Manufacturing & Packaging

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.

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.

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.

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.

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.

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.

The fallout is impacting partners Scholar Rock and Regeneron, both of whom have pending regulatory applications tied to the facility.

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.