A Deep Dive Into FDA’s Approval of First OTC Birth Control Pill

Image Credit: Adobe Stock Images/9DreamStudio.com In 2023, the FDA approved the first over-the-counter (OTC) birth control pill for use in the United States, with Opill becoming available for purchasing in stores and online in April 2024. Oral contraceptive pills (OCP)—those that are progestin-only and combined—are considered effective, and safe, along with simple to use.1 Having […]

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Communicating the Value of Approved Therapies

In a video interview with Pharma Commerce, Derrick Gastineau, head of marketing with Currax Pharmaceuticals, emphasizes the importance of pricing consistency in improving access, affordability, and long-term adherence to obesity treatments, particularly with FDA-approved oral weight loss drugs. He explained that one of the primary frustrations patients face is the unpredictability of out-of-pocket costs. This […]

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Oral Weight Loss Treatments Offer Patients and Clinicians New Options in Obesity Care

In a video interview with Pharma Commerce, Derrick Gastineau, head of marketing with Currax Pharmaceuticals, emphasizes the importance of pricing consistency in improving access, affordability, and long-term adherence to obesity treatments, particularly with FDA-approved oral weight loss drugs. He explained that one of the primary frustrations patients face is the unpredictability of out-of-pocket costs. This […]

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New Phononic–Peltier Partnership Targets Safer, Smarter Cold Chain for Medicines

Image Credit: Adobe Stock Images/DragoDesigner.com Phononic, a company that specializes cooling technology, including for the pharma sector, has reached a cold chain licensing agreement with Peltier Technology, Inc.1 The company’s branded Active Cooling Solutions (ACS) platform is utilized throughout the cold chain, including in fulfillment centers to last-mile delivery. It also features a combination of […]

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Ascensia to Transfer Eversense CGM Commercial Operations to Senseonics

Image Credit: Adobe Stock Images/Jordi.com Ascensia Diabetes Care—a part of PHC Group—has signed a memorandum of understanding (MOU) to transfer the commercial operations for its branded Eversense Continuous Glucose Monitoring (CGM) systems to Eversense designer Senseonics Holdings, Inc.1 Pending an official agreement, the parties are aiming to merge Eversense R&D, manufacturing, and commercial services with […]

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What the President’s Drug Pricing Push Means for Pharma, Payers, and Patients

Ned Milenkovich, PharmD, JD The Most Favored Nation Mandate: What the President’s Drug Pricing Push Means for Pharma, Payers, and Patients Register for the full webinar here! President Trump’s executive order pushing for most-favored-nation (MFN) pricing for pharmaceuticals sent shockwaves through the industry. While most people agree that healthcare and pharmaceuticals are often prohibitively expensive […]

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Samsung Biologics Secures $1.3B US Manufacturing Deal Amidst Tariff Uncertainty

Image Credit: Adobe Stock Images/Wichayada.com According to FirstWord Pharma, Samsung Biologics, a contract development and manufacturing organization (CDMO) based in South Korea, has inked a $1.3 billion production contract with a mega pharma partner in a deal that is expected to run until the end of 2029.1 A corporate filing noted that the company—who is […]

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Consistent Cash-Pay Options Could Transform Access to Obesity Medications

In a video interview with Pharma Commerce, Derrick Gastineau, Head of Marketing with Currax Pharmaceuticals, emphasizes the importance of pricing consistency in improving access, affordability, and long-term adherence to obesity treatments, particularly with FDA-approved oral weight loss drugs. He explained that one of the primary frustrations patients face is the unpredictability of out-of-pocket costs. This […]

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White House Eyes China Drug Restrictions, Pfizer-BioNTech Vaccine Data Strong, and Samsung Biologics Secures US Deal

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re looking at potential new trade restrictions on China-discovered treatments, fresh clinical data on Pfizer and BioNTech’s COVID-19 vaccine, and Samsung Biologics’ US expansion […]

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Harnessing Tech to Build Resilient Hospital Supply Chains

Drug shortages continue to create significant financial and operational strain on hospitals, impacting both patient care and workforce efficiency. In a video interview with Pharma Commerce, Boyede Sobitan, global healthcare strategy lead, and Annika Matas,senior director of product management and business operations, supplies and sensors—both with Zebra Technologies—they describe how hospitals are increasingly forced to adapt […]

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Measles Outbreak Spurs Vaccine Mandate Debate, Trump Eyes DTC Ad Restrictions, and ICER Reviews GLP-1 Costs

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering the latest measles outbreak in Florida, new scrutiny of pharma advertising, and a cost-effectiveness review of obesity treatments. Florida’s Surgeon General has […]

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ICER Releases Cost Analysis Report on Obesity Treatments Semaglutide, Tirzepatide

Image Credit: Adobe Stock Images/Enigma Topline Findings Significant Weight Loss Achieved: Zepbound delivers 17.8%–20.8% average weight loss, while injectable Wegovy achieves 14%–17%, and oral Wegovy 11.4%, highlighting effective obesity management options. Cost-Effectiveness Highlighted: All therapies are highly cost-effective at conventional thresholds, with QALY estimates of $53,400 for tirzepatide, $61,400 for injectable semaglutide, and $69,300 for […]

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Novartis Expands Cardiovascular Pipeline, Flu Severity Drivers Identified in Seniors, and Fixing Medication Nonadherence

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering a major cardiovascular acquisition by Novartis, new research into flu severity in older adults, and practical solutions for improving medication adherence. Novartis […]

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Hospitals Weigh ROI of RFID and RTLS for Smarter Medication Management

Drug shortages continue to create significant financial and operational strain on hospitals, impacting both patient care and workforce efficiency. In a video interview with Pharma Commerce, Boyede Sobitan, global healthcare strategy lead, and Annika Matas, senior director of product management and business operations, supplies and sensors—both with Zebra Technologies—they describe how hospitals are increasingly forced to […]

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How Model-Informed Tools Drive Cost, Speed and Access

Sharmeen Roy, PharmD, BCPS The pharmaceutical industry’s digital shift now influences not just R&D, but delivery, pricing, and utilization. Precision dosing, powered by model-informed tools such as Bayesian analytics and real-time pharmacokinetic modeling, is no longer a clinical “nice-to-have.” It’s a boardroom lever. While the clinical benefits of model-informed precision dosing (MIPD) have been increasingly […]

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Transforming Hospital Pharmacy Inventory Management

Drug shortages continue to create significant financial and operational strain on hospitals, impacting both patient care and workforce efficiency. In a video interview with Pharma Commerce, Boyede Sobitan, global healthcare strategy lead, and Annika Matas, senior director of product management and business operations, supplies and sensors—both with Zebra Technologies—they describe how hospitals are increasingly forced to […]

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Amgen to Invest $600M in New Science and Innovation Center at California HQ

Image Credit: Adobe Stock Images/MichaelVi.com Amgen will be financially committing upwards of $600 million into a new, state-of-the-art, science and innovation center at its global HQ in Thousand Oaks, CA.1 Construction is anticipated to begin Q3 2025. The facility is intended to unite various stakeholders—including engineers, scientists, and researchers—across multiple areas as a way to boost collaboration, while aiming […]

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Amgen Invests $600M in Innovation Hub, Novartis Collaborates With Argo, and Wegovy Tops Tirzepatide in Heart Outcomes

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering a major R&D investment from Amgen, a multi-billion-dollar acquisition by Novartis, and new head-to-head data on GLP-1 therapies for cardiovascular outcomes. Amgen […]

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Gilead Breaks Ground on Technical Development Hub to Drive US Biopharma Innovation

Image Credit: Adobe Stock Images/SundryPhotography.com Gilead Sciences has unveiled its new Pharmaceutical Development and Manufacturing (PDM) Technical Development Center (NTDC), nestled in the company’s Foster City, CA headquarters.1 The new 180,000 square-foot plant spans five stories, and represents another accomplished goal in Gilead’s multi-year plan to generate growth and scientific leadership across various sectors, including inflammation, […]

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How Drug Shortages Could Disrupt Hospital Operations and Strain Patient Care

