The FDA Opened the Door For Rare Disease Patients — Here’s What It Takes to Walk Through It
The Plausible Mechanism Framework is a breakthrough. Turning it into treatments that reach families will take five things the framework doesn't provide.
The Drug Companies Avoiding Trump’s Tariffs — For Now
Generic medicines face no tariffs, though the Trump administration reserves the right to revisit that in the future. Some branded drugmakers face a reduced tariff rate, but that could change if they don’t reach a so-called most-favored nation drug price deal.
presented by
Inside an Automated Healthcare Practice: Redesigning Care Around People, Not Paperwork
By reducing administrative burden and redesigning workflows around human needs, it creates space for what matters most: connection between clinicians and patients.
Frozen Does Not Mean Stable: Rethinking Cryopreservation in Cell and Gene Therapy Manufacturing
As cell-based therapies grow more complex and manufacturing networks expand, resilience can’t be an afterthought, and cryopreservation can no longer just be a step that gets validated during development and left alone. It needs to play an ongoing role in product consistency, potency, and reliability.
Moving Beyond the Mega-Factory: Why the Future of Biomanufacturing is Agile, Distributed, and Resilient
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.
Data at Work: How Advanced Analytics Are Transforming Cell and Gene Therapy Manufacturing
The growing use of advanced analytics and artificial intelligence (AI) is reshaping this landscape by enabling data-driven process control, predictive manufacturing, and greater transparency across the development lifecycle.
Galapagos to Wind Down Cell Therapy Business After Search for a Buyer Comes Up Empty
Non-binding offers for Galapagos’s cell therapies assets came mostly from financial investors, and none offered sufficient terms or financing to support the business, the company said. Galapagos’s exit from cell therapy work will lead to site closures in Europe, China, and the U.S.
presented by
The Power of Real World Data to Study Women’s Health at Scale
Veradigm examines key clinical trends, comorbidity profiles, and treatment trends across adolescence, reproductive years, and peri-/post-menopause. Download it today!
GSK Plans to Spend $30B on U.S. Manufacturing and R&D Infrastructure Over the Next 5 Years
President Trump has been pursuing policies intended to entice drugmakers to bring manufacturing and jobs to the U.S. GSK’s announcement makes it the latest big pharma company to unveil a multi-billion dollar plan for new U.S. facilities.
The Discipline of Differentiation: Winning Strategies in a Crowded Cell and Gene Therapy Market
The cell and gene therapy sector has hit incredible milestones in recent years. As the sector continues to evolve and the climate becomes increasingly crowded and volatile, leaders must remain flexible in constantly refining the pipeline.
Are There Any Healthcare Wins Hidden Inside the One Big Beautiful Bill Act? Yes, a Few…
The One Big Beautiful Bill Act has drawn criticism from healthcare groups for slashing Medicaid and ACA subsidies, but it contains a few provisions that could drive progress.
Radiopharmaceutical Manufacturing: A High-Stakes Race Against Time
From the executive boardrooms of pharma companies to academic research centers, one fact is becoming unmistakably clear: making radiopharmaceuticals is an inherently complex, high-stakes endeavor, and the industry is racing to manage the risks of these perishable therapies before the clock runs out
presented by
The Healthcare Payments Industry Has a Perception Problem
Healthcare payments are no longer about transactions. It’s about controlling the revenue cycle. And increasingly, that control is not sitting with ISOs.
Thermo Fisher Beefs Up in Bioprocessing With $4B Acquisition of Solventum Biz Segment
Thermo Fisher Scientific agreed to acquire the Purification and Filtration business of 3M spinoff Solventum. Filters and membranes from this business segment are used globally in applications such as biopharmaceutical manufacturing.
Novo Nordisk Adds to Manufacturing Capacity, Pumping Billions Into New Rare Disease Site
Novo Nordisk’s new Denmark site will produce drugs for rare diseases, such as hemophilias. Separately, the pharma giant said all regulatory conditions have been met for Novo Holdings’ acquisition of Catalent, which will bring to Novo Nordisk three manufacturing sites for GLP-1 medications.
Private Equity Is Picking Up Biologics CDMO Avid Bioservices in $1.1B Acquisition
CDMO Avid Bioservices is being acquired by the private equity firms GHO Capital Partners and Ampersand Capital Partners. Avid specializes in manufacturing biologic products for companies at all stages of development.
Eli Lilly Plans $4.5B Medicine Foundry to Foster Innovations in Drug Manufacturing
Lilly Medicine Foundry will research new ways to manufacture medicines. Eli Lilly says in addition to supporting the manufacturing of drugs for clinical trials, manufacturing innovations from the site will be transferred to the company’s other facilities for use in full-scale drug production.
Medical Device Recycling Programs Are Manufacturer Money-Grabs Disguised as Sustainability Initiatives
Hospitals would be much better served by focusing on reuse and reprocessing programs. So why isn't that happening and what can be done about it?