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
Supreme Court Hears Argument on Traceability Requirement in Circuit-Split Slack v. Pirani - Key Points - - Before the end of June, the U.S. Supreme Court is expected to issue a decision in a high-profile securities case...more
Although the record-breaking deal activity of 2021 spilled over into 2022, headwinds in the first quarter developed into a significant slowdown during the rest of 2022, with an expectation of continued slowness as we enter...more
Some important insurance decisions were handed down over the past month. We begin in Ohio, where public nuisance claims by state and local governments over opioids and lead paint were on full display. In Acuity, the...more
Just days after U.S. corporate titan General Electric announced that it would divide itself into three companies, another storied American brand—Johnson & Johnson—laid out plans to “break itself up into two publicly traded...more
Six months into the 117th Congress, the U.S. Senate has recently increased its oversight activities following a slow start. Since April, newly empowered Democratic Members have launched or requested more than 20 inquiries...more
Gilead Sciences Inc. reports that its remdesivir virus treatment has been positively correlated with a 62% reduction in death risks compared with the standard of care in an initial analysis....more
Blockchain Solutions Launch in Pharma, Energy and Food Industries - According to reports, the Chinese branch of one of the largest pharmaceutical companies in the world recently announced that it will work with VeChain to...more
When members of the U.S. House of Representatives and Senate were sworn into office in January 2019, Democrats took control of the House and its oversight agenda for the first time in eight years, 235-200 seats, and...more
Blockchain Solutions Advance in Manufacturing, Food, Pharma and Grant Management - Last week, one of the world’s largest industrial cobalt producers announced plans to join the Responsible Sourcing Blockchain Network (RSBN)....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
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
This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including a review of the first year of GDPR enforcement, analysis of...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
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
Drug giants Pfizer and Mylan have inked a deal that will merge the former’s off-patent drugs with the latter’s generics business, a tie-up that creates a mammoth global seller of lower-priced medicines....more
Taiwanese Manufacturer of Smartphones Subject to Personal Jurisdiction in Texas in Patent Infringement Case Because of its Allegedly Purposeful Efforts to Serve the US Market Even Though all US Distribution was Orchestrated...more
Blockchain Initiatives in Healthcare and Other Industries Target Data Integrity, Speed and Analytics - Last week, a not-for-profit alliance of life sciences industries firms announced an expansion of its blockchain project...more
More on yesterday’s news of a split power-generation division at GE, including why fixing the ailing business is such an important task for new CEO Larry Culp and what federal criminal and civil accounting probes mean for the...more
Outlook for This Week in the Nation's Capital - Recess. The Senate recessed last week after leadership reached an agreement to accelerate consideration of multiple juridical nominations in order to depart two weeks earlier...more
To no one’s surprise, the Fed followed through with its months of promises and raised its benchmark interest rate by 25 basis points yesterday. The FOMC also indicated that it’s planning to raise rates again in December....more
As expected based on buzz from late last week, longtime CBS chief Les Moonves is out at the network he’s led for more than 20 years. While his exit has been in the works for some time, a report out yesterday detailing new...more
Theranos founder and ex-CEO Elizabeth Holmes has been indicted on federal fraud charges along with former company president Ramesh Balwani. The charges come three months after Holmes settled civil charges with the SEC....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