Drug shortages continue to create significant financial and operational strain on hospitals, impacting both patient care and workforce efficiency. In a video interview with Pharma Commerce, Boyede Sobitan, global healthcare strategy lead, and Annika Matas, senior director of product management and business operations, supplies and sensors—both with Zebra Technologies—they describe how hospitals are increasingly forced to […]

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Trump Appeals Tariff Ruling, Sanofi Shares Slide on Trial Miss, and COVID-19 Alters Pneumococcal Mortality

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering the latest legal battle over pharmaceutical tariffs, Sanofi’s market setback following Phase III results, and new research on how the COVID-19 pandemic […]

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Overcoming Barriers to Full e-Prescribing Adoption

The Prescription Information Modernization Act of 2025 (PIMA) is being hailed as a significant development for the pharmaceutical industry because it represents rare bipartisan agreement on an issue that directly impacts both healthcare providers and patients. In a video interview with Pharma Commerce, Diogo Rau, executive vice president and chief information and digital officer for […]

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AI’s New Role in Pharma Strategy

Avinob Roy, Vice President & General Manager of Global Commercial Product Offerings at IQVIA, spoke with Pharmaceutical Commerce about how advancements in AI, particularly agentic AI, are reshaping the future of commercial operations in life sciences. From understanding disease landscapes and identifying patient populations to optimizing brand strategy and field engagement, Avinob outlines how AI […]

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Why Reducing Paper Inserts Is About Access as Much as Sustainability

The Prescription Information Modernization Act of 2025 (PIMA) is being hailed as a significant development for the pharmaceutical industry because it represents rare bipartisan agreement on an issue that directly impacts both healthcare providers and patients. In a video interview with Pharma Commerce, Diogo Rau, executive vice president and chief information and digital officer for […]

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FDA Approves Sanofi’s Wayrilz, OTC Triptans Show Public Health Gains, and Biosimilar Rules Streamlined

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re looking at a new FDA approval in rare disease, fresh evidence on the impact of Rx-to-OTC drug switches, and regulatory changes for biosimilars. […]

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Modernizing Prescription Information

The Prescription Information Modernization Act of 2025 (PIMA) is being hailed as a significant development for the pharmaceutical industry because it represents rare bipartisan agreement on an issue that directly impacts both healthcare providers and patients. In a video interview with Pharma Commerce, Diogo Rau, executive vice president and chief information and digital officer for […]

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Flu Vaccination Rates Improve, AI Powers RNA Therapeutics, and Statin Intolerance Spurs Self-Medication Risks

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re highlighting encouraging progress in flu vaccination rates, a new AI-driven partnership in RNA therapeutics, and concerns about how patients are managing statin intolerance. […]

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Child Vaccines Show Adult Protection, Lilly Pauses Mounjaro Shipments, and FDA Rejects Lytenava Resubmission

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering new research on vaccine protection, Eli Lilly’s pause in UK shipments of Mounjaro, and the FDA’s response to Outlook Therapeutics’ eye drug […]

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The Great Pharma Reshoring

This video was created based on various Pharma Commerce articles: AbbVie Invests $195 Million to Expand Stateside API Manufacturing AstraZeneca Commits $50 Billion to US Manufacturing and R&D Efforts by 2030 Battelle and Aprecia Partner With HHS and DARPA to Advance Agile Drug Manufacturing Genentech Breaks Ground on $700M North Carolina Manufacturing Facility Johnson & […]

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Cold Chain Technologies Expands APAC Presence With New Hubs, Distributors, and Manufacturing Investment

Image Credit: Cold Chain Technologies Cold Chain Technologies (CCT), is solidifying its commitment to growing its Asia-Pacific (APAC) presence by continuing to seek out new investment and partnership opportunities across the region.1 These new initiatives aim to combine CCT’s global expertise with its local resources in order to strengthen support for pharmaceutical, airline, and third-party […]

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CDC Director Pushback, Persistent Drug Shortages, and FDA Clears First Generic GLP-1 for Weight Loss

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering a high-profile leadership dispute at the CDC, the persistence of drug shortages, and the FDA’s approval of the first generic GLP-1 for […]

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Balancing Tariffs and Patient Access in Pharma Policy

In a video interview with Pharma Commerce, Dave Malenfant, a healthcare supply chain expert, discusses the potential impact of a proposed 250% tariff on pharmaceutical imports, emphasizing that the effect depends heavily on where in the supply chain the tariff is applied. If imposed on active pharmaceutical ingredients (APIs), the impact would be minimal, as […]

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ACOG Reaffirms COVID-19 Vaccine in Pregnancy, SGLT2 Real-World Safety Data, and EVERSANA–Waltz Tackle Drug Costs

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering updates in maternal health guidance, real-world diabetes data, and a new partnership aimed at lowering drug costs and improving access. The American College […]

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FDA Boosts Transparency, CDC Appoints mRNA Critic, and Genentech Invests $700M in US Manufacturing

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering new steps from the FDA to expand safety transparency, a controversial leadership appointment at the CDC, and Genentech’s latest manufacturing investment in […]

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AI Fuels Surge in Counterfeit Drug Websites

In a video interview with Pharma Commerce, Mark Lee, MarqVision’s founder and CEO, highlights the rapid growth and increasing sophistication of the counterfeit pharmaceutical market, driven in large part by bad actors leveraging artificial intelligence (AI). Counterfeiters are now using AI to replicate authentic pharmaceutical packaging with high accuracy, build convincing fake websites, and manipulate […]

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Novo Nordisk Plant Faces FDA Scrutiny, Off-Label GLP-1 Use Grows, and AbbVie Expands Psychiatry Pipeline

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering FDA safety concerns at a major Novo Nordisk facility, the growing trend of off-label GLP-1 prescribing, and AbbVie’s latest move to expand […]

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Top Questions Regarding the DSCSA

Image Credit: Adobe Stock Images/DreamerStudio.com DSCSA stands for the Drug Supply Chain Security Act, and is enforced by the FDA. It was originally signed into law aspart of the Drug Quality and Security Act (DQSA) in November of 2013 as a way to help bolster security and traceability of products passing through the pharma supply […]

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Johnson & Johnson Commits $2 Billion to North Carolina Manufacturing Expansion

Image Credit: Adobe Stock Images/MichaelVi.com Johnson & Johnson is all in on domestic manufacturing. The company announced plans to boost its North Carolina presence by constructing a 160,0000-plus-square-foot manufacturing facility at FUJIFILM’s new biopharmaceutical manufacturing site in Holly Springs, NC.1 The $2 billion investment in the contract development and manufacturing organization (CDMO) over the next decade […]

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Combating Counterfeit Medicines Requires AI Integration and Industry Collaboration

In a video interview with Pharma Commerce, Mark Lee, MarqVision’s founder and CEO, highlights the rapid growth and increasing sophistication of the counterfeit pharmaceutical market, driven in large part by bad actors leveraging artificial intelligence (AI). Counterfeiters are now using AI to replicate authentic pharmaceutical packaging with high accuracy, build convincing fake websites, and manipulate […]

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Pharma Tariffs Take Shape, J&J Invests $2 Billion in US Manufacturing, and New EHR Rule Targets Prior Authorization

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering updates on international trade, a US manufacturing investment, and new federal rules shaping electronic health records. The White House and European Union […]

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CVS Caremark Ordered to Pay $290 Million in False Claims Act Whistleblower Case

Image Credit: Adobe Stock Images/ImagingL.com Following an eight-day bench trial, a judge has issued a final judgement ruling that pharmacy benefits manager Caremark—a subsidiary of CVS Health—must pay $289.9 million in damages to Sarah Behnke, in a False Claims Act whistleblower case.1 Caremark plans to appeal the decision. In June, the court had originally ruled that […]

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Building the Next-Generation Supply Chain Talent Pipeline (Episode 9)

In this Pharmaceutical Commerce roundtable discussion, Nicholas Saraceno, editor of Pharmaceutical Commerce and the peer exchange’s moderator, introduced a discussion on the pharmaceutical supply chain, highlighting its complexity and importance in delivering medications safely and efficiently from manufacturers to patients. The conversation explored the roles of various stakeholders, the need for supply chain resilience and quality control, […]

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Pharma Regulatory Strategies Could Shift as Vaccine Support Declines

