whitepaper
Delivering market success for concept to patient
24 October 2024 | By
Whitepaper - Delivering Market Success for Pharma Partners from Concept to Patient
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Biologics
article
Developing donanemab – balancing cost versus benefit
This article summarises recent regulatory developments surrounding the Alzheimer’s treatment donanemab and considers the future therapeutic market for this disease.
news
Eli Lilly secures MHRA authorisation for Alzheimer’s treatment
Authorisation in Great Britain means eligible Alzheimer's patients can access the treatment, which is part of a new class of amyloid targeting therapies.
news
World-first medicine manufacturing regulatory framework to be implemented
The new regulation could become lawful in the UK next year, according to the Medicines and Healthcare products Regulatory Agency (MHRA).
webinar
Turning quality management into quality leadership
9 October 2024 | By MasterControl
This webinar discusses the power of a comprehensive QMS to ensure efficiency, compliance, and product quality.
whitepaper
A data-driven approach to Container Closure Integrity
Selecting container closure components with confidence:A data-driven approach to Container Closure Integrity.
article
Pharma Horizons: Biologics
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key developments in pharmaceutical biologics for drug development, pharmaceutical manufacturing and quality control.
news
Innovative medicine production site inaugurated in France
Sanofi’s novel manufacturing unit in France shortens production timelines and enables rapid changes in production capacities for medicines such as biologics and vaccines.
webinar
Monocyte activation test (MAT): Insight into examining regulations and markets prospects
9 September 2024 | By FUJIFILM Wako
Watch this webinar to learn about the current regulations on the monocyte activation test (MAT) and the new type of MAT entering the markets.
webinar
An alternative medium to support sterility testing using the Growth Direct® Rapid Sterility System
4 September 2024 | By Rapid Micro Biosystems
Watch on demand to learn how a new single medium, Rapid Sterility Medium (RSM), performs as well as or better for the growth promotion of test microorganisms compared to compendial sterility test media.
news
Novartis collaboration to innovate subcutaneous drug delivery
The multi-target biologic-focused agreement could enhance treatment convenience by improving subcutaneous administration options for patients.
whitepaper
eBook: Successfully navigating complex and evolving regulatory environment for combination products
With complex processes and stringent regulatory requirements, the path to developing a combination product can be uncertain and challenging
news
AstraZeneca investment to increase biologic capacity in Sweden
The planned expansion is set to strengthen AstraZeneca’s capability to manufacture biologic medicines for patients globally.
news
Alzheimer’s drug milestone “bittersweet” for certain patients
The first new dementia medicine to be licensed in over two decades shows for first time, that the course of Alzheimer disease can be modified and slow cognitive decline.
article
Are we set for the revised EU GMP Annex 1?
23 August 2024 | By
This blog is a summary of the key changes of relevance to primary packaging components
