Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
Podcast — Drug Pricing: How Might the Trump Administration Transform FDA Enforcement Activities?
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 217: Japanese Investment in North Carolina’s Life Sciences Industry with David Robinson of Maynard Nexsen
12 Days of Regulatory Insights: Day 3 - State AG Oversight in the Health Care Industry — Regulatory Oversight Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
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
Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •FTC Accuses Cash-Advance App of Misleading Consumers - ...more
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