In a recent interview with Pharmaceutical Commerce, Ron Lanton, partner at Lanton Law, discussed the high-stakes implications of a new lawsuit filed by leading medical organizations to restore access to COVID-19 vaccines for children and pregnant people. Lanton explained how the case reflects deeper tensions between scientific standards, federal authority, and political influence, while also outlining […]

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Catalent Layoffs, Diabetes Tech Adoption, and Long-Term Heart Risks from Childhood COVID-19

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re looking at layoffs in gene therapy manufacturing, new technology trends in diabetes care, and research linking childhood COVID-19 to long-term cardiovascular risk. Catalent […]

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Agile Drug Manufacturing Advances, Merck–Skyhawk RNA Deal, and Telehealth Expands Pharmacists’ Role

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering advances in agile drug manufacturing, a multi-billion-dollar RNA therapy collaboration, and how pharmacists are using telehealth to improve diabetes care in emergencies. […]

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AI-Powered Tools Transform Fight Against Counterfeit Drugs

In a video interview with Pharma Commerce, Mark Lee, MarqVision’s founder and CEO, highlights the rapid growth and increasing sophistication of the counterfeit pharmaceutical market, driven in large part by bad actors leveraging artificial intelligence (AI). Counterfeiters are now using AI to replicate authentic pharmaceutical packaging with high accuracy, build convincing fake websites, and manipulate […]

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Wegovy Wins Accelerated Approval, New Flu Combo Emerges, and Community Pharmacies Expand Access

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re looking at a major regulatory milestone for Novo Nordisk, a promising new antiviral combination for influenza, and the growing role of community pharmacies […]

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Counterfeiters Target Fragmented Pharma Supply Chains Through Digital Marketplaces

In a video interview with Pharma Commerce, Mark Lee, MarqVision’s founder and CEO, highlights the rapid growth and increasing sophistication of the counterfeit pharmaceutical market, driven in large part by bad actors leveraging artificial intelligence (AI). Counterfeiters are now using AI to replicate authentic pharmaceutical packaging with high accuracy, build convincing fake websites, and manipulate […]

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The Tariff Saga Continues

It’s been about six months since the trade wars pitting the US vs. various global nations and regions have commenced, and in my unbiased opinion, Pharmaceutical Commerce has done as exceptional of a job as any news outlet in providing developments as they’ve ensued. As of press time—which was a few days before the long-anticipated […]

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A Pharma Wholesaler Scorecard

Mike Hennessy Jr, chairman and CEO, MJH Life Sciences Every stakeholder’s role in the pharmaceutical supply chain is just as important as the next, and that certainly holds true for that of the drug wholesaler. Essentially, these businesses serve as an intermediary between manufacturers and the downstream chain—after buying medications in bulk from manufacturers, they […]

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Gross-to-Net Bubble Reshapes Drug Pricing Strategy

This video was created based on Bill Roth’s “Popping the Gross-to-Net Bubble” article series. Welcome to the explainer. Today, we are talking about the wild and honestly, super complex world of drug pricing, and we’re going to tackle what some experts call the gross-to-net bubble. It’s a huge shift that’s happening right now, and you […]

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Goodpath Partners With GiftHealth to Expand Access to GLP-1 Therapies Through LillyDirect

Image Credit: Adobe Stock Images/Thanayut.com Goodpath, a virtual clinic for chronic health conditions, has reached a pharmacy integration deal with GiftHealth, Eli Lilly and Company’s LillyDirect pharmacy provider.1 LillyDirect is Lilly’s direct-to-consumer digital healthcare platform that was launched back in January 2024.2 It’s known for providing resources for disease management, featuring access to independent healthcare providers, support, and […]

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Pharma Leaders Stress Tailored, Balanced Approach to Long-Term Manufacturing Strategy (Episode 8)

In this Pharmaceutical Commerce roundtable discussion, Nicholas Saraceno, editor of Pharmaceutical Commerce and the peer exchange’s moderator, introduced a discussion on the pharmaceutical supply chain, highlighting its complexity and importance in delivering medications safely and efficiently from manufacturers to patients. The conversation explored the roles of various stakeholders, the need for supply chain resilience and quality control, […]

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US API Stockpile Plan, Mounjaro Price Hike in UK, and New Data on Vaccine Safety

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering three major developments—from new US policy on drug manufacturing to a high-profile pricing change for a leading obesity drug, and new research […]

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AbbVie Boosts Domestic API Manufacturing, Supermarkets Lead in Pharmacy Satisfaction, and GLP-1 Coverage Tightens

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation.I’m your host, and today we’re covering three key developments—from major manufacturing investments to a shake-up in pharmacy customer satisfaction rankings, and shifting insurance coverage for GLP-1 drugs. AbbVie has […]

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AI-Powered Counterfeit Drug Schemes Pose Growing Threat to Patient Safety

In a video interview with Pharma Commerce, Mark Lee, MarqVision’s founder and CEO, highlights the rapid growth and increasing sophistication of the counterfeit pharmaceutical market, driven in large part by bad actors leveraging artificial intelligence (AI). Counterfeiters are now using AI to replicate authentic pharmaceutical packaging with high accuracy, build convincing fake websites, and manipulate […]

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Cardinal Health Expands with Solaris Acquisition, Hospitals Centralize Pharmacy Hubs, and GLP-1 Safety Signals Emerge

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re looking at three stories shaping the intersection of pharmaceutical business, healthcare delivery, and patient safety. Cardinal Health has announced plans to acquire Solaris Health, […]

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Vinay Prasad Reinstated as FDA CBER Head, New COVID-19 Risk Data, and the Industry’s Response to Rising Costs

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering leadership changes at the FDA, new research on COVID-19 risks for childhood cancer survivors, and strategies pharma companies are using to stay […]

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Tariffs Could Potentially Hit 250%

Image Credit: Adobe Stock Images/DavideBonaldo.com Last week, President Trump issued letters to 17 of the largest pharmaceutical companies, expressing dire urgency for making changes along the drug pricing front.1 These letters date back to an executive order (EO) he enacted in May that essentially proclaimed that pharma companies need to treat the United States as a […]

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Balancing AI Ambition With Cost Pressures in Pharma

In a video interview with Pharma Commerce, Philip Sclafani, PwC’s pharmaceutical and life sciences lead, he describes how the One Big Beautiful Bill Act (OBBBA) is expected to significantly influence prescription drug spending by reshaping access and reimbursement within Medicaid, certain Medicare segments, and ACA exchange plans. The OBBBA introduces pressure on pharmaceutical revenues, particularly by […]

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Ways Pharma Supply Chains Can Cut Scope 3 Emissions Now

In a video interview with Pharma Commerce, Heather Zenk, Cencora’s president of US supply chain, describes how today’s distribution networks must seamlessly connect manufacturers to care sites that range from large academic centers to rural pharmacies and physician offices. This “last mile” delivery is essential because, as Zenk notes, “all healthcare is local.” Patients want […]

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Noom Debuts Microdose GLP-1 Program to Help Reduce Side Effects and Boost Affordability

Image Credit: Adobe Stock Images/Ishika.com Noom, an online weight loss company, is unveiling its Microdose GLP-1Rx Program, a service intended to limit side effects via personalized microdoses of GLP-1s, when clinically appropriate of course.1 The initial price of the program is $119 to start, and $199 per month for a maximum 0.6-milligram dose thereafter. The prices […]

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Lessons From Shortages and Global Disruptions

In a video interview with Pharma Commerce, Heather Zenk, Cencora’s president of US supply chain, describes how today’s distribution networks must seamlessly connect manufacturers to care sites that range from large academic centers to rural pharmacies and physician offices. This “last mile” delivery is essential because, as Zenk notes, “all healthcare is local.” Patients want […]

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Esteve Expands US Footprint With Acquisition of Regis Technologies, Boosts Rare Disease Portfolio

Image Credit: Adobe Stock Images/JozefMicic.com Esteve has purchased Regis Technologies, a Chicago-based contract development and manufacturing organization (CDMO), for an undisclosed amount.1 The deal provides Esteve CDMO—a Spain-based, third-party CDMO that operates under the Esteve Química brand—the opportunity to have a physical presence in the United States, a country where the company has been looking to […]

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Pharma Industry Shifts Toward Full Activation

In a video interview with Pharma Commerce, Heather Zenk, Cencora’s president of supply chain operations & distribution services, describes how today’s distribution networks must seamlessly connect manufacturers to care sites that range from large academic centers to rural pharmacies and physician offices. This “last mile” delivery is essential because, as Zenk notes, “all healthcare is […]

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What Clinical Ops Teams Must Know About Biomarkers in Trials; What is the Timeline for True AI Implementation for Digital Twins?

