News – Page 13
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NewsFDA hits Sarepta with liver warning labelling for its DMD drug Elevidys
As well as the new safety warnings for the Duchenne muscular dystrophy gene therapy, the biopharma company also faced a new, more restrictive licence for the treatment.
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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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NewsGenetically engineered iPSCs see clinical-scale platelet manufacturing potential
By utilising patient-derived instead of donor-derived platelets, the method could offer a safer approach to platelet transfusions.
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NewsCRDMO BioDuro appoints Yaohui Ji as global president for CMC
He joins from contract development and manufacturing organisation Porton Pharma Solutions.
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NewsPharma's sustainability push continues as Merck signs renewable energy deal
The German pharma company’s agreement for its South Korea sites is the latest green initiative to be unveiled by the industry.
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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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Novartis opens third US radioligand manufacturing facility
California site adds to the Swiss pharma company’s operations in Florida and Texas.
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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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Pfizer’s Metsera hunger sees it beat Novo Nordisk’s obesity biopharma offer
The deal puts Pfizer’s plans to acquire the US firm, and a portfolio that includes injectable GLP-1 drugs, back on track.
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NewsAstraZeneca seals obesity deal as Pfizer-Novo Nordisk battle for Metsera
After Wegovy and Zepbound's success, competition for the next potential weight loss blockbuster heats up.
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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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Galapagos set for small molecule and biologics pivot after cell therapy exit
But the Belgium biotech’s decision to winddown the cell business will cause it to cut around 90 percent of its headcount.
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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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NewsChiesi completes expansion of French metered dose inhaler facility
The enlarged La Chaussée-Saint-Victor site will serve as a manufacturing hub for the biopharma company.
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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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NewsHovione doubles spray drying capacity with $100m US investment round
The CDMO’s New Jersey manufacturing site expansion will eventually cover more than 200,000 square feet.
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NewsCPHI Europe adds AI and tech zone for its return to Milan in 2026
Following 2025’s event in Frankfurt, Informa’s flagship pharma exhibition will next year include an area for artificial intelligence.
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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.