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 a letter dated March 21, 2023, the National Institutes of Health (“NIH”) again refused the request of petitioners to exercise march-in rights under the Bayh-Dole Act to control the price of a drug. Here, as before, the NIH...more
On July 11, 2022, the United States District Court for the District of Kansas approved a $264 million settlement against Mylan and certain of its subsidiaries in the case In Re EpiPen (Epinephrine Injection, USP) Marketing,...more
For the first time, the Israel Competition Authority has opened enforcement proceedings against a monopolist for abuse of its dominant position by charging an unfairly high price. Subject to a hearing, the authority intends...more
Notable Cases - Here are a few of the major cases of interest within the state Attorneys General community that are receiving significant press coverage. ...more
Since the ongoing states of emergency were put in place in response to a health crisis, pricing in the pharmaceutical industry is under more of a microscope than usual. While the immediate focus may be on products that are...more
In Washington: White House press secretary Kayleigh McEnany on Monday said that President Trump is “open” to another coronavirus stimulus package and that he still wants a payroll tax cut, which many Republicans do not...more
According to the new Order SND/354/2020 of 19 April issued by the Spanish Ministry of Health, the pricing authority has 48 hours to set the maximum retail price of surgical masks, nitrile gloves, hygienic masks, antiseptics,...more
Earlier this year, I commented on state drug pricing transparency laws in effect and/or enacted during 2017. I also opined that it was likely more states would pass similar transparency laws requiring drug manufacturers to...more
The U.S. Court of Appeals for the Fourth Circuit last month handed manufacturers and wholesalers of off-patent drugs a victory by ruling that Maryland’s anti-price gouging act violates the U.S. Constitution’s dormant commerce...more
Executive Summary - Going back a number of years, federal and state policymakers have discussed various mechanisms to address the increasing costs of certain prescription drugs in the United States. This issue gained...more
In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more
Maryland became the first state to enact legislation that outlaws “price gouging” in the generic drug market. H.B. 631, enacted on May 27, 2017 (the “Act”), has two components: (1) a prohibition on price gouging; and (2) a...more
Just under a century ago, a team of Canadian scientists made the breakthrough that led to widely available insulin as an effective treatment for diabetes, which then was a deadly disease. The researchers, who won the Nobel...more
Congress must stop Big Pharma predators from ripping off American consumers by acting like hedge funds, buying up decades-old, off-patent drugs and jacking up prices on long-standing “gold standard” prescription medications,...more
Two executives were charged last week with criminal violations in the Southern District of New York relating to Valeant Pharmaceuticals activities. These charges are the first of more to come in an ongoing investigation...more
In a letter sent earlier this month to Secretary Sylvia Mathews Burwell of the U.S. Department of Health & Human Services and Director Francis S. Collins of the National Institutes of Health, fifty members of the U.S. House...more