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 “African Group” in the World Trade Organization (WTO) is pushing for discussions—and potentially renegotiation of international trading rules—on how developing countries do and can acquire technology to build resilience...more
Among other things, on May 19, 2023, the U.S. Department of Commerce’s Bureau of Industry and Security (“BIS”) issued a sweeping new set of restrictions that collectively operate to deter the Putin Regime from acquiring...more
On July 27, Reps. John Joyce (R-PA) and Jim Banks (R-IN) introduced legislation that would establish new US trade negotiating objectives for the pharmaceutical sector, in the context of a broader renewal of the trade...more
1. BIS Eliminates Reporting Requirements for Certain Encryption Items Effective March 29, 2021, BIS eliminated or reduced reporting requirements for certain encryption items. For encryption source code and beta test...more
American Airlines is pushing forward with plans to furlough 19,000 workers this fall, even as the airline industry lobbies a stalemated Congress for another multi-billion dollar bailout. That figure, “when combined with the...more
The COVID-19 pandemic is significantly disrupting international trade as global and domestic supply chains grapple with declining trade volumes and inadequate supplies of medical goods, including personal protective equipment...more
Since the start of this year, trade relations with China, previously marked by an escalating trade war, have reached a major inflection point. Recently, on March 12, the U.S. reacted to the growing COVID-19 pandemic by...more
More detail is emerging on the DOJ’s ongoing antitrust probe into Google, with recent attention to the company’s online ad tools suggesting the topic has become “a major focus of the investigation,” with special focus on “how...more
A mounting death toll (over 106 and counting) and fears of a coronavirus pandemic sent markets tumbling early on Monday and kicked off a selloff that continued all day....more
Congress returns to Washington this week after the Thanksgiving recess to find a feast of leftover legislative items still on the table. Congress has a limited number of days remaining on the 2019 legislative calendar to...more
The City of London has denied Uber’s request to extend its license in the city over concerns for rider safety. The decision puts Uber’s 45,000 drivers there in limbo, though they’ll be able to continue operating while the...more
Dean Foods, the largest milk company in the U.S., has filed for bankruptcy protection, a “fresh setback to a U.S. dairy industry struggling against declining U.S. milk consumption and rising competition.” Industry experts...more
We Work’s largest investor, SoftBank, is reportedly sketching out plans in which it would drop billions of additional money on the company in return for giving Masa Son control of WeWork “and further sidelin[ing] its founder...more
Top Tidjane Thiam ally Pierre-Olivier Bouee, Credit Suisse’s COO, has resigned in the wake of an internal probe finding that he “ordered the surveillance of the bank’s former wealth-management chief, Iqbal Khan, without...more
Fintech firm Stripe Inc., which “allows internet companies and online marketplaces to accept credit cards for their goods and services and pay out money to the people and firms that sell on their platforms,” just wrapped a...more
Congress returns to D.C. this week for a short three-week sprint to a series of important deadlines on September 30. Chief among them is funding the federal government for Fiscal Year (FY) 2020 which begins on October 1,...more
A bad day for J&J in Oklahoma at the close of the state’s trial against Johnson & Johnson means that the company’s on the hook for upwards of $572 million for its role in the opioid crisis that’s decimated swaths of the...more
Amgen will pay $13.4 billion in cash to buy psoriasis treatment Otezla, a deal that will “pave the way for Bristol-Myers Squibb to complete its acquisition of Celgene” by addressing “regulatory concerns over their union”....more
Credit bureau Equifax is closing in on an agreement with federal and state authorities in which it would pay $650-700 million to resolve claims related to the massive breach it revealed in September 2017 that exposed personal...more
The US and China agreed to resume trade talks after a 7-week hiatus, “averting for now an escalation of their multibillion-dollar tariff war that has roiled global markets and threatened the future of the world’s two largest...more
Opioid manufacturer Insys Therapeutics, which just last week agreed to pay $225 million to “settle a federal investigation into the marketing practices for its powerful fentanyl painkiller,” has filed for bankruptcy...more
Outlook for This Week in the Nation's Capital - Congress. House Majority Leader Steny Hoyer announced last week that the full House of Representatives will vote this week on whether to hold Attorney General William Barr...more
Below is the Federal Policy team’s weekly preview, published when Congress is in session. HEADLINES - • Chinese Vice Premier Liu He is scheduled to visit Washington, but President Donald Trump’s Twitter threats to raise...more
OxyContin-maker Purdue Pharma and its owners, the Sackler family, reached a deal this week with the state of Oklahoma in which they will pay “$270 million to avoid going to a state court trial over the company’s role in the...more
GE—still in streamlining mode—agreed yesterday to sell its biopharma business to Danaher (current CEO Larry’s Culp’s former company, btw) for a reported $21.4 billion in the form of $21 billion in cash and $400 million in...more