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
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 U.S. Department of Justice announced on July 24 that Admera Health LLC, a New Jersey-based biopharmaceutical research and clinical laboratory testing company, agreed to pay $5,389,648 to resolve kickback allegations...more
During this session, the panelists discussed the current market outlook for CROs and the key differentiators making them attractive to private equity investors, such as therapeutic area (TA) specialization, their ability to...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
On April 30, 2024, in Himawan, et al. v. Cephalon, Inc., et al., the Delaware Court of Chancery held that the defendant acquiror complied with its contractual obligations to use commercially reasonable efforts to achieve...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
In a previous Update, we reported on the Biomedical Advanced Research and Development Authority’s (BARDA) plans to implement the new Biopharmaceutical Manufacturing Preparedness-Consortium (BioMaP-Consortium or Consortium),...more
Manufacturer-sponsored genetic testing programs provide several benefits to patients, including expanding access to genetic testing, providing opportunities for patients to participate in research, empowering patients to make...more
The Biomedical Advanced Research and Development Authority (BARDA) held its first in-person BARDA Industry Day (BID) since the beginning of the COVID-19 pandemic in Washington, D.C., on November 13-14, 2023. BID is an annual...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
Navigating the complex landscape of drug discovery requires innovative strategies and interdisciplinary collaborations spanning biotechnology, pharmacology, medicine and engineering. As the cost of developing new drugs...more
Supreme Court Hears Argument on Traceability Requirement in Circuit-Split Slack v. Pirani - Key Points - - Before the end of June, the U.S. Supreme Court is expected to issue a decision in a high-profile securities case...more
We previously reported on the ongoing dispute between Amgen and Sanofi regarding enablement of genus claims. But, the case is nearing a final decision. On January 31, the Supreme Court set arguments to address Question 2...more
Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug coverage through...more
Hosted by American Conference Institute (ACI), the National Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies will highlight leveraging technology, safeguarding IP, and securing...more
Biopharmaceutical New Technologies (BioNTech), the global immunotherapy company based in Mainz, Germany, is scheduled to ship its BioNTainer modular mRNA vaccine factory to Rwanda. According to BioNTech’s press release, the...more
Come together with key decision-makers, innovators and investors from across the healthcare, life sciences and private equity (PE) industries during the year’s largest healthcare investment symposium....more
Perspectives on Life Sciences Webinar Series: Explore Key Life Sciences Issues at the Intersection of Law, Policy & Business Strategy - The COVID-19 pandemic has entrenched telehealth into the fabric of modern health care...more
With the proliferation of precision and individualized medicine, genetic testing and counseling will likely remain on the radar of the Department of Health and Human Services’ Office of Inspector General (OIG) and the...more
How is orphan drug exclusivity affected when the FDA-approved use for an orphan drug is arguably narrower than the treatment of the rare disease it was designated for? By way of background, a sponsor can obtain orphan drug...more
It seems like there is a new article every day about how the COVID-19 pandemic has impacted the supply chain, particularly as economies reopen and we move into the next phase of the “new normal.” The disruptions in the supply...more
General Trends in Life Sciences M&A - If 2019 was the year of life sciences mega-deals, 2020 was the year of COVID-19, as the global pandemic permeated every aspect of the dealmaking landscape, with the life sciences...more
On November 11, 2020, I had the pleasure of participating in a virtual fireside chat with Dr. Jeremy Levin at the first AdvanSE Life Sciences Conference held by the Southeast Life Sciences Association. Dr. Levin has a long...more
The Italian pharmaceutical company Angelini Pharma announced on January 4, 2021, that it will acquire emerging Swiss biotech company Arvelle Therapeutics for a total aggregate valuation of up to $960 million. Angelini Pharma...more
You won’t want to miss four days of exclusive, virtual events that bring together industry leaders, emerging standouts, innovators and investors from across the industry landscape at the largest healthcare investment...more