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
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
The US Senate voted on February 15 to confirm Dr. Robert M. Califf as the next commissioner of the US Food and Drug Administration (FDA), a position that has been filled since April 2021 by acting commissioner Dr. Janet...more
On January 12, the International Generic and Biosimilar Medicines Association (IGBA) announced that Vivian Fritelli, Chief Executive of Generic and Biosimilar Medicines of Southern Africa, will be the next IGBA Chair for...more
In Washington: President Biden on Tuesday began what is expected to be a weeks-long sales pitch to tout the new coronavirus relief package. Biden visited Smith Flooring in Chester, Pennsylvania, a small business that received...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
U.S. drug giant Merck is shuttering its coronavirus vaccine development “after early trial data showed [its pair of vaccines] failed to generate immune responses comparable to natural infection or existing vaccines.” ...more
In Tuesday's Report: European Commission proposes far-reaching pharmaceutical strategic plan, Biden names health care nominees, and warnings over Christmas COVID-19 spread....more
Emer Cooke, with 30 years’ experience in international regulatory affairs, took up her position this morning as Executive Director of EMA with a renewable five-year mandate. Previously, Ms. Cooke worked for the pharmaceutical...more
In Washington: Today, the House will meet for a pro forma session and the Senate will resume consideration of John Badalamenti to be United States District Judge for the Middle District of Florida. The full House will be...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
Man-of-the-people PM Boris Johnson is set to as the Queen to suspend parliament for 5 weeks in an attempt to squeeze the time for opposition to the October 31st Brexit deadline, a move that’s prompting concerns about a...more
Norman E. (Ned) Sharpless, M.D., recently took the helm as Acting Commissioner of the US Food and Drug Administration (FDA). Dr. Sharpless most recently served as the director of the National Cancer Institute, part of the...more
Jobs report Friday again. Which, after February’s dismal numbers, is carrying extra importance today. We’ll be keeping an eye on US manufacturing, among other things. Here’s what to watch....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
The Trump Administration has lost yet another top health official: So, what happens now with key policies pushed by Scott Gottlieb, the departing federal Food and Drug Administration commissioner, to battle teen nicotine...more
There will soon be a new director of Therapeutic Biologics & Biosimilars Staff (TBBS) in the Office of New Drugs (OND) at the FDA. Dr. Sarah Yim will become the new acting director of TBBS beginning in March. ...more
We’ve already considered what the arrest of Huawei’s CFO will mean for the trade war between the U.S. and China. Now let’s dig in to what that move—and a host of recent country-level rejections of Huawei’s 5G...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
Richard A. Powers has recently joined the Department of Justice (DOJ) Antitrust Division as the acting deputy assistant attorney general (DAAG) for criminal enforcement and is expected to take on the role permanently. This is...more
After almost a year of fending off a hostile takeover bid from rival PPG Industries, Dutch paint and chemical giant Akzo Nobel has agreed to sell its specialty chemicals unit to PE firm Carlyle Group for $12.5 billion in a...more
There’s falling from grace, and then there’s Elizabeth Holmes. Once compared glowingly to Steve Jobs, Holmes’ well-documented Theranos ills (including exaggerated and faked blood-test results) have landed her with SEC...more
While President Donald Trump made repeal of the Affordable Care Act (ACA) a centerpiece of his 2016 presidential campaign, he offered few details about how he would replace it or address other health care issues. More...more