What Clinical Ops Teams Must Know About Biomarkers in Trials In an interview with Applied Clinical Trials, Michael Miller, COO of Quanterix, emphasized that clinical operations teams must carefully consider the purpose, technical requirements, and regulatory implications of biomarkers in trials—especially as their use expands in neurology, oncology, and platform studies driving accelerated drug approvals. […]

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Balancing Compliance and Supply Chain Continuity

In a video interview with Pharma Commerce, Heather Zenk, Cencora’s president of supply chain operations & distribution services, describes how today’s distribution networks must seamlessly connect manufacturers to care sites that range from large academic centers to rural pharmacies and physician offices. This “last mile” delivery is essential because, as Zenk notes, “all healthcare is […]

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How Grocery-Based Pharmacies are Evolving into Community Health Hubs

Image Credit: Adobe Stock Images/AMuhSakaria.com As large pharmacy retailers scale back operations, community pharmacies—particularly those embedded within grocery stores—are stepping into expanded roles as accessible healthcare touchpoints. This shift reflects a broader trend toward integrating healthcare services into everyday consumer environments, enhancing patient engagement and access to care. “Pharmacies today are more than just places […]

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FDA Delays Regeneron’s Odronextamab, Eylea HD Regulatory Decisions Over Catalent Site Issues

Credit: Ascannio | stock.adobe.com. The FDA has issued a second complete response letter (CRL) to Regeneron’s odronextamab based on issues with a third-party manufacturing site, Catalent Indiana LLC, the company announced in its Q2 earnings report.1 Regeneron’s Biologics License Application (BLA) is seeking the approval of odronextamab for the treatment of relapsed/refractory (R/R) follicular lymphoma […]

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Trump’s MFN Drug Pricing Push Targets 17 Big Pharma Companies, Spurs Global Industry Response

As reported by Pharma Commerce sister publication, Pharmaceutical Executive,1 President Trump recently issued letters to 17 of the largest pharmaceutical companies, expressing urgency for making changes along the drug pricing front. These letters stem from an executive order (EO) he enacted in May1 that essentially proclaimed that pharma companies need to treat the United States […]

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Leveraging Technology to Strengthen Pharma’s Fight Against Counterfeits (Episode 6)

In this Pharmaceutical Commerce roundtable discussion, Nicholas Saraceno, editor of Pharmaceutical Commerce and the peer exchange’s moderator, introduced a discussion on the pharmaceutical supply chain, highlighting its complexity and importance in delivering medications safely and efficiently from manufacturers to patients. The conversation explored the roles of various stakeholders, the need for supply chain resilience and quality control, […]

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Emission-Reduction Strategies That Save Money and Preserve Performance

In a video interview with Pharma Commerce, Nate Chenenko, principal with Ducker Carlisle, sheds light on the critical issue of Scope 3 emissions and their growing relevance in the pharmaceutical industry, particularly across warehousing, packaging, and outbound transportation. Chenenko defines Scope 3 emissions as all indirect emissions that occur after a pharmaceutical product is manufactured. […]

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High Out-of-Pocket Costs Burden Privately Insured Cancer Patients, Study Finds

With there being challenges in analyzing OOPCs that were related to certain cancer diagnoses in patients that privately insured, a retrospective cohort study published in JAMA Network Open sought toinvestigate this further. Image Credit: Adobe Stock Images/CDavids/peopleimages.com It is no secret that the out-of-pocket costs (OOPCs) associated with cancer care in the United States can […]

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Tackling ESG Data Gaps in Supplier and Third-Party Reporting

In a video interview with Pharma Commerce, Nate Chenenko, principal with Ducker Carlisle, sheds light on the critical issue of Scope 3 emissions and their growing relevance in the pharmaceutical industry, particularly across warehousing, packaging, and outbound transportation. Chenenko defines Scope 3 emissions as all indirect emissions that occur after a pharmaceutical product is manufactured. […]

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United States, European Union Reach Trade Pact

President Trump reached a formal trade agreement with the European Union in which a maximum 15% levy will be imposed on “most” EU exports, including autos and their parts; semiconductors; and pharmaceuticals. Image Credit: Adobe Stock Images/RealisticAIStudio.com Earlier this week, per CBS News, President Trump reached a formal trade agreement with the European Union in […]

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Weighing Cost Savings Against Safety and Regulatory Risks

In a video interview with Pharma Commerce, Hyung Heon Kim, CEO of MetaVia, describes how the current US payer ecosystem, including commercial insurers and Medicaid, exhibits a divided approach when it comes to supporting access to obesity medications. Coverage largely depends on whether obesity is accompanied by additional health complications. He explains that there are […]

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Unlocking Sustainability Across the Supply Chain

In a video interview with Pharma Commerce, Nate Chenenko, principal with Ducker Carlisle, sheds light on the critical issue of Scope 3 emissions and their growing relevance in the pharmaceutical industry, particularly across warehousing, packaging, and outbound transportation. Chenenko defines Scope 3 emissions as all indirect emissions that occur after a pharmaceutical product is manufactured. […]

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How CGT Developers Can Overcome Market Access, Regulatory, and Commercialization Hurdles

PC: As CGTs expand to serve broader patient populations, what strategies can developers use to overcome market access barriers such as payer skepticism and limited reimbursement pathways? Kevin Chinn: Central to overcoming the challenges is the need to increase payer awareness of the product’s clinical and economic value, including its safety, efficacy and durability. Conducting […]

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Recapping the Sarepta Saga—And Implications for Industry

The controversy surrounding embattled gene therapy company Sarepta Therapeutics, including its drug, Elevidys, for Duchenne muscular dystrophy, continues to captivate industry observers—with the latest twist being Sarepta’s decision late Monday to voluntarily pause Elevidys shipments in the US. Monday’s action marked an about-face by the company from just a few days earlier, when it rejected […]

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Leveraging Digital Twins and Analytics to Optimize Global Pharma Supply Chains

In a video interview with Pharma Commerce, Brad Stewart, BDO’s national life sciences co-leader, describes how a proposed 200% tariff on pharmaceutical imports could have significant short- and long-term impacts on US drug manufacturing and distribution, with immediate concerns focused on the stability of the generic drug market. According to Stewart, generic drugs make up […]

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How Pharma Executives Can Prepare for Tariff Uncertainty

In a video interview with Pharma Commerce, Brad Stewart, BDO’s national life sciences co-leader, describes how a proposed 200% tariff on pharmaceutical imports could have significant short- and long-term impacts on US drug manufacturing and distribution, with immediate concerns focused on the stability of the generic drug market. According to Stewart, generic drugs make up […]

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How Life Sciences Firms Are Evolving to Navigate Trade, Tariff, and Pricing Turbulence

Sixty percent of life sciences and healthcare leaders are anticipating that the current or forthcoming tariffs and pricing policies will have “some impact” on their businesses. Image Credit: Adobe Stock Images/Thanawat_Suesoypan.com According to the Deloitte Center for Health Solutions’ “2025 Tariffs, Pricing, and Taxes Survey,”1 60% of life sciences and healthcare leaders are anticipating that […]

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Cold Chain Technologies, E&I Cooperative Services Strike Deal to Provide Schools with Expedited Access to Cold Chain Solutions

Image Credit: Adobe Stock Images/Sardar Key Takeaways Expanded Educational Access: Cold Chain Technologies (CCT) partners with E&I Cooperative Services to provide over 6,000 educational institutions expedited access to advanced cold chain packaging solutions. Streamlined Procurement Process: The partnership enables members to bypass lengthy RFP procedures, accelerating acquisition of temperature-controlled packaging for medical, scientific, and health […]

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Supply Chain Blind Spots Threatening Pharma Integrity (Episode 5)

