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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

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

Amgen’s Biosimilar Trends Report shows benefit of competition from biosimilars

Competition created by biosimilars has delivered $9.8bn in savings over five years and could reduce patients’ out-of-pocket costs by $238m

- PMLiVE

Green light for Amgen’s KRAS inhibitor in the UK

Lumakras – known as Lumykras in the UK – will be available to 600 lung cancer patients in England through an early access scheme.

- 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

- PMLiVE

Tezepelumab effective in severe asthma with comorbid nasal polyps

Amgen’s novel drug offers hope to the one-in-five people with severe asthma who also have nasal polyps

- PMLiVE

CureVac to push ahead with first- and second-generation COVID-19 vaccines

The biotech will seek EMA approval for first-generation jab while trials are due to start for second-generation jabs in Q4

- PMLiVE

EMA to evaluate Roche arthritis drug RoActemra for severe COVID-19

FDA approval has already been granted following positive phase 3 trials

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