the life sciences industry. The bill, now amended to...more
Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more
The inaugural Pharma and MedTech Services Investment Summit brought together C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more
This latest edition features articles on biotech client Siolta Therapeutics, the use of safety and efficacy findings to extend drug exclusivity periods, life sciences venture financings for clients in 2023, and updated USPTO...more
YOUR SOURCE FOR SUCCESS IN PHARMA AND DEVICE SERVICES INVESTING - Join C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more
Heading into 2024, expectations for biotech venture capital (VC) and private equity (PE) investments were low following two lackluster years, but as we wrap up Q1, those expectations have been turned on their head after a...more
In the second week of January, Goodwin and KPMG convened innovators, practitioners, regulators, and others for our annual symposium on the future of life sciences and healthcare. This marked the fifth year that Goodwin...more
This report series examines quarterly trends in life sciences venture investment. Key findings for Q4 2023 include: • Life sciences VC deal value in Q4 2023 totaled $6.6 billion, representing a 25.0% decrease from the prior...more
The Fenwick life sciences team recently returned from the 2024 JP Morgan Healthcare conference. As we reflect back on the week, there were several key themes and trends that we expect will continue to resonate and evolve over...more
Digital health is showing signs of life despite financial markets that seem determined to bring some of 2023’s volatility into the new year. Stocks are up and down, and bond yields are climbing. Inflation is proving stubborn,...more
This report series examines quarterly trends in life sciences venture investment. Key findings for Q3 2023 include: Life sciences VC deal value in Q3 2023 totaled $7.7 billion, representing an uptick from last quarter...more
Originally published in Genetic Engineering News on October 10, 2023. Reprinted with permission. The biotechnology sector has long been characterized by its constant innovation, rapid technological progress, and unyielding...more
Substantial changes to the European life sciences and healthcare regulatory landscape are expected to reshape the sector. EU regulators have outlined a raft of reforms to modernise regulatory architecture, simplify product...more
A “picture” claim refers to a patent claim precisely tailored to track a particular product’s important advantages and features. When drafting a patent application, one should describe various embodiments of the invention and...more
Recent reports, including one by PitchBook, indicate that both venture capitalist funding for medtech companies and the variety of medtech companies receiving venture capitalist funding has increased since the first quarter...more
Presidio Medical, Inc. announced that the company successfully concluded a Series C funding round, raising a total of $72 million. The round was led by Deerfield Management, Invus Opportunities, Action Potential Venture...more
For digital health startups, the first two months of this year were a welcome departure from 2022, when high inflation and other economic challenges caused investors to press on the brakes and proceed with caution....more
This report series examines quarterly trends in life sciences venture investment. Key findings for Q4 2022 include: • Deal value reached $7.1 billion in Q4 across 392 deals, bringing the 2022 annual total to $38.0 billion...more
As the industry readies itself for the January 2023 pilgrimage to the J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry team has prepared...more
This report series examines quarterly trends in life sciences venture investment. Key findings for Q3 2022 include: • The industry generated $6.2 billion in deal value across 352 deals in Q3, exhibiting further quarterly...more
Digital health has been a powerhouse investment sector since it emerged more than a decade ago. Year-after-year, startups consistently demonstrate their innovations bring real-world benefits and our healthcare system...more
This report series examines quarterly trends in life sciences venture investment. Key findings for Q2 2022 include: • The industry generated $8.8 billion in deal value across 362 deals in Q2, a material decline from Q1, as...more
Recent reporting by the Financial Times shows that valuations and funding for biotech companies has fallen significantly, as “just nine biotech companies have listed in the U.S. this year, raising a total of $1bn … almost 60...more
Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation, Hogan Lovells partners Andrew Strong and Barry Burgdorf provided best practices for launching a start-up biotech company in the cell,...more
This edition of Orrick’s life sciences publication series breaks down the key drivers of venture investment in the life sciences industry during Q1 2022, which saw some disruptions following a record year in 2021. Key...more