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Chinese regulator approves personalised cancer vaccine trial

Drug Discovery World

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. Hence, there is a need to increase clinical investigations in this promising area.”

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Gene Therapy Clinical Trials for Rare Diseases: 5 Key Takeaways from FDA’s Recent Town Hall

XTalks

The US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) held a recent town hall where three experts from the regulator provided guidance on how to design and conduct gene therapy clinical trials for rare diseases. All except for Adstiladrin were cleared for rare disease indications.

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Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate

The Pharma Data

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

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GSK’s Maria Reyes Boceta-Muñoz Talks Vaccine Development in a Post-Pandemic World

XTalks

Xtalks spoke with Maria Reyes Boceta-Muñoz, Clinical Operations Head of Development R&D at GlaxoSmithKline in Spain, Portugal & Israel, to understand the current vaccine development climate and where the sector is headed. However, guidelines do not provide matters specific to each vaccine type.

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Sanofi/GSK trial woes delay a billion COVID-19 shots by nine months

pharmaphorum

Sanofi and GlaxoSmithKline have said their COVID-19 vaccine has hit a snag in clinical development, prompting analysts to note this could delay delivery of potentially more than a billion shots globally by up to nine months.

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UK gears up for ‘challenge trial’ of COVID-19 vaccine

pharmaphorum

.” A vaccine is seen as a way out of the social distancing and lockdown regulations that are crippling large parts of the economy and causing immense disruption to peoples’ lives. That vaccine is top of the World Health Organization’s list of vaccines in clinical development, which shows there are 38 potential shots in human trials.

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The Achilles’ heel of cancer

Drug Discovery World

Based on this data, ezurpimtrostat completed a first-in-human clinical trial for patients with advanced cancer 5 showing sustained stabilisation in heavily pre- treated patient with mild toxicity. Recent studies have suggested that palmitoylation can regulate the expression and activity of PD-L1 6. Lan J, Li C, et al.

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