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UK regulator has approved a new age-appropriate formulation of the Pfizer BioNTech Covid-19 vaccine for use in children aged 5 to 11 years old. The new paediatric formulation of Covid vaccine meets the required safety, quality and effectiveness standards, the Medicines and Healthcare products Regulatory Agency (MHRA) announced on Wednesday (December 22). Dr June Raine, MHRA chief executive said that parents and carers can be reassured that this approval has been given after robust review of safety data. These data showed a favourable safety profile for use in 5-11-year olds compared with that seen in other age groups, the regulator said. Raine said: "We have carefully considered all the available data and reached the decision that there is robust evidence to support a positive benefit risk for children in this age group.

The General Pharmaceutical Council reiterated its stand on Covid-19 vaccination, saying, "Pharmacists and pharmacy technicians working in all settings across Great Britain should be vaccinated against Covid -19, unless they are medically exempt." In a statement issued today (February 11), it strongly urged all pharmacyprofessionals, students and trainees to get fully vaccinated at the earliest. This reiteration follows the government's announcement on January 31, 2022 that it would not proceed with Covid vaccination as a mandatory condition of deployment for health and care staff providing CQC-regulated services in England. The Council stated that clinical trials have proven the efficacy and safety of Covid vaccines and the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised their use in the UK.

The Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday (9 January) announced that the novel type 2 oral polio vaccine (nOPV2) has been quality-assured (prequalified) by the World Health Organization (WHO). Developed by a team including scientists from the MHRA, nOPV2 is considered a safer polio vaccine that helps to protect children from the disabling and life-threatening disease and lower the risk of vaccine-derived outbreaks. The vaccine received WHO Emergency Use Listing three years ago, and since then 950 million doses have been delivered worldwide. The UN health agency's decision to add it to the list of prequalified vaccines is based on the analysis of outcomes in vaccinated populations that has confirmed strong safety profile and effectiveness.

A study by scientists in a UK university has shown the scale of the prevalence of a condition that can lead to various cardiometabolic diseases. The study published in the Annals of Internal Medicine journal on Tuesday (January 4) has prompted calls for changes to healthcare policy after researchers revealed, for the first time, the scale of the impact of the condition associated with benign tumours that can lead to type 2 diabetes and high blood pressure. Up to 10 per cent of adults have a benign tumour, or lump, known as an 'adrenal incidentaloma' in their adrenal glands which can be associated with the overproduction of hormones including the stress steroid hormone cortisol that can lead to type 2 diabetes and high blood pressure. Previous small studies suggested that one in three adrenal incidentalomas produce excess cortisol, a condition called mild autonomous cortisol secretion (MACS). An international research team led by the University of Birmingham carried out the largest ever prospective study of over 1,305 patients with adrenal incidentalomas to assess their risk of high blood pressure and type 2 diabetes and their cortisol production by comparing patients with and without MACS.

British health agencies have secured funding to develop a standardised approach to test the performance of vaccines being used or in development against monkeypox, days after the World Health Organization labelled the growing outbreak a global health emergency. The Coalition for Epidemic Preparedness Innovations (CEPI) said it would give up to $375,000 to the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Security Agency (UKHSA) to develop standard tools to assess the strength and duration of immune responses generated by current vaccines, and for tests used to detect monkeypox antibody levels. Apart from administration fees, these tools will be made freely available to the global scientific community, paving the way for a common standardised assessment between countries documenting vaccine performance against monkeypox, CEPI said. Until this year, the viral disease has rarely spread outside Africa where it is endemic. But reports of a handful of cases in Britain in early May signalled that the outbreak had moved into Europe. So far, there have been more than 16,000 confirmed cases of monkeypox in more than 75 countries.

In a significant leap forward in the fight against HIV, the Medicines and Healthcare products Regulatory Agency (MHRA) has given the green light to two groundbreaking formulations of cabotegravir. Apretude 30 mg film-coated tablets and Apretude 600 mg prolonged-release suspension for injection are now authorized for preventing sexually transmitted HIV-1 infection in adults and adolescents weighing at least 35kg at increased risk. This approval marks a pivotal moment in HIV (human immunodeficiency virus) prevention, offering an alternative to existing standard pre-exposure prophylaxis or PrEP treatments. HIV, a virus notorious for compromising the immune system, has long been a global health concern. Cabotegravir, a member of the integrase inhibitor group, works by blocking a key enzyme necessary for the replication of HIV-1, thereby reducing the virus's ability to spread.

