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Insomnia treatment approved in Japan

Drug Discovery World

Nxera Pharma Japan has received approval from the Ministry of Health, Labour and Welfare of Japan (MHLW) of its New Drug Application (NDA) for ACT-541468 (daridorexant or Quviviq) in 25 and 50mg doses for the treatment of adult patients with insomnia. of the patients treated with 50mg and 25mg daridorexant, respectively (24.4% for placebo).

Treatment 147
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AI digital twins could replace control arm in clinical trials

Drug Discovery World

A new study demonstrates that AI-powered digital twin solutions can potentially replace the standard-of-care (SOC) control arm of a clinical trial. The paper was co-authored by analytics company Phesi and Dr Yi-Bin Chen, Director for the Blood and Marrow Transplant Program at Massachusetts General Hospital.

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Investigational therapy for advanced cancers enters trials

Drug Discovery World

CV6 Therapeutics has initiated patient dosing in Phase Ia clinical trial evaluating its investigational first-in-class, specific dUTPase inhibitor CV6-168 + infusional 5-fluorouracil (5-FU).

Trials 147
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UK trial will test new mAb treatment in heart attack patients

Drug Discovery World

According to the partnership between the University of Birmingham and Acticor Biotech, the trial will take place in two hospitals in the UK: the Queen Elizabeth Hospital, Birmingham and the Northern General Hospital, Sheffield.

Trials 130
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Phase II brain metastases trial advances after futility analysis 

Drug Discovery World

The Phase II NANOBRAINMETS trial of AGuIX has been validated by the Data Safety and Monitoring Board (DSMB) following a futility analysis scheduled after the enrolment and follow-up of 50% of patients in the study. A total of 96 patients have been randomised to date of the 134 scheduled in the study’s protocol.

Trials 130
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NHS England launches country-wide cancer vaccine trials

Drug Discovery World

Thousands of cancer patients in England are set to gain fast-tracked access to trials of mRNA personalised cancer vaccines following the launch of an NHS trial ‘matchmaking’ service to help find new life-saving treatments.

Vaccine 147
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‘Encouraging’ trial results for potential disease-modifying ALS drug

Drug Discovery World

The trial was carried out at the Queen Elizabeth Hospital, Birmingham, UK, by the University of Birmingham’s Drugs, Devices, Diagnostics and Biomarkers (D3B) team. I am very grateful for the engaging participation by the patients in especially difficult circumstances due to the onset of the pandemic during the trial period.”

Trials 130