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New Phase III Tezspire data signals advance in epithelial-driven inflammatory disease treatment
First-in-class monoclonal antibody significantly improved both underlying inflammation and dysphagia in eosinophilic esophagitis, extending its potential beyond the airways to the oesophagus.
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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.
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.
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.
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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New conference report highlights progress towards non-animal vaccine testing
Discussions from the Animal Testing Replacement for Vaccines: A One Health View – Global Outlook and Future Strategy conference have been summarised in a recent report, highlighting progress towards non-animal vaccine testing alongside the regulatory and operational challenges that remain.
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SGS expands Saint-Benoît laboratory increasing bioanalytical capacity for complex drug development
SGS has expanded its Saint-Benoît laboratory in France, bringing the total footprint to nearly 4,500m² of modernised space, as they scale up bioanalytical capacity to meet increasing complex drug development programmes.
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Type 2 diabetes comorbidity burden to rise across major markets
The diagnosed prevalence of type 2 diabetes is expected to increase across the seven major markets (7MM) by 2035, alongside a growing burden of comorbidities, according to GlobalData.
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AbCellera’s ABCL635 delivers positive Phase II data for vasomotor symptoms
In early Phase II data, investigational antibody ABCL635 achieved all primary efficacy endpoints in postmenopausal women experiencing vasomotor symptoms.
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Jazz Pharmaceuticals expands rare epilepsy pipeline with Actio Biosciences deal
Jazz Pharmaceuticals has entered into a definitive agreement to acquire privately held Actio Biosciences for $820 million upfront, with up to a further $500 million available in contingent approval and sales milestones.
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Yochanra approved in China as world-first for FGFR inhibitor-resistant cancer
This approval offers a potential new treatment approach for acquired resistance to FGFR inhibitors in advanced cholangiocarcinoma.
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Takeda’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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European 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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Biopharmaceutical PAT market forecast to reach $4.32bn
Growing demand for real-time process monitoring and more consistent biopharmaceutical manufacturing is expected to drive investment in process analytical technology.
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Sanofi’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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BioNTech 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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WHO 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.