United Kingdom

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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

UK-based Biocomposites will begin selling in the UK its next-generation osteoinductive bone graft substitute, NanoBone, which came with its acquisition of Artoss GmbH in June 2023. Meanwhile, the company has purchased remaining shares in the manufacturers of SYNICEM and Subiton antibiotic bone cements and preformed antibiotic-loaded spacers.

The firm’s dual-chamber leadless pacemaker system with is expected to be a growth driver for Abbott and already has acquired approximately 30%-40% of market share from Medtronic since its approval by the US FDA in July 2023, according to GlobalData.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.

The UK will require all antibiotic manufacturers looking to apply for funding under its subscription payment model to demonstrate they are meeting waste discharge standards in a bid to reduce antimicrobial resistance.

Perrigo aims its new SolpaOne high-strength paracetamol effervescent at UK pharmacists, who now have expanded powers as part of the UK government's Pharmacy First initiative. 

Pharmaceutical companies should only use AI in evidence generation and reporting where there is “demonstrable value from doing so,” according to England’s health technology assessment body, NICE.

While the drug regulator has approved Eisai/Biogen’s early Alzheimer’s disease treatment, the health technology assessment institute is worried that its benefits are too small to justify its costs – a concern that Eisai has pledged to address.

It is “absolutely fundamental” that manufacturers of cell and gene therapies interact with inspectors from regulatory agencies to understand their expectations around good manufacturing practice, a compliance consultant at CDMO eXmoor pharma says.

The MHRA says that having a complete picture of all upcoming filings will allow it to ensure “consistent and predictable” timelines for assessments and identify “potentially transformative technologies” at an early stage.

Brexit has been cited as a cause of the UK’s 2020 decline in clinical trials, but research suggests that other global trends including the pandemic also had a large impact. Meanwhile, the MHRA’s efforts to incentivize sponsors could boost trial figures “substantially,” an expert says.

Germany's Alzchem failed to convince the UK's health claims committee that daily creatine supplementation can contribute to improved cognitive function. 

A round-up of the latest moves in Europe's consumer health industry: Galenica names head of new Products & Home Care business unit; Haleon appoints general counsel; Alliance Pharma eliminates COO role.

Taylor Wessing investment partners share their thoughts about market trends, the surge in AI interest and the new UK government’s approach to the life sciences agenda.

In this third article of a series on new drug reimbursement recommendations by the HTA body NICE, the Pink Sheet finds that fewer innovative medicines are reimbursed in England than in eight other European nations.

July’s UK generic pricing figures from WaveData show captopril tablets rocketing up in price, while aripiprazole prices continue to plummet.

Generics Bulletin reviews the latest regulatory events across the world.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.