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.
List view / Grid view
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.
Moderna alleges that Pfizer and BioNTech used its patented mRNA vaccine technologies in the Comirnaty® COVID-19 vaccine without its permission.
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…
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.
EMA’s pharmacovigilance committee recommends product information updates for two COVID-19 vaccines - Janssen COVID-19 Vaccine and Moderna’s Spikevax.
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.
A review of studies involving 65,000 pregnancies suggests mRNA COVID-19 vaccines do not increase the risk of pregnancy complications.
Pfizer reveals co-administering its Prevnar 20™ pneumococcal vaccine and a booster dose of Comirnaty® COVID-19 vaccine was safe and immunogenic.
Study finds six different COVID-19 vaccine boosters increase immunity and pose no safety concerns, although immune responses varied.
EMA's drug safety committee (PRAC) confirmed the risks of myocarditis and pericarditis with COVID-19 messenger RNA (mRNA) vaccines.
The human medicines committee issue a positive opinion on the COVID-19 vaccine Comirnaty® in children aged five to under 12 years.
The US Food and Drug Administration has authorised the emergency use of COVID-19 vaccine Comirnaty in children aged five to 11 years.