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15 January 2025 | By
NSF invites pharmaceutical professionals to tune in to its new groundbreaking podcast series “Compliance Unlocked” and join the conversation on critical industry issues.
The positive two-year findings from the Phase I/II gene therapy trial in retinitis pigmentosa reiterate the potential of mutation-agnostic therapies.
Eleven drugs are poised to make waves in the pharmaceutical industry in 2025, according to the annual report.
The new US Food and Drug Administration (FDA) guidance will enhance credibility of AI models in drug and biological product regulatory submissions.
As part of the collaboration and license agreement, Innovent Biologics, Inc. could receive up to $1 billion, subject to developmental success of the biologic candidate.
As the industry prepares for a new year, Dr Kate Broderick, PhD, Chief Innovation Officer of Maravai Life Sciences and TriLink Biotechnologies, shares her thoughts on what the RNA therapeutics landscape of 2024 can tell us about what may be on the horizon in 2025.
Automation and digital technologies, combined with workforce training and regulatory advancements, hold the key to transforming the production of advanced therapies. Dr Stephen Ward, Executive Director at CGT Catapult, shares how leveraging these innovations can facilitate the delivery of life-changing therapies to patients at scale, opening new possibilities for treating…
Dave Elder shares industry thoughts on an ICH Q6(R1) concept paper that aims to revise general principles for uniformity and consistency across ICH Q6 guidelines for test criteria and specifications.
The new agreement between Bristol Myers Squibb and BioArctic is set to advance development of anti-amyloid-beta antibody treatments, which have shown symptomatic benefit in Alzheimer's.
Based on positive outcomes of the clinical trial, a high dose of the cell therapy is expected to advance to Phase III pivotal trials.
With its best-in-class potential, the biologic could provide a new treatment option for patients with inflammatory bowel disease (IBD), say Teva Pharmaceuticals and Sanofi.
A total of DKK 8.5 billion will fund the new production facility in Odense, Denmark, which is set to facilitate the manufacture of medicines for rare diseases.
The new treatment option provides a convenient alternative to currently available vials of the bispecific antibody for EU patients with common vision conditions.
Christina Pelizon, International Medical Affairs Head for Oncology at AbbVie discusses the significance and impact of the European Commission’s approval last month of Elahere® (mirvetuximab soravtansine) to treat ovarian cancer.
The cell therapy could increase survival in certain lymphomas without requiring patients to undertake subsequent therapy, the new analysis suggests.
