MHRA and Health Canada release new clinical safety reporting guidance
Under the new guidance, Development Safety Update Reports must include a description of the process used to review the worldwide safety data of the investigational drug.
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Global sterilisation monitoring market to value $913mn by 2027
Market research suggests the biological indicators segment will retain the largest share of the global sterilisation monitoring market through 2027.
Ongoing pharma productivity requires a focus on upskilling
Research suggests that if pharma does not address staff capability gaps and support employee training and development, then there will be a significant impact on productivity.
GSK to collaborate on development of antibodies for neurodegeneration
GSK will support the development of Alector’s immuno-neurology monoclonal antibodies for Parkinson’s disease, frontotemporal dementia and Alzheimer’s.
Diabetes treatment pump trial begins in Canada
A Phase I trial evaluating Adocia’s BioChaperone® Lispro Pramlintide formulation for insulin pump delivery in type 1 diabetics has begun.
EU approves Opdivo plus Yervoy for colorectal cancer
The European Commission approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for certain metastatic colorectal cancers after a trial found the combination meaningfully improved response rates.
First patients vaccinated with AstraZeneca’s COVID-19 variant vaccine
The Phase II/III trial will assess the safety and immunogenicity of AstraZeneca’s novel COVID-19 variant vaccine candidate, AZD2816.
US grants new patent targeting major neurodegenerative diseases
Alterity Therapeutics have been granted a patent for compounds able to redistribute excess iron in the brain being developed as a treatment for neurodegenerative diseases including Alzheimer's and Parkinson's.
Novel COVID-19 vaccine shows promise in Canadian trial
Phase I data shows VBI-2902a induced neutralisation and antibody titres up to five times that of people who had recovered from COVID-19 infection.
Pharmaceutical QC market to value $9,700mn by 2027
Market research shows increasing pharmaceutical R&D investment and advances in quality control (QC) technologies will drive pharmaceutical QC market growth.
Novavax’ COVID-19 vaccine almost 90 percent effective in Phase III trials
In UK trials where 60 percent of COVID-19 cases were caused by the Alpha SARS-CoV-2 variant, the NVX-CoV2373 COVID-19 vaccine was 89.7 percent effective.
British pharma’s 2021 Code of Practice now in force
The ABPI’s 2021 pharmaceutical industry Code of Practice aims to increase transparency, encourage collaboration and improve patient care.
Germany still second largest producer of EU-approved active biopharmaceutical substances, finds report
A new medical biotechnology report shows Germany’s biopharmaceutical industry is thriving with recombinant antibodies being a key focus area.
Collaboration to develop neurostimulator for inflammatory disease treatment
neuroloop and Merck will combine their expertise to develop a neurostimulator that can safely and effectively treat chronic inflammatory diseases.
Extended dosing intervals may increase efficacy of Vaxzevria COVID-19 vaccine
An analysis shows a single dose of Vaxzevria induced immunity lasting at least a year and an interval of up to 45 weeks significantly increases neutralising antibody titres.
