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CHMP recommends updated Omicron vaccine
Pfizer and BioNTech’s adapted Omicron XBB.1.5 COVID-19 vaccine has been recommended for two additional indications in the EU.
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Biopharmaceuticals
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Stem cell therapy delivers potential for sickle cell disease
A Novartis’ Phase I/II study for sickle cell disease trialling the gene therapy OTQ92 is the first treatment to target a new genetic area and use cryopreserved stem cells, according to new paper published in NEMJ.
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Curbing AMR through sustainable antibiotic manufacturing
Key recommendations highlighted in a recent report by the Access to Medicine Foundation offer pharmaceutical manufacturers ways to effectively manage the release of antibiotic waste into the environment, and thus contribute to the reduction of antimicrobial resistance (AMR).
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CGT manufacturing QC market to value $2.8b by 2031
Advanced analytical technologies in quality control (QC) processes in cell and gene therapy manufacturing is anticipated to help deliver a 24.6 percent market CAGR between 2023 and 2031.
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Guidance for medicine packaging under Windsor Framework
The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance to support implementation of new requirements for medicine packaging in 2025 under the Windsor Framework.
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European regulatory perspective on nitrosamine mitigation strategies
With nitrite concentration in excipients being a key risk factor in nitrosamine drug substance related impurities (NDSRI) formation, there is opportunity to implement corrective and preventative actions (CAPAs), EMA experts say.
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Roche subcutaneous cancer immunotherapy granted MHRA approval
The first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain on the NHS reduces treatment time to under ten minutes.
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siRNA therapy shows long-term potential in lowering LDL-C
New data presented at the European Society of Cardiology (ESC) Congress 2023, showed Novartis’ Leqvio® (inclisiran) provided an approximate 49 percent reduction in LDL cholesterol beyond six years of clinical observation.
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Pharmaceutical migration study sampling procedure reported
A study incorporating new methodologies has described a stratified sampling procedure used for analyte response evaluation in pharmaceutical migration studies.
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Revised Annex 1 now effective
The much-anticipated Annex 1 revision is finally operational; manufacturers in the EU must be compliant with the GMP guideline updates when manufacturing sterile medicinal products.
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FDA grants first approval for multiple sclerosis biosimilar
Sandoz’s Tyruko (natalizumab-sztn) is now the first US Food and Drug Administration (FDA)-approved biosimilar to Tysabri (natalizumab) injection for relapsing forms of multiple sclerosis.
webinar
Gaining competitive advantage in digital quality management
25 August 2023 | By Mastercontrol
Watch this webinar to learn about the current state of digitisation in life sciences and where your peers rank on the quality digital maturity spectrum.
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New Parkinson’s drug formulation “nearly doubles” exposure
Inhibikase Therapeutics’ new drug tablet formulation could potentially facilitate a lower dose of its Parkinson's drug candidate for it to reach therapeutic efficacy.
whitepaper
Report: Accelerate the RMM validation process
To address the perceived barrier to entry for rapid microbiological methods, new validation packages are now available for Celsis® rapid microbial detection.
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GSK shingles vaccine achieves 100 percent efficacy in China trial
In the first-ever efficacy trial of GSK’s Shingrix in China, no cases of shingles (herpes zoster) were reported after administration of the vaccine, new data shows.
