Why is there no standard MALDI-TOF MS procedure for bacterial identification?
Here, EPR summarises a review outlining how different sample preparation protocols, culture media and conditions affect MALDI-TOF MS identification of bacteria.
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FDA sets up Novel Excipient Review Pilot Program
Manufacturers can submit their novel excipients for FDA review under the voluntary Novel Excipient Review Pilot Program.
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.
FDA awards 11 grants for rare disease treatment developments
The FDA has awarded 11 grants equating to about $25 million of funding to clinical trials for the development of rare disease treatments.
Using mass spectrometry data to expedite drug discovery
A new algorithm uses mass spectrometry data and machine learning to predict whether a molecule has been discovered before, saving drug discovery time and cost.
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.
Ultrasound delivers antibody therapy for HER2-positive brain metastasis
MR-guided focused ultrasound safely delivered antibody therapy to breast cancer that has metastasised to the brain in Phase I study.
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.
Do we need gloves? Cleanroom dressing processes may not, finds study
Research indicates, with robust handwashing protocols, there is no difference in cleanroom garment bacterial contamination with or without gloves in the dressing process.
Is your microbial air sampler fit for purpose?
Here, EPR summarises Tim Eaton’s explanation of the importance of assessing biological collection efficiency when selecting an air sampler.
Smart use of off-patent medicines critical for post-COVID healthcare
2021 Medicines for Europe-IGBA conference speakers assert that off-patent medicines will be crucial to rebuild healthcare post-COVID-19.
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.
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.
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.
Revolutionary biomass-based plastic used for blister packaging
Astellas' use of biomass-based plastics represents the world's first use of biomass plastic for drug blister packaging.
