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American pharmaceutical giant Pfizer has received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for its medication Etrasimod, marketed as Velsipity, used to treat people with moderately to severely active ulcerative colitis. Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) that causes inflammation and ulcers (sores) in the lining of the large intestine (colon) and rectum. The approved recommended dose for Velsipity is one 2 mg tablet to be taken once daily. For the first three days, it is advised to take the medication with food, and subsequently, it can be taken daily either with or without food. According to the regulator, the approval of the medication is based on evidence from two clinical studies, which showed that 26 per cent of patients taking etrasimod achieved clinical remission after 12 weeks of treatment compared with 11 per cent of those receiving placebo. The studies included more than 740 patients aged 16 years and over for whom standard treatment or other treatments did not work well enough or could not be used.

The Association of the British Pharmaceutical Industry (ABPI) has laid out a series of urgent actions it wants the newly elected Labour government to implement within its first 100 days in office. Among the top priorities, the ABPI has emphasised the urgent need to appoint a new Chair and Chief Executive for the Medicines and Healthcare products Regulatory Agency (MHRA). Additionally, the ABPI has urged the new government to launch the Life Sciences Manufacturing Capital Grants Facility without delay. Other measures the ABPI wants Labour to prioritise include: Rapidly passing outstanding UK clinical trials legislation to enhance the UK's attractiveness for inward investment, including into research within the NHS. Increasing commercial flexibility in the NHS England Commercial Framework for New Medicines to remove barriers for companies to launch new medicines and indications so that NHS patients can access the latest innovative medicines.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Anastrozole in a new use to prevent the disease. The off-patent drug has been used as a breast cancer treatment for many years. Clinical trials have shown that it can reduce the incidence of breast cancer in post-menopausal women with increased risk by almost 50 per cent. Health Minister Will Quince expressed his happiness on the approval of the drug that can help to prevent this "cruel disease". He said: "We've already seen the positive effect Anastrozole can have in treating the disease when it has been detected in post-menopausal women and now we can use it to stop it developing at all in some women.

A diabetes medicine, Mounjaro, has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat overweight patients. The weight loss medication originally developed for Type 2 diabetes is now accessible to individuals aged 18 and over who are dealing with obesity and weight-related health issues. The active ingredient, tirzepatide, works by making the patient feel fuller and reducing food cravings. The injection helps individuals lose 20 per cent of their body weight, and are advised to follow a reduced-calorie diet and increase physical activity simultaneously. Although it is not authorised to use on the NHS as yet but future approvals can be predicted.

In a recent announcement, Mundipharma, a leading global pharmaceutical company, has announced its acquisition of all assets and rights related to rezafungin from Cidara Therapeutics. This solidified Mundipharma's dedication to managing infectious diseases and specialty care therapeutic areas, especially invasisve candidiasis which over the 15 years has seen no new therapeutic developments underscoring for alternative options. The FDA and MHRA approved rezafungin is a groundbreaking once-weekly echinocandin antifungal drug specifically designed for the treatment of invasive candidiasis in adults. While Mundipharma will oversee global commercialization efforts, Melinta Therapeutics will retain commercialization rights for rezafungin in the United States. Moreover, the acquisition empowers the pharmaceutical company with global ownership of rezafungin, encompassing its ongoing development and distribution.

Kent Pharma UK has announced a precautionary recall of multiple batches of Itraconazole 10mg/ml oral solution following the identification of out-of-specification appearance in the solution, particularly the presence of suspended particles or clusters of crystals. Itraconazole is an antifungal medication prescribed for treating fungal or yeast infections in different parts of the body. Its oral solution form is specifically intended for treating oropharyngeal or esophageal candidiasis, commonly known as thrush or oral thrush. The Medicines and Healthcare products Regulatory Agency (MHRA) has advised the recall following initial investigations, which indicated a solubilisation issue of the active ingredient, itraconazole. This problem may result in some doses containing lower amounts of the active ingredient. The root cause of the issue is currently under investigation. However, due to the potential for underdosage, the affected batches are being recalled as a precautionary measure.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a company-led drug recall for Sodium Chloride Eye Drops 5% 1x10ml (unlicensed medicine) Stockport Pharmaceuticals. Stockport Pharmaceuticals said that the above batch of Sodium Chloride Eye Drops 5% w/v as the sterile eye droppers supplied with the medicinal product have expired (Jan 2022). The authority said, "This recall is being issued as a company-led medicines recall, as this product is only supplied to a small number of customers, and the manufacturer has full traceability of the product's distribution." "Remaining stock of the above batch should be quarantined and returned to Stockport Pharmaceuticals directly."

