Month: May 2025

Main Takeaways 503B outsourcing facilities must comply with various FDA regulations, including current good manufacturing practices (cGMP), registration, labeling, and adverse-event reporting requirements, which distinguish them from 503A pharmacies and enable them to mass-produce and distribute compounded drugs for office use without patient-specific prescriptions. The FDA’s increased oversight has raised quality and safety standards in […]

In a video interview with Pharma Commerce, Kevin Dondarski, Deloitte’s life sciences R&D strategy leader, describes how his company’s 15th annual Deloitte report on the return on investment (ROI) in pharmaceutical R&D reveals a continued upward trend, with a projected ROI of 5.9% for 2024. This marks a notable reversal from the consistent decline seen […]

Image Credit: © JHVEPhoto – stock.adobe.com Key takeaways Placebo-controlled trials now required for low-risk groups: FDA will require placebo-controlled trials for COVID-19 vaccines in low-risk populations before granting full approval—adding complexity to trial design, ethics reviews, and recruitment. New focus on clinical outcomes & longer follow-up: Trials must now measure symptomatic COVID-19 as the primary […]

Less is More in Clinical Data: The Road to Simpler and Better Trials In an article for Applied Clinical Trials, Drew Garty, chief technology officer, Veeva, emphasizes that simplifying clinical trial data management through pragmatic strategies—like endpoint-driven design, risk-based approaches, and smart automation—can reduce waste, improve site and patient experiences, and lay the groundwork for […]

Image Credit: Adobe Stock Images/Weerasak.com The Low-Income Subsidy, or “Extra Help,” significantly reduces prescription drug costs for 14 million Medicare beneficiaries with limited income and resources. The Inflation Reduction Act eliminated the partial LIS program, making full benefits available to individuals with incomes up to 150% of the federal poverty level. A New England Journal […]

In a video interview with Pharma Commerce, Kevin Dondarski, Deloitte’s life sciences R&D strategy leader, describes how his company’s 15th annual Deloitte report on the return on investment (ROI) in pharmaceutical R&D reveals a continued upward trend, with a projected ROI of 5.9% for 2024. This marks a notable reversal from the consistent decline seen […]

Image Credit: Adobe Stock Images/GorodenKoff.com Invensify and GO2 Delivery’s partnership significantly reduces cold chain packaging costs—by up to 50%—while ensuring regulatory compliance for temperature-sensitive medications. The collaboration promotes sustainable healthcare logistics through real-time tracking and fully carbon-neutral same-day delivery operations. Invensify, a cold chain shipper for healthcare supply chains, is collaborating with GO2 Delivery, a 100% […]

Navigating the Payer-Health System Nexus: A Strategic Imperative for Biopharma Commercial Success Biopharma companies must adopt integrated strategies that engage both payers and health systems—each now powerful, parallel decision-makers—to overcome hidden barriers like “shadow formularies” and ensure successful therapeutic adoption in today’s vertically integrated healthcare landscape, according to a feature in Pharmaceutical Executive. Advocate for […]

White House Unveils Pharma Most-Favored-Nation Executive Order Pharmaceutical Executive reported that President Trump issued an executive order titled Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients, aiming to lower US drug prices by requiring pharmaceutical companies to match or beat prices offered in other developed countries, with potential penalties including tariffs and FDA action. FDA, […]

Image Credit: Adobe Stock Images/LucianoLuppa.com 1. Leadership shakeup amid crises: UnitedHealth Group CEO Andrew Witty has abruptly stepped down, citing personal reasons. His departure follows a year of major turmoil for the company, including a DOJ investigation, a massive cyberattack affecting 190 million people, and the murder of a senior executive. Former CEO and current […]

Image Credit: Adobe Stock Images/Suriyo.com 1. Five-step repurposing process: The study outlined a five-stage process: enabling, identifying, validating, testing, and implementing repurposed drugs. 2. RDNPs drive success: Nonprofit involvement, especially in patient recruitment, was linked to successful repurposing outcomes, including FDA approvals and off-label use. 3. New DDDR Framework: Researchers proposed a data-driven drug repurposing […]

A Closer Look at NIH Grant Terminations In an interview with Applied Clinical Trials, Harvard Medical School researcher Michael Liu discussed a recent study analyzing NIH grant terminations, revealing that 20% of the cuts affected early career training grants—critical to the biomedical research pipeline—and disproportionately impacted institutions and clinical trials serving marginalized populations. Simulated Pre-Launch […]

Pharmaceutical Commerce: What specific pricing practice by pharmacy benefit managers (PBMs) does the Protecting Pharmacies in Medicaid Act aim to address? Anne Cassity: The Protecting Pharmacies in Medicaid Act really aims at getting rid of spread pricing and the Medicaid managed care programs in every state in the country. Spread pricing is when pharmacy benefit […]

In a video interview with Pharma Commerce, Kevin Dondarski, Deloitte’s life sciences R&D strategy leader, describes how his company’s 15th annual Deloitte report on the return on investment (ROI) in pharmaceutical R&D reveals a continued upward trend, with a projected ROI of 5.9% for 2024. This marks a notable reversal from the consistent decline seen […]

PC: As the head of global supply chain, what does your day-to-day workflow typically consist of? Beadle: Our primary responsibility is getting products to patients—that’s at the heart of what we do. Every day, I focus on identifying potential challenges and working with my team to mitigate risks, ensuring patients receive the medications they need […]

Five questions on Trump’s plan to lower US drug prices President Trump’s new plan to lower US drug prices by tying them to the lowest prices paid in other countries aims to fulfill campaign promises and pressure the pharmaceutical industry, but faces significant legal, political, and economic hurdles, with uncertain impact on actual patient costs. […]