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Dual cystic fibrosis modulator therapy shows efficacy in four-year study
Cystic fibrosis patients can safely take a dual combination of cystic fibrosis modulator drugs for four years, a study has shown.
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Learning from lecanemab: a breakthrough treatment
Here, Dr Michael Irizarry, Eisai’s Senior Vice President of Clinical Research and Deputy Chief Clinical Officer for Alzheimer’s Disease and Brain Health discusses its highly anticipated Alzheimer’s drug, lecanemab.
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New purification method could enhance protein drug manufacturing
Bioconjugate-functionalised nanoparticles can isolate proteins from a bioreactor fast and inexpensively, MIT researchers have found.
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Pfizer and BioNTech mRNA shingles vaccine study begins
A Phase I/II trial for the first mRNA-based shingles vaccine programme has been initiated by Pfizer Inc. and BioNTech SE.
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Citrate-free HCF of adalimumab biosimilar gets positive opinion
A positive opinion has been adopted by the CHMP for a citrate-free high concentration formulation of its biosimilar Hyrimoz® (adalimumab).
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Clinical trial-first for liver cancer immunotherapy combo
IMbrave050 is the first Phase III study to show a cancer immunotherapy combo reduced risk of disease recurrence for early-stage hepatocellular carcinoma.
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Potential treatment identified for septic patients
CER-001 is a potentially game-changing treatment for septic patients at high risk of acute kidney injury, suggested a ABIONYX Pharma VP.
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First targeted delivery of siRNA into muscle
A Phase I/II trial demonstrated the first successful targeted delivery of siRNA into muscle, using monoclonal antibody AOC 1001.
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mRNA non-vaccine therapeutics to generate $2 billion by 2028
Driven by the approval of pipeline agents, mRNA non-vaccine therapeutics are set to reach $2 billion in sales by 2028, says GlobalData.
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FDA priority review for AbbVie lymphoma bispecific antibody
The FDA has accepted priority review of epcoritamab for adults with relapsed/refractory large B-cell lymphoma, which could be the first subcutaneous bispecific antibody for large B-cell lymphoma.
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First-in-human gene therapy trial for major cardiac syndrome
The US Food & Drug Administration (FDA) has approved the first-in-human gene therapy trial for heart failure patients with preserved ejection fraction.
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Large bacterial culture volumes can be filtered without centrifuge
The study observed that using a modified vacuum filtration system assisted in the filtration of large volumes of bacterial cultures, removing the need for centrifuges.
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Nitrogen dioxide for sterilisation of protein-filled polymer-based syringes
Nitrogen dioxide (NO2) gas found not to ingress and cause protein degradation when sterilising polymer-based prefilled syringes (P-PFSs), according to study.
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Enabling multi-dimensional biotherapeutic analysis
EPR highlights the development of a simple, flexible two-dimensional liquid chromatography-native mass spectrometry method for the in-line analysis of biotherapeutics.
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Is albumin the key to successful nasal vaccines?
A new method of mucosal vaccine delivery that uses albumin to help transport vaccine antigens could lead to better vaccines for HIV and COVID-19.
