All Therapeutics articles – Page 49
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NewsUK 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.
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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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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.
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NewsAlzheimer’s senescent cell combination therapy presents promise
Evidence from a Phase I trial suggests that the tyrosine kinase inhibitor dasatinib in combination with quercetin clears amyloid from the brain and lowers inflammation in the blood.
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NewsHorizon Europe deal signals UK research reinvigoration
From the 7 September 2023, UK scientists can apply for funding from the largest R&D collaboration programme globally, thus accelerating therapeutic advancement.
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ArticleBioprocessing & Bioproduction In-Depth Focus 2023
In this in-depth focus are articles on reducing production time for allogenic CAR T-cell therapies and the complexities of mRNA development, from design intricacies to scalability.
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ArticleQA/QC & Environmental Monitoring In-Depth Focus 2023
In this in-depth focus, explore how automation is transforming environmental monitoring in line with Annex 1, implementation of contamination control strategies and discover the emerging trends and challenges in pharmaceutical microbiology.
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NewsGuidance recommending BMS cardiac myosin inhibitor published
NICE’s final guidance recommending Bristol Myers Squibb’s first-in-class obstructive hypertrophic cardiomyopathy (oHCM) drug on the NHS, is now published.
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NewsRaman spectroscopy market expected to value $875m by 2028
A report has shown that growing demand for accurate identification of pharmaceutical raw materials is anticipated to boost the global Raman spectroscopy market.
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ArticleNitrosamines: the beginning of the end?
Dave Elder explores evolving concerns surrounding nitrosamine-related impurities while calling for continued collaboration to harmonise regulatory approaches.
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NewsSemaglutide weight loss injection launched in UK
Following Novo Nordisk’s announcement that its Wegovy injection for obesity demonstrated a 20 percent reduction in major adverse cardiovascular outcomes, the pharma giant has launched the semaglutide treatment in the UK.