The Manchester Crown Court on Friday (9 December) sentenced three men, Cleave Lewis (35) and brothers, Denis Sutherland (58) and David Sutherland (59), to a total of three years in jail after they pleaded guilty to the illegal sale and supply online of prescription-only medicines and controlled Class B and Class C drugs, worth more than £1.5m. They were found in possession of nearly 1.3m tablets of prescription-only drugs, including powerful sleeping pills, painkillers and anti-anxiety meds, when officers from the Medicines and Healthcare products Regulatory Agency (MHRA) and Greater Manchester Police searched their residential homes and business premises in October 2017. Following investigations by the agency, they also pleaded guilty to illegally making these medicines available online on three different websites for the public to purchase without prescriptions. The officials also recovered controlled medicines, over half a million (525,737) erectile dysfunction, slimming and herbal tablets, with an estimated value of approximately £500k, from them.

Proprietary Association of Great Britain, PAGB - which represents manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices and food supplements - on Tuesday (12 December) celebrated 40 years of reclassification of medicines. Expanding self-care for common ailments and minor injuries will not only help ease pressure on primary care services, but also provides significant potential savings for the NHS, the consumer healthcare association highlighted during the event. Nurofen (ibuprofen) and Imodium (loperamide) were the first medicines to go through Medicines and Healthcare products Regulatory Agency (MHRA)'s switch process in 1983 to make them available over the counter - OTC. Other reclassified medicines which were once available on prescription only include Voltarol (diclofenac dimethylammonium), Canesten (clotrimazole), Nexium (esomeprazole), Nicorette, Nicotinell and Niquitin (nicotine replacement therapies), Regaine (minoxidil), Viagra Connect (sildenafil), Cialis Together (tadalafil) for erectile dysfunction and Gina (estradiol hemihydrate) for the treatment of postmenopausal symptoms such as vaginal dryness.

The Medicines and Health products Regulatory Agency (MHRA) on Thursday issued a class 4 medicines defect information notice for Cozaar 100mg film-coated tablets due to an error in the Patient Information Leaflets (PILs) reported by the company. Cozaar is used to treat high blood pressure (hypertension) as well as to slow the progression of kidney disease in people who have type 2 diabetes mellitus. Quadrant Pharmaceuticals Ltd has informed the UK regulatory authority that the PILs that have been packed in certain batches of the products do not have the most up to date safety information. 'Grapefruit juice should be avoided while taking Cozaar'- This information is missing in Section 2 'What you need to know before you take Cozaar', sub section 'Cozaar with food and drink', the company clarified.

Great news for multiple sclerosis patients! The NHS has introduced a new 10-minute injection that can slow the progression of disability while reducing hospital treatment time by over 90 per cent. Currently, MS patients in England receive ocrelizumab (Ocrevus), manufactured by Roche, through twice-yearly intravenous (IV) infusions that can last up to four hours. Now, around 9,000 NHS patients in England will be able to receive the drug via a quick 'under-the-skin' twice-yearly injection. It takes just ten minutes, enabling patients to spend less time in the hospital receiving treatment. This roll-out follows approval from the Medicines and Healthcare products Regulatory Agency (MHRA), making the NHS one of the first healthcare systems worldwide to offer this new MS injection. Drug stocks are expected to be available in the coming weeks.

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.

HRA Pharma's progestogen-only contraceptive pill, Hana, has won the 'Special Achievement Award' at the Nicolas Hall awards. The awards took place on May 5, 2022 in Athens. HRA's Marketing Director for the UK, Ireland and the Nordics, Kate Evans, was in attendance to represent the Hana team and accept the award. The Hana pill became available in July 2021 for women in the UK to purchase without a prescription following a pharmacy consultation. The launch has made it easier for women to access effective daily contraception. This reclassification made HRA Pharma one of the leaders in this new healthcare category. The switch followed the authorisation of reclassification of desogestrel by UK regulator MHRA. Hana was one of the first products to enter this new market.

