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- 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

Lilly signs $1.25bn collaboration deal with MiNA Therapeutics

Lilly will pay MiNA $25m upfront as well as milestones payments of up to a total of $245m per target

- 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

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

Eli Lilly/AbCellera’s COVID-19 variant-targeting antibody enters clinical trials

Drug will be evaluted alone and together with other monoclonal antibodies in the expanded BLAZE-4 trial

- PMLiVE

Novartis announces delay in UK cholesterol drug study

The delay was caused by recruitment issues during the COVID-19 pandemic

- PMLiVE

Lilly cuts 2021 guidance to reflect ‘lower expected revenue’ from COVID-19 antibody sales

FDA recently removed emergency authorisation for bamlanivimab monotherapy

- 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

- PMLiVE

J&J halts manufacturing of COVID-19 at US plant after FDA warning

Inspection report found facility was “not maintained in a clean and sanitary condition”

- PMLiVE

Lilly asks to revoke emergency authorisation for bamlanivimab monotherapy in the US

Decision prompted by the ‘evolving variant landscape’ in the US

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