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- PMLiVE

Sobi

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Sobi receives EC marketing authorisation for Altuvoct in haemophilia A

The rare bleeding disorder affects approximately one in every 5,000 male births annually

- PMLiVE

AstraZeneca’s Truqap plus Faslodex granted EC approval to treat advanced breast cancer

More than 550,000 new cases of breast cancer were diagnosed in Europe in 2022

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EMA announces launch of two advice pilots to improve clinical trials in Europe

The pilots are part of the Accelerating Clinical Trials in the EU initiative to foster high-quality clinical research

- PMLiVE

Roche’s ALK inhibitor Alecensa granted EC approval to treat early-stage lung cancer

Non-small cell lung cancer represents up to 85% of all lung cancer diagnoses

Biogen Idec building

Biogen’s Qalsody granted EC approval to treat rare form of ALS in adults

Mutations in the SOD1 gene are responsible for an estimated 2% of all ALS cases

- PMLiVE

Bristol Myers Squibb’s Opdivo approved by EC for adults with urothelial carcinoma

UC accounts for approximately 90% of all bladder cancers, the ninth most common cancer globally

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European Commission finalises joint clinical assessment rules for faster access to medicines

Established under the regulation on Health Technology Assessment, the new rules are set to commence in January 2025

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EC approves Celltrion’s omalizumab biosimilar Omlyclo for immunological conditions

The drug can be used to treat patients with conditions including chronic spontaneous urticaria

- PMLiVE

Sanofi and Sobi’s Altuviiio label updated by FDA with expanded paediatric data in haemophilia A

The therapy’s weekly dosing has a half-life of up to four times longer than current factor VIII therapies

- PMLiVE

Novo Nordisk’s haemophilia A therapy Mim8 shows promise in late-stage study

Haemophilia A accounts for up to 85% of the 1,125,000 global haemophilia cases

- PMLiVE

Sobi’s Aspaveli receives expanded EC approval for rare blood disorder PNH

The C3 therapy can now be used as a first-line treatment for paroxysmal nocturnal haemoglobinuria

- PMLiVE

Sanofi/Sobi’s efanesoctocog alfa recommended by CHMP to treat haemophilia A

The rare genetic condition reduces production of factor VIII, an essential protein for blood clotting

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