News Global gains in TB response
endangered by funding challenges Tuberculosis (TB) remains one of the world’s deadliest infectious killers, claiming over 1.2 million lives and affecting an estimated 10.7 million people last year. According to a new report from the WHO, progress in tackling the global burden is now under threat. The Global Tuberculosis Report 2025 warns that
challenges in funding and equitable access to care risk reversing hard-won gains in the global fight against TB, despite measurable progress in diagnosis, treatment and innovation. “Declines in the global burden of TB, and
progress in testing, treatment, social protection and research are all welcome news after years of setbacks, but progress is not victory,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director- General. “The fact that TB continues to claim over a million lives each year, despite being preventable and curable, is simply unconscionable. WHO is working with countries to build on the progress
they have made and accelerate the path to ending TB by 2030.” Between 2023 and 2024, the global rate of people falling ill with TB declined by nearly 2%, while deaths from TB fell by 3%. These reductions signal a continued recovery of essential health services following disruptions caused by the COVID-19 pandemic. Some regions and countries show sustained progress, demonstrating that strong political commitment and investment address this ancient disease. Between 2015 and 2024, the WHO African Region achieved a 28% reduction in the TB incidence rate (number of people falling ill with TB per 100 000 population per year) and a 46% reduction in deaths. The European Region saw even greater declines, with a 39% drop in incidence and a 49% reduction in deaths. During the same period, over 100 countries
achieved at least a 20% reduction in TB incidence rates, and 65 countries achieved reductions of 35% or more in TB-related deaths. These countries have attained the first milestones of the WHO End TB Strategy. However, ending TB globally will require accelerated progress in countries with the highest burden. In 2024, 87% of the global number of people who developed TB disease was concentrated in 30 countries. Just eight of them accounted for 67% of the global total: India (25%), Indonesia (10%), the Philippines (6.8%), China (6.5%), Pakistan (6.3%), Nigeria (4.8%), the Democratic Republic of the Congo (3.9%) and Bangladesh (3.6%).
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Up to 6,000 NHS patients to benefit from cancer drug
Darolutamide, also known as Nubeqa and made by Bayer, is recommended in final draft guidance to treat adults with metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy (ADT), a hormone therapy which lowers testosterone levels. Taken as two tablets twice daily alongside hormone treatment, darolutamide blocks the hormones fuelling cancer growth by starving prostate cancer cells of the testosterone they need to multiply and spread. For those with metastatic hormone-sensitive prostate cancer, where the disease has spread to other parts of the body, treatment options typically involve ADT, either on its own or combined with other drugs. Clinical trials show that adding darolutamide to standard ADT delivers better results than ADT alone, with evidence suggesting it is as effective as other combination treatments already recommended by NICE and available on the NHS. “With several proven therapies already
available on the NHS, this approval gives clinicians and their patients more flexibility to choose the approach best suited to individual circumstances and clinical needs,” commented Peter Johnson, national clinical director for cancer at NHS England.
Major change for rare disease treatments on way, signals MHRA
The rulebook for rare disease therapies will be overhauled to make it quicker and easier to get these therapies tested, manufactured and approved in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. Central to this reform will be tackling the unique barriers that currently prevent life- changing rare disease therapies from reaching patients, like small patient numbers and difficult evidence generation, while maintaining safety. Around 3.5 million people in the UK – one in 17 – live with a rare disease, equivalent to one child in every classroom. When carers are included, this community is larger than the population of London. Yet fewer than 5% of rare diseases currently have an approved treatment. The average diagnostic journey takes 5.6 years, and 30% of affected children die before the age of five. The cost of delayed diagnosis and limited treatment options is estimated at £340 million annually, with a further
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www.clinicalservicesjournal.com I January 2026
£4.7 billion in health-related disability costs and a £14.9 billion annual loss to the economy. A new paper sets out how the MHRA plans to
change this, with major reform. Supporting the development of the reforms is a newly formed Rare Disease Consortium, which includes patients and their representatives, academics and industry. Currently, each new rare therapy requires
a separate route through regulatory approval, including an approval to get the clinical trial set up and then an approval to be marketed in the UK (known as a marketing authorisation or licence). This approach is costly and inefficient, making it unviable to develop multiple highly targeted treatments. While the framework won’t be published in full until 2026, the paper outlines some bold ideas, including whether an early, single approval could be issued for both a clinical trial application and marketing authorisation based on compelling but limited evidence. This approval
would be granted with a strict safety monitoring plan with real-world evidence review at a set frequency. Julian Beach, MHRA Executive Director, Healthcare Quality and Access, said: “The UK has the ingredients to be a global leader in rare disease therapies, with a rich academic base, a single provider of genomics and the unique, diverse datasets of the NHS. The challenge is bringing all these elements together, which our new framework will do. “There is still more work to be done, but I hope this paper reassures all those affected by rare disease that we are listening and are prepared to take bold action to speed the path from discovery to delivery, while maintaining strict standards of safety.”
Visit:
https://www.gov.uk/government/ publications/rare-therapies-and-uk-regulatory- considerations
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