Northern Ireland will see changes in the regulatory landscape following the issuance of the Windsor Framework on 27th Feb 2023 and the corresponding EU Commission proposal. An agreement, in principle, has been reached by the UK and EU. The new path forward of the Windsor Framework marks a turning point in how both the UK and the EU will work together collaboratively and constructively to ensure that the same medicines are available in Northern Ireland at the same time as they are in the rest of the United Kingdom. Whilst this is a successful result for Northern Ireland patients, this is major change for companies that have made specific provisions in their supply chains for Northern Ireland. The supply chains of companies where provisions and changes were made such as introduction of GB specific pack may be impacted as a result. However, the burden on the UK Pharma supply chain will be eased. Prime Minister Rishi Sunak walks with European Commission chief Ursula von der Leyen in Windsor on February 27, 2023 Pharma companies will need to carefully consider making changes within their processes and supply chains pending the issuance of clear guidance from the MHRA on the regulation changes resulting from the Windsor Agreement and the corresponding EU Commission proposed regulatory changes associated with medicinal products within the Northern Ireland market. Smooth access to the EU market for Northern Ireland pharmaceutical and medical technology firms has been safeguarded within the constraints of the agreement. The pragmatic dual-regulatory system protects business, patients and healthcare services, and reflects that it is an essential state function to maintain and oversee the supply of medicines within the whole United Kingdom.

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.

The Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have authorised community pharmacies throughout the UK to dispense original full packs of Valproate-containing medicines upon prescription. The necessary changes in regulations came into effect on 11 October which was strongly supported by 85 per cent of respondents concerned about risks to the unborn baby if valproate-containing medicines are used in pregnancy. The decision was made to ensure patients receive safety warnings and pictograms, including a patient card and the Patient Information Leaflet (PIL), contained in the manufacturer's original full pack. Valproate is a treatment for epilepsy and bipolar disorder but is also associated with birth defects and neurological disabilities.

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised healthcare professionals to ensure appropriate patient counselling takes place and patients are aware of the missing information on the patient information leaflet (PIL) of Decongestant Tablets and Decongestant with Pain Relief Tablets. The advise came after Boots has identified an error with the printed PIL provided with batches of the tablets. Check the website for more information.

Global logistics company, JAS has received the Wholesale Distribution Authorisation (WDA(H)) license from the UK's Medicine and Healthcare Products Regulatory Agency (MHRA) for its Pharma and Healthcare Division. In a press release issued on Thursday (22 February), the company said that securing the license empowers its UK healthcare division to "seamlessly connect" with its more than 40 GDP (Good Distribution Practice) certified overseas stations, strengthening its capabilities for handling pharmaceutical shipments. Headquartered in Atlanta, Georgia, USA, the company boasts a team of over 7,000 professionals, with operations spanning over 100 countries. Adrian Frodsham, Regional Director for JAS, said that they were granted the WDA(H) license after a "stringent audit process." "JAS UK's pharma and healthcare division prides itself of offering innovative solutions for the international delivery of pharmaceutical products, further enhancing the growth of our pre-established healthcare division," he added.

The Medicines and Healthcare products Regulatory Agency (MHRA) has reclassified codeine linctus, a medicine used for the treatment of dry cough, from a pharmacy-only medicine (P) to a prescription-only medicine (POM) owing to the risk of dependence, addiction, and overdose. This implies that the dry cough syrup, which is also known as codeine oral solution, can only be dispensed upon the submission of a prescription at a pharmacy, rather than being accessible over the counter upon request. Patients are cautioned that as an opioid medicine, codeine can be addictive, and the risk of addiction may increase, particularly with prolonged use over an extended period. According to the medicines regulator, codeine is converted into morphine by the liver enzyme CYP2D6. In individuals identified as ultra-rapid metabolizers, this conversion from codeine to morphine occurs at a faster rate than in others. "If you want to stop taking it and have been taking codeine linctus for a long time, then it is important to reduce the amount you take slowly with the help of your prescriber," the agency said in its drug safety update issued on Tuesday, 20 February.

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.