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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.

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.

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.

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 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."

Britain has approved Novavax's Covid-19 vaccine for use in those 18 years of age and older, the country's medicines regulator said on Thursday (February 3), bringing a fifth coronavirus shot to its roster