All articles by CE – Page 14
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NewsFDA names Dr Richard Pazdur to replace George Tidmarsh as CDER Director
The FDA-veteran and oncology specialist will lead the US drug agency’s work ensuring the safety and efficacy of medicines.
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NewsRoche’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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Policy reform call to secure Europe’s antibiotics supply
Supply crisis of antibiotics in Europe adds burden to regional efforts to overcome antimicrobial resistance (AMR), says a new report.
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NewsLilly 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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NewsThermally driven chemical reaction shows drug manufacturing promise
The “simple” approach for initiating electron transfer reactions could enable synthesis of small molecule drugs, researchers say.
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NewsMHRA selects Prof Jacob George as its first Chief Medical and Scientific Officer
The cardiovascular expert will head the UK medicines regulator’s science and innovation strategies.
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Lilly boosts oral GLP-1 manufacturing capability with new Netherlands facility
The €2.6 billion manufacturing investment complements the recent US manufacturing expansion for its next potential blockbuster obesity treatment orforglipron.
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NewsMHRA 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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Pfizer and Novo Nordisk battle for obesity market dominance
Novo Nordisk’s “bold” $6.5 billion bid subject to a final verdict by Metsera’s board of directors.
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FDA draft guidance on biosimilars offers “regulatory relief”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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NewsRaman-based PAT tool could advance continuous vaccine manufacturing
Study demonstrates the non-invasive tool’s potential for real-time monitoring of cytomegalovirus (CMV) viral particles.
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Lilly AI factory to accelerate pharmaceutical manufacturing and development
Pharma giant plans to harness its “decades of data” and use AI to set a new scientific standard that accelerates pharmaceutical innovation.
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NewsSirolimus-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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NewsAlexion 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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NewsAI/ML investment strong as UK biotech weathers economic strain
With Q3 2025 venture capital figures representing “a fragile moment” for the UK biotech sector, BIA says sustained government action is needed to secure its global competitive edge.
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NewsNovartis 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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NewsLilly'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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NewsRentschler Biopharma marks construction milestone at new German buffer media facility
The new biopharmaceutical production facility represents the CDMO’s largest single investment at its headquarters in Lauphei, Germany.
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NewsPhase 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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NewsIpsen 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.