Gareth Macdonald

France

Business and Science Writer at Freelance

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Articles

Psyence Biomed hires Southern Star for Phase II psilocybin study

3 days ago | informaconnect.com | Gareth Macdonald

Psyence BioMed has hired Southern Star Research to run a clinical trial of the magic mushroom-derivative psilocybin in patients with adjustment disorder. The study — a Phase IIb trial — will examine the drug as a treatment for the psychological condition in people diagnosed with cancer. According to a recently published letter of intent, Sydney, Australia-based contractor Southern Star will manage the study at sites across the country.
Strategic alliance: PSI CRO joins forces with Seoul’s Severance Hospital

3 days ago | informaconnect.com | Gareth Macdonald

PSI CRO has formed a strategic partnership with Severance Hospital in Seoul, joining the growing list of international contractors building in South Korea by teaming with medical centers. The deal will see PSI manage clinical trials at the hospital. The organizations will collaborate on study feasibility assessments and patient recruitment. Financial terms were not disclosed.
Source Biosciences buys Cambridge Clinical Laboratories to expand clinical offering

3 days ago | informaconnect.com | Gareth Macdonald

Source BioScience has acquired Cambridge Clinical Laboratories (CCL), framing the move as a part of an effort to build its trials and diagnostics businesses. The deal will add capabilities in clinical and personalized healthcare testing and a recently built clinical laboratory at the Vision Park campus in Cambridge, UK. Financial details were not disclosed.
Lindus receives UK funding for safe AI trial design optimization project

1 week ago | informaconnect.com | Gareth Macdonald

UK R&D agency Advanced Research + Invention Agency (ARIA) awarded Lindus Health funding to develop an artificial intelligence (AI) system for clinical trial design optimization as part of a wider safety program. The project, a collaboration between Lindus and Nobuko Yoshida, a professor at the University of Oxford, aims to develop an AI-based technology that recommends safe and efficient trial designs.
MHRA reports high pharma investment in UK trials

1 week ago | informaconnect.com | Gareth Macdonald

Drug companies are continuing to invest in trials in the UK, according to new Medicines and Healthcare products Regulatory Agency (MHRA)-backed research. The study looked at 4,616 clinical trial submissions received by the UK regulator between February 2019 and October 2023 and found that the majority came from for-profit drug developers.
WHO’s primary registry designation for CTIS a boost for EU trials, says EMA

1 week ago | informaconnect.com | Gareth Macdonald

The WHO has designated the EU Clinical Trials Information System (CTIS) as a primary registry in a move that will make publishing results easier for sponsors and CROs.The designation means the CTIS complies with WHO standards for content, data quality and validity, accessibility, unique identification, technical capacity, and administration.
Vantage Biosciences’ oral diabetic retinopathy drug enters Phase II

2 weeks ago | informaconnect.com | Gareth Macdonald

Novotech and Icon are running a Phase II study of a candidate oral drug for diabetic retinopathy being developed by Vantage Biosciences. The study — which started last week — will evaluate VX-01 for non-proliferative diabetic retinopathy (NPDR) at 27 research sites across the US, Australia, and several Southeast Asian countries. Vantage CEO Alek Safarian told Clinical Insider, “We are working with Novotech and Icon on this study.
Calla Lily Clinical Care secures UK NIHR funding for progesterone device trial

2 weeks ago | informaconnect.com | Gareth Macdonald

Researchers trialing a progesterone delivery device for miscarriage prevention say the technology could help over 150,000 women in the UK each year. The study — for which developer Calla Lily Clinical Care secured £1 million in funding from the UK National Institute for Health and Care Research (NIHR) — will be carried out by a team at the University Hospitals Coventry and Warwickshire NHS Trust.
Automation, AI, and Closed Systems in Cell and Gene Therapy Production

2 weeks ago | genengnews.com | Gareth Macdonald

Pressure to make cell and gene therapies more affordable will force the industry to overcome its reticence and embrace closed production systems, automation, and artificial intelligence (AI). So says, Gerhard Bauer, ex-director of the UC Davis GMP manufacturing facility and co-author of a new study examining cell and gene therapy production in the United States. “New manufacturing technologies are under development but have not made it into commercial product manufacturing to a large extent.
Singapore’s GIC and Temasek join TPG as Novotech investors

2 weeks ago | informaconnect.com | Gareth Macdonald

Singapore-based, state-owned investors GIC and Temasek have acquired holdings in Novotech, with current owner TPG reinvesting in the CRO through its TPG Asia fund. The investments—announced last week—follow various reports suggesting that TPG, headquartered in San Francisco, California, had been looking to sell the clinical research organization (CRO).