Regulators

Are PBMs and Pharma Companies Driving High Insulin Prices?
Regulatory & Compliance Are PBMs and Pharma Companies Driving High Insulin Prices?

The rise in insulin prices has become a heated topic in healthcare discussions, drawing scrutiny towards the roles played by pharmacy benefit managers (PBMs) and pharmaceutical companies. Recently, Texas Attorney General Ken Paxton has taken a significant legal step by suing major PBMs and pharma

October 8, 2024
How Will the EU AI Act Impact Life Sciences and Digital Health?
Regulatory & Compliance How Will the EU AI Act Impact Life Sciences and Digital Health?

New regulations often elicit a mix of anticipation and apprehension, and the EU AI Act is no exception, especially in the life sciences and digital health sectors. As companies navigate the evolving regulatory landscape, understanding the implications of this legislative framework becomes essential

October 1, 2024
Are Pharmacy Benefit Managers Behind Soaring Insulin Prices?
Regulatory & Compliance Are Pharmacy Benefit Managers Behind Soaring Insulin Prices?

The cost of insulin has surged dramatically over the past decades, burdening patients who rely on this life-saving medication. Rising costs have drawn scrutiny from regulators, lawmakers, and consumers, leading to investigations into the pharmaceutical industry's pricing mechanisms. Among the

September 23, 2024
Labs Urge Lawmakers to Rescind FDA Rule on Lab-Developed Tests
Regulatory & Compliance Labs Urge Lawmakers to Rescind FDA Rule on Lab-Developed Tests

The call for legislative intervention to overturn the FDA's final rule on the regulation of laboratory-developed tests (LDTs) has intensified. The Association for Diagnostics and Laboratory Medicine (ADLM) has been at the forefront, urging lawmakers to take action against the FDA's new

September 11, 2024
Biden Administration Expands Mental Health Coverage in Private Plans
Regulatory & Compliance Biden Administration Expands Mental Health Coverage in Private Plans

The Biden administration has taken a remarkable step forward in mental health care by finalizing rules that expand mental health coverage standards in private insurance plans. This bold move aims to address the longstanding disparities between mental and physical health benefits, ensuring millions

September 11, 2024
How Are Drug Distributors Contributing to the Opioid Crisis Settlement?
Regulatory & Compliance How Are Drug Distributors Contributing to the Opioid Crisis Settlement?

The opioid crisis has left an indelible mark on American society, thrusting numerous stakeholders, particularly drug distributors, into the spotlight. The recent $300 million settlement by McKesson, Cardinal, and Cencora represents one of the latest significant efforts to address the multifaceted

September 4, 2024
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