AstraZeneca, Daiichi win EU backing for breast cancer drug Dato-DXd
Daiichi Sankyo (OTCPK:DSKYF) (OTCPK:DSNKY) announced Friday that an expert panel of the EU drug regulator, the European Medicines Agency (EMA), endorsed its antibody-drug conjugate Dato-DXd marketed with AstraZeneca (NASDAQ:AZN) as a late-line option for certain cases of breast cancer.
pharmaphorum21m
EMA experts will look again at Leqembi's safety data
In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at up-to-date safety data on Leqembi (lecanemab) at its next meeting in February.
EU medicines agency quits X, moves to Bluesky
The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming the latest organisation to quit a social media platform that some have criticised for its content.
Merck’s capvaxive receives positive EU CHMP opinion for pneumococcal vaccine
Merck (MRK) announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, recommended
The Pharma Letter1d
EU’s shortages monitoring platform fully operational
The use of the ESMP will become mandatory for MAHs and NCAs as of Sunday, February 2. The platform is a key requirement of the European Medicines Agency’s extended mandate, enhancing shortages monitoring and preparedness across the European Union (EU)/European Economic Area (EEA).
GSK says asthma and nasal polyps therapy under EU review
GSK (GSK) stock in focus as its experimental drug depemokimab undergoes EU review for asthma and nasal polyps. Read more here.
devdiscourse4d
EMA Shifts Digital Platform from X to Bluesky Amid Content Concerns
The European Medicines Agency (EMA) has decided to stop using the social media platform X due to content concerns and will instead use Bluesky. This move aligns with other organizations stepping back from X,
Euro Weekly News5d
Paracetamol risk: EU watchdog demands urgent review over new side effect
Paracetamol, now comes with a shocking new warning: it could lead to a dangerous condition called metabolic acidosis if misused or overused.
Pharm Exec3d
EMA Takes Break From X, Joins Bluesky
The government agency says X no longer suits its communication needs.
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Merck Receives Positive EU CHMP Opinion for CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Pneumococcal Vaccination in Adults
Vaccination with CAPVAXIVE may not protect all vaccine recipients.
pharmaphorum9d
EMA’s strategy for speeding up drug approvals in the EU
The EMA is implementing major changes to accelerate drug approvals in the EU, addressing delays that affect patients and businesses alike. Following a turbulent period marked by Brexit and the ...
EuropaWire3d
GSK Announces EMA Review of Prefilled Syringe Presentation for Shingrix Vaccine
GSK has announced that the European Medicines Agency (EMA) has accepted its regulatory application for a prefilled syringe presentation of Shingrix