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MHRA approves Leqembi IV maintenance as additional Alzheimer’s option
Decision provides UK Alzheimer’s patients with an alternative administration method for Eisai and Biogen’s antibody drug.
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Clinical Development
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Roche’s fenebrutinib shows best-in-disease potential in multiple sclerosis
Phase III data suggest the drug could be the first high-efficacy, oral therapy for relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis.
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Lilly bolsters leadership team with neuroscience and immunology in mind
Dr Carole Ho joins from Denali Therapeutics and there are promotions for Adrienne Brown and Daniel Skovronsky.
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MHRA set to overhaul the UK’s rare disease drug regulatory pathway
The medicines regulator will aim to take a more flexible licensing approach for the research and manufacture of rare disease therapies in the UK.
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FDA draft guidance on biosimilars offers “regulatory relief”
US agency follows in footsteps of European Medicines Agency (EMA) in efforts to streamline biosimilar development.
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Sirolimus-eluting balloon offers potential “paradigm shift” in restenosis treatment
Treatment provided a promising alternative to standard care in repeat percutaneous coronary interventions in the first-of-a-kind trial.
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Alexion wins EU label expansion for kinase inhibitor Koselugo
Approval provides continuity of care into adulthood for patients with neurofibromatosis type 1 (NF1) using Koselugo (selumetinib) to manage symptoms.
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Novartis strengthens neuroscience pipeline with $12bn Avidity acquisition
Deal to advance potential first-in-class RNA therapeutics focused on genetic neuromuscular diseases such as Duchenne muscular dystrophy.
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Lilly’s baricitinib exhibits paediatric potential in major alopecia areata study
Results from the phase III study signify a successful collaboration with biopharma firm Incyte.
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Phase III data for next-gen green inhaler push GSK closer to Net Zero targets
New findings support use of salbutamol MDI formulation in the next-generation low carbon propellant as a more sustainable option for patients with respiratory disease.
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Ipsen strikes €1bn deal to acquire French biotech ImCheck Therapeutics
The move will boost its oncology pipeline, adding a potential first-in-class anti-BTN3A monoclonal antibody for acute myeloid leukaemia.
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Keytruda post-surgery could halt return of distant tumours in rare skin cancer
Merck & Co’s anti-PD-1 immunotherapy showed evidence at ESMO of its ability to prevent cancer recurrence in Merkel cell carcinoma.
![Close up view of the Merck logo on the top corner of a glass building [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Merck-aquisition-300x278.jpg)
![Close up view of the Merck logo on the top corner of a glass building [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Merck-aquisition-scaled-e1605009301887.jpg)
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Merck & Co starts phase IIb study of tulisokibart in rheumatoid arthritis
The study is one of three to start, along with those in hidradenitis suppurativa and radiographic axial spondyloarthritis.
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Novel topical formulation demonstrates potential in peripheral neuropathy
Offers potential symptomatic relief for cancer patients with chemotherapy-induced peripheral neuropathy (CIPN).
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Takeda withdraws from clinical cell therapy activities
The company will instead focus its attention on advancing candidates for modalities that include biologics and ADCs.
