Drug Delivery
The Swiss contract development and manufacturing organization will more than double its U.S. footprint by acquiring the Merck KGaA plants.
FEATURED STORIES
To successfully challenge Novartis on two planned fronts, Curium will need to overcome the unique challenges posed by radiopharmaceutical supply to get products to patients and win market share.
Blood centers have the donors, resources and community footprint drug sponsors need to solve supply chain issues around cell and gene therapies.
After mastering mass-market mRNA production during the pandemic, the industry now needs to achieve the timely delivery of individualized vaccines to thousands of patients.
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As companies invest billions of dollars to reshore manufacturing, 10 biotech and pharma businesses are reportedly trimming staff at manufacturing locations in 2026 or the coming years, with BioNTech having the deepest cuts.
The FDA has outlined a process for allowing a single application to cover multiple variants of a gene therapy. At the same time, the Centers for Medicare & Medicaid Services has revealed plans to expand the Cell and Gene Therapy Access Model to increase patient access to these products.
CROs cite faster startup timelines, regulatory predictability and tax incentives as reasons for growing interest in Australia. State investments in manufacturing, translational research and advanced therapies aim to expand that advantage into a broader biotech ecosystem. The question remains whether Australia can support drug development at broader scale.
Following the withdrawal of billions of dollars in investments from Boehringer Ingelheim and Eli Lilly, German lawmakers have proposed a clause to the country’s healthcare reforms set to take effect Jan. 1.
In this episode of Denatured, you’ll hear from Bruce Culleton, CEO at ProKidney and Demetri Maxim, CEO at Nephrogen. We discuss why kidney disease has long been a hard target for cell and gene therapies, and what new delivery strategies, therapeutic approaches and regulatory clarity mean for commercially viable products.
The recurrence of violations at multiple sites led the FDA to conclude that Baxter management must improve its oversight and control of manufacturing.
Just one-third of patients prescribed new medicines filled them within 30 days, with a new report from the Institute for Clinical and Economic Review and West Health suggesting that cost is the problem.
The European Commission approved Germany’s financial support after assessing the risks of Sanofi stopping insulin API production at the Frankfurt campus.
As trispecifics, cell engagers and other complex formats multiply, drug developers are seeking discovery and engineering partners to help navigate an expanding universe of molecular possibilities.
Inconsistent reporting at a Pennsylvania site affected microbiological analyses of components and drug products that analytical testing service provider Eurofins ran for customers.