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- PMLiVE

Ebola virus

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EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine

The vaccine is currently the only inactivated, whole virus adjuvanted candidate in clinical trials in Europe

- PMLiVE

Biogen retracts EMA application for Alzheimer’s drug Aduhelm

The application was pulled after the CHMP said the data provided was not enough to support a marketing authorisation

- PMLiVE

EMA and ECDC publish advice on fourth doses of mRNA COVID-19 vaccines

The regulators have concluded that there is not enough supporting evidence for an immediate fourth dose

- PMLiVE

FDA delays Merck’s pneumococcal vaccine Vaxneuvance

It is predicted that the vaccine could make over $1bn in peak sales

- PMLiVE

Merck’s Keytruda receives FDA approval for advanced endometrial cancer

The approval was based on new data from the KEYNOTE-158 trial

- PMLiVE

Merck and Ridgeback fulfil US deal for molnupiravir

Over three million courses of the investigational oral antiviral COVID-19 treatment have been supplied

- PMLiVE

Merck’s Keytruda combined with chemotherapy could benefit thousands of breast cancer patients

The combination significantly reduces cancer recurrence by approximately 37% and reduces secondary breast cancer by 39%

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EMA establishes DARWIN EU Coordination Centre

The new centre will give the EMA and other EU member states access to reliable, real-world evidence for EU medicine assessments

- PMLiVE

Merck and Eisai share crucial phase 3 trial results for advanced endometrial carcinoma treatment

The study evaluated the combination of Lenvima plus Keytruda versus chemotherapy for patients diagnosed with advanced, metastatic, or recurrent endometrial carcinoma

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EMA proposes EU clinical trial reforms

The ACT EU paper provides a list of regulatory network objectives, priorities and governance strategies for 2022-2023

- PMLiVE

Keytruda gains eighth FDA approval this year

Merck’s megablockbuster Keytruda has returned to its roots with a new indication in melanoma, the therapy area where it was first approved seven years ago

- PMLiVE

Results for Merck’s oral cholesterol inhibitor show it to be ‘highly effective’

Results announced at the American Heart Association Scientific Sessions this week suggest the drug dramatically cuts LDL cholesterol levels

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