CHMP’s September 2023 meeting highlights
In its September 2023 meeting, the EMA’s human medicines committee (CHMP) recommended nine medicines for approval and the extension of therapeutic indications for 11 medicines.
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News
CPHI Pharma Awards 2023 finalists announced
The finalists for CPHI’s Pharma Awards 2023 across twelve categories for innovation, manufacturing, sustainability, best start-up initiative and breakthrough digital technologies have been announced.
Small molecule drug shows promise in rare disease
In a Phase II trial, the small-molecule drug CBL-514 demonstrated significant reduction in lipoma size and pain improvement in Dercum's disease, a rare disorder.
Janssen rebrands its identity
Johnson & Johnson has updated the branding for its Janssen division, enabling its pharmaceutical and medtech segments to modernise and be more connected to its J&J brand.
Pfizer’s migraine medicine recommended by NICE
The National Institute for Health and Care Excellence (NICE) has published final draft guidance on Pfizer’s Rimegepant, recommending it for the first time as a treatment for acute migraines.
AstraZeneca partnership to pioneer UK’s first commercial biomethane supply
Part of AstraZeneca's £100 million renewable energy commitment involves a 15-year partnership to establish the UK’s first unsubsidised industrial-scale supply of biomethane, supporting sustainable pharmaceutical manufacturing.
EU tax compliance proposals to streamline business investment
New tax compliance cost and transfer pricing proposals from the European Commission (EC) aim to support simpler, clearer and more cost-effective tax systems in the EU.
MSD Ireland’s €1b facility investment achieves new milestone
Opening of a new facility in Dunboyne, Co. Meath and expansion of MSD’s first vaccines operation outside of the US enables MSD Ireland to help address the demand for vaccines and medicines worldwide.
New regulatory relief to benefit Europe’s pharma SMEs
To support small and medium-sized enterprises (SMEs) in the current economic climate, newly proposed measures aim to provide short-term relief, increase long-term competitiveness, and improve equality in the business environment across the Single Market.
UK ATMP facility granted cGMP approval
A UK CDMO is now permitted through MHRA certification to produce clinical supply of gene therapy AAV, including bioprocess through to cGMP manufacturing.
AI to revolutionise drug development by 2026
CPHI's Annual Report 2023 for the first time reveals that pharmaceutical ‘AI companies’ have overtaken ‘late stage’ as the industry’s most appealing investment option for venture capital (VCs).
Microbiome therapy manufacturing facility completed
Europe’s largest microbiome ecosystem therapies manufacturing facility is set to begin production by the end of Q3 2023.
Novel vaccine delivers significant survival in lung cancer trial
The most advanced therapeutic cancer vaccine in clinical development has demonstrated a 41 percent reduction of the risk of death for non-small cell lung cancer (NSCLC) in a Phase III trial.
Pioneering PAT to improve gene therapy AAV manufacture
The CGT Catapult and two other collaborators have agreed to work together and use advanced process analytical technologies (PAT) to improve the process and efficiency of gene therapy AAV manufacturing.
Novel strategy could facilitate rapid online-endotoxin monitoring
An innovative, chemosensor-based method for detection of lipopolysaccharide (LPS) is set to facilitate development of a rapid online-endotoxin monitor.
