All Drug Development articles – Page 37
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NewsCPHI 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.
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NewsSmall 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.
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NewsPfizer’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The National Institute for Health and Care Excellence (NICE) has published final draft guidance on Pfizer’s Rimegepant, recommending it for the first time as a treatment for acute migraines.
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NewsAstraZeneca 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.
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ArticleAchieving scale up success under economic uncertainty
Avoiding risk by studying past challenges and the lessons learned can help biotechs navigate the current uncertain macroeconomic climate, says Brandon Fincher, President of Early Stage Development & Testing at the CDMO Cambrex.
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EventBarcelona Breakfast Briefing: how is Pharma 4.0 shaping manufacturing?
European Pharmaceutical Review will host an exclusive, free-to-attend, breakfast briefing during CPhI in Barcelona this October. The highly anticipated breakfast briefing is open to all CPhI attendees and European Pharmaceutical Review members and is free to attend.
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NewsMSD 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.
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NewsNew 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.
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NewsAI 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).
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ArticleHow breakthrough CAR-T cancer therapies could be made more widely accessible
The development and regulatory approval of the first autologous CAR T-cell therapies is a huge advance for modern medicine and has been greeted with justifiable excitement. But applications of this technology are still limited, and given the time and cost constraints, more must be done to broaden access to this ...
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ArticleImplementing the future of mRNA therapeutics
Here, Chief Scientist Bruce Lahn of the CDMO VectorBuilder discusses best practices, common problems, and possible solutions to mitigate risk and free up capacity when developing and designing mRNA therapeutics.
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NewsMicrobiome therapy manufacturing facility completed
Europe’s largest microbiome ecosystem therapies manufacturing facility is set to begin production by the end of Q3 2023.
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NewsNovel 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.
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ArticleDeveloping an effective contamination control strategy
A key part of Annex 1, due to come into effect on 25 August 2023, is the development of a holistic contamination control strategy (CCS). In this article, EPR’s Caroline Peachey summarises an expert panel discussion, which explored common challenges in implementing a CCS and made several recommendations.
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NewsPioneering 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.
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NewsNovel 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.
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NewsSandoz to commercialise mAb biosimilar candidate
A new commercialisation agreement between Sandoz and Samsung Bioepis’ for its ustekinumab biosimilar candidate, means Sandoz now has five potential high-value biosimilars anticipated to launch over the next two years.
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Whitepaper
Technical document: Introducing: Ami Polymer's Sterile Sampling Systems
Next-Gen Sterile Sampling System: Pinnacle Compliance - USP Standards 87, 88, 85, 661.1, 788, 71, and ISO 11737-1 for Unparalleled Pharma & Biopharma
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NewsMHRA releases its CTA application performance metrics
Recent data reveals how many clinical trial authorisation (CTA) applications and substantial amendments the Medicines and Healthcare products Regulatory Agency (MHRA) received and assessed in the past year, including statistics for novel trial designs.
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NewsNICE recommends new type 2 diabetes treatment
A safer alternative to current first line therapies has been recommended by the National Institute for Health and Care Excellence (NICE) as a new treatment option for type 2 diabetes.