Celadon – a company focused on the development of cannabis-based medicines – has announced that its Midlands-based UK facility has now been registered by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the Good Manufacturing Practice (GMP) manufacturing of its cannabis active pharmaceutical ingredient (API).

GMP is the globally recognised quality standard required to manufacture pharmaceutical medicines for clinical trials and human use. The approval is a compulsory requirement for the commercialisation of Celadon’s medicinal cannabis product, which is supplied in oil form as an API.

Celadon’s API is manufactured using a combination of genetics, extraction technology and indoor hydroponic cultivation. Incorporating a controlled environment allows Celadon to achieve pharmaceutical-level consistency and replicability.

The company’s GMP product and its ongoing R&D programme has seen it partner with leading universities, government bodies and fellow pharmaceutical companies undertaking cannabinoid research and drug development.

Celadon’s current home office licence permits it to legally grow medicinal cannabis for the purpose of producing test batches of cannabis oil to support its application to the MHRA. While there is no guarantee that the home office will update the current licence, nor any timeframe for this, the company’s directors are confident that the licence will be updated in due course.

AstraZeneca’s Tezspire has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP).

It concerns a self-administration treatment in the form of a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. Meanwhile, the CHMP opinion can be implemented without the need for a European Commission decision due to the nature of the type-2 label variation.

The approval for self-administration followed results from the PATHFINDER clinical trial programme, which included results from the PATH-BRIDGE phase 1 trial as well as the PATH-HOME phase 3 trial.

The majority – 92% – of healthcare providers, patients and caregivers were able to successfully administer Tezspire, also known as tezepelumab, both in the clinic setting and at home.

Improvements in asthma control and the safety profile of Tezspire observed in the PATH-HOME trial were consistent with previous clinical trials. Furthermore, the therapy is the only biologic approved for severe asthma with no phenotype or biomarker limitation within its approved label.

AstraZeneca is confident that a regulatory decision by the US Food and Drug Administration on self-administration and the new pre-filled pen will follow in the first half of this year. Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan and other countries.

Mission Therapeutics – a company that concentrates on selecting inhibiting deubiquitylating enzymes (DUBs) – has announced the successful completion of its first phase 1 clinical assessment for its lead USP30 DUB inhibitor, MTX652.

The phase 1 first time in human study began in May last year, following clinical trial approval in March. It involved over 80 healthy volunteers and research was led by Principal Investigator Dr Annelize Koch, senior medical director at Simbec-Orion.

The study achieved its key goals of demonstrating the safety, tolerability and pharmacokinetics of MTX652, with the treatment provided as a single and multiple-ascending doses of oral solution or suspension to healthy participants.

The therapy was shown to be well tolerated and safe up to a single dose of 200mg and multiple doses of 100mg once daily for 14 days. It also demonstrated a sound pharmacokinetic profile with dose proportionality and time independent exposure.