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- PMLiVE

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Merck & Co spinoff Organon launches with the aim of ‘improving health outcomes for women’

Merck & Co – known as MSD outside the US and Canada – announced its plans for the women’s health spinoff company last month

- PMLiVE

EMA authorises Pfizer/BioNTech’s COVID-19 vaccine for children aged 12 to 15

Clinical trial data recently showed that the vaccine is safe and effective in individuals in this age group

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bluebird bio’s CALD gene therapy Skysona gains positive opinion from CHMP

CHMP's marketing authorisation recommendation is a step towards gaining EU approval

- PMLiVE

New trial data for Keytruda in triple-negative breast cancer

Keytruda plus chemotherapy showed significant and meaningful improvement

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EMA introduces new measures to enable flexibility for non-COVID-19 procedures

Regulator will streamline processes to allow its experts to focus on COVID-19-related assessments

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FDA approval for Keytruda/Herceptin combination in first-line advanced gastric cancer

Approval is based on positive overall response rate (ORR) data from KEYNOTE-811 trial

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Merck & Co reveals plans for women’s health spinoff Organon

Company is expecting tax-free dividend of $9bn following close of spinoff

- PMLiVE

Janssen will not seek regulatory approval for Erleada plus Zytiga in prostate cancer

Decision follows mixed results from the phase 3 ACIS study

- PMLiVE

Merck & Co halts development of potential COVID-19 drug MK-7110

Pharma company has abandoned drug due to technical, clinical and regulatory uncertainties

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J&J’s multiple sclerosis therapy Ponvory moves closer to EU approval

CHMP issues a positive opinion for S1P1 modulator based on positive phase 3 results

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EMA begins accelerated review of Gilead’s Trodelvy for triple-negative breast cancer

FDA approved the antibody-drug conjugate in this indication in April 2020

- PMLiVE

Keytruda plus chemotherapy gains US approval for advanced oesophageal cancer

First checkpoint inhibitor to win approval in the first-line setting for this cancer type

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