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- PMLiVE

NICE approval for Lilly’s Verzenios is “fantastic news for thousands of women”

NICE declares Lilly’s breast cancer drug to be cost-effective, allowing routine use on the NHS

- PMLiVE

Lilly and Kumquat Biosciences link up in $2bn-plus immuno-oncology deal

The deal will see Kumquat utilise its small molecule immune-oncology platform to discover novel clinical assets

- PMLiVE

Lilly and Banner Alzheimer’s Institute collaborate on donanemab prevention trial

Trial will evaluate donanemab in participants at risk for cognitive and functional decline related to Alzheimer’s

- PMLiVE

Eli Lilly to acquire Protomer Technologies in a deal worth over $1bn

Protomer Technologies is a US biotech company focused on engineering glucose-responsive insulin

- PMLiVE

FDA leaders offer perspective on accelerated approval of Biogen’s Aduhelm

Leaders maintain that Aduhelm fits into the regulatory paradigm of the FDA’s accelerated approval pathway

- PMLiVE

FDA questions safety profile of AZ, FibroGen’s anaemia drug roxadustat

AZ and FibroGen are aiming for approval of roxadustat in anaemia caused by chronic kidney disease

- PMLiVE

FDA acting commissioner Janet Woodcock requests independent review of Aduhelm approval

Approval of Biogen's Alzheimer's disease treatment has raised concerns over FDA staff interactions with the company

- PMLiVE

Pfizer, BioNTech eye US approval for COVID-19 booster dose

Companies plan to request an emergency use authorisation from the FDA for the booster dose in August

- PMLiVE

Breakthrough therapy designated for Lilly’s investigational Alzheimer’s drug donanemab

The BTD is based on data from the phase 2 TRAILBLAZER-ALZ study in early symptomatic Alzheimer's patients

- PMLiVE

Lilly showcases tirzepatide type 2 diabetes data at ADA 2021

Company is planning to submit the full data package for tirzepatide to regulatory authorities by the end of 2021

- PMLiVE

US pauses shipments of Eli Lilly’s COVID-19 antibody treatment due to variant concerns

Laboratory analyses found the therapy was not effective against variants first discovered in South Africa and Brazil

- PMLiVE

Eli Lilly demonstrates Verzenio win in high-risk breast cancer subset at ASCO

Verzenio plus endocrine therapy reduced the risk of patients developing metastatic disease by 39%

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