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Clinical reports

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Janssen submits marketing authorisation to EMA for teclistamab

The drug has been developed to treat patients with relapsed or refractory multiple myeloma, an incurable blood cancer

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EMA proposes EU clinical trial reforms

The ACT EU paper provides a list of regulatory network objectives, priorities and governance strategies for 2022-2023

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Amgen’s Lumykras receives conditional marketing authorisation from EC

The drug is the first targeted therapy for patients diagnosed with advanced NSCLC with the KRAS G12C mutation

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AstraZeneca’s Saphnelo to be approved in Europe for lupus

The EMA is set to approve the first new treatment for systemic lupus erythematosus in Europe in more than a decade

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Gilead’s Trodelvy approved for triple-negative breast cancer in Europe

European patients with metastatic triple-negative breast cancer can now receive the antibody-drug conjugate as second-line monotherapy

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

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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

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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

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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

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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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