Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
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?
Share on Twitter Print Share by Email Share Back to top In spring 2025, the Food and Drug Administration (FDA) resolved and ended the GLP-1 medications shortage, subsequently releasing declaratory orders that neither...more
The future direction of the Alabama Board of Pharmacy (“the Board”) hangs in the balance following recent legislation that, if passed, would revise many portions of the state Pharmacy Practice Act. House Bill 123, sponsored...more
The pharmacy landscape has evolved considerably over the past year, shining a spotlight on pharmacy “patient steering”, the practice of directing patients to certain preferred pharmacies. Though Quebec has long required that...more
Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, we see Georgia pharmacies selling medical marijuana. We have an update on the Ohio legalization ballot...more
On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more
On February 23, 2023, The New York Department of Financial Services’ (“Department”) Pharmacy Benefits Bureau (“PBB”) announced a final request for public engagement as the Department looks to develop regulatory standards...more
On February 4, 2022—more than six years after the deadline imposed by statute—the U.S. Food and Drug Administration (“FDA”) issued a proposed rule titled “National Standards for the Licensure of Wholesale Drug Distributors...more
On September 21, 2021, D.C. District Court Judge Christopher Cooper gave an initial victory to the seven compounding pharmacies (“the pharmacies”) challenging Food and Drug Administration’s (“FDA”) final standard Memorandum...more
At its August 31, 2021 meeting, the Nevada Board of Pharmacy moved to seek a formal opinion from the Nevada Attorney General Office regarding the legality of the requirement of all non-resident pharmacists who dispense or...more
Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots of...more
On April 3, FDA Commissioner Scott Gottlieb released a statement outlining the agency’s priorities for 2019 with respect to compounding pharmacies and the compounding industry. ...more
U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning...more
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
California recently passed Assembly Bill 315 to create greater regulatory oversight of pharmacy benefit managers (“PBMs”). The bill requires PBMs to provide more transparency regarding their operations. PBMs will have to...more
The 340B Drug Pricing Program has spawned two antitrust lawsuits related to CVS’s acquisition of Wellpartner, a 340B administrator. 340B administrators contract with 340B covered entities (e.g., hospitals) to provide a...more
The opioid crisis in America is now well known, affecting a staggering number of people directly or indirectly and occupying a regular place in media reports and political discussions. In addition to potential public health...more
Notwithstanding the enactment of a first-in-the-nation drug spending cap last year, in light of the $4.4 billion deficit and ongoing concerns about the opioid crisis it was inevitable that this year New York State would once...more
This week, the U.S. Food & Drug Administration (FDA) published draft guidance, describing FDA’s policy and process for evaluating bulk drug substances used in compounding by outsourcing facilities that are registered under...more
In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and Section 503B of the Federal...more
Samsung, beset by top-level resignations and a mess of bribery allegations reaching the former South Korean President and the crown prince of the family’s chaebol, has announced a new slate of execs “In an effort to bring...more
By Law passed today, August 2nd, 2017 (Law for the improvement of the competition on the market), further to a recommendation of the Italian Competition Authority (“ICA“), the Italian legislature enacted provisions for the...more
On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United...more
And we thought Brexit was something. Buckle up. It’s going to be a wild market ride... Whoa....more