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Kala Shankle, JD, HDA’s vice president of regulatory affairs, shares that as DSCSA traceability requirements take full effect, distributors and trading partners are preparing for long-term gains in supply chain security, recall efficiency, and counterfeit prevention.

This episode of Pharma Pulse covers Amazon and WeightWatchers’ partnership to deliver FDA-approved weight-loss medications, Merck’s new biomanufacturing center of excellence in Virginia, and the FDA’s first-ever approval of a TSLP-targeting biologic, Tezspire, for chronic rhinosinusitis with nasal polyps.

The company’s new 400,000-square-foot facility in Elkton will boost small molecule manufacturing, create hundreds of jobs, and strengthen US innovation and supply chain resilience.

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.