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Tirzepatide maintains AC1 and weight control in type 2 diabetes patients
The highest dose of tirzepatide led to an A1C reduction of 2.58 percent and reduced body weight by 11.7kg in Phase III study.
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Drug Safety
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New mass spectrometry technique to detect low-level host cell proteins
Host cell protein-automated iterative mass spectrometry (HCP-AIMS) enables the robust, reproducible and high throughput analysis of host cell proteins, says study.
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Excipient knowledgebase to optimise the formulation and dosing of drugs
Researchers have compiled a repository of clinical and in vitro data for excipients to enable their potential to interact with drugs to be modelled.
podcast
EPR Podcast Episode 4 – UV/Vis in mRNA vaccine QC with Dr Hans-Joachim Muhr, Mettler Toledo
Join Mettler Toledo's Dr Hans-Joachim Muhr as he explains the key quality considerations for mRNA vaccines and why UV/Vis spectrophotometry should be applied in their QA/QC.
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Imfinzi™ improves liver cancer survival in Phase III trial
Imfinzi (durvalumab) demonstrated a meaningful overall survival (OS) benefit versus sorafenib as a first-line treatment for liver cancer.
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Enspryng® prevents relapse in over 70 percent of NMOSD patients
Enspryng (satralizumab) significantly reduced relapse in patients with neuromyelitis optica spectrum disorder (NMOSD) in Phase III study.
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Seventy percent of MS patients relapse-free with Zeposia®(ozanimod)
Zeposia® (ozanimod) also demonstrated a low annualised relapse rate (ARR) of 0.103 in the five-year Phase III DAYBREAK study.
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Influenza vaccine with COVID-19 booster shot shows positive results
Sanofi’s Fluzone® with Moderna’s COVID-19 mRNA investigational booster dose showed an immunogenicity response similar to individual doses.
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AZD7442 antibody combination reduces COVID-19 risk by 50 percent
AZD7442 is the first long acting antibody (LAAB) combination shown to prevent and treat severe COVID-19 infection in Phase III trial.
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Anti-amyloid antibody receives Breakthrough Therapy Designation in US
Roche's gantenerumab is an anti-amyloid beta antibody developed for subcutaneous administration in Alzheimer’s disease patients.
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Lumakras™ displays positive results in Phase Ib cancer study
Lumakras™ (sotorasib) demonstrated effective response rates against non-small cell lung cancer and colorectal cancer in Phase Ib trial.
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Merck’s Keytruda®: update on trials and outcomes
EPR’s Anna Begley summarises some of the key results from trials of Merck’s Keytruda® (pembrolizumab) cancer treatment.
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WHO recommends groundbreaking malaria vaccine for children
The World Health Organization (WHO) recommends GSK's RTS,S/AS01 (RTS,S) malaria vaccine for use in children in sub-Saharan Africa.
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EMA approve Comirnaty®and Spikevax booster doses
The EMA concludes that booster doses of the COVID-19 vaccines Comirnaty and Spikevax can be given to people with severely weakened immune systems.
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New FDA draft guidance on microbiological quality of NSDs
The draft guidance discusses product development considerations, risk assessments and cGMPs relevant to microbiological control in non-sterile drug (NSD) manufacturing.