News – Page 38
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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The World Health Organization (WHO)’s draft guidance on nitrosamines is applicable to manufacturers of excipients, active pharmaceutical ingredients (APIs) and finished pharmaceutical products.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.
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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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NewsMicrobe-carrying particle recovery efficacy with manual surface sampling
Three different contact plate methods were tested to determine a convenient manual surface sampling technique for microbial contamination recovery, the paper explained.
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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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NewsStudy monitors particles and falling bacteria in biosafety cabinets
The type of clothing worn in aseptic manufacturing areas may impact the number of particle and airborne bacteria detected in biosafety cabinets.
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NewsBMS inks CAR T cell therapy manufacturing deal with Cellares
Bristol Myers Squibb has signed a worldwide capacity reservation and supply agreement with Cellares for CAR T-cell therapy manufacturing.
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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).