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- PMLiVE

FDA approves Apellis’ Empaveli for rare blood disease

PEGASUS study results show Empaveli is better than Soliris at improving haemoglobin levels

- PMLiVE

Sanofi, GSK’s COVID-19 vaccine generates strong immune responses across all age groups

Sanofi/GSK delayed their COVID-19 vaccine programme in December 2020 after the vaccine candidate induced low immune responses in older adults

- PMLiVE

Positive results for GSK/CureVac’s COVID-19 vaccine

Vaccine candidate generated strong immune responses in preclinical testing

- PMLiVE

New court filing alleges Sanofi destroyed emails relating to Zantac recall

Drugmaker began recalling heartburn drug in 2019 after link to probable human carcinogen

- PMLiVE

Emergency authorisation for Pfizer/BioNTech vaccine expanded in the US

Data from a study involving 12 to 15 year olds has also been submitted to the EMA for potential approval

- PMLiVE

Pfizer, BioNTech file for full US approval of COVID-19 vaccine

Pfizer chief executive Albert Bourla said last week the company is on track to supply 2.7bn doses in 2021

- PMLiVE

EMA launches rolling review of GSK/Vir Biotech’s mAb for early COVID-19

Rolling review supported by interim analysis of data from phase 3 COMET-ICE trial

- PMLiVE

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

- PMLiVE

US backs proposal to waive IP protection for COVID-19 vaccines

"Monumental decision" could see IP protections for COVID-19 vaccines temporarily removed

- PMLiVE

GSK’s revenue drops by 18% in Q1 as performance pressures mount

Chief executive Emma Walmsley said results ‘reflect the anticipated impacts of COVID-19’

- PMLiVE

J&J resumes US rollout of single-dose COVID-19 vaccine

CDC and FDA recommended pause be lifted after ‘rigorous review’ of very rare blood clots

- PMLiVE

GSK wins approval for anti-PD-1 antibody Jemperli in endometrial cancer

AnaptysBio earns a $20m milestone payment on approval after originally developing the drug

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