News

This episode of Pharma Pulse covers ACOG’s renewed support for COVID-19 vaccination during pregnancy, new real-world evidence confirming the safety of dapagliflozin and empagliflozin for type 2 diabetes, and a partnership between EVERSANA and Waltz Health to improve affordability and patient access.

FDA approves COVID-19 vaccines from Moderna, Pfizer-BioNTech, and Novavax targeting the LP.8.1 sublineage of SARS-CoV-2, with eligibility limited to adults aged 65 years and older and those with underlying medical conditions that place them with a high risk for severe disease.

In the fourth part of his Pharma Commerce video interview, Dave Malenfant, a healthcare supply chain expert, cautions that stockpiling to offset tariffs could backfire for pharma companies, leading to expired inventory, higher waste, and costly trade-offs, unless renegotiation strategies are pursued.

As of today, Aug. 27, wholesale distributors must fully comply with the Drug Supply Chain Security Act’s enhanced drug distribution requirements, closing the FDA’s exemption period and advancing efforts to strengthen patient safety and supply chain integrity.

The merger integrates EVERSANA’s commercialization services with Waltz Health’s AI-powered payer tools to address patient affordability, streamline drug access, and reduce costs for high-expense therapies such as GLP-1s.

This episode of Pharma Pulse covers the FDA’s new daily adverse event reporting initiative, the CDC’s appointment of an mRNA vaccine critic to lead its COVID-19 immunization workgroup, and Genentech’s $700 million investment in a North Carolina biologics facility.

In the final part of his Pharma Commerce video interview, Mark Lee, MarqVision’s founder and CEO, warns that pharmaceutical companies are facing an exponential rise in counterfeit threats as AI accelerates the creation of fake websites, social media profiles, and manipulated product catalogs, making urgent investment in protective technologies a critical priority.

The new 700,000-square-foot Holly Springs site—part of Roche’s $50 billion US investment plan—will focus on metabolic and obesity treatments, create 400 jobs, and strengthen domestic biopharma manufacturing amid shifting tariff and drug pricing policies.

An FDA Form 483 cited unaddressed contamination, pest infestations, and equipment failures at manufacturer’s Bloomington, IN facility, which was acquired in the Catalent buyout.

Addressing the most common concerns surrounding the legislation intended to establish interoperability within the pharma supply chain.

This episode of Pharma Pulse covers a $290 million False Claims Act ruling against CVS Caremark, a new report showing most small medical practices fall short on HIPAA compliance, and research revealing why pharmacists underreport adverse drug reactions.

In the ninth part of this roundtable discussion, industry experts discuss how the pharma supply chain is evolving into an integrated business planning function, highlighting the need for diverse skill sets, digital dexterity, and AI-enabled capabilities to prepare Gen Z and future leaders for patient-centric problem solving.

A federal judge tripled damages against the pharmacy benefits manager after finding it encouraged inflated Medicare drug claims and underpaid pharmacies.

Ron Lanton, partner, Lanton Law, explains that declining public trust and political support for vaccines could force pharmaceutical companies to rethink regulatory strategies and investment priorities in biologics and vaccine development.

This episode of Pharma Pulse covers the White House–EU agreement on pharmaceutical tariffs, Johnson & Johnson’s $2 billion expansion of its North Carolina manufacturing site, and a new federal rule requiring e-prescribing and prior authorization tools in certified EHR systems.

The new framework, set to take effect Sept. 1, limits tariffs on pharmaceutical imports to 15% but follows months of shifting proposals, including threats of tariffs as high as 250%.

In the fourth part of his Pharma Commerce video interview, Mark Lee, MarqVision’s founder and CEO, discusses how healthcare companies and regulators can strengthen defenses against counterfeit drugs by integrating AI with physical authentication methods and enabling secure, anonymized data sharing across the pharm sector.

The company will be heavily investing over the next decade to build a new biopharmaceutical facility in Holly Springs, NC, creating 120 jobs and reinforcing its $55 billion pledge to strengthen US manufacturing, R&D, and innovation.

Ron Lanton, Partner, Lanton Law, warns that shifting federal policies and ongoing lawsuits could create compliance challenges and operational risks that pharmaceutical supply chain leaders must closely monitor.

This episode of Pharma Pulse covers Catalent’s decision to cut 350 jobs at its Baltimore gene therapy site, new data showing rising adoption of digital tools for glycemic control in type 1 diabetes, and research linking severe childhood COVID-19 to heightened cardiovascular risk later in life.

In the third part of his Pharma Commerce video interview, Dave Malenfant, a healthcare supply chain expert, discusses how predictive analytics, AI, and automation are streamlining US pharmaceutical manufacturing—cutting overhead, boosting efficiency, and enhancing safety.

The CDMO will be cutting 350 jobs at its Baltimore gene therapy site after a major client’s demand shift, less than a year after Novo Holdings’ $16.5 billion acquisition.

This episode of Pharma Pulse explores a Battelle–Aprecia partnership with HHS and DARPA to accelerate on-demand drug manufacturing, a multi-billion-dollar Merck KGaA–Skyhawk collaboration to advance RNA therapies in neurology, and how pharmacist-led telehealth is improving diabetes care during emergencies.

In the third part of his Pharma Commerce video interview, Mark Lee, MarqVision’s founder and CEO, describes how AI-driven surveillance and image recognition vastly outpace traditional brand protection methods, enabling pharmaceutical companies to detect and remove millions of counterfeit listings across global online marketplaces and social media in real time.

The EQUIP-A-Pharma program will combine Battelle’s synthesis platform and Aprecia’s 3D printing technology to produce APIs and finished drugs at the same site, aiming to strengthen US pharma supply resilience and support essential medicines.

This episode of Pharma Pulse covers Novo Nordisk’s FDA win for Wegovy in MASH-related liver fibrosis, new research on a promising drug combination against resistant influenza strains, and how community pharmacies are strengthening healthcare access in underserved areas.

Payer-level reporting should do more than track performance—it must guide strategy, focus resources, and drive measurable brand impact.

This episode of Pharma Pulse covers a new collaboration to expand access to GLP-1 therapies via LillyDirect, Pfizer’s Phase III miss in sickle cell disease, and how patient portals are improving access to care while creating new workload challenges for providers.

In the eighth part of this roundtable discussion, supply chain experts emphasize that effective manufacturing strategies depend on product type, market location, and regulatory complexity, requiring a careful balance between outsourcing, internal production, regional distribution, and patient-centric priorities.

The integration aims to simplify access to Zepbound for eligible members while providing comprehensive, whole-person care to support safe use, adherence, and management of related chronic health needs.