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- PMLiVE

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EMA reports actions to improve EU clinical trials conducted during health emergencies

All proposed actions will be acknowledged by the European Commission, EMA and member states

- PMLiVE

Sandoz granted positive CHMP opinion for multiple sclerosis biosimilar

The neurological disease affects approximately 2.8 million people worldwide

- PMLiVE

AstraZeneca/Sanofi’s RSV antibody receives FDA approval for use in infants

Beyfortus is the now first preventive option approved in the US to protect a broad infant population

- PMLiVE

Sanofi and Scribe announce in vivo genetic therapy partnership worth over $1.2bn

The agreement expands the companies’ existing collaboration focused on ex vivo editing

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EU establishes €100m funding scheme for projects tackling public health threats

The HERA Invest fund will focus on health emergency prevention and preparedness initiatives

- PMLiVE

Roche’s Ocrevus shows promise as a subcutaneous injection in phase 3 MS trial

The therapy is already approved for certain MS patients as a twice-yearly intravenous infusion

- PMLiVE

Roche’s fixed-duration lymphoma treatment approved by European Commission

Approximately 36,000 people are diagnosed with DLBCL each year in Europe

- PMLiVE

Novavax’s COVID-19 vaccine granted full marketing authorisation in EU

The EC’s decision was supported by positive results from a phase 3 trial evaluating Nuvaxovid

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European Commission approves Amicus Therapeutics’ Pompe disease therapy

The company can now offer Opfolda together with its previously-approved Pombiliti

- PMLiVE

Sanofi’s amlitelimab shows promise in phase 2b atopic dermatitis trial

The inflammatory skin disease affects an estimated 16.5 million adults in the US

- PMLiVE

Sanofi and Sobi’s haemophilia A treatment shows effective bleed protection in children

Current factor VIII therapies usually require patients to receive treatment multiple times a week

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European Commission grants two new marketing authorisations for UCB’s Bimzelx

The drug is now approved to treat psoriatic arthritis and axial spondyloarthritis

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