UK partnership set to revolutionise oligonucleotide manufacture
CPI, AstraZeneca, Novartis, and The University of Manchester will collaborate to facilitate large-scale manufacture of oligonucleotides.
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Cell therapy first for chronic heart failure
In a Phase III trial, a new cell therapy has shown potential for the first time to treat inflammation, a major contributor to heart failure.
CHMP recommends first pegylated enzyme for Fabry disease
A PEGylated enzyme replacement therapy for Fabry disease has received recommendation for a marketing authorisation from the European Medicines Agency (EMA)'s human medicines committee.
Bioavailability enhancement services market to exhibit 11 percent CAGR
Between 2022 and 2035, the bioavailability enhancement services market will see an 11 percent compound annual growth rate, a report has predicted.
Vitiligo treatment gets positive CHMP opinion
If approved, the cream formulation of the JAK inhibitor ruxolitinib will be the first treatment for repigmentation in non-segmental vitiligo available in the European Union.
Collaboration to support quality production of biologics
US Pharmacopeia (USP) and American Type Culture Collection (ATCC) will collaborate to better support the biologics sector in R&D, process development and release of high-quality biologics.
First successful CAR-T treatment for muscle inflammation
Researchers in Germany have helped a patient to overcome anti-synthetase syndrome muscle inflammation using CAR-T cells.
Imfinzi plus Imjudo approved in EU for advanced cancers
Hepatocellular carcinoma and non-small cell lung cancer patients are set to benefit from the recent approval of Imfinzi plus Imjudo combinations in the EU.
Ph. Eur. rabbit pyrogen test replacement texts ready for public consultation
The rabbit pyrogen test replacement texts in Pharmeuropa 35.1 by the European Pharmacopoeia have been published for public comment.
Simplified HIV treatment options effective in major trial
The world‘s first international trial into second-line HIV therapy has shown two simplified treatments are at least as effective as standard of care.
Developing terminal sterilisation processes for oligonucleotide drugs
A report reviewing the state of sterile oligonucleotide drug processing has recommended ways to aid development of terminal sterilisation processes.
PDA releases contamination control strategy report
Technical Report 90: Contamination Control Strategy Development has been released by the Parenteral Drug Association (PDA).
AstraZeneca BTK inhibitor tablet approved in EU for leukaemia
The tablet formulation for AstraZeneca’s BTK inhibitor has gained EU approval for co-administration with gastric acid-reducing agents in chronic lymphocytic leukaemia patients.
Identifying bacterial isolates to help prevent cleanroom contamination
A paper aiming to identify bacterial isolates on cleanroom operators’ garments, showed these surfaces were a major source of contamination.
FDA approves first treatment for geographic atrophy
The first-ever treatment for geographic atrophy has been approved by the US Food and Drug Administration (FDA).
