New cell therapy company will treat solid tumours
Adaptimmune Therapeutics and TCR² Therapeutics’ new cell therapy company could gain the first approval for an engineered T-cell receptor (TCR) T-cell therapy for a solid tumour.
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Oral PCSK9 inhibitor substantially reduces cholesterol, study finds
One of the first oral PCSK9 inhibitors tested in clinical trials significantly reduced low-density lipoprotein (LDL) cholesterol levels in patients with high cholesterol and/or heart disease.
Pistoia Alliance launches Pharma Innovation Council
The Pharma Innovation Council will work to overcome industry barriers such as R&D challenges and the adoption of emerging technologies.
Combination therapy significantly improves pulmonary hemodynamics
Janssen’s single tablet of macitentan plus tadalafil significantly improved pulmonary hemodynamics in a Phase III trial for pulmonary arterial hypertension (PAH).
Temperature-stable tuberculosis vaccine induces immune response
A National Institutes of Health (NIH)-supported trial has demonstrated the safety and efficiency of a freeze-dried thermostable tuberculosis vaccine.
Moderna chooses mRNA vaccine manufacturing centre location
Following finalisation a ten-year strategic partnership with the UK government, Moderna has chosen the location for its Innovation and Technology Centre (MITC).
Pharma responds to UK government Statutory Scheme rise
The ABPI and Lilly have responded to the UK government’s confirmed plans to increase the payment percentage in the Statutory Scheme to control the costs of branded medicines.
New working party to address excipients in Ph. Eur. monographs
The European Pharmacopoeia Commission’s new Excipients Strategy Working Party will address specificities of excipients in European Pharmacopoeia monographs.
Enhancing bioavailability formulations containing soluble acidic drugs
Research has revealed efficiency of a multi-compartmental dissolution method used to predict in vivo performance of BCS Class IIa compounds.
EMA’s human medicines committee (CHMP) meeting highlights – February 2023
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval, including an enzyme replacement therapy for a rare disease.
Immunotherapy before surgery benefits melanoma patients
In a Phase II trial, immunotherapy drug pembrolizumab significantly lowered the risk of recurrence for stage III-IV melanoma patients when given before and after surgery.
New purification method could enhance protein drug manufacturing
Bioconjugate-functionalised nanoparticles can isolate proteins from a bioreactor fast and inexpensively, MIT researchers have found.
UK partnership set to revolutionise oligonucleotide manufacture
CPI, AstraZeneca, Novartis, and The University of Manchester will collaborate to facilitate large-scale manufacture of oligonucleotides.
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.
