Final positive results of Zolgensma® trial for SMA published
After previous reports that nearly all spinal muscular atrophy (SMA) patients treated with Zolgensma® achieved key motor milestones, Novartis announces publication of full SPR1NT results.
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Machine learning model enables adventitious agent detection in cell cultures
Researchers have developed a rapid, label-free process analytical technology, called the anomaly detection model, to monitor microbial contamination in cell cultures in near-real-time.
Highs and lows of DEI representation in the biotech industry
BIO International Convention 2022 shared the latest insights into diversity, equity and inclusion (DEI) in the biotechnology industry this week.
WTO waives intellectual property rights for COVID-19 vaccines
According to IFPMA, the World Trade Organization decision to waive intellectual property rights for COVID-19 vaccines fails to tackle the biggest barrier to access: trade.
Radionuclide alpha therapy shows promising survival rates in neuroendocrine tumour patients
A targeted radionuclide alpha therapy, 225Ac-DOTATATE, has been shown to have long-term anti-tumour effects in patients with advanced gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
Advancing nitrosamines analysis with gas chromatography
Researchers suggest full evaporation static headspace gas chromatography (FE-SHSGC) could be a universal method for the analysis of semi-volatile nitrosamines in pharmaceutical products.
Raman spectroscopy – a promising alternative approach for sterility testing
Study combining Raman spectroscopy with PLS-DA multivariate analysis achieves fast and non-invasive detection of contaminated drug products within vials.
Standard for antibiotic manufacturing to help combat AMR
The standard requires antibiotics manufacturers to have effective environmental management systems in order to minimise pharma’s role in spread of environmental antimicrobial resistance (AMR).
Bavarian Nordic to supply EU Member States with monkeypox vaccine
Bavarian Nordic has announced it will supply 110,000 doses of its MVA-BN smallpox/monkeypox vaccine to the European Health Emergency Preparedness and Response Authority (HERA) over the coming months.
EMA’s PRAC June meeting highlights
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) finds the benefits of amfepramone medicines do not outweigh their risks and addressed possible links between COVID-19 vaccines and menstruation.
New guidance for membrane-based water for injection systems
The new Guide from ISPE presents best practices for design, operation, maintenance and quality of membrane-based water for injection (WFI) systems.
Digital growth focus of Sanofi’s new Digital Accelerator
Sanofi announces first Digital Accelerator to develop products and solutions that foster the use of digital, data and artificial intelligence.
Detecting and eradicating mycoplasmas in ATMP cell lines
Here, EPR summarises the key points of Tim Sandle’s recent review of mycoplasma risks, detection and eradication techniques for cell cultures.
New Berlin site to accelerate cell therapy innovation for BlueRock Therapeutics
BlueRock Therapeutics LP has established a new site for cell therapy innovation on Bayer’s campus in Berlin, Germany.
Fund to fast-track innovative drugs to NHS
The UK Government has announced the launch of the Innovative Medicines Fund to bring cutting-edge treatment more quickly to NHS patients.
