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CHMP’s September 2023 meeting highlights
In its September 2023 meeting, the EMA’s human medicines committee (CHMP) recommended nine medicines for approval and the extension of therapeutic indications for 11 medicines.
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COMIRNATY®
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CHMP recommends updated Omicron vaccine
Pfizer and BioNTech’s adapted Omicron XBB.1.5 COVID-19 vaccine has been recommended for two additional indications in the EU.
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Comirnaty® authorised for patients six months to four years
Comirnaty® has been authorised by the MHRA as a vaccine to protect against Covid-19 for individuals from six months to four years old.
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EMA human medicines committee (CHMP) highlights, November 2022
The Committee for Medicinal Products for Human Use (CHMP)’s November meeting consisted of approval recommendations for four medicines, including a biosimilar for osteoporosis and a new COVID-19 vaccine.
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EMA human medicines committee (CHMP) highlights, September 2022
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval, including those for rare diseases, osteoporosis and cancer.
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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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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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Shifting from megamergers to strategic collaboration: M&A predictions for biopharma
In 2021 we saw deals move away from the massive megamergers of 2019 to smaller collaboration and partnership agreements. In this article, European Pharmaceutical Review’s Hannah Balfour discusses the key deals of last year, whether the trend of high volume but small value will continue in 2022, and the motivations…
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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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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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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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Promising results for COVID-19 and pneumococcal vaccine co-administration
Pfizer reveals co-administering its Prevnar 20™ pneumococcal vaccine and a booster dose of Comirnaty® COVID-19 vaccine was safe and immunogenic.
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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.
