List view / Grid view
As the next stage of their co-development of vepdegestrant, the Medicines and Healthcare products Regulatory Agency (MHRA) has granted Pfizer and Arvinas its Innovation Passport to advance development of the oestrogen receptor (ER) degrader for ER+HER2- breast cancer.
A paper has stated that applying the quality by design (QbD) principle during development of bilayer tablets will “help improve product design while also enhancing the quality, safety, and efficacy of drug products”.
The planned €50 million investment at the Finland-based CDMO facility will enable advanced technologies to be used for development and manufacture of advanced therapy medicinal products (ATMPs).
Key opportunities within the small molecule active pharmaceutical ingredient (API) market include adopting continuous manufacturing and delving into niche disease areas, research has indicated.
Transferring analytical methods between companies is often a challenging, time-consuming manual process. In this Q&A, Dr Birthe Nielsen, Project Lead at The Pistoia Alliance, speaks about an ongoing project to digitally transfer HPLC data between different vendors.
An RNAi therapeutic that has best-in-disease potential for hypertension is set to be developed under a partnership between Roche and Alnylam Pharmaceuticals.
Public consultation is open for the European Medicines Agency (EMA)’s draft reflection paper on using artificial intelligence (AI) when developing and regulating medicines.
Autonomous biologics manufacturing with process analytical technology (PAT) “opens up a new frontier for aqueous two-phase extraction (ATPE)" in this sector, according to research.
AAV development for cell and gene therapy in 2023 is being impacted by manufacturing and regulation challenges, however advancing technologies offer opportunity, according to leaders in the field.
Research predicts the pharma quality management systems (QMS) market will grow significantly in the next several years and is projected to value $3.97 billion by 2030.
Design of the world’s first continuous mRNA manufacturing platform, an $82 million, three-year, FDA-funded project aims to help accelerate development of mRNA technologies.
Research has shown that Europe holds the largest share within the global aseptic fill finish services market.
An agreement to obtain a global license for KSQ Therapeutics’ small molecule USP1 inhibitor, which has potential to treat a variety of cancers, has been signed by Roche.
A Phase III trial for the only therapy approved for both relapsing and primary progressive multiple sclerosis (MS) met its clinical endpoints, Genentech has announced.
In this Q&A, Recipharm’s Torkel Gren discusses developments in capsule formulation, including the shift away from gelatine and the potential for growth in the inhalation capsule market.
