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The Medicines and Healthcare products Regulatory Agency (MHRA) has been accepted as a full member of three international work-sharing partnerships. Through these partnerships the agency said it will play vital international role in making sure medicines and medical devices are regulated safely and efficiently worldwide, Two of these, the International Medical Device Regulatory Forum (IMDRF) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are focused on improving the harmonisation and convergence of medicines and medical devices regulation globally. The partnerships will also help the MHRA to share expertise with other leading organisations, support the development of regulatory guidelines and drive greater harmonisation of regulation around the world. This will help deliver timely access to innovative medical products not just in the UK but globally.

The Medicines and Healthcare products Regulatory Agency (MHRA) made its new International Recognition procedure (IRP) fully operational from 1 January 2024, inviting developers of new medicines to submit their applications for marketing authorisation. Beginning this year, the EC Decision Reliance Procedure (ECDRP) has been replaced by IRP, and the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) has come under its umbrella. The move is expected to further improve access to life-saving medicines for UK patients following the UK's departure from the European Union.

Britain's GlaxoSmithKline will receive $1.25 billion (about £921 million) from Gilead Sciences as part of a settlement between its HIV medicines unit and the US-based drugmaker, ending a long-drawn patent dispute. The settlement, announced by GSK on Tuesday (February 1), relates to Gilead's antiretroviral drug Biktarvy, a medicine used to check the AIDS-causing virus, which GSK said in 2018 infringed on its unit ViiV Healthcare's dolutegravir and other similar compounds. HIV medicines developed by ViiV, in which Pfizer and Japan's Shionogi also hold small stakes, are a major part of GSK's plan to support its lagging pharmaceuticals business as it readies to spin off its consumer healthcare arm. The payment is expected to be made in the first quarter this year, London-listed GSK said. Gilead will also pay a 3 per cent royalty until 2027 on sales of Biktarvy and on future US sales of any product containing its main component.

The Medicines and Healthcare products Regulatory (MHRA) and Genomics England to launch a brand-new genetic research resource, known as a 'biobank' on Thursday (June 01) to tackle the issue of Adverse Drug Reactions (ADRs). Biobank will help to better understand how a patient's genetic makeup can impact the safety of their medicines. "The Yellow Card biobank, which will contain genetic data and patient samples, will operate alongside the MHRA's Yellow Card reporting site for suspected side effects and adverse incidents involving medicines and medical devices," said MHRA. The biobank pilot will officially begin on 1 June 2023 with participant recruitment commencing later this year, on 1 September. The sequencing of participants' genetic material will begin in Spring 2024, with initial research findings from the pilot due to be published in 2025. Genomics England will be supporting the MHRA with sequencing and storage of genetic material through use of their well-established and secure infrastructure.

Positive Solutions is set to launch its new, innovative, cloud-based medicines management system - HxCare which will be showcased in October at the Care Show. HxCare will be free of charge to community pharmacies signing up to the HxCare Affiliate Programme (HxCAP) making it an ideal platform to support existing care home business and attract new ones. The cloud-based medicines management system aims to digitise workflows, reduce errors and free up care providers to spend more time delivering care to their residents. Designed to be truly mobile, HxCare will be tablet based and has been developed by working closely with both care homes across the sector and their pharmacy partners who relish the prospect of an eMAR solution that integrates into their Analyst PMR. It is one of five new products being launched by Positive Solutions on the Hx platform this year. HxConsult is already live supporting pharmacies looking to maximise their service revenue. HxIntel will deliver real-time dashboards, reports and insights into the performance of pharmacy businesses of all sizes. My Health Hub will revolutionise patient pharmacy relationships whilst HxDispense is set to be the ultimate next generation PMR system. This modular, cloud-based interoperable ecosystem takes healthcare technology to a new level.

The Medicines & Healthcare products Regulatory Agency has initiated a recall of three batches of Quantum Pharmaceutical's Diltiazem HCl 2% Cream, which is an unlicensed medicine. MHRA issued a precautionary recall of the cream due to a change in the product's appearance that affected its thickness. Pharmacists are instructed to halt supply, quarantine remaining stock, and contact Quantum Pharmaceutical to return affected batches M1402497, M1402574, and M1402680. Patients using this product may encounter application issues with the cream due to its consistency. However, MHRA said that this has not impacted the product's effectiveness or posed any risk to patient safety. The MHRA also reported that medac GmbH (t/a medac Pharma LLP) is conducting a recall of two batches of Sodiofolin 50 mg/ml solution for injection/infusion (400mg/8ml vial) with batch numbers G220393B and G220393C. This class 2 medicines recall is a result of particles detected during long-term stability tests.

