Drug Delivery
The FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal years 2028–2032.
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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.
Thanks in part to the revolution cell therapy brought to treating blood cancers, the modality is now showing promise in some autoimmune applications. This expansion is poised to yield even wider benefits.
Biopharmas developing CAR T therapies for autoimmune indications face major barriers to maximizing the market. Advances in the provider ecosystem and clinical infrastructure, as well as access and education, will be key to launching at scale.
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With multiple drug pricing initiatives like Most Favored Nation now in force, drugmakers have to reinvent their commercial strategies to stay ahead of the fast-moving policy environment, according to a new report from Numerof & Associates.
Encoded Therapeutics’ lead asset ETX101 is a gene therapy being tested for Dravet syndrome. Phase 1/2 data showed substantial reductions in seizures.
In this episode of Denatured, sponsored by SK pharmteco, Jennifer Smith-Parker speaks to Arvind Singh, vice president and global head of supply chain. In this episode, we explore how CDMOs are reshaping supply‑chain strategy for a new generation of complex modalities.
The company is investing billions of dollars to construct a European biosimilar hub capable of supporting the rapid expansion of its portfolio.
Belgium and the Netherlands have built some of Europe’s strongest life sciences ecosystems, powered by leading research institutions and a growing pool of experienced biotech talent. While early-stage funding remains scarce and investment is often fragmented across regions, investors see national biotech initiatives and broader EU support as catalysts for future growth.
Contract development and manufacturing organizations looking to do business with biopharmas include Lonza, which has more than 30 sites, and Samsung Biologics, which recently announced a planned acquisition of another CDMO.
A new program from ARPA-H has devoted funding to make individualized RNA-based genetic medicine more efficient to produce and improve accessibility.
Efficacy plateaus, muscle loss and weight rebound are testing the limits of GLP-1 success, pushing companies toward new mechanisms and multitarget designs to close the gap. But progress depends on understanding disease biology and selecting the right drug candidates to derisk clinical trials.
Astellas Pharma, BridgeBio, BeOne Medicines and six other large biotechs join the 17 Big Pharmas that previously signed on to President Donald Trump’s Most Favored Nation (MFN) drug pricing program, representing some 89% of the branded drug market.
Manufacturers are being pushed beyond mAb‑era platforms into a new design model built around molecular engineering, complex analytics and amplified upstream and downstream processing.