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 D.C. Circuit recently affirmed a lower court’s decision upholding regulations adopted by the Federal Trade Commission (FTC) requiring a Hart Scott Rodino (HSR) Act premerger notification filing for transfers of patent...more
On Nov. 6, 2013, the Federal Trade Commission (FTC or Commission) modified its Hart-Scott-Rodino Act (HSR) rules to clarify that transfers of patent rights within the pharmaceutical industry constitute potentially reportable...more
Background – the HSR Act: Under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the HSR Act), acquisitions of voting securities, assets and other commercial interests which exceed certain monetary thresholds...more
In a confluence of IP and antitrust law, a three judge panel for the D.C. Circuit recently affirmed a lower court decision upholding the Federal Trade Commission’s (“FTC”) 2013 modification of regulations under the Hart Scott...more
A federal court has upheld the validity of the FTC’s recent rules for reporting certain transfers of exclusive patent rights in the pharmaceutical industry under the Hart-Scott-Rodino Antitrust Improvements (“HSR”) Act. We...more
On May 30, 2014, the U.S. District Court for the District of Columbia ruled in favor of the Federal Trade Commission (FTC) in a dispute with the Pharmaceutical Research and Manufacturers of America (PhRMA) regarding the...more
The transfer of certain patent rights in the pharmaceutical industry will remain subject to the premerger notification rules under the Hart-Scott-Rodino Act (HSR Act) after a federal judge rejected a challenge brought by the...more
On November 15, 2013, the Federal Trade Commission (“FTC”) adopted special rules for determining whether “exclusive” licenses of pharmaceutical patents are required to be reported to the FTC and the Antitrust Division of the...more
The Federal Trade Commission (FTC) has asked a federal court to find that the agency has authority under the Hart-Scott-Rodino Act (HSR Act) to promulgate reporting requirements that apply solely to transfers of patent rights...more
US: Agencies Continue Aggressive Enforcement - Despite changes in leadership at the U.S. Department of Justice’s (DOJ) Antitrust Division and the Federal Trade Commission (FTC) (collectively, the Agencies) in 2013, the...more
The Federal Trade Commission has broadened the rules dictating when pharmaceutical companies must report a transfer of exclusive patent rights to the U.S. Department of Justice and FTC for antitrust review and approval. Under...more
The Federal Trade Commission (FTC) has issued final rules under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) relating to the transfer of exclusive patent rights in the pharmaceutical industry. These new...more
The Federal Trade Commission (FTC) has announced revisions to the rules under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) that will apply to certain transactions involving the transfer of patent rights in...more
The Federal Trade Commission (FTC) has finalized certain amendments to the Hart-Scott-Rodino (HSR) premerger notification regulations clarifying the scope of reportable transactions involving transfers of patent rights in the...more
The Federal Trade Commission (FTC) recently announced that it has finalized amendments to the premerger notification rules (HSR Rules) that provide a framework for determining when a transaction involving the transfer of...more
The Federal Trade Commission (FTC) has revised the rule for determining when a transfer of exclusive rights to a patent in the pharmaceutical industry (including biologics and medicine manufacturing) results in a potentially...more
The Federal Trade Commission (FTC) issued final changes to the premerger notification rules to expand the circumstances that require pharmaceutical industry companies to report proposed acquisitions of exclusive patent rights...more
The U.S. Federal Trade Commission (FTC) announced final changes to the Hart-Scott-Rodino (HSR) Act premerger notification rules that will broaden the circumstances under which parties must file premerger notifications in...more
The FTC has proposed amendments to the premerger notification Rules to codify prior FTC guidance concerning when a transaction involving the transfer of rights to a patent in the pharmaceutical and medicine manufacturing...more
The Federal Trade Commission (“FTC”) recently announced and asked for comments on proposed changes to the premerger notification rules under the Hart-Scott-Rodino Act (“HSR Act”). The proposed rules would require...more
The Federal Trade Commission has proposed expanding Hart-Scott-Rodino reporting and waiting period obligations for certain pharmaceutical, biologics and medicine manufacturing licenses. The new rules are subject to public...more
Proposed rule includes new requirements for reporting pharmaceutical patent transfers. On August 13, the Federal Trade Commission (FTC) released proposed amendments to the premerger notification rules (the Proposed...more
Fresh from its victory in the Third Circuit on “pay-for-delay” deals involving brand name and generic pharmaceutical companies, the Federal Trade Commission (“FTC”) has announced yet another initiative aimed at the...more