UK regulator has approved a second oral antiviral for early treatment of Covid-19 in high-risk adults, after molnupiravir. The Medicines and Healthcare products Regulatory Agency (MHRA) gave its nod for a new treatment called Paxlovid (PF-07321332 and ritonavir), after finding it safe and effective at reducing the risk of hospitalisation and death in people diagnosed with mild Covid-19 infection. Developed by Pfizer, Paxlovid prevents the multiplying of virus, helping the body to overcome the infection. A clinical trial for the treatment in high risk individuals revealed that a five-days course of Paxlovid reduces the risk of hospitalisation and death by 89 per cent. It further revealed that Paxlovid is most effective when taken in the early stage of infection. Dr June Raine, MHRA chief executive, said: "We now have a further antiviral medicine for the treatment of Covid-19 that can be taken by mouth rather than administered intravenously. This means it can be administered outside a hospital setting, before Covid-19 has progressed to a severe stage."

The Medicines and Healthcare products Regulatory Agency (MHRA) has warned the public to avoid buying pre-filled weight loss pens without a prescription. The warning came after 369 fake Ozempic injections have been seized since January 2023. However, Saxenda pens were obtained by members of the public in the UK through "non-legitimate routes". The health regulator has urged the public to buy the pens after consulting a healthcare professional and with a prescription. Dr Alison Cave, MHRA Chief Safety Officer shared her opinion on the matter, she said: "Buying products such as Ozempic or Saxenda without a prescription, from illegally trading suppliers, significantly increases the risk of receiving something which is either fake or not licensed for use in the UK.

Maxwellia has appointed Ian Adamson as strategic advisor to shape the next phase of pharmacy medicine launches - a process which involves identifying and converting suitable prescription only medicines into versions people can choose to buy under the supervision of a pharmacist. Ian brings over 30 years' international consumer health and personal care experience to the Maxwellia team. He is currently an advisor to the board of the UK independent pharmacy chain Day Lewis plc, an advisor to the board of Spanish healthcare company ReVa Europe S.L and board advisor to East Midlands Pharmaceuticals Ltd. Prior to this Ian was Chief Commercial Officer and a main board director at SSL International plc (prior to its sale to Reckitt Benckiser) with responsibility for a $1bn portfolio of brands, which included Durex and Scholl. Ian's appointment follows the landmark reclassification of the progestogen only pill by the MHRA, a change spearheaded by Maxwellia, and the company's subsequent launch of its first product Lovima in July 2021; and the current MHRA public consultation on the reclassification of Maxwellia's new pharmacy brand, Aquiette 2.5mg Tablets (Oxybutynin Hydrochloride) for the treatment of overactive bladder symptoms which are not adequately controlled by bladder training alone.

AstraZeneca UK has revised the expiry dates for certain batches of Fluenz Tetra nasal spray vaccines as a precautionary measure, after finding that their potency (strength) dropped faster than predicted once thawed, during routine testing. The Medicines and Healthcare products Regulatory Agency (MHRA) has been informed by the manufacturer that the printed expiry date for a limited number of batches is "incorrect." However, the MHRA has assured patients that the affected batches are safe to use and fully effective within the amended expiry date. If the vaccine is administered after the amended expiry date, it may be less effective in protecting against flu, it said. The UK regulatory authority also reiterated that it "keeps the safety of medicines, including vaccines, under review, and acts where necessary to protect patients and the public."

The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the marketing authorisation of Adtralza, a dermatological solution developed by Danish specialist LEO Pharma. This injectable solution contains 300 mg of tralokinumab in a 2 mL pre-filled pen and will be available for tralokinumab patients in the UK from early 2024. Tralokinumab is indicated for treating moderate-to-severe atopic dermatitis in adult and adolescent patients aged 12 and older who require systemic therapy, Leo Pharma said in a statement. It is a fully human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine. Previously, it was available in a 150 mg in 1 mL pre-filled syringe. According to Leo Pharma, the 300 mg tralokinumab in a 2 mL pre-filled pen offers a streamlined administration for both patients and prescribers. It begins with an initial 600 mg dose in two injections, followed by a single 300 mg maintenance dose administered every other week. "We're pleased that this simplified administration method for tralokinumab will soon benefit eligible atopic dermatitis patients in the UK. It aligns with our commitment to elevate the standard of care and support for individuals with skin conditions," said Leanne Walsh, Vice President and General Manager of UK and Ireland at LEO Pharma.

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.

The latest formulation of XGEVA (denosumab) is now available to patients in the UK, offering a more convenient treatment option for bone metastasis. It is the first product to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new International Recognition Procedure (IRP). Denosumab (XGEVA) is used to prevent serious bone-related complications resulting from bone metastasis in adults and to treat giant cell tumour of bone in both adults and adolescents. The medicine was authorised on 29 February 2024 as a 120 mg solution for injection in a prefilled syringe. In contrast to the current vial presentation, this simplifies the administration process, reducing the volume of liquid injected and lowering the risk of dosing errors. The product was authorised in 30 days by the MHRA, thanks to the new IRP that facilitated a rapid approval process.

