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EMA human medicines committee (CHMP) meeting highlights, March 2022
The March meeting saw the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommend five medications for approval including a multiple myeloma gene therapy.
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Covid-19
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Moderna launches two new mRNA vaccine programmes
The new mRNA vaccine programmes are aimed at the major causative agents of respiratory tract infections, respiratory syncytial virus (RSV), influenza and coronaviruses.
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Lumen publishes details of spirulina biomanufacturing platform
In a new paper, Lumen Bioscience detailed how spirulina can be genetically engineered for to rapidly produce large quantities of biologic drugs.
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New preventative medicine for COVID-19 authorised in UK
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has reported that Evusheld, developed by AstraZeneca, has been granted approval to help protect against the effects of COVID-19.
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Potential for a new one-and-done COVID-19 treatment
Investigational drug Lambda reduced risk of COVID-19-related death in one of the largest studies of its kind to date.
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Generic manufacturers to produce COVID-19 treatment nirmatrelvir
Pfizer’s oral COVID-19 treatment nirmatrelvir will be produced by 35 generic manufacturers to increase supply for low- and middle-income countries.
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First participants dosed with pan-antiviral nasal spray in Phase IIa trial
The Phase IIa influenza-challenge study will enrol 123 healthy adults and support the development of INNA-051 as a pan-antiviral nasal spray.
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Could AAT be the answer to COVID-19 ARDS?
Clinical study finds alpha-1 antitryspin (AAT) reduces pro-inflammatory IL-6 and therefore may benefit COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS).
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, March 2022
EMA’s pharmacovigilance committee recommends product information updates for two COVID-19 vaccines - Janssen COVID-19 Vaccine and Moderna’s Spikevax.
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New agreement makes “Africa’s own COVID-19 vaccine” a reality
Under a new agreement with J&J, Aspen SA Operations will be able to manufacture and make available Aspen-branded COVID-19 vaccines in Africa.
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EMA’s human medicines committee (CHMP) Feb meeting highlights
Highlights of the February 2022 meeting of EMA’s human medicines committee (CHMP) include the recommendation of 13 medicines for approval, along with updates to other drugs and COVID-19 vaccines.
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Prioritising bold innovation throughout the pandemic and beyond
Following his first full year as Managing Director UK, Ireland & Nordics for Novartis Pharmaceuticals, healthcare leader Chinmay Bhatt shares his learnings from the pandemic and reflects on what’s next.
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New regulation strengthens role of EMA in EU crisis response
The regulation sees tools, structures and processes set up by EMA during the pandemic to accelerate clinical trial approval and regulatory assessments in the EU being formally recognised.
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Plant “biofactories” produce proteins for potential COVID-19 vaccine
Transiently infecting tobacco plants, researchers were able to produce recombinant proteins that could be developed into COVID-19 vaccines.
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Could COVID-19 vaccines be swallowed?
New pre-clinical research demonstrates the potential of gastric autoinjectors to deliver mRNA in sufficient quantities for vaccination.
