All Therapeutics articles – Page 33
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NewsNovel haemophilia B gene therapy approved
Pfizer has attained its first approval for a gene therapy from the US Food and Drug Administration (FDA), which is indicated to treat the rare blood disorder haemophilia B.
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NewsRapid method for whole-genome fungal ID
The novel technique for whole-genome analysis of fungal species is “highly suitable” for quality and safety monitoring of medicinal materials, the paper suggests.
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NewsCGT Catapult appoints new Non-Executive Directors
The new members of the Cell and Gene Therapy Catapult’s board hold expertise across therapy development, digitalisation and leadership.
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NewsBenefits of 3D printing for personalised medicine formulation
A study has demonstrated how 3D printing can be used to manufacture tailored, safe, and effective treatments for patients with rare diseases via pharmaceutical compounding.
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NewsEuropean Commission authorises one of first ustekinumab biosimilars in Europe
This approval follows a development and commercialisation agreement made in September 2023 between Sandoz and Samsung Bioepis for the biosimilar ustekinumab.
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NewsAbbVie JAK inhibitor shows potential in novel atopic dermatitis head-to-head trial
Patients with moderate-to-severe atopic dermatitis can strive for both little to no itch and clearer skin with AbbVie’s upadacitinib, topline Phase IIIb/IV study results suggest.
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NewsStress impact on protein particle formation for monoclonal antibody formulation
The driving factor for protein particle formation is surface mediated in protein only formulations in manufacturing, research asserts.
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NewsResearch calls for greater investment in Alzheimer’s clinical trials
Despite some challenges, for the Alzheimer’s drug development pipeline, 2024 is a “learning year”, an expert on the disease says.
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NewsGenerics propelling pharmaceutical parenteral packaging market
Preference for small molecule prefilled syringes and a greater demand for prefilled insulin syringes for diabetes is driving growth of the pharmaceutical parenteral packaging market, a report states.
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ArticleSupporting female leaders to advance cell and gene therapies
At the 2024 Advanced Therapies conference, panellists discussed the lack of women in leadership positions within the cell and gene therapy space and what could be contributing to this.
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NewsNICE recommends Novartis precision brain cancer treatment
An “innovative, life-extending treatment” for BRAF V600E mutation-positive glioma has been recommended for certain young people on the NHS.
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NewsAAV gene therapy demonstrates positive activity in Duchenne muscular dystrophy
Initial trial results show the gene therapy enabled up to 85 percent of muscle fibres expressing microdystrophin in boys with Duchenne muscular dystrophy eight weeks post-injection.
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NewsEuropean Commission approves novel antibiotic
Authorisation of the antibiotic combination, which targets multidrug-resistant bacteria, could help to address the global challenge of antimicrobial resistance (AMR).
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NewsUtilising rapid UHPLC for tablet QC analysis
The proposed UHPLC method is suitable for routine quantitative analysis of teneligliptin and pioglitazone, a paper reports.
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NewsWidening adoption of animal-free reagents for endotoxin testing
If the proposed USP Chapter on using non-animal derived reagents is approved, it will be published for early adoption in November 2024, USP states.
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NewsMicrobial burden assessment of solid pharmaceutical products
Employing an automated, alternative microbiological method (AMM) means water activity could be used as a microbial indicator for bioburden assessment in tablets and capsules, a study suggests.
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NewsGenentech oncology treatment granted first-of-a-kind approval
The novel approval provides a dedicated therapy option for patients with ALK-positive early-stage lung cancer.
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NewsEnhancing competitiveness of European life sciences
EFPIA’s reflections on the recent Conclusions of the Special Meeting of the European Council assert the importance of ensuring a more resilient and competitive life sciences sector.
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NewsAntibiotic demonstrates non-inferiority to a leading gonorrhoea treatment
Based on its novel mechanism of action, GSK’s gepotidacin could provide a new oral option for the treatment of gonorrhoea.
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NewsAnalysis of corticosteroid formulations in metered dose inhalers
The spectrophotometric-based method offers rapid and reliable analysis of formoterol and beclomethasone formulations in metered dose inhalers, according to research.