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised 'no one should stop taking valproate without advice from their healthcare professional.' The latest data on the use of valproate in England revealed that in the last 6 months the number of pregnant women prescribed valproate in a 6-month period has fallen from 68 women in April to September 2018, to 17 women in October 2021 to March 2022. In light of concerns that the current regulatory requirements for safe use are not being consistently followed, the MHRA conducted a review of the available data and asked for advice from the independent Commission on Human Medicines (CHM). "The CHM has advised that no one under the age of 55 should be initiated on valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment," said MHRA. "Where possible, existing patients should be switched to another treatment unless two specialists independently consider and document that there is no other effective or tolerated treatment or the risks do not apply."

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for Sabril 500 mg film-coated tablets & Sabril 500 mg granules for oral solution. Sanofi UK has recalled the batches of Sabril tablets and Sabril granules as a precautionary measure due to the detection of traces of tiapride in the batches of the source material of the manufacturer for vigabatrin. Sabril (vigabatrin) is indicated for adjunctive treatment of focal seizures with or without secondary generalisation not satisfactorily controlled with other antiepileptics (under expert supervision) and monotherapy in the treatment of infantile spasms (West's syndrome). All patients are advised not to discontinue Sabril tablets or Sabril granules without consulting with their prescriber. The risks of suddenly stopping medication for seizures/epilepsy is higher than the potential risk presented by the presence of tiapride. Sanofi UK have confirmed to DHSC that no other batches are impacted, and other stock remains available.

Hospitals and healthcare providers across the UK have been notified about the shortage of an anti-inflammatory medicine caused by a manufacturing failure. The Department of Health and Social Care (DHSC) on Friday (3 May) issued a National Patient Safety Alert stating that Erelzi 50mg solution for injection in pre-filled pen will be out of stock from early May until mid-July 2024. "The supply issues have been caused by a manufacturing failure resulting in delays in production and the implementation of global allocations," it said. However, it noted that homecare providers (Alcura, Healthnet and Sciensus) have sufficient stock to supply existing patients until mid/late May 2024. Although Erelzi 50mg pre-filled syringes (PFS) are still available, they cannot support a full increase in demand, the DHSC warned.

Britain has approved a new coronavirus vaccine by the Austrian-French drugmaker Valneva. "An approval has been granted after the Valneva Covid-19 vaccine was found to meet the required safety, quality and effectiveness standards," the Medicines and Healthcare products Regulatory Agency said in a statement on Thursday (April 14), adding: "It is also the first, whole-virus inactivated Covid-19 vaccine to gain regulatory approval in the UK." In vaccines such as Valneva's VLA2001, the virus is grown in a lab and then made completely inactive so that it cannot infect cells or replicate in the body but can still trigger an immune response. It is seen by some as having the potential to win over people wary of some which use new mRNA technology. Valneva CEO Thomas Lingelbach said that "this authorisation could pave the way for the availability of an alternative vaccine solution for the UK population."

The Royal Pharmaceutical Society (RPS) has said that multi-buy deals on paracetamol violate the existing voluntary sales guidelines. The professional body is urging the government to pass legislation that prohibits retailers from making such offers on medicines for pain relief. They have also sent letters to MP Maria Caulfield who is the Minister for Mental Health and Women's Health. The Medicines and Healthcare Products Regulatory Agency (MHRA) is requesting to take action on the legislation at the earliest. The concern raised is that multi-buy offers such as 'buy one get one free' can encourage people to buy and store excess packs, which may lead to accidental or impulsive overdose.

The Medicines and Healthcare products Regulatory Agency has issued a class 2 medicines recall notice for Olopatadine USV 1mg/ml eye drops. Specific batches of this product are being recalled by USV UK Limited as a precautionary measure due to the identification of out of specification results for impurities during routine stability testing. USV UK Limited are recalling the affected batches as a precautionary measure due to out of specification results for impurities during routine stability testing.

The Medicines and Healthcare products Regulatory Agency (MHRA) has asked the pharmacies and wholesalers to stop supplying and quarantine all remaining stock of Dr Reddy's Laboratories (UK)'s Lacidipine 4 mg Film-Coated tablets. The company has recalled two batches of Lacidipine 4 mg Film-Coated tablets as a precautionary measure due to the presence of an unknown solvent-like odour. MHRA said: "The tablets are normally odourless. However, in the affected batches, a solvent-like odour is present when the individual blisters are opened. Additionally, some patient complaints have noted that the tablets have an unusual taste. The investigation to determine the root cause and to identify and quantify the odour is ongoing. "The issue is confined to batches B2202043 and B2202044 only. Other batches of Lacidipine 4 mg Film-Coated tablets marketed by Dr Reddy's Laboratories (UK) are not affected."