Personalized and highly-targeted therapeutics are becoming more common, making local or regional production increasingly valuable for faster patient access. This underscores how a hybrid network combining large, centralized plants coupled with flexible regional sites will define the next era of resilient biomanufacturing.
The FDA will provide faster regulatory review of generic drugs that are tested and manufactured in the U.S. using domestically sourced active pharmaceutical ingredients. This FDA pilot program is part of a broader Trump administration strategy to reshore pharmaceutical production.
Veradigm examines key clinical trends, comorbidity profiles, and treatment trends across adolescence, reproductive years, and peri-/post-menopause. Download it today!
Pharmaceutical tariffs are coming, part of President Trump’s stated goal of bringing drug manufacturing back to the U.S. Untangling the sprawling, global supply chain will be complicated and expensive, and could inadvertently compete with other administration goals regarding drug pricing and availability.
Roche said it will expand existing sites and construct new U.S. manufacturing and R&D infrastructure in areas such as gene therapy and cardiometabolic disease. The plans follow U.S. capital expenditure announcements from several big pharmaceutical companies.
Creating adequate capacity for any therapeutic can be challenging, and the specialized technologies for manufacturing complex biologics require flexibility and agility in production processes. Here's how contract development and manufacturing organizations (CDMOs) ensure that biopharmaceutical companies have a partner with the speed, flexibility, and expertise necessary for successful drug development and manufacturing.
Halozyme views its drug delivery technology for biologic medicines as complementary to Evotec’s biologic drug manufacturing capabilities. But according to Halozyme, Evotec was unwilling to engage in any merger discussions.
Data exchange lies at the heart of innovation. With the right data available, BioPharma companies can best implement advanced analytics tools for timely interventions in manufacturing deficiencies and optimize processes.
Generic drugs are the pharmaceutical products mainly affected by the missile attacks disrupting shipping in the Red Sea. While the extra costs borne by drug companies aren’t causing an immediate spike in product prices, experts say they’ll eventually be factored into prices if the attacks become a long-term problem.
After Novo Holdings acquires Catalent, it will sell three of the contract manufacturing giant’s sites to Novo Nordisk. Those facilities already make Novo Nordisk’s GLP-1 drugs for metabolic conditions, and they will help the company meet projected demand for these products in years to come.
Generative AI further enhances the value of prompt engineering by synthesizing important insights from various interactions, including text, images, compliant transcripts, and call notes. By automating this process, generative AI quickly transforms on-the-ground insights into robust analytics.
Healthcare payments are no longer about transactions. It’s about controlling the revenue cycle. And increasingly, that control is not sitting with ISOs.
Cell therapy offers a treatment option for some advanced blood cancers, but the manufacturing process is lengthy and complex. The biopharmaceutical industry is working on various technologies that could make manufacturing faster and more efficient, or perhaps supplant the current process altogether.
Cloud-based data management solutions help the industry meet its business and compliance challenges. These platforms need to replace traditional data management methods and workflows for biopharma companies and contract development and manufacturing organizations that seek competitive advantages.
Emergn Principal Consultant Mario Moreira shared insights on how pharma companies can use the principles of Value, Flow and Quality to shorten drug development timelines and deliver better patient outcomes through improved ways of working.
Biomanufacturing technologies company Resilience is partnering with Harvard in a deal that could see innovations from the university’s labs commercialized under new businesses. Resilience has committed $30 million in funding to support Harvard biomanufacturing research.
Life sciences companies are using “digital twins” for everything from drug discovery to manufacturing. A panel of experts at MedCity News’ INVEST Digital Health conference discussed how this capability to run virtual simulations is changing practices now while also shaping the industry for the years to come.