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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.
10 December 2024 | By
NSF’s quality management maturity (QMM) assessment model: future-proofing quality and supporting supply chain robustness
The joint agreement between two key global players in life sciences, the UK and Switzerland, marks a long-term commitment to strengthening research in the sector.
9 December 2024 | By European Pharmaceutical Review, sponsored by Charles River Laboratories
During this virtual panel, industry experts explore the latest advances in environmental monitoring, discuss key challenges within the sector and approaches that can prevent and mitigate these issues.
Troy Wright, Senior Vice President and Global Head of Quality at Abzena, shares an overview of current major challenges within pharmaceutical microbiology quality control, including the lack of staff knowledge in advanced technologies and how the sector’s importance can be overlooked, despite its key role in bringing safe, quality products…
IMA Pharma discusses approaches to keeping Amoxicillin and Clavulanic Acid tablets stable and effective by addressing moisture sensitivity and preventing degradation.
The Association of the British Pharmaceutical Industry (ABPI) asserts that the recommendations will help generate confidence and predictability in medicine regulation in the UK.
As part of the agreement with Novartis Pharmaceuticals, PTC will receive an initial $1 billion to develop the potential first-in-class oral therapy.
