NICE recommends Novartis precision brain cancer treatment
An “innovative, life-extending treatment” for BRAF V600E mutation-positive glioma has been recommended for certain young people on the NHS.
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AAV gene therapy demonstrates positive activity in Duchenne muscular dystrophy
Initial trial results show the gene therapy enabled up to 85 percent of muscle fibres expressing microdystrophin in boys with Duchenne muscular dystrophy eight weeks post-injection.
Study monitors particles and falling bacteria in biosafety cabinets
The type of clothing worn in aseptic manufacturing areas may impact the number of particle and airborne bacteria detected in biosafety cabinets.
BMS inks CAR T cell therapy manufacturing deal with Cellares
Bristol Myers Squibb has signed a worldwide capacity reservation and supply agreement with Cellares for CAR T-cell therapy manufacturing.
European Commission approves novel antibiotic
Authorisation of the antibiotic combination, which targets multidrug-resistant bacteria, could help to address the global challenge of antimicrobial resistance (AMR).
Utilising rapid UHPLC for tablet QC analysis
The proposed UHPLC method is suitable for routine quantitative analysis of teneligliptin and pioglitazone, a paper reports.
Widening adoption of animal-free reagents for endotoxin testing
If the proposed USP Chapter < 86 > on using non-animal derived reagents is approved, it will be published for early adoption in November 2024, USP states.
Microbial burden assessment of solid pharmaceutical products
Employing an automated, alternative microbiological method (AMM) means water activity could be used as a microbial indicator for bioburden assessment in tablets and capsules, a study suggests.
Genentech oncology treatment granted first-of-a-kind approval
The novel approval provides a dedicated therapy option for patients with ALK-positive early-stage lung cancer.
Enhancing competitiveness of European life sciences
EFPIA’s reflections on the recent Conclusions of the Special Meeting of the European Council assert the importance of ensuring a more resilient and competitive life sciences sector.
Antibiotic demonstrates non-inferiority to a leading gonorrhoea treatment
Based on its novel mechanism of action, GSK’s gepotidacin could provide a new oral option for the treatment of gonorrhoea.
Analysis of corticosteroid formulations in metered dose inhalers
The spectrophotometric-based method offers rapid and reliable analysis of formoterol and beclomethasone formulations in metered dose inhalers, according to research.
Using mass spectrometry to improve quality and safety of levothyroxine
A study investigating levothyroxine has reported a new non-targeted analytical approach for pharmaceutical quality control analysis.
Encouraging data for Roche multiple sclerosis injection
EU approval for Roche’s subcutaneous OCREVUS is anticipated mid-2024, depending on acceptance of regulatory submission.
Technology advancement driving growth of rapid sterility testing market
Rising demand for sterility tests and an expanding biotechnology industry is set to boost growth of the rapid sterility testing market between 2023 and 2032, a report states.
