Ionis Pharmaceuticals Achieves Milestone with FDA Approval of Treatment for Familial Chylomicronemia Syndrome (FCS)
Ionis Pharmaceuticals marks a new commercial era with the FDA approval of Tryngolza, a novel RNA-targeted treatment for familial chylomicronemia syndrome, embarking on its first solo drug launch to address unmet medical needs.
FDA Updates “Healthy” Claim to Empower Consumer Nutrition Choices
The FDA has finalized an updated definition for the "healthy" nutrient content claim on food labels, helping consumers identify nutritious foods and encouraging manufacturers to develop healthier products.
Bipartisan Bill Introduces Key Healthcare Reforms to Enhance Transparency and Access
On December 18, 2024, U.S. lawmakers unveiled a bipartisan stopgap funding bill to finance the federal government through March, incorporating significant healthcare provisions.
Pfizer Projects $1 Billion Revenue Impact from IRA Changes and Foresees No Major M&A in 2025
Pfizer anticipates a $1 billion revenue reduction in 2025 due to Medicare Part D redesign while maintaining revenue forecasts. The company plans no major acquisitions, focusing instead on cost savings and operational growth.
FDA Identifies New Safety Concerns for Ocaliva in Treating Rare Liver Disease
The FDA has reported additional safety risks linked to Ocaliva, a drug for primary biliary cholangitis, citing serious liver injuries in patients. This marks another setback for the drug, originally poised as a blockbuster.
Eli Lilly CEO Discusses Speculations on Drug Pricing and Healthcare Priorities Under Trump
Following a dinner at Trump’s Mar-a-Lago estate last week, Eli Lilly CEO David Ricks pointed to raising drug prices in other developed nations as a key strategy to reduce costs in the United States.
Novo Nordisk Announces Significant Insulin Price Cuts for 2026
Novo Nordisk plans to reduce U.S. insulin prices significantly by 2026, aligning with Medicare mandates. The cuts follow industry trends and government pressure to lower diabetes treatment costs.
The Decline of Retail Pharmacies: A Decade of Closures and Disparities
Discover the findings of a Health Affairs study revealing the closure of one in three U.S. pharmacies since 2010, with independent pharmacies and marginalized communities hit hardest. Learn about the role of pharmacy benefit managers in this trend and its impact on healthcare disparities.
High Out-of-Pocket Costs Leave Nearly a Quarter of Americans Underinsured, Survey Reveals
A recent Commonwealth Fund survey highlights that 23% of working-age Americans are underinsured, facing high out-of-pocket costs that hinder access to necessary healthcare. The report also notes significant coverage gaps, with many delaying care due to cost barriers.
Biden Administration Proposes Expanding Medicare & Medicaid Coverage for Weight Loss Drugs
The Biden administration proposes a rule to allow Medicare and Medicaid to cover anti-obesity drugs like Wegovy and Zepbound, potentially providing access to millions but posing a $40 billion cost over a decade.
Uncertain Future for Continuous Medicaid Eligibility for Children Under Potential Policy Changes
The Biden administration's approval of multiyear continuous Medicaid eligibility for children in five states faces uncertainty with the incoming Trump administration. Explore the implications of potential policy changes impacting Medicaid and CHIP enrollment.
Enhancing Diversity in Clinical Trials: The Role of Systematic Literature Reviews in FDA’s DEI Initiatives
Systematic literature reviews (SLRs) play a crucial role in shaping inclusive and diverse clinical trials by offering insights into the demographics and health factors of various patient populations. Aligned with the FDA’s DEI initiatives, SLRs help clinical trial sponsors understand the diversity of treatment populations, ensuring trials are representative and addressing potential biases in healthcare research. By drawing on comprehensive data, SLRs support the FDA’s goals for more equitable and generalizable clinical trials.
UPDATE: Eli Lilly Joins J&J in Challenging Federal 340B Drug Discount Program in Court
Eli Lilly and Johnson & Johnson have filed lawsuits against the U.S. government over the administration of the 340B drug discount program, seeking to implement rebate systems for hospitals instead of providing upfront drug discounts. The legal actions highlight ongoing tensions between pharmaceutical companies and healthcare providers over program costs and compliance.
Best practices and opportunities for advancing health equity through research
Health equity is about creating fair opportunities for all individuals to achieve optimal health. Through a structured, three-phase approach—detecting, understanding, and reducing health disparities—researchers and life sciences companies can make meaningful progress toward this goal. By leveraging high-quality data, community partnerships, and multi-level interventions, researchers can address systemic health inequities, ultimately driving better health outcomes for vulnerable populations.
RFK Jr.’s HHS Appointment Sparks Vaccine Stock Declines and Policy Concerns
Robert F. Kennedy Jr.’s appointment as Secretary of Health and Human Services (HHS) has caused vaccine stocks to drop, with companies like Moderna and Bavarian Nordic seeing significant losses.
Johnson & Johnson Challenges Federal Government Over 340B Rebate Plan
Johnson & Johnson has filed a lawsuit against the Biden administration, seeking to implement a rebate model for the 340B drug discount program. The pharmaceutical giant aims to replace upfront discounts with after-the-fact rebates, a move met with opposition from hospitals and federal regulators.
Senate Scrutiny on Pfizer and Lilly’s Telehealth Platforms Over Potential Anti-Kickback Violations
Pfizer and Eli Lilly face Senate inquiries over their telehealth prescription platforms amid concerns of potential violations of anti-kickback rules and inappropriate prescribing practices. Lawmakers are demanding clarity on these direct-to-patient programs.
ModEx: Revolutionizing Cancer Drug Pricing and Access Through Open-Source Health Economic Models
Discover how ModEx is transforming cancer drug pricing and accessibility by providing a decentralized platform for open-source health economic models. Learn about the innovative approach to model sharing, including royalty incentives for developers and enhanced validation for users, aimed at ensuring cost-effective healthcare solutions.
Anticipated Policies and Reactions as the Healthcare Industry Braces for Second Trump Term
As Donald Trump enters his second term, the healthcare sector prepares for intensified policies affecting the Affordable Care Act, Medicaid, and industry regulations. Explore how major healthcare organizations respond and what changes might lie ahead in access, affordability, and coverage.
APhA Supports ECAPS Act to Preserve Essential Pharmacy Access in Underserved Communities
In the wake of increased pharmacy closures, the American Pharmacists Association (APhA) has expressed support for [...]
Novo Nordisk Urges FDA to Cease Compounding of Semaglutide Due to Safety Concerns
Novo Nordisk has petitioned the FDA to halt the widespread compounding of semaglutide, citing safety concerns [...]
FDA Expands Approval of Pfizer’s RSV Vaccine Amid Slow Uptake and Awaited CDC Guidance
The U.S. Food and Drug Administration (FDA) has expanded the approval of Pfizer's RSV vaccine, Abrysvo, [...]
Study Finds Access to Public Health Insurance Boosts Cognitive Development in Children
A recent study published in the Journal of Health Economics reveals that expanding public health insurance [...]
President Biden Announces Major Prescription Drug Savings
In a statement from President Joe Biden, he highlights that due to the Inflation Reduction Act, [...]
New Bill Aims to Strengthen Healthcare Cybersecurity
The Health Infrastructure Security and Accountability Act seeks to bolster healthcare cybersecurity by mandating the HHS [...]
