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Bayer’s BlueRock Therapeutics gains FDA fast track for Parkinson’s disease cell therapy

In 2019, Bayer bought out its private equity partner Versant Ventures and founders in BlueRock Therapeutics for $240m

- PMLiVE

GSK reveals plans for £400m R&D facility expansion in England

GSK has formally started the process of seeking a development partner for the expansion plans

- PMLiVE

Keytruda scores a win in treating early-stage breast cancer pre- and post-surgery

The FDA had previously rejected a supplemental biologics licence application in this indication

- PMLiVE

FDA advisory committee votes against approval of AZ, FibroGen’s roxadustat

Briefing documents published earlier this week raised questions over the safety profile of roxadustat

- PMLiVE

FDA rejects Provention Bio’s type 1 diabetes prevention drug

FDA said a study of healthy volunteers failed to demonstrate that the planned commercial product is comparable to an older version used in previous clinical trials

- PMLiVE

GSK supports CEO Emma Walmsley following Elliott’s demands for leadership overhaul

GSK’s board said that it ‘strongly believes’ Walmsley is the ‘right leader’ for the new biopharma business

- PMLiVE

GlaxoSmithKline agrees $2.2bn dementia mAb deal with Alector

The focus of the deal is two clinical-stage monoclonal antibodies in development for a number of neurodegenerative diseases

- PMLiVE

Elliott Management puts pressure on GSK after years of ‘disappointing performance’

Hedge fund has published a 17-page letter outlining recommendations following GSK's investor day last week

- 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

GSK aims for £33bn in sales by 2031 as CEO Walmsley lays out ten-year strategy

'New' GSK will build on growth potential of its vaccines and speciality medicines portfolios

Biogen Idec building

Biogen plans confirmatory trial as FDA documents show struggle over Aduhelm approval

Confirmatory trial is planned to be completed ahead of nine-year time frame

- PMLiVE

GSK partners with iTeos Therapeutics on next-gen immuno-oncology drug

British drug-maker will pay $625m upfront for access to iTeos' anti-TIGIT monoclonal antibody

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