Category: European Medicines Agency

Biogen pulls Alzheimer’s drug application in Europe as EMA calls data insufficient

April 22, 2022 Auto Bot 0

Biogen withdrew an application seeking approval in Europe for Alzheimer’s disease drug Aduhelm, a move that follows a negative opinion on the therapy issued by […]

Biogen’s Alzheimer’s drug is unlikely to win E.U. approval.

November 18, 2021 Auto Bot 0

The drug, Aduhelm, has been mired in controversy since it was in approved in the United States in June.

Biogen’s Alzheimer’s drug is unlikely to win E.U. approval.

November 18, 2021 Auto Bot 0

The drug, Aduhelm, has been mired in controversy since it was in approved in the United States in June.

Biogen’s Alzheimer’s drug is unlikely to win E.U. approval.

November 17, 2021 Auto Bot 0

The drug, Aduhelm, has been mired in controversy since it was in approved in the United States in June.

Biogen’s Alzheimer’s drug is unlikely to win E.U. approval.

November 17, 2021 Auto Bot 0

The drug, Aduhelm, has been mired in controversy since it was in approved in the United States in June.

Pfizer Booster Can Be Given After 6 Months, European Drug Agency Says

October 5, 2021 Auto Bot 0

The European Medicines Agency also said that extra doses of the Moderna and Pfizer-BioNTech vaccines could be given to people with underlying health conditions as […]

Pfizer Booster Can Be Given After 6 Months, European Drug Agency Says

October 4, 2021 Auto Bot 0

The E.U.’s main drug regulator also said that extra doses of the Moderna and Pfizer-BioNTech vaccines can be given to those with underlying health conditions […]

European Union Regulator Authorizes Vaccine for Children 12 to 15 Years Old

May 28, 2021 Auto Bot 0

The United States began vaccinating children in that age group earlier this month.

European Union Regulator Authorizes Vaccine for Children 12 to 15 Years Old

May 28, 2021 Auto Bot 0

The United States began vaccinating children in that age group earlier this month.

European Union Regulator Authorizes Vaccine for Children 12 to 15 Years Old

May 28, 2021 Auto Bot 0

The United States began vaccinating children in that age group earlier this month.

How will NICE fare in a post-Brexit world?

May 14, 2021 Auto Bot 0

NICE has a global reputation as a pioneering HTA – but is that influence at risk now that the UK has left the EU? Experts […]

EMA: Blood clots are ‘very rare’ side effect of AstraZeneca Covid-19 vaccine

April 7, 2021 Auto Bot 0

A European Medicines Agency review concluded AstraZeneca’s Covid-19 vaccine may be linked to cases of blood clots. The regulator directed the company to conduct more […]

Why Supply Isn’t the Only Thing Stymying Europe’s Coronavirus Vaccine Rollout

March 25, 2021 Auto Bot 0

Bureaucratic inertia, a diffusion of responsibility and logistical problems have seriously undercut vaccination efforts. In Italy, it’s the older population that bears the brunt.

Why Supply Isn’t the Only Thing Stymying Europe’s Coronavirus Vaccine Rollout

March 25, 2021 Auto Bot 0

Bureaucratic inertia, a diffusion of responsibility and logistical problems have seriously undercut vaccination efforts. In Italy, it’s the older population that bears the brunt.

Supply Isn’t the Only Thing Stymying Europe’s Vaccine Rollout

March 25, 2021 Auto Bot 0

Bureaucratic inertia, a diffusion of responsibility and logistical problems have seriously undercut vaccination efforts. In Italy, it’s the older population that bears the brunt.