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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

GSK’s ViiV submits application for cabotegravir to EMA for HIV-1 prevention

Cabotegravir offers up to two months of protection from a single injection

- PMLiVE

GSK’s ViiV and Medicines Patent Pool agree deal for HIV prevention

The agreement aims to expand access to HIV prevention in the developing world

- 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

- PMLiVE

NICE recommends long-acting HIV therapy developed by ViiV Healthcare and Janssen

People with HIV-1 in England and Wales can swap their daily tablets for a two-monthly injection regimen from 2022, joining HIV patients in Europe and the US

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

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