The company reported strong demand for bioconjugates, mammalian, and small molecules, with no material financial impact expected from current U.S. trade policies.
Marc Casper contends Thermo Fisher’s pharma and biotech customers will be able to navigate the Trump administration’s MFN drug pricing framework and tariffs.
The CDMO has expanded production at its Bioconjugation Center of Excellence in St. Louis and partnered with Simtra to better serve the growing antibody-drug conjugate market.
While the plant was recently hit with the FDA’s most severe post-inspection classification, it is a facility that has been plagued with problems for several years.
An AI-powered platform creates a digital replica of manufacturing sites, helping companies improve efficiency, reduce downtime, and prepare for supply chain disruptions.
The drugmaker said it is in active dialogue with the regulator and its contract development and manufacturing organization (CDMO) customers about the matter.
Glenn Youngkin, Governor of the Commonwealth of Virginia, has called out North Carolina’s status as a top U.S. biomanufacturing hub — a competition he intends to win.
CEO Pascal Soriot announced the deal with President Trump on Friday, noting that it includes a three-year exemption from U.S. tariffs for AstraZeneca’s products.
Industry stakeholders who attended the annual Cell & Gene Meeting on the Mesa this week in Phoenix emphasized the positive, despite formidable challenges.
The company said the additional $500 million investment will support an enhanced production capability for a broader range of medicines, including cancer treatments.
The Garden State had the largest concentration of biomanufacturing professionals and a high concentration of CDMO facilities, according to JLL’s analysis.
The industry’s inability to make products efficiently and at scale is due to the complexity of the supply chain, panelists said at the Cell & Gene Meeting on the Mesa.
Panelists at the 2025 Cell & Gene Meeting on the Mesa laid out the challenges and opportunities facing the industry as it looks to produce these therapies at scale.
Designed for the review of abbreviated new drug applications, the program is meant to strengthen the domestic pharmaceutical supply chain in the United States.
Since the start of his second term, President Trump has doubled, tripled, and quadrupled down on his threat to impose tariffs on pharmaceuticals. Is it just bluster?
The deadline for imposing a 100% tariff on branded pharmaceuticals passed, without going into effect, as the Trump administration looks to strike deals to lower drug prices.
The drugmaker secured a three-year reprieve for its products from tariffs under a Section 232 investigation, provided it further invests in U.S. manufacturing.
At the agency’s public meeting on the proposed PreCheck framework, companies said reductions in inspection-related delays could significantly de-risk and reduce timelines.
The Michigan-based pharmaceutical contract manufacturer is investing $2 billion in seven planned plants, with an injectable production facility already completed.
In a post on Truth Social, President Trump warned that companies who are not “building” their pharmaceutical manufacturing plants in the U.S. will be hit with tariffs.
Companies are competing to secure construction workers including electricians in the Tar Heel State, where biotechnology ranks as the fastest growing sector.
The Holly Springs facility represents one of the largest commercial-scale cell culture biomanufacturing sites in North America, according to the company.
The active pharmaceutical ingredient site will focus on domestic production of small molecule synthetic medicines, including Lilly's first oral GLP-1 receptor agonist.
Standing up GMP facilities in the United States takes approximately 32 months given permitting hurdles, say CDMOs who spoke with Leerink Partners analysts.