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Terrosa

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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

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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

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CHMP recommends eight new medicines for EU approval

BMS’ CAR T therapy Abecma and BioMarin’s dwarfism drug Voxzogo among positive recommendations

Sanofi reception

Sanofi’s oral therapy Aubagio approved in the EU for paediatric MS patients

EC approval comes a few weeks after the FDA rejected Aubagio in the same patient population

- PMLiVE

Piloting a route to the biosimilars opportunities in Europe

Investigating the EU regulatory hurdles that life sciences companies face as they seek to improve patient access to biosimilar therapy

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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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Positive results for AZ, Merck & Co’s Lynparza in early breast cancer presented at ASCO

Lynparza reduced the risk of invasive breast cancer recurrence, second cancers or death by 42% in the overall trial population

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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

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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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Sanofi, GSK begin enrolment for phase 3 COVID-19 vaccine study

Study will investigate two formulations targeting the Wuhan strain and the South African variant

- PMLiVE

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

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

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