All news articles – Page 52
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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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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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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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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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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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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.
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NewsNew medicines manufacturing centre to enhance UK talent
Part of the £650 million ‘Life Sci for Growth’ funding package announced in May 2023, £5.5 million is set to deliver a new UK Medicines Manufacturing Skills Centre of Excellence to boost the skills of talent in the life sciences sector.
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NewsMiniaturised PAT tool demonstrates real-time aggregation measurement
Researchers have described how a process analytical technologies (PAT) fluorescent dye (FD)-based microfluidic sensor facilitated immediate feedback and control of process parameters for continuous downstream processing.
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NewsNICE recommends new Fabry disease treatment
Recommendation of Elfabrio® (pegunigalsidase alfa) means patients with Fabry disease in England will be able to access a new treatment option.
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NewsFTC order could ease biopharma competition
In Amgen’s consent order with the US Federal Trade Commission (FTC) addressing the intended acquisition of Horizon Therapeutics, once finalised, some requirements will be effective for 15 years.
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NewsTrial-first for Roche lung cancer ALK inhibitor
Roche has provided the first evidence that its oral anaplastic lymphoma kinase (ALK) inhibitor for non-small cell lung cancer (NSCLC) could be key in treating the early-stage disease.
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News$2 billion mRNA-based oncology therapy market anticipated by 2029
As the pharmaceutical industry awaits the first regulatory approval of an mRNA-based oncology therapy, research predicts BioNTech will lead the market by 2029, which by then, is anticipated to value $2 billion.