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
In June 2021, Philips notified the ANSM of a field safety action that related to the potential risk of degradation and inhalation of carcinogenic compounds from the sound-absorbing foam used in its ventilation devices for...more
In late 2019, Congress enacted the “CREATES Act”, which established a private right of action in which generic or biosimilar manufacturers may sue an innovator for an injunction and monetary award for not selling samples of...more
In its recent decision granting a preliminary injunction in GlaxoSmithKline v. Boehringer Ingelheim Pharmaceuticals, No. 19-5321, the United States District Court for the Eastern District of Pennsylvania enjoined a...more
A group of three major drug distributors—McKesson, AmerisourceBergen, and Cardinal Health—are in the midst of talks with representatives of state and local governments who have brought more than 2000 opioid-related lawsuits...more
Increasing competition within Europe’s pharmaceutical space makes knowing the market and understanding available patent protections more critical than ever for both well established and new market players. Andreas von Falck...more
On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic of Sunrise, Florida, and California Stem Cell...more
An Update on Brazilian Patent Law – Emergency Backlog/Fast-Track Options and Enforcement Issues - We are delighted to have as contributors to the November Global Patent Prosecution newsletter, Ricardo Nunes and Andre...more
On June 12, 2017, the Supreme Court decided Amgen v. Sandoz, the landmark case about the meaning of the Biologics Price Competition and Innovation Act (BPCIA). First, the Supreme Court held that no federal injunction is...more
There’s been a lot of talk in recent years about “BYOD” (“Bring Your Own Device”) policies, which are becoming increasingly common in the workplace. Employees want the flexibility and ease that comes with being able to use a...more
The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch...more
In the latest chapter of a year-long battle between an individual inventor and two companies, Lisa Duer (“Duer”), a resident of Woodstock, Georgia, filed her Third Amended Complaint alleging patent infringement, trademark...more
A pharmaceutical firm’s ability to efficiently produce and promote a better treatment for Alzheimer’s disease lies at the center of an antitrust lawsuit pending before the U.S. Court of Appeals for the Second Circuit. In...more
Following the S.D.N.Y.’s award to the New York State Attorney General of an injunction requiring Actavis to continue distributing the immediate-release tablet version of its dementia drug, Namenda (which we analyzed...more
The Third Circuit ruled in Ferring Pharmaceuticals v. Watson Pharmaceuticals on August 26 that “a party seeking a preliminary injunction in a Lanham Act case is not entitled to a presumption of irreparable harm but rather is...more
The Commission filed two settled insider trading cases against medical practitioners who traded while in possession of material non-public information regarding clinical trials for a drug. SEC v. Lama, Case No. 5:14-cv-00996...more
Insider trading continues to be a key priority in the new get tough enforcement era. Last week closed with the filing of an insider trading action centered on the BP oil spill in the Gulf of Mexico. This week begins with...more
This is the third edition of The Class Action Chronicle, a quarterly publication that provides an analysis of recent class action trends, along with a summary of class certification and Class Action Fairness Act rulings...more