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
Recently, the Delaware Chancery Court and the Third Circuit issued three significant decisions on key issues affecting licensing and M&A transactions in the life sciences industry....more
Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more
Hear from a global team on the crucial legal and regulatory topics investors need to know when buying or investing in Clinical Trial Site Management Organizations. Investing in pharma services is complicated, but our team...more
Hosted by American Conference Institute, the 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement returns for another exciting year for lively discussions on FCA enforcement including the ramifications of two...more
ACI’s 6th Annual Life Sciences IP Due Diligence Summit is devoted to providing corporate and IP counsel with expert strategies for assessing, valuing, and commercializing IP assets when conducting strategic IP due diligence –...more
Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and evolving...more
Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more
While the ability to market medical products is bound by the claims that can be lawfully made, it does not mean the claims available at acquisition are all your company will have. Consider developing a plan to create...more
Join Gardner Law and colleagues live from Lord Fletcher's on Lake Minnetonka, Minnesota for a complimentary CLE event. Hear from a panel of experts on compliance, data breaches, FDA regulations, privacy, and more....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
What if I told you that there was a plant that could be used to treat diabetes, liver problems, ulcers, leukemia, and malaria? Understandably, you would want that plant to be studied and turned into medicine if possible....more
As we predicted in the previous edition of this report, 2021 turned out to be a very strong year indeed for US life sciences dealmaking, marked by high transaction values and volumes as the industry continued on its...more
Join us in person on Miami Beach for exclusive networking and to hear from leading investors helping shape the future of healthcare private equity. The annual HPE Miami event features a world-class faculty, offers creative...more
Takeaways - ..The Biden administration’s recent executive order takes a hard line on limits to employment mobility, such as non-compete agreements. ..No-poach agreements—companies agreeing not to recruit each other’s...more
In recent years, the service offerings available at urgent care centers have expanded beyond traditional “urgent care” into several ancillary services. “Historically, urgent care was for urgent needs, such as flu or strep or...more
It has been a long time coming. On November 2, 2020, the Drug Enforcement Administration (DEA) released its long-awaited proposed rule to revise the regulations related to suspicious orders of controlled substances. The...more
Complimentary webinar with the DEA on Controlled Substances! During this global pandemic, the Diversion Control Division is working to assure that there is an adequate supply of controlled substances in the United States,...more
Across the US and EU, life sciences companies are pushing diagnostics, antibody testing, vaccines and other efforts forward to flatten the Coronavirus (COVID-19) curve. Our multidisciplinary cross-border life sciences team...more
In the first case following Akorn v. Fresenius to rule on a party’s entitlement to terminate a merger agreement on the basis of a material adverse effect (MAE), the Delaware Court of Chancery ordered Boston Scientific...more
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...more
Data Inspections in China: Increased Supervision and Compliance - Data protection inspections have become more frequent for companies with operations in China. Many companies are struggling for guidance on how to comply. ...more
The recent decision of the Delaware Court of Chancery in Akorn, Inc. v. Fresenius Kabi AG et. al is the first time a Delaware court has found a material adverse effect in the M&A context, and reinforces current Delaware law...more
• In an unusual move, the government has decided to pursue a False Claims Act (FCA) suit against a private equity firm based on an alleged commission scheme at its pharmacy portfolio company to promote sales of products...more
This is the fourth article in our five-part series on PTE. When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or the approval...more
On 3 February 2017, the U.S. Federal Trade Commission (FTC) released its Merger Remedies Study, which analyzed the success of merger remedies imposed by the FTC from 2006 to 2012. Nearly two decades after it issued a similar...more