In this Pharmaceutical Commerce roundtable discussion, Nicholas Saraceno, editor of Pharmaceutical Commerce and the peer exchange’s moderator, introduced a discussion on the pharmaceutical supply chain, highlighting its complexity and importance in delivering medications safely and efficiently from manufacturers to patients. The conversation explored the roles of various stakeholders, the need for supply chain resilience and quality control, […]

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Driving Adherence and Safety Through Digital Innovation

Patient safety and medication adherence are some of the major concerns in the pharmaceutical industry. With an increase in medication errors, counterfeit medicines, and supply chain mismanagement, the industry has seen a rising demand for transparency, security, engagement, and digitization.1 Smart packaging has emerged as a key solution to address these problems by integrating digital […]

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Balancing DEI Reporting with Legal Risk; What the Emrelis Approval Means for Pharma and Biotech ADC Strategies

Balancing DEI Reporting with Legal Risk In an interview with Applied Clinical Trials, Kate Gallin Heffernan, a life sciences attorney at Epstein Becker Green, discussed how clinical research teams can balance accurate DEI-related reporting with minimizing legal risk, emphasizing the need for careful language and documentation to avoid potential False Claims Act exposure amid evolving […]

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Balancing Awareness and Assurance

In a video interview with Pharma Commerce, Sean O’Hearen, founder and principal consultant at 1st Line Partners, discusses the critical issue of substandard and falsified (SF) medicines and the lack of awareness among healthcare professionals (HCPs). Despite SF drugs posing a growing global health risk, only 2% of HCPs are trained to detect them, and […]

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Knipper Health Purchases eBlu Solutions to Accelerate Therapy Initiation

The combination of both parties’ offerings is a platform for managing the entire journey, from order to therapy initiation. Image Credit: Adobe Stock Images/NicoElNino.com Knipper Health has purchased eBlu Solutions, a provider-integrated tech platform.1 Via its services, specialty provider practices are reportedly able to automate over 80% of medical benefit investigations in under one minute, […]

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Inside the GLP-1 Strategy Driving Competitive Edge in Obesity Clinical Research; Eisai Highlights Long-Term Efficacy of Lenvima in Advanced HCC Treatment

Inside the GLP-1 Strategy Driving Competitive Edge in Obesity Clinical Research In an interview with Applied Clinical Trials, Shipra Patel, global therapeutic area section head for endocrinology and global head of pediatrics at Parexel, discussed how the company is using therapeutic expertise, real-world evidence, and a dedicated GLP-1 task force to navigate the competitive obesity […]

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Cracking Down on Illegal Online Pharmacies

In a video interview with Pharma Commerce, Sean O’Hearen, founder and principal consultant at 1st Line Partners, discusses the critical issue of substandard and falsified (SF) medicines and the lack of awareness among healthcare professionals (HCPs). Despite SF drugs posing a growing global health risk, only 2% of HCPs are trained to detect them, and […]

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How Parexel Supports Cross Functional Trials for Emerging GLP-1 Therapies; Eisai Explores Novel Dual Mechanism Therapy for Advanced Endometrial Carcinoma

How Parexel Supports Cross Functional Trials for Emerging GLP-1 Therapies In an interview with Applied Clinical Trials, Shipra Patel, global therapeutic area section head for endocrinology and global head of pediatrics at Parexel, explained how the company supports cross-functional GLP-1 trials by leveraging therapeutic alignment, real-world evidence, and collaborative infrastructure to address growing complexity and […]

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How DSCSA Is Transforming Supply Chain Data Exchange (Episode 4)

In this Pharmaceutical Commerce roundtable discussion, Nicholas Saraceno, editor of Pharmaceutical Commerce and the peer exchange’s moderator, introduced a discussion on the pharmaceutical supply chain, highlighting its complexity and importance in delivering medications safely and efficiently from manufacturers to patients. The conversation explored the roles of various stakeholders, the need for supply chain resilience and quality control, […]

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Racial, Social, and Economic Factors Drive Resilience During COVID-19 Pandemic, Study Finds

Resilience, which is the concept of defying adversity and recovering from hardship, is connected to one’s health and well-being. Image Credit: Adobe Stock Images/Jaman_Visual.com Resilience, which is the concept of defying adversity and recovering from hardship, is connected to one’s health and well-being.1 However, on the other hand, via behavioral, inflammatory, metabolic, and pathways, acute […]

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The Biosimilar Void

In a video interview with Pharma Commerce, Murray Aitken, executive director of the IQVIA Institute for Human Data Science, explains the extensive process behind developing the “Global Use of Medicines Outlook Through 2029” report. The creation of this comprehensive resource spans several months and integrates proprietary IQVIA datasets, including the MIDAS (Market Intelligence Data Analytics […]

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Thermo Fisher, Sanofi Expand Partnership to Boost Sterile Drug Production

Image Credit: Adobe Stock Images/ASDF Key Takeaways Strategic site acquisition: Thermo Fisher will acquire Sanofi’s sterile drug product manufacturing facility in Ridgefield, NJ, expanding its US-based fill-finish capabilities. Workforce integration: More than 200 Sanofi employees will transition to Thermo Fisher following the close of the transaction in the second half of 2025. Domestic manufacturing focus: […]

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New UK Consortium Obtains $1.34M Grant to Launch Automated Cell Therapy Manufacturing Platform

The consortium will be focused on deploying novel technologies to launch a fully automated, scalable, and hyper-efficient cell therapy manufacturing platform on a global scale. Image Credit: Cellular Origins Cellular Origins, a TTP company that prioritizes the scalable, robotic production of cell and gene therapies (CGTs), the Cell and Gene Therapy Catapult (CGT Catapult), a tech organization concentrating […]

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Why Medical Education Must Catch Up

In a video interview with Pharma Commerce, Sean O’Hearen, founder and principal consultant at 1st Line Partners, discusses the critical issue of substandard and falsified (SF) medicines and the lack of awareness among healthcare professionals (HCPs). Despite SF drugs posing a growing global health risk, only 2% of HCPs are trained to detect them, and […]

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Knipper Health Taps Willis Chandler as New President and CEO

Chandler’s pharmaceutical experience spans years in the pharma services space, powered by strategic leadership roles. Image Credit: Knipper Health Following Frazier Healthcare Partners’ investment in Knipper Health, Willis Chandler has officially been appointed as Knipper’s president and CEO.1 How exactly does Knipper aim to get patients started on treatment at a faster rate? The therapy […]

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LEO Pharma to Head Global Commercialization of Spevigo in $105M Deal with Boehringer Ingelheim

LEO Pharma will pay Boehringer Ingelheim $105.2 million (€90 million) upfront, with the opportunity for additional payment, if specific milestones are met. Image Credit: Adobe Stock Images/JHVEPhoto.com Boehringer Ingelheim and LEO Pharma have reached an exclusive global license and transfer agreement for the commercialization and further development of Spevigo, a proprietary form of spesolimab.1 The […]

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Reducing Healthcare Prices

In a video interview with Pharma Commerce, Marschall Runge, MD, PhD, dean of the University of Michigan Medical School and author of The Great Healthcare Disruption, addresses the potential impacts of a federal cap on Medicaid provider taxes and how such a policy could affect hospital systems. particularly in states like Michigan that have uniquely […]

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Removing Financial Barriers to Boost Trial Diversity; How Prescribing Power Has Shifted Beyond Physicians

Removing Financial Barriers to Boost Trial Diversity In an interview with Applied Clinical Trials, Heather Horville, solutions consultant, Greenphire, emphasized the importance of removing financial and logistical barriers—such as through reimbursements, stipends, and prepaid travel—to improve clinical trial diversity and retention, stressing the need for early planning, site-level coordination, and patient-centered support. How Prescribing Power […]

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How Pharma Can Detect Supply Chain Failures Before They Happen (Episode 3)

In this Pharmaceutical Commerce roundtable discussion, Nicholas Saraceno, editor of Pharmaceutical Commerce and the peer exchange’s moderator, introduced a discussion on the pharmaceutical supply chain, highlighting its complexity and importance in delivering medications safely and efficiently from manufacturers to patients. The conversation explored the roles of various stakeholders, the need for supply chain resilience and quality control, […]

