Lilly IBD biologic receives expanded US approval
The drug is the first biologic in over 15 years to have disclosed two-year Phase III efficacy data in Crohn's disease at the time of approval.
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The drug is the first biologic in over 15 years to have disclosed two-year Phase III efficacy data in Crohn's disease at the time of approval.
The positive two-year findings from the Phase I/II gene therapy trial in retinitis pigmentosa reiterate the potential of mutation-agnostic therapies.
The new acquisition by GSK could enable major advancement in the standard of care for gastrointestinal stromal tumours (GIST) after nearly two decades.
Eleven drugs are poised to make waves in the pharmaceutical industry in 2025, according to the annual report.
The regulatory recommendation provides a targeted therapy option for eligible patients with the most common cancer in the UK.
The industry associations uphold that adopting digital formats for medicine information will simplify supply chain and improve patient safety.
Findings from the interim clinical study showed that the gel formulation enhanced quality of life in over half of cancer patients.
In this article, Dr Stephen Harrington, Director of Cell and Hydrogel Formulation and Francis Karanu, Vice President of Cell Therapy R&D, Likarda, discuss the benefits of hydrogel encapsulation in drug delivery and enhancing the bioavailability and functionality of cell therapies.
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.
The HPLC technique provides “significant improvements” over traditional methods for carvedilol determination and has broad applications for pharmaceutical quality control, research suggests.
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.
With advantages such as utilising bio-compatible materials, the biomolecule-based drug delivery system enables potentially safer drug development, according to the researchers.
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.