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First patient enrolled in cisplatin-induced ototoxicity Phase II trial
A Phase II proof of concept trial evaluating SENS-401 for cisplatin-induced ototoxicity has enrolled its first patient.
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Research & Development (R&D)
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First treatment approval for advanced ASPS
A Phase II trial has led to the FDA approval of atezolizumab for individuals over two years old with advanced alveolar soft part sarcoma.
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Whitepaper: Imaweld® heat sealable & weldable tube bioprocess media
Imaweld® is distinct due to its composition, which seals and welds tubes and highly endorsed in biopharma for cell membrane and cell culture applications
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Kite to buy Tmunity, expanding its CAR T pipeline
The acquisition of Tmunity Therapeutics supports Kite’s plans to develop next generation CAR T-cell therapies for cancer.
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Moderna finalises plans for UK mRNA vaccine manufacturing centre
Moderna is to build an mRNA vaccine manufacturing centre in the UK after finalising a ten-year agreement with the UK government.
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Raman mapping to visualise the three-dimensional structure of pharmaceutical tablets
Raman mapping is a powerful tool that can be used to reveal details about the size and spatial arrangement of components throughout a tablet matrix. Here, Andrew Ewing, Don Clark and Fiona Clarke from the Materials Characterisation Team at Pfizer present a 3D imaging approach using Raman mapping to investigate…
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Stem cell transplants may slow disability progression in MS
Study suggests stem cell transplants may delay disability longer than some other medications in patients with active secondary progressive multiple sclerosis.
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Breakthrough gene therapy gives hope for Artemis-SCID
A new gene therapy developed by UC San Francisco has enabled ten young Artemis-SCID patients to achieve full T-cell immunity.
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Lynparza combination approved in EU for advanced prostate cancer
Patients in the EU with an advanced prostate cancer will benefit from a newly approved Lynparza-based treatment combination for the first time.
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AstraZeneca to manufacture pharmaceuticals in Abu Dhabi
AstraZeneca has signed a strategic agreement to expand its existing partnership with a healthcare company in Abu Dhabi to locally manufacture innovative drugs.
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MHRA granted almost £1m to advance digital and data regulation
Almost £1m awarded to MHRA will advance projects to innovate AI and microbiome regulation and develop synthetic clinical trial data.
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Psychedelic research: evaluating the fast-evolving regulatory roadmap
In this article, Aman Khera and Dr Christine Moore of Worldwide Clinical Trials share how regulatory agencies are supporting psychedelic research through expedited pathways and outline some of the key considerations for clinical trials sponsors.
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World’s first approval of an allogeneic T-cell immunotherapy
Ebvallo™ is the first authorised allogeneic T-cell immunotherapy and has been approved for EU patients with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease.
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CHMP recommends fenfluramine for LGS-associated seizures
Positive Phase III study data has prompted the CHMP to recommend FINTEPLA ®▼ (fenfluramine) for seizures associated with Lennox-Gastaut syndrome (LGS).
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Sanofi licenses Innate Pharma’s NK cell platform with €25m upfront payment
Innate Pharma will receive a €25m upfront payment from Sanofi to license its B7H3 ANKETTM platform, which is creating a new class of molecules to induce synthetic cancer immunity.
