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- PMLiVE

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Biogen Idec building

Biogen’s Aduhelm unlikely to get approval in Europe

In another setback for the controversial Alzheimer’s disease antibody, the EMA’s review committee has voted against recommending the treatment

regeneron headquarters

Regeneron’s COVID-19 antibody cocktail approved in Europe

Ronapreve (REGEN-COV in the US) has been approved for non-hospitalised, at-risk patients and for prevention of COVID-19

- PMLiVE

Roche and Novartis part ways with share purchase

Novartis is to sell its one-third stake in Roche for more than $20bn, paving the way for potential acquisitions

- PMLiVE

Novartis invests $1.3bn in protein degradation technology

Novartis will work with UK-based start-up Dunad Therapeutics to develop protein degradation drugs

- PMLiVE

Novartis receives approval for third-generation leukaemia therapy

With a novel mechanism of action, Scemblix is a new option for people with chronic myeloid leukaemia who experience intolerance or inadequate response to standard therapy

- PMLiVE

Eli Lilly focuses on 2022 launches as revenues climb by 18%

Revenues in the third quarter of 2021 were driven by volume growth in new medicines, but earnings per share were a fraction below analysts’ predictions

- PMLiVE

Novartis sales top £13bn in Q3 as the company reviews its generic business Sandoz

The company has started a strategic review of Sandoz as sales drop 20% in ‘challenging’ US market

- PMLiVE

Gilead’s Trodelvy set for EU approval in breast cancer

The positive opinion from EMA’s CHMP means Trodelvy could be available as second-line treatment for unresectable or metastatic breast cancer before the end of the year

regeneron headquarters

FDA accepts Regeneron’s REGEN-COV for priority review for treatment of COVID-19

In Europe, the EMA will review a Marketing Authorisation Application for the antibody cocktail

- PMLiVE

NICE recommends Novartis’ Adakveo for sickle cell disease

The treatment for sickle cell disease is the first in more than 20 years

- PMLiVE

Strong five-year survival data for Kisqali in breast cancer

Novartis’ Kisqali plus letrozole offers more than a year survival benefit for postmenopausal women with HR+/HER2 advanced breast cancer

- PMLiVE

Future of MHRA uncertain amid Brexit-fuelled shake up

Trade unions and regulatory experts warn that budget and staff cuts may lead to drug approval delays or the UK regulator simply rubber-stamping EMA decisions

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