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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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Regulation & Legislation
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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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Whole genome sequencing and analysis of live biotherapeutic products
Here, Snehit Satish Mhatre and Michael Timm of Eurofins discuss considerations and recommendations for the testing of live biotherapeutic products.
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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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Interchangeability of biosimilars in the EU – the industry impact
In a reversal of approach, EU medicines regulators have for the first time published a statement supporting the interchangeability of biosimilar medicines in the EU. Here, Marie Manley and Chris Boyle from Sidley Austin LLP explore what this could mean for biopharma companies.
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FDA approves first gene therapy for high-risk early bladder cancer
The first gene therapy for high-risk non-muscle-invasive bladder cancer has been approved by The US Food and Drug Administration (FDA).
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CHMP meeting highlights – December 2022
A total of five drugs were recommended for approval at the CHMP’s December meeting, including a gene therapy and two cancer drugs.
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WHO updates guidelines for treating drug-resistant tuberculosis
A historic change to guidelines for treating drug-resistant tuberculosis has been published by the World Health Organization.
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CHMP adopts positive opinion for haemophilia B gene therapy
Gene therapy etranacogene dezaparvovec has been granted a positive opinion by the CHMP as a haemophilia B treatment for adults in Europe.
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European Commission approves first medicine for prurigo nodularis
Dupixent®, the first and only targeted medicine for prurigo nodularis has been approved by the EC for adults with a moderate-to-severe form of the condition.
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European Commission approves Pluvicto® for prostate cancer
The European Commission has approved Pluvicto® as the first targeted radioligand therapy for advanced prostate cancer, based on significant results from the Phase III VISION trial.
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The lingering menace of diethylene glycol / ethylene glycol adulteration
Although it was first identified in the 1930s, diethylene and ethylene glycol contamination remains an issue today, as Dave Elder explains.
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Utrogestan accepted as HRT in Scotland
Utrogestan, the only adjunctive micronised progesterone as hormone replacement therapy alongside any oestrogen therapy has been accepted by the SMC for women in Scotland.
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Dapagliflozin approved for heart failure across LVEFs
The MHRA has approved dapagliflozin for chronic heart failure across the full spectrum of left ventricular ejection fraction.
