Nicholas Saraceno is Editor of Pharmaceutical Commerce. He can be reached at [email protected].
Kala Shankle, JD, HDA’s vice president of regulatory affairs, describes how FDA officials are signaling a balanced enforcement approach when it comes to DSCSA enforcement, expecting compliance efforts and documentation, but also recognizing that perfection will take time.
This episode of Pharma Pulse discusses new research linking severe COVID-19 to increased stroke risk among asthma patients, a KFF poll showing divided parental support for vaccine-related agendas, and US News & World Report’s 2026 list of top Medicare Advantage and Part D plan providers.
Aetna, Devoted Health, and UnitedHealth headline the list best Medicare Advantage insurers for next year, while Centene and Humana lead the pack in Part D prescription drug coverage.
Kala Shankle, JD, HDA’s vice president of regulatory affairs, details that after a year of steady progress, manufacturers and distributors report over 97% data accuracy under DSCSA traceability requirements, marking a major milestone in supply chain interoperability and signaling confidence ahead of the November compliance deadline.
The collaboration demonstrates that ocean freight can safely transport temperature-sensitive medicines, offering the pharma industry a cost-effective, sustainable alternative to air cargo.
This episode of Pharma Pulse discusses new research revealing persistent disparities in women’s cancer outcomes, record-high physician pay amid steady productivity, and AstraZeneca’s major Texas expansion to double production of its hyperkalemia treatment, Lokelma.
The $445 million expansion of AstraZeneca’s Coppelsite will boost global production capacity for Lokelma, enhance local job growth, and strengthen the company’s US manufacturing footprint amid industry-wide onshoring trends.
Kala Shankle, JD, HDA’s vice president of regulatory affairs, describes how at this year’s seminar, attendees emphasized pragmatic approaches to achieving full compliance while anticipating upcoming FDA rules that could reshape wholesale and 3PL licensure standards across the pharma supply chain.
This episode of Pharma Pulse covers the FDA’s approval of a rapid one-minute HIV self-test, the US government’s decision to delay tariffs on pharmaceutical exports from Singapore, and CVS Pharmacy’s acquisition of more than 600 Rite Aid stores across three states to expand its community health footprint.
A planned 100% tariff on branded and patented drugs from Singapore is being postponed as US and Singapore officials explore potential exemptions.
In the third part of her Pharma Commerce video interview, Linda Malek, JD, partner at Crowell & Moring, explains how healthcare organizations can harmonize both approaches by prioritizing fairness, transparency, and adaptable systems.
This episode of Pharma Pulse covers the nationwide Kaiser Permanente strike involving more than 40,000 healthcare workers, Takeda’s new AI-driven antibody discovery partnership with Nabla Bio, and the FDA’s OAI designation for Novo Nordisk’s Bloomington manufacturing facility.
In the second part of her Pharma Commerce video interview, Linda Malek, JD, partner at Crowell & Moring, notes that by bringing regulators and innovators together, regulatory sandboxes could help US healthcare organizations test and refine AI tools responsibly, which allows oversight agencies to keep pace with rapid technological change.
In a video interview with Pharma Commerce, Mark Lee, Marqvision’s founder and CEO, and Sean O’Hearen, founder and principal consultant at 1st Line Partners, warn that counterfeiters are rapidly leveraging AI to create fake websites, social profiles, and manipulated product content—outpacing traditional protections and highlighting widespread underreporting of falsified medicines.
The fallout is impacting partners Scholar Rock and Regeneron, both of whom have pending regulatory applications tied to the facility.
Krenar Komoni, founder and CEO of Tive, predicts that AI-driven automation and its accelerating impact on pharmaceutical supply chains will remain a headline topic at LogiPharma USA, as the industry faces growing pressure to innovate while balancing strict regulatory requirements.
This episode of Pharma Pulse covers how recent CDC layoffs are fueling concerns about disease surveillance, Ypsomed’s new autoinjector manufacturing site in North Carolina, and Lupin’s $250 million investment to build a respiratory and specialty drug facility in Florida.
The global generics maker’s new Florida site will produce more than 25 critical respiratory medicines, create over 200 jobs, and reinforce domestic manufacturing and drug security.
Krenar Komoni, founder and CEO of Tive, highlights the transition in pharma from passive to real-time temperature control, noting delays in technology adoption but emphasizing how AI and automation will soon drive cost savings, improved quality, and stronger customer experience.
This episode of Pharma Pulse covers how Mark Cuban’s direct-to-consumer pharmacy is challenging traditional drug pricing models, AstraZeneca’s $4.5 billion investment to expand its Virginia manufacturing site, and Bristol Myers Squibb’s $1.5 billion acquisition of Orbital Therapeutics to advance RNA-based medicines.
In the final part of his Pharma Commerce video interview, Shawn Opatka, VP and GM, Honeywell Life Sciences, explains that as pharma quality systems evolve, AI is shifting from reactive problem-solving to proactive, closed-loop risk prevention, enhancing operator insight, decision-making, and continuous process improvement.
Ammie McAsey, SVP of Supply Chain Operations, McKesson, explains the critical role of real-time visibility, digital tools, and cold chain innovation in ensuring product quality, reducing disruptions, and strengthening patient care.
The new Albemarle County site—reportedly the largest investment in AstraZeneca’s history—will focus on API and ADC production, create 3,600 jobs, while strengthening US pharma supply chain resilience.
Set to debut in California this December, Amazon’s new pharmacy kiosks aim to streamline care by letting One Medical patients pick up prescriptions right after appointments, eliminating the need for a separate pharmacy visit.
This episode of Pharma Pulse covers the CDC’s new individualized approach to COVID-19 vaccination and changes to chickenpox guidance for toddlers, new research showing how GLP-1 therapies can interfere with PET-CT imaging results, and the Third Circuit Court’s rejection of Novo Nordisk’s IRA challenge.
In the second part of his Pharma Commerce video interview, Shawn Opatka, VP and GM, Honeywell Life Sciences, notes that nearly all pharma organizations are experimenting with AI to address labor shortages, data challenges, and regulatory demands, but full-scale adoption remains on the horizon as companies balance innovation with compliance.
The appellate court upheld Medicare’s authority to negotiate lower drug prices under the Inflation Reduction Act, following similar rulings against AstraZeneca, Bristol Myers Squibb, and Novartis.
Krenar Komoni, founder and CEO of Tive, explains how the pharmaceutical industry’s transition from passive to real-time temperature control creates short-term challenges but will ultimately enable AI-driven automation, lower costs, higher quality, and better customer experiences.
This episode of Pharma Pulse covers the FDA’s approval of golimumab for pediatric ulcerative colitis, AstraZeneca’s new multi-target neuroscience partnership with Algen, and Peli BioThermal’s acquisition of Evo to strengthen its global cold chain portfolio.
As precision medicine reshapes drug distribution, Ammie McAsey, SVP of Supply Chain Operations, McKesson, highlights the need for deeper investments in technology, temperature control, and end-to-end visibility to ensure quality and patient safety in advanced therapy supply chains.