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A Look Under the Hood of Medicaid Support

In a video interview with Pharma Commerce, Marschall Runge, MD, PhD, dean of the University of Michigan Medical School and author of The Great Healthcare Disruption, addresses the potential impacts of a federal cap on Medicaid provider taxes and how such a policy could affect hospital systems. particularly in states like Michigan that have uniquely […]

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Why Every Employee Needs to Be Part of the Journey

Few times in the evolution of a pharmaceutical company are as exciting as during the flurry of launch readiness activities focused on bringing a new drug to market. From the new drug application (NDA) submission to the Prescription Drug User Fee Act (PDUFA) date, the brand team is fully engaged—selecting a product name, developing marketing […]

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Navigating Market Entry Challenges for Orphan Drugs

July 9, 2025 Edward Ahn, CEO of MEDIPOST, Inc., reacts to the challenge of launching orphan drugs without complete evidence, particularly given their high cost and limited patient populations, and suggests strategies that can be used to address evidence gaps, enable market access, and support long-term patient benefit. Not every product has a perfect data […]

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What Payers Really Want from High Cost Therapies in Rare Diseases

PC: How might this change affect payer negotiations and reimbursement decisions, particularly for innovative or high-cost therapies? Leuchter: When it comes to rare diseases, patients often suffer from a wide range of symptoms—some of which receive more attention from drug developers than others. That’s often because targeting specific symptoms can be a higher-probability path to […]

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How Industry Stakeholders View Medicare Advantage Expansion for Patients with Kidney Disease

A qualitative study explored how representatives from MA plans, kidney care management companies, and dialysis organizations view the expansion and marketing of MA products for individuals with ESKD. Image Credit: Adobe Stock Images/CrystalLight.com By this year, enrollment in Medicare Advantage (MA) plans, which feature private managed care insurers to receive payments from the governments to […]

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Aligning Real-World Evidence with Payer Perspectives

The trust gap between real-world evidence (RWE)/data and randomized controlled trials is growing. This episode examines when each evidence type is appropriate, how to reduce perceived bias in RWE, and how payer context varies by geography and structure. Insights from academic and payer partnerships show how joint research can establish credibility and unlock market access. […]

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Building Patient Centricity into Clinical Trial Software from Day One; Industry Voices on Current Pricing and Reimbursement Models

2025 DIA Annual Meeting: Building Patient Centricity into Clinical Trial Software from Day One In an interview with Applied Clinical Trials, Brian Ongioni, chief product officer, uMotif, discussed how the company integrates patient and site feedback from the earliest stages of software development to create intuitive, regulatory-ready digital health tools that reduce burden and improve […]

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Patient Engagement Is Critical to Developing Breakthrough Treatments

PC: What risks do you foresee for companies developing first-in-class therapies if patient perspectives are no longer formally incorporated into regulatory discussions? Leuchter: Eliminating patient perspectives from regulatory discussions would remove a key source of value—especially in the context of rare or recently characterized diseases. In many of these cases, there are no formal natural […]

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Preparing for CGT Launches

In a video interview with Pharma Commerce, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, discusses the evolving state of global cell and gene therapy commercialization. Sawicki highlighted significant progress in key operational areas, noting that companies are now better prepared for commercial launches than in the past. Early challenges in manufacturing readiness have been […]

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Preparing for Federal Regulations; Funding Cuts Threaten Diversity in Clinical Research

Preparing for Federal Regulations: Q&A with John Stanford In an interview with Pharmaceutical Executive, John Stanford, executive director at Incubate, emphasized the importance of sustained investment in early-stage biotech to drive long-term innovation and ensure a robust drug development pipeline. Funding Cuts Threaten Diversity in Clinical Research In an interview with Applied Clinical Trials, Kyle […]

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Leading by Example

In the fourth part of his Pharma Commerce video interview, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, explains the lessons pharma leaders in traditional therapeutic areas can learn from CGT’s highly specialized operational strategies, particularly in terms of supply chain resilience and adaptability.

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Oncology Care Index Spurs J&J to Address Fragmentation in Cancer Treatment; How Funding Cuts Are Undermining Patient Recruitment in Clinical Trials

Oncology Care Index Spurs J&J to Address Fragmentation in Cancer Treatment In an interview with Pharmaceutical Executive, Biljana Naumovic, US President, oncology, solid tumor, Johnson & Johnson Innovative Medicine, shared how insights from the company’s Oncology Care Index are shaping efforts to reduce fragmentation in cancer care by expanding community-based clinical research, improving care continuity, […]

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The Impact of FDA’s Ban on Compounded GLP-1s; How Sites and Sponsors Are Adapting to Clinical Trial Budget Cuts

The Impact of FDA’s Ban on Compounded GLP-1s A Pharmaceutical Executive article explores how the FDA’s ban on compounded semaglutides—following stabilized supply from Novo Nordisk and Eli Lilly—has significantly disrupted access for patients who relied on these lower-cost alternatives, prompting Olympia Pharmaceuticals to shift its focus to legal and in-demand options like liraglutide. How Sites […]

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Hikma Commits $1 Billion to Boost US Drug Manufacturing and R&D Services by 2030

This investment exemplifies Hikma’s interest in raising the volume of meds it creates and produces across its various R&D and manufacturing sites in Columbus and Cleveland, OH and in Cherry Hill and Dayton, NJ. Image Credit: Adobe Stock Images/Deep.com Hikma Pharmaceuticals USA today will be financially committing $1 billion by the year 2030 to further grow its US manufacturing and R&D capabilities.1 With an investment of […]

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Multi-Indication Drug Branding in Today’s Pharmaceutical Industry

Historically, new drugs were approved for a single therapeutic use. However, industry trends have shifted, with pharmaceutical companies increasingly identifying and developing additional indications for existing medicines. This approach is supported by regulatory agencies such as the FDA and EMA, which recognize the value of leveraging established safety profiles for new uses. As a result, […]

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Medicaid’s Role in the CGT Sector

Medicaid is especially critical for children with rare diseases, due to their need for intensive specialty care and higher risk for financial distress. Image Credit: Adobe Stock Images/Ivlianna.com In the United States, Medicaid is considered the largest payer of healthcare, serving nearly a quarter of the total population; this includes nearly 40 million children. And […]

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Delivering Value Beyond the Trial with Real-World Evidence

Real-world evidence (RWE) is no longer optional—it’s expected. This episode dives into how payers assess RWE alongside clinical trial data, especially in competitive therapeutic areas. The panel stresses the importance of linking RWE to financial outcomes and making data relevant to specific patient populations. It’s not just about data quality; it’s about context and credibility. […]

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The Importance of Early Patient Feedback in Digital Endpoint Development; Developing FP&A Strategies in Today’s Environment

2025 DIA Annual Meeting: The Importance of Early Patient Feedback in Digital Endpoint Development In an interview with Applied Clinical Trials at the 2025 DIA Annual Meeting, Brian Ongioni, chief product officer, uMotif, emphasized the importance of incorporating early patient and site feedback into the digital health product lifecycle to ensure digital endpoints are accessible, […]

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Supply Chain Planning in the Current CGT Climate

In a video interview with Pharma Commerce, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, discusses the evolving state of global cell and gene therapy commercialization. Sawicki highlighted significant progress in key operational areas, noting that companies are now better prepared for commercial launches than in the past. Early challenges in manufacturing readiness have been […]

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How CRO Partnerships Are Evolving to Meet Changing Industry Demands; Don’t Fall for the Call of Placebo-Controlled Vaccine Trials

How CRO Partnerships Are Evolving to Meet Changing Industry Demands In an interview with Applied Clinical Trials, Judith Ng-Cashin, MD, chief medical officer, Novotech, emphasized the need for CRO partnerships to become more collaborative, cost-efficient, and insight-driven in response to evolving regulatory and funding challenges, highlighting Novotech’s award-winning collaboration with Tune Therapeutics as a model […]

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How AI and Machine Learning Can Improve Patient Reported Outcomes in Clinical Trials; The Role of Patient Advocacy in Shaping AbbVie’s Cancer Therapies

