All articles by CE – Page 2
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NewsGenentech invests $750m in Oregon fill-finish expansion
Advances firm’s end-to-end drug manufacturing capabilities in the US, doubling the size of the existing facility at its Hillsboro, Oregon campus.
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NewsMSD-Moderna Phase III readout backs personalised mRNA neoantigen combination adjuvant therapy for melanoma
First combination regimen to demonstrate significant reduction in recurrence risk in completely resected stage IIB-IV melanoma compared to Keytruda alone as adjuvant treatment.
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NewsSK pharmteco expands HPAPI and small molecule capacity in Ireland
Opening of the two advanced manufacturing facility expansions strengthens the CDMO’s capabilities in large-scale commercial small molecule API production and HPAPI manufacture.
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NewsMHRA sets out licensing pathway for microbiome-based medicinal products
The regulator’s new position paper provides developers with a defined regulatory route to licence microbiome-based medicinal products in the UK.
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NewsTakeda’s Orzeyful approved in US as first-in-class orexin treatment for narcolepsy Type 1
FDA’s authorisation addresses the condition’s full symptom burden instead of just symptomatic relief.
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NewsEuropean Pharmacopoeia opens revised monograph Macrogols (1444) for consultation
New publication aligns with Eur. Ph.’s initiatives aimed at safeguarding contamination of ethylene glycol and diethylene glycol in pharmaceutical excipients.
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NewsSanofi’s MenQuadfi approval expanded to infants from six weeks in Europe
Broader indication boosts protection against invasive meningococcal disease across a wider paediatric population in the EU.
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NewsBioNTech appoints Guido Oelkers as new Chief Executive Officer
German biotech’s incoming leader set ahead of its goal of having multiple approved products by 2030.
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NewsWHO proposes regulatory recommendations to support pharmaceutical decarbonisation
United Nations agency calls for coordinated action across the pharmaceutical value chain to align with existing regulatory practices that aid sustainable medicine innovation.
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NewsJ&J wagers on next cell therapy frontier with $2.6bn Sail Bio acquisition option
In vivo-focused collaboration has scope to considerably boost therapeutic innovation and address unmet need in immune-mediated diseases.
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NewsGSK to relocate UK R&D centre from Stevenage to Cambridge
Investment provides significant growth opportunity for UK’s life sciences sector and in shaping the country’s research and manufacturing footprint.
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NewsCHMP backs Roche’s Susvimo as first continuous nAMD therapy
Committee’s positive opinion supports a new, less burdensome treatment option for patients with the leading cause of vision loss in individuals over 60 years old.
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NewsBeOne Medicines commits $300m to expand New Jersey manufacturing
Facility expansion combines biologics and small molecule drug product manufacturing under one roof to accelerate its haematology and oncology pipeline.
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NewsMHRA approves first HFA-152a propellant pMDI inhalers
Authorisation of Chiesi’s next-generation propellant signals a significant step in the pharmaceutical industry’s efforts to decarbonise respiratory medicine.
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NewsFDA approves MSD’s Lipfendra as first oral PCSK9 inhibitor
Regulatory win facilitates the growing market demand for peptide therapeutics.
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NewsEli Lilly bets $2.8bn on AtaiBeckley’s psychedelic therapies for depression
AtaiBeckley’s lead asset addresses synaptic connectivity rather than neurotransmitter levels, as targeted by traditional antidepressants.
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NewsPh. Eur. revises general chapter on alternative microbiological methods
The updated general chapter 5.1.6 provides a modernised text intended to streamline implementation for users.
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NewsSandoz reshapes leadership to capitalise on biosimilar golden decade
New appointments will drive manufacturing efficiency in Sandoz’s generics business and merger and acquisition activities globally.
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NewsAstraZeneca licenses novel oral EGFR inhibitor for $1.5bn
Agreement with Dizal Pharmaceutical gives the pharmaceutical giant access to the only approved oral targeted therapy for EGFR exon 20 insertion NSCLC in both the US and China.