In what's seen as a major step forward for the treatment of schizophrenia, the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised a new Johnson & Johnson drug in Britain. Byannli is a six-monthly paliperidone palmitate (PP6M) and is the first long-acting injectable schizophrenia treatment which offers patients the potential for up to six months of symptom control and a reduction in their risk of relapse with only two doses a year. It is a long-acting injectable that works by dissolving and entering the bloodstream slowly, due to its extremely low water solubility, resulting in continuous absorption of paliperidone palmitate over a six-month period. "Schizophrenia is a chronic and severe brain disorder, and antipsychotic medication plays an important role in its treatment. However, many people with the illness experience relapses which are often caused by poor adherence to oral medication," said Prof David Taylor, director of Pharmacy and Pathology at the Maudsley Hospital.

Southwark Crown Court on Thursday sentenced two pharmacists to two years of imprisonment each, suspended for 24 months, after they were found guilty of selling 'industrial' quantities of Class C controlled drugs. Mandip Sidhu (47) of Littleover, Derby and Nabeil Nasr (42) of Cheadle, Greater Manchester, pleaded guilty at an earlier hearing following an investigation by the Criminal Enforcement Unit of the Medicines and Healthcare Products Regulatory Authority (MHRA). Both Sidhu and Nasr were pharmacists registered with the General Pharmaceutical Council at the time of the offenses, which took place between May 2013 and June 2017. Sidhu was the director of Pharmaceutical Health Limited (PHL) in Derby, while Nasr owned several pharmacies across the North West of England. Sidhu was sentenced to two years imprisonment on each of five counts of supplying Class C drugs and four months for forgery, all to run concurrently and suspended for 24 months. Additionally, she must complete 200 hours of community service for her role in the illegal supply of diazepam, zolpidem, and zopiclone.

To complete the evaluations of Lateral Flow Device (LFD) test kits, the UK Health Security Agency (UKHSA) will approach pharmacies and send 15 combined kits to pharmacies in December. The combined kits will contain a standard LFD pack, one PCR test along with comprehensive instructions. For the evaluation, a part of meeting Medicines and Healthcare products Regulatory Agency (MHRA) obligations, UKSHA needs "dual swabbing through the community pharmacy Covid-19 lateral flow device distribution service." Pharmacies receiving these kits need to finish the current open carton of LFD packs and then open the next standard carton. Pharmacy negotiator PSNC has advised pharmacies to be mindful of "the expiration date of the kit and ensure these are handed out in sufficient time."

Thousands of lung cancer patients in England will benefit from a ground-breaking new drug that can reduce the risk of relapse. This follows a deal brokered by NHS England and approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for atezolizumab therapy to treat non-small cell lung cancer (NSCLC). More than 850 patients are expected to be eligible for the drug in the first year, rising to more than 1000 in the third year. It is the first immunotherapy approved for patients with early-stage NSCLC who have undergone surgery and chemotherapy. Clinical trials have shown that atezolizumab can reduce the risk of cancer relapse or death by 34 per cent in patients with early-stage NSCLC.

Hundreds of children in England are set to benefit from a treatment for cystic fibrosis - Kaftrio, after the UK's Medicines and Healthcare products Regulatory Agency (MHRA) confirmed an extension to its licence. With the licence extension, more than 1,300 children in England with cystic fibrosis, aged six to 11, are newly eligible for this treatment, which improves lung function and improves overall quality of life of patients. Earlier, Kaftrio was only licensed for those aged 12 and above. British patients were the first in Europe to benefit from Kaftrio, when NHS England secured a landmark deal in June 2020. NHS chief executive Amanda Pritchard said: "Since NHS staff delivered one of the fastest rollouts of Kaftrio in the world just over a year ago, the lives of thousands of patients with cystic fibrosis have been transformed. "Innovative treatments like Kaftrio are life-changing for patients and their families, and that is why the NHS has done all it can since we secured the deal for Kaftrio to ensure patients benefit as soon as possible.

Sun Pharmaceutical Industries, India's largest drugmaker by revenue, reported a better-than-expected 5.2 per cent rise in third-quarter profit on Tuesday, driven by higher sales of its specialty drugs. The company, known for its consumer healthcare products such as Revital vitamins and pain relief medicine Volini, said it earned a consolidated net profit of 21.66 billion rupees ($265.23 million) in three months ended Dec. 31, up from 20.59 billion rupees last year. Analysts, on average, had expected the company to report a profit of 21.26 billion rupees, according to Refinitiv IBES data. Total revenue from operations climbed nearly 14 per cent to 112.41 billion rupees. Input costs rose 8.5 per cent. Drug sales in India rose 7.1 per cent to 33.92 billion rupees, whereas sales in the United States climbed 16.6 per cent to 34.66 billion rupees, with each of the two regions accounting for 31 per cent of the company's total consolidated sales. The company, founded in 1983, makes over-the-counter medications, anti-retrovirals and active pharmaceutical ingredients for chronic and acute treatments.