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- PMLiVE

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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

- PMLiVE

AstraZeneca’s Tagrisso combination receives CHMP recommendation for advanced lung cancer

More than 450,000 people are diagnosed with lung cancer every year in Europe

- PMLiVE

Pfizer shares positive five-year results for Lorbrena in advanced lung cancer

The majority of Lorbrena-treated patients were alive without disease progression after five years

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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

- 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

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

- PMLiVE

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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