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- PMLiVE

European Commission

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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

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Biogen to expand immunology and rare disease portfolio with $1.8bn HI-Bio acquisition

The company will gain access to HI-Bio’s lead asset for immune-mediated and rare diseases

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Biogen and Eisai announce rolling FDA submission for injectable version of Alzheimer’s drug

The Leqembi SC autoinjector could reduce the need for hospital visits and nursing care compared to IV administration

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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

BeiGene’s Tizveni receives EC approval to treat non-small cell lung cancer

Under the brand name Tevimbra, the company will combine the NSCLC indications with the second-line ESCC indication in late 2024

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Biogen’s tocilizumab biosimilar Tofidence recommended by CHMP to treat arthritis and COVID-19

The committee’s decision was supported by evidence demonstrating Tofidence’s similarity to Roche’s RoActemra

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J&J and Legend’s Carvykti receives EC approval to treat relapsed and refractory multiple myeloma

The BCMA-targeted therapy is the first to receive approval in Europe for RRMM patients as early as first relapse

- PMLiVE

Astellas announces EC approval of Xtandi for expanded prostate cancer use

Up to 40% of patients who have undergone definitive prostate cancer treatment will experience biochemical recurrence within ten years

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AstraZeneca’s Voydeya granted EC approval to treat rare blood disease PNH

The factor D inhibitor has been authorised for use alongside the company’s complement C5 inhibitors

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