All Drug Development articles – Page 38
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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.
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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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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.
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ArticleMeeting rising demands of a new radiotheranostic era
Targeted radiotheranostics are on the path to becoming integral to cancer diagnosis and treatment. Their success, however, depends on patient benefit and the ability to meet commercial demands for broader indications. Aside from the therapeutic or diagnostic efficacy, decisions on suitable radionuclide properties and owning the supply chain will be ...
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NewsCHMP recommends updated Omicron vaccine
Pfizer and BioNTech’s adapted Omicron XBB.1.5 COVID-19 vaccine has been recommended for two additional indications in the EU.
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NewsStem cell therapy delivers potential for sickle cell disease
A Novartis’ Phase I/II study for sickle cell disease trialling the gene therapy OTQ92 is the first treatment to target a new genetic area and use cryopreserved stem cells, according to new paper published in NEMJ.
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NewsCGT manufacturing QC market to value $2.8b by 2031
Advanced analytical technologies in quality control (QC) processes in cell and gene therapy manufacturing is anticipated to help deliver a 24.6 percent market CAGR between 2023 and 2031.
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NewsEuropean regulatory perspective on nitrosamine mitigation strategies
With nitrite concentration in excipients being a key risk factor in nitrosamine drug substance related impurities (NDSRI) formation, there is opportunity to implement corrective and preventative actions (CAPAs), EMA experts say.
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NewsRoche subcutaneous cancer immunotherapy granted MHRA approval
The first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain on the NHS reduces treatment time to under ten minutes.
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NewssiRNA therapy shows long-term potential in lowering LDL-C
New data presented at the European Society of Cardiology (ESC) Congress 2023, showed Novartis’ Leqvio® (inclisiran) provided an approximate 49 percent reduction in LDL cholesterol beyond six years of clinical observation.