2025 DIA Annual Meeting: How AI and Machine Learning Can Improve Patient Reported Outcomes in Clinical Trials In an interview with Applied Clinical Trials, Brian Ongioni, chief product officer at uMotif, explained how the company integrates patient and site feedback early in the development process to improve the usability and regulatory strength of digital health […]

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Developing a Manufacturing Contingency Plan (Episode 2)

In this Pharmaceutical Commerce roundtable discussion, Nicholas Saraceno, editor of Pharmaceutical Commerce and the peer exchange’s moderator, introduced a discussion on the pharmaceutical supply chain, highlighting its complexity and importance in delivering medications safely and efficiently from manufacturers to patients. The conversation explored the roles of various stakeholders, the need for supply chain resilience and quality control, […]

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Discovering AI’s Role in Drug Safety Monitoring

Pharmaceutical Commerce: FDA staff cuts have created a critical gap in adverse drug event (ADE) monitoring. With ADEs being the third leading cause of death in the United States,1 what role do you see AI playing in preventing these events, especially when up to 56% are considered preventable through faster detection? Dipanwita Das: For decades, […]

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Utilizing AI in Today’s Current Landscape

In a video interview with Pharma Commerce, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, discusses the evolving state of global cell and gene therapy commercialization. Sawicki highlighted significant progress in key operational areas, noting that companies are now better prepared for commercial launches than in the past. Early challenges in manufacturing readiness have been […]

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Overcoming Regulatory Barriers to Market Access

As international price referencing tightens and payer expectations rise, companies face a shrinking margin for error. The panel explores how clinical trial design and early payer engagement are key to meeting both regulatory and reimbursement demands across global markets. With real-world evidence (RWE) from markets like Korea and Japan in hand, forward-thinking strategies can prove […]

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The Hidden Costs of Zero-Premium Plan Turnover

Image Credit: Adobe Stock Images/TadaImages.com As a result of the Patient Protection and Affordable Care Act (ACA), 24.2 million people enrolled in the health insurance marketplaces this year, a record number.1 However, sustaining that coverage can potentially be a major challenge, given the administrative obstacles that they can face. Why zero-dollar premium plans matter for […]

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Evaluate Issues Annual World Preview Report

Image Credit: Adobe Stock Images/StockMediaLabs.com Evaluate, who provides market insights for the pharma industry, has unveiled its “2025 World Preview Report,” which offers insights for the global pharmaceutical market through the year 2030.1,2 The breakdown is headlined by the prediction that worldwide prescription pharmaceutical sales will grow at a compound annual growth rate (CAGR) of […]

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The Art of Agility

Mike Hennessy Jr, chairman and CEO, MJH Life Sciences A common thread across our content offerings in the June issue of Pharma Commerce is the need for life sciences companies—and their supply chain partners—to be perhaps more agile than ever in the face of today’s host of industry challenges and disruption. Take, for example, our […]

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TekniPlex Healthcare Unveils New Barrier Protection Systems Plant

TekniPlex Healthcare, a supplier of barrier films, unit-dose containers, and more, has opened its new 200,000-square-foot facility in Madison, WI, which was made official with a ribbon-cutting ceremony last week. The new site—representing its second Madison plant—acts as the flagship location for the company’s barrier protection systems business, and will strive to further grow its protective […]

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Strategic Planning in the Rebate Economy; The Truth About AI Adoption Speed in Clinical Research

Strategic Planning in the Rebate Economy: What Pharma Must Do Now A recent Pharmaceutical Executive article outlines how, despite decades of evolving policy from OBRA ’90 to the Inflation Reduction Act, the US pharmaceutical system remains deeply reliant on manufacturer rebates—prompting drugmakers to shift from workaround tactics to strategic execution in order to thrive in […]

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Building Strong CRO-Sponsor Partnerships to Improve Clinical Trial Success; Innovation Requires Investment—and Sustained Investment Requires Sufficient Returns

Building Strong CRO-Sponsor Partnerships to Improve Clinical Trial Success In an interview with Applied Clinical Trials, Judith Ng-Cashin, MD, chief medical officer at Novotech, emphasized the value of trust-based CRO-sponsor relationships and celebrated the company’s Citeline CRO Partnership of the Year Award for its collaboration with Tune Therapeutics as a model of strategic, patient-centered clinical […]

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Antares Vision Group Debuts AI-Powered Visual Inspection Platform

AI-GO blister inspection. Image Credit: Antares Vision Group Antares Vision Group, a provider of track-and-trace systems for several fields including the life sciences, and Oròbix, an artificial intelligence (AI) service company that’s part of Antares, have launched AI-GO, an AI-powered visual inspection platform that is expected to boost standards that span multiple key performance indicators.1 […]

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Understanding the Pharma Supply Chain (Episode 1)

In this Pharmaceutical Commerce roundtable discussion, Nicholas Saraceno, editor of Pharmaceutical Commerce and the peer exchange’s moderator, introduced a discussion on the pharmaceutical supply chain, highlighting its complexity and importance in delivering medications safely and efficiently from manufacturers to patients. The conversation explored the roles of various stakeholders, the need for supply chain resilience and quality control, […]

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How Medicare Eligibility Affects Healthcare Use in Adults with Psychological Distress

Image Credit: Adobe Stock Images/DigitalMagicVisions.com One of several public health issues of utmost importance are mental health disorders, which are quite commonplace. In the United States, millions of adults suffer from psychological distress, which can significantly impair their ability to carry out major life activities.1 Given its impact, patients, clinicians, and policymakers alike have all […]

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Establishing Additional Transparency

In a video interview with Pharma Commerce, LeAnn Boyd, PharmD, Liviniti’s founder and CEO, discusses the deeper, systemic issues behind rising healthcare and drug costs that are not fully addressed by the MFN (Most-Favored Nation) executive order. She acknowledges that the healthcare landscape has seen incredible advancements in therapies that significantly improve patient outcomes and […]

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The Impact of Initial Coverage Choice

Image Credit: Adobe Stock Images/Rawpixel.com Data show that nearly two-thirds of Medicare beneficiaries feel that their coverage completely meets their expectations. Despite this, a recent survey also showed that 15% of Medicare beneficiaries changed their coverage in the past two years, while another 6% had the intention of doing so, but had not yet changed […]

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June 2025 Interactive Digital Edition

Pharmaceutical Commerce: June 2025 Interactive Digital Edition DSCSA Compliance: The Time is Now Conference Connect: Determining the Future of Specialty Pharmacy Bolstering Health Technology Assessment With the Help of AI Building Intelligent Pharma Supply Chain Management with Real-World Data Policy Whiplash? 24 Hours in the Hub Still Matters More Financial Assistance: Matching Awareness With Action […]

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Bolstering Health Technology Assessment With the Help of AI

Key Takeaways AI enhances traditional HTA by improving accuracy and efficiency. Artificial intelligence addresses key limitations of traditional health technology assessments—such as data gaps and time-intensive processes—through automation, real-time data integration, and advanced predictive modeling, leading to faster and more informed decisions. AI supports personalized medicine and real-world evidence integration. By analyzing large datasets from […]

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Building Intelligent Pharma Supply Chain Management with Real-World Data

Key Takeaways Real-world data enhances medication safety and supply chain efficiency. By collecting and applying data from manufacturing through administration, stakeholders can optimize inventory, track usage trends, and improve predictive analytics to ensure medication availability and safety. Advanced tracking technologies like RFID improve visibility and reduce risks. Continuous, real-time monitoring enables more accurate inventory management, […]

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Policy Whiplash? 24 Hours in the Hub Still Matters More

Key Takeaways Speed is Critical. The first 24 hours after a prescription are crucial—nearly half of patients are lost immediately without efficient onboarding. Rapid, streamlined hub services are essential to keep patients engaged and on therapy. Digital and Multichannel Enrollment Is Key. Combining traditional methods (fax, phone) with digital tools (EHR integration, portals, NCP channels) […]

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UCB to Invest $5 Billion into US Production Plant

Image Credit: Adobe Stock Images/JHVEPhoto.com Key Takeaways UCB is investing $5 billion in a new US biologics manufacturing facility, aiming to boost its production capabilities, create 800 jobs, and strengthen its global supply chain. The company’s US expansion reflects a broader industry trend, with major biopharma firms like Regeneron, Roche, Merck, and Thermo Fisher also […]

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What Is Smart Pharma Packaging?

In a video interview with Pharma Commerce, Kirsten Newquist, Identiv’s CEO, defines “smart pharma packaging” as the integration of technology into pharmaceutical packaging to enhance product identification, tracking, and patient engagement. She explains that packaging primarily involves embedding technologies such as RFID radio-frequency identification (RFID) or Bluetooth low energy (BLE) into pharmaceutical containers. These technologies […]

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Navigating the Intersection of Accessibility and Measurement Integrity in eCOA; Do We Really Pay More for Prescription Drugs in the United States?

Navigating the Intersection of Accessibility and Measurement Integrity in eCOA An article in Applied Clinical Trials explores how clinical research’s shift toward patient-centered outcomes is prompting the eCOA field to reconcile long-standing tensions between accessibility and measurement integrity, calling for the integration of modern accessibility standards to ensure digital tools used in trials are inclusive […]

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Embedded Product Intelligence’s Role in Maintaining Cold Chain Integrity

In a video interview with Pharma Commerce, Kirsten Newquist, Identiv’s CEO, defines “smart pharma packaging” as the integration of technology into pharmaceutical packaging to enhance product identification, tracking, and patient engagement. She explains that packaging primarily involves embedding technologies such as RFID radio-frequency identification (RFID) or Bluetooth low energy (BLE) into pharmaceutical containers. These technologies […]

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Extreme Examples of Who Grew the Bubble

Key Takeaways Price hikes, not launch prices, drove the GTN bubble. The real driver of the gross-to-net (GTN) bubble was the pharmaceutical industry’s ability to raise drug prices year after year—enabled by loopholes in PBM contracts—rather than high launch prices alone. PBMs enabled the bubble through rebate structures. PBMs often profited from list price increases […]

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Addressing the Threat of Prescription Abandonment

Sticker shock at the pharmacy counter has become an all-too-familiar experience for both patients and providers. The rising cost of prescription medications in the United States creates a growing obstacle for millions of people. In 2022, more than 4,200 drug products experienced price increases (many of which were higher than the rate of inflation), compared […]

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Reviewing the Most-Favored Nation Model

Key Takeaways Reintroduction of the MFN model. The Trump Administration has revived the most-favored nation (MFN) drug pricing model as a seven-year test, which would tie US drug prices to the lowest prices paid by certain OECD countries—an approach previously blocked by courts. Concerns over price controls. Critics argue that the MFN model imports restrictive […]

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DHL Officially Obtains CRYOPDP

Image Credit: Adobe Stock Images/Tippapatt.com Key Takeaways DHL has acquired Cryoport’s specialty courier business, CRYOPDP, for approximately $200 million, strengthening its position in temperature-controlled logistics for the life sciences sector. A strategic partnership between DHL and Cryoport has been formed to enhance global supply chain capabilities, particularly in the APAC and EMEA regions. DHL is […]

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Using Data to Influence Drug Pricing Policy

In a video interview with Pharma Commerce, Maggie McCullough, PolicyMap’s CEO, highlights how geospatial mapping can play a critical role in identifying and addressing pharmacy deserts—areas where access to pharmacies is limited or nonexistent. With an estimated 17.7% of the US population affected, the issue is increasingly urgent, particularly as major chains like Rite Aid […]

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The Connection Between Virtual Care and Language Barriers

Image Credit: Adobe Stock Images/Nattakorn.com Key Takeaways Language barriers reduce access to video-based virtual care: Adult patients facing language barriers are significantly less likely to use video visits compared to telephone visits, especially in specialist care settings. Overall virtual care use isn’t drastically different: There is no significant difference in the overall use of virtual […]

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Bridging Access Gaps

In a video interview with Pharma Commerce, Maggie McCullough, PolicyMap’s CEO, highlights how geospatial mapping can play a critical role in identifying and addressing pharmacy deserts—areas where access to pharmacies is limited or nonexistent. With an estimated 17.7% of the US population affected, the issue is increasingly urgent, particularly as major chains like Rite Aid […]

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How MFN Executive Order Could Affect International Drug Costs

PC: Although ways to decrease healthcare costs are certainly encouraged by pharma supply chain stakeholders, what potential long-term repercussions (if any) could President Trump’s MFN executive order have on the industry? Lanton: The executive order mandates that pharmaceutical companies match or beat the lowest price paid by certain countries—such as Canada, Germany, or France—or face […]

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Preparing for the Pharma C-Suite; America’s Vanishing Scientific Research Workforce is a Threat to Public Health

Preparing for the Pharma C-Suite In a Pharmaceutical Executive feature, Aileen Fernandes, Chief Business Officer at Arcellx, reflects on how her early roles at Morgan Stanley and Deloitte Consulting, combined with strategic career decisions and authentic leadership development, prepared her for biotechnology C-suite success and offers MBA students key advice on culture fit, building healthcare […]

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Five Critical Challenges in Investigator Site Selection and How Clinical Data Science Can Solve Them; Wegovy Use Up 50% Among US Teens

Five Critical Challenges in Investigator Site Selection and How Clinical Data Science Can Solve Them In a Pharmaceutical Executive feature, Gen Li, founder, CEO, Phesi, outlines five key challenges hindering investigator site selection in clinical trials—including unreliable performance predictions and lack of real-world data—and explains how clinical data science and AI-driven tools can optimize site […]

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Forging a Brighter Future for Rare Disease Outcomes with Specialty Pharmacy Utilization; Rethinking Clinical Trial Efficiency Amidst Cost Pressures on Pharma

Forging a Brighter Future for Rare Disease Outcomes with Specialty Pharmacy Utilization A Pharmaceutical Executive article explores how specialty pharmacy programs can significantly improve outcomes for patients with rare diseases—like cystic fibrosis—by providing faster access to treatment, better medication adherence, and personalized support that addresses the complex challenges of managing lifelong conditions. Rethinking Clinical Trial […]

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GLP-1 Drugs May be Linked to Elevated Risk of Serious Eye Disease; Incyte’s Zynyz Wins FDA Approval as Single and Combo Therapy for Anal Cancer

GLP-1 Drugs may be Linked to Elevated Risk of Serious Eye Disease, Study Finds A new observational study finds that people with diabetes taking GLP-1 drugs have a low but doubled risk of developing neovascular age-related macular degeneration, an eye disease that can cause blindness, highlighting the need for increased awareness and monitoring of eye […]

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The Variation in Dual-Eligible Beneficiary Characteristics across Medicare Advantage Plan Types

Image Credit: Adobe Stock Images/Wladimir1804.com Key Takeaways MA enrollment among full-benefit dual-eligible beneficiaries is rising, reaching nearly 50% by 2022. FIDE-SNP enrollees have greater health and support needs than those in other MA plan types. FIDE-SNP enrollees are more likely to live in less disadvantaged areas, pointing to access disparities. Enrollment in Medicare Advantage (MA) […]

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Mapping the Hidden Costs

In a video interview with Pharma Commerce, Maggie McCullough, PolicyMap’s CEO, highlights how geospatial mapping can play a critical role in identifying and addressing pharmacy deserts—areas where access to pharmacies is limited or nonexistent. With an estimated 17.7% of the US population affected, the issue is increasingly urgent, particularly as major chains like Rite Aid […]

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BioNTech, BMS to Co-Design and Co-Commercialize New Antibody Candidate for Various Types of Tumors

Image Credit: Adobe Stock Images/Hugnaka.com Key Takeaways BioNTech and Bristol Myers Squibb have entered a major global collaboration to co-develop and co-commercialize BNT327, a bispecific antibody for solid tumors, with $1.5B upfront, $2 billion total in non-contingent anniversary payments through 2028, and up to $7.6B in milestone payments. BNT327 is already in global Phase III […]

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Driving Supply Chain Resilience

In a video interview with Pharma Commerce, Scott Tillman, Logility’s senior vice president of innovation, addresses the gap between high interest in generative AI (GenAI) and its relatively low adoption in supply chain-specific applications, as highlighted in Logility’s Supply Chain Horizons 2025 Market Report. He identified several key reasons for this disconnect. First, many companies […]

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