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- PMLiVE

CHMP recommends use of Moderna’s Omicron BA.1 booster in children in the EU

The company is also evaluating the use of the vaccine in children aged from six months

- PMLiVE

Sanofi/ Regeneron’s Dupixent recommended by CHMP to treat eosinophilic oesophagitis

Patients in a phase 3 trial experienced improvements in their ability to swallow after four weeks

- PMLiVE

AstraZeneca’s Tezspire recommended for approval in the EU by CHMP

The recommendation is for the treatment of severe asthma as an add-on therapy for patients 12 years and above

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- 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

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