Month: May 2025

Bridging Innovation and Trust with Artificial Intelligence In a recent interview with Applied Clinical Trials, Michel van Harten, MD, CEO of myTomorrows, discussed how AI is transforming clinical trials by reducing costs, accelerating timelines, and enhancing patient inclusion—while emphasizing the need for data quality, transparency, and trust to ensure responsible implementation. AZ partners with Aptar […]

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 […]

PC: How would you define successful E2E, and what specific processes are necessary in order to achieve this? Beadle: The first thing I’d highlight—and I mentioned this in the keynote—is that we are a company of scale and history. It’s hard to visualize that scale without digitization. We’ve moved away from Excel and connected our […]

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 […]

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/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 […]

PC: You recently delivered a keynote presentation surrounding “How to Integrate E2E and Deliver ‘Miracles of Science’ to your Patients.” Could you provide a brief synopsis of what your session entailed? Beadle: Sanofi is undergoing a major transformation with the ambition to become the first biopharma company powered by AI at scale. To achieve that, […]

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% […]

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, […]

Bluebird bio warns of potential bankruptcy as buyout faces another delay Bluebird bio has warned of possible bankruptcy after buyers Carlyle and SK Capital extended their acquisition deadline yet again due to insufficient shareholder participation, as only about 26% of shares have been tendered—far below the required threshold to complete the deal. Pharmacists stockpile most […]

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. […]

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 […]

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 […]

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 […]