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CHMP meeting highlights – December 2022
A total of five drugs were recommended for approval at the CHMP’s December meeting, including a gene therapy and two cancer drugs.
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Spikevax
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Moderna sues Pfizer and BioNTech over mRNA COVID-19 vaccines
Moderna alleges that Pfizer and BioNTech used its patented mRNA vaccine technologies in the Comirnaty® COVID-19 vaccine without its permission.
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UK approves Moderna’s bivalent COVID-19 vaccine
MHRA approves Moderna’s adapted COVID-19 vaccine, Spikevax bivalent Original/Omicron, for use as a booster.
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CHMP meeting highlights – July 2022
At its July meeting, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended 11 medicines for approval and extended the indication of six more, including Imvanex for the prevention of monkeypox.
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Moderna announces UK mRNA Innovation and Technology Centre
Moderna to establish a UK mRNA Innovation and Technology Centre to produce mRNA vaccines for COVID-19, influenza, respiratory syncytial virus (RSV) and more.
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EMA’s PRAC June meeting highlights
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) finds the benefits of amfepramone medicines do not outweigh their risks and addressed possible links between COVID-19 vaccines and menstruation.
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Moderna and ROVI face further particulate problems with Spikevax®
A lot of Moderna’s Spikevax® vaccine is being recalled due to particulates, just six months after previous contamination concerns were supposedly solved.
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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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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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Second COVID-19 vaccine ‘Spikevax’ is approved by the FDA
The FDA has approved a second vaccine, marketed as Spikevax, shown to be 93 percent effective in preventing COVID-19.
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MCAP for top bio/pharma companies reached $3.4 trillion in 2021
Market capitalisation (MCAP) for the top bio/pharma companies grew 24.9 percent in 2021, with BioNTech and Moderna entering the top 20 for the first time.
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Could COVID-19 vaccines be freeze dried?
US researchers have been granted $930,000 to develop a freeze drying technique for mRNA-based COVID-19 vaccines.
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mRNA COVID-19 vaccines safe for pregnant women, finds EMA review
A review of studies involving 65,000 pregnancies suggests mRNA COVID-19 vaccines do not increase the risk of pregnancy complications.
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Six COVID-19 boosters are safe and effective, shows Phase II study
Study finds six different COVID-19 vaccine boosters increase immunity and pose no safety concerns, although immune responses varied.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Dec 2021
EMA's drug safety committee (PRAC) confirmed the risks of myocarditis and pericarditis with COVID-19 messenger RNA (mRNA) vaccines.
