Manufacturing & Packaging

The CDMO’s latest GMP-qualified line strengthens sterile manufacturing scalability.

The pharmaceutical giant’s new 700,000-square-foot hub aims to onshore production of key medicines and strengthen the US drug supply chain.

CoverMyMeds’ Megan Wetzel unpacks the forces behind rising specialty spend, the real impact of access barriers, and how field reimbursement teams help providers guide patients through today’s fragmented system.

AI-powered control towers and digital twins are emerging as essential tools to prevent costly supply chain failures and restore operational reliability.

The entrepreneur urges the Trump administration to eliminate costly FDA generic drug fees, part of a broader push to scale domestic production, address shortages, and challenge PBM-driven pricing models.

The agreement includes exemptions for UK-produced drugs and medical devices from Section 232 tariffs, but mandates a significant change to the UK's NICE value appraisal framework.

A new Pharma Pulse briefing unpacks declining RSV vaccine durability in older adults, AstraZeneca’s $2 billion expansion of its US biologics manufacturing footprint, and the stock-shaking Phase III struggle affecting Novo Nordisk’s Alzheimer’s ambitions.

The pharmaceutical giant will be nearly doubling biologics production in Frederick and build a new clinical supply facility in Gaithersburg, projects that will create thousands of jobs, enhance US supply chain resilience, and advance its growing rare disease portfolio.

In the first part of his Pharma Commerce video interview, Brad Stewart, BDO’s national life sciences co leader, explains why large-volume, high-need drugs—especially those heavily sourced overseas—may be the strongest candidates, and how the pandemic’s supply chain lessons are influencing the program’s future direction.

In the fourth part of her Pharma Commerce video interview, Christy Christian, senior industry principal with Kinaxis, shares how reducing inefficiencies cuts waste, preserves profitability, and ultimately lowers consumer prices while increasing production capacity to meet rising demand.

The pharma giant’s new 10,000-square-foot Carlsbad plant strengthens its US manufacturing network and supports its overarching $50 billion investment plan committed to operations.

In the first part of her Pharma Commerce video interview, Christy Christian, senior industry principal with Kinaxis, describes how manufacturers face mounting challenges managing long, complex supply chains, including limited inventory buffers, tight cash flow constraints, and constant policy changes.

The investment is aimed at boosting oral medicine manufacturing capacity.

The move adds new tension to US-Canada trade relations under the USMCA and raises questions about pending pharmaceutical import policies.

This episode of Pharma Pulse discusses new research linking cholesterol imbalance in obesity to higher depression risk, Eli Lilly’s acquisition of Aderum Biotechnologies to strengthen its neuroscience pipeline, and Cambrex’s $120 million investment to boost US. API manufacturing capacity.

The CDMO’s latest investment will boost capacity at its Charles City, IA facility by 40%, underscoring Cambrex’s focus on reshoring drug manufacturing, advancing peptide and small molecule production, and supporting the long-term stability of the US pharma supply chain.

This episode of Pharma Pulse covers Alkermes’ acquisition of Avadel Pharmaceuticals to expand its portfolio, BioNTech’s public exchange offer for CureVac to strengthen its mRNA pipeline, and a new report revealing how US medical device manufacturers are adopting digital-first models to boost compliance and patient engagement.

The acquisition brings together two leaders in mRNA innovation, strengthening BioNTech’s oncology strategy and expanding its R&D and commercialization capabilities.

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.

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.

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.