More news – Page 38
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NewsMHRA approves new medicine formulations for HIV prevention
The authorised formulations are a tablet and a long-acting injection used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis (PrEP).
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NewsInjectable drug delivery market to value $1139.4b by 2029
Key drivers of the global injectable drug market include technological advancement and an increase in chronic diseases such as cancer, due to treatments utilising this drug delivery method.
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News“Landmark” genetic blindness CRISPR trial outcomes released
A Phase I/II trial has shown that a CRISPR-based gene editing therapy can be safely delivered to the retina and provide clinically meaningful outcomes.
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NewsAlternative methods for mycobacterial testing in biological products
Considering the limited available information on implementing mycobacterial testing for quality control of biologicals, researchers have highlighted a suitable potential alternative detection method.
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NewsCombination treatment could provide new standard-of-care for aggressive lymphoma
AstraZeneca has released new clinical data demonstrating the first BTK inhibitor to show a favourable trend in overall survival versus standard-of-care chemoimmunotherapy in adults with untreated mantle cell lymphoma (MCL).
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NewsNICE recommends new haemolytic anaemia treatment
The National Institute For Health and Care Excellence (NICE)'s decision follows a reduction in the price of Pfizer’s small molecule treatment for sickle cell disease.
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NewsNovel PAT tool could improve pharmaceutical QC
The at-line PAT method utilised machine-vision and was able to predict API content of tablets containing amlodipine and valsartan with low relative errors.
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NewsMHRA publishes strategy on AI regulation
Incorporating artificial intelligence (AI) into the MHRA’s regulatory processes could help the agency focus on key priorities such as innovation.
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NewsLong-acting antibody demonstrates promising efficacy in infant RSV
New real-world evidence from a long-term follow up study adds to evidence of the high efficacy of Beyfortus in infant RSV.
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NewsAbbVie breaks ground on new R&D centre
The company’s €150 million investment in its new research and development facility will enable “cutting-edge” research to be conducted at its Ludwigshafen site in Germany long term.
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NewsEnhancing medicine manufacturing through digitalisation
Under a new initiative, manufacturers could increase productivity via innovative technologies, enabling faster patient access to new medicines.
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NewsCHMP meeting highlights: April 2024
In its April meeting, the EMA’s human medicines committee recommended eight new medicines, including treatments for cancer and autoimmune diseases.
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NewsAccelerating spectroscopic analysis for data acquisition
A study has reported the first experimental evidence of time-domain compressed sensing, which could accelerate data acquisition in ultrafast spectroscopy.
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NewsWHO proposes recommendations for preventing nitrosamine contamination
The World Health Organization (WHO)’s draft guidance on nitrosamines is applicable to manufacturers of excipients, active pharmaceutical ingredients (APIs) and finished pharmaceutical products.
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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.