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
Welcome to our Q2 Trade Secret and Restrictive Covenant Update. As you can tell from the update, Q2 was a busy quarter in this space from both a regulatory, legislative, civil litigation and criminal litigation perspective....more
In the first half of 2022, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to July and...more
1. PAAB’s Accelerated Review Options - In July 2022, the Pharmaceutical Advertising Advisory Board (PAAB) will launch four Accelerated Review Options (ARO) to its standard pre-clearance pathway, covering a range of...more
A new ban on “Detailed Targeting” options for advertisers on Facebook and other Meta-owned social media platforms – which includes restricting marketing based on “health causes” – takes effect January 19, and may make it more...more
In Washington: President Joe Biden is considering Gene Sperling for a role to oversee the implementation of the administration’s $1.9 trillion coronavirus relief plan. Sperling served as the director of the National...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
After more than half a year without a leader, the WTO is poised to welcome its “first woman and first African” to the role in the form of Nigerian economist and former finance minister Dr. Ngozi Okonjo-Iweala. ...more
Welcome back to the Class Action & MDL Roundup! Our summer edition covers notable class actions from the second quarter of 2020. In this edition, the Judicial Panel on Multidistrict Litigation (JPML) weighed in on several...more
Never one to let a competitor’s misfortune pass by without looking for an opportunity, Facebook’s Instagram is hoping to capitalize on TikTok’s questionable U.S. status by launching Reels, a new feature that allows users to...more
Much more on what to expect from Big Tech’s “Big Tobacco Moment” on the Hill today, at which Google, Amazon, Facebook, and Apple’s CEOs will endeavor to make the case that their massive companies don’t “stifle rivals and...more
Optimism over promising results for a coronavirus vaccine from Moderna helped drive stocks up on Monday after a rough go of it last week....more
While there’s plenty of other business afoot in D.C. these days, it also happens to have been a pretty big week for trade deals. A day after Phase One with China was inked, the Senate overwhelmingly approved a revised...more
Outlook for This Week in the Nation’s Capital - Thank you to all who have served. Happy Veterans Day from Clark Hill....more
SoftBank’s plan to help bail out WeWork would mean not only a takeover by Masa Son’s crew but also “would slash the co-working company’s valuation to about $8 billion”—a staggering drop of nearly $40 billion. The plan would...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
Fed Chair Powell, speaking at an economics conference in Denver yesterday, made news by indicating that the central bank would “once again begin expanding its portfolio of government-backed securities”—a shift in policy...more
A drone attack on Saudi Aramco oilfields this weekend affected 5% of global production and sent “energy prices substantially higher” late Sunday and early today. Analysts don’t anticipate a “severe shock to energy markets and...more
The European Central Bank announced on Thursday that is likely to revive the quantitative easing program aimed at “pump[ing] money into the region’s financial system,” a major reversal from just 6 months ago, when the ECB...more
Welcome back to the Class Action & MDL Roundup! This year has begun with cases all over the map, from California to Florida to Massachusetts. The West Coast features overbearing manufacturers, allegedly underpaid lenders,...more
All of that SuperBowling seems to have put activist investor Starboard in the mood for some pizza—specifically, former NFL-partner Papa John’s, which has struggled in the wake of the removal of its founder and namesake John...more
The US House included the revised Volcker Rule that we’ve discussed in a broader package of Dodd-Frank reforms that it passed with bipartisan support last night. The bill—ostensibly aimed at easing restrictions on small to...more
Lack of workable replacement (so far, at least) be damned—the UK’s Financial Conduct Authority has announced that [the scandal-plagued] Libor will be phased out by 2021 in favor of “transaction-based benchmarks”....more
EU Regulators Open Pharma Pricing Investigations Focusing on Abuse of Dominance - The European Commission and UK Competition and Markets Authority (CMA) have both opened new investigations into alleged abuses of...more
We welcome the opportunity to provide comments to the European Commission in its evaluation of procedural and jurisdictional aspects of EU merger control. A NEW JURISDICTIONAL THRESHOLD - We respond here to section...more
Even as auto lending continues at near break-neck pace, regulators are expressing concerns about the rise (again) of subprime delinquencies from borrowers. The trend, at a time when the US economy is doing relatively well,...more