BioNTech to develop and supply mRNA malaria vaccine
Collaborating with global partners BioNTech will work to develop a safe and effective malaria vaccine and set up its sustainable supply for the African continent.
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Regulators call for clinical research to include pregnant and breastfeeding women
The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
EMA recommends approving Spikevax COVID-19 vaccine for adolescents
Based on new clinical results, the EMA is recommending Moderna’s Spikevax COVID-19 vaccine be approved for use in children aged 12 to 17 years.
J&J to pay up to $5bn in US opioid settlement
Johnson & Johnson has signed a nationwide opioid settlement agreement and will pay billions to settle opioid-related claims and litigation in the US.
Bayer appoints Head of Research and Early Development for Oncology
Bayer have announced that Professor Dominik Ruettinger will be its new Head of Research and Early Development for Oncology, effective 1 October 2021.
EMA’s human medicine committee (CHMP) meeting highlights, July 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended two medicines for approval and provided a negative opinion on Nouryant.
eTheRNA immunotherapies joins forces with Ghent University
eTheRNA has announced a collaboration and license agreement with renowned Belgian research institution, Ghent University.
Lilly to acquire biotech company Protomer Technologies
Eli Lilly and Company has announced the acquisition of California-based biotech company, Protomer Technologies.
2021 a pivotal year for personalised neoantigens, says GlobalData
With multiple catalysts coming up in late 2021, GlobalData reports a boom in the field of personalised neoantigen immuno-oncology therapeutics.
‘Marketplace’ launched to speed up global access to COVID-19 vaccine
CEPI has launched COVAX Marketplace to accelerate the global production of COVID-19 vaccines, increasing access to doses.
AI and big data will continue to disrupt pharma sector, says survey
A GlobalData report has revealed the extent to which companies will be using AI and big data in drug discovery and development processes.
Revised general chapter on chemometric methods available for comment
The revised general chapter 5.21 has been published in Pharmeuropa 33.3, the European Pharmacopoeia online forum, for public comment.
New targeted gene therapy could reverse neurological diseases
Researchers have developed a novel gene therapy that could help treat children with incurable genetic and neurodegenerative diseases.
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, July 2021
The Pharmacovigilance Risk Assessment Committee (PRAC) provided safety warnings on COVID-19 vaccines, and found no evidence linking Zynteglo to blood cancer.
FDA suggests principles for implementing bio-fluorescent particle counters
FDA provides guidance on the validation and regulations for bio-fluorescent particle counting technology as an alternative, continuous method for bioburden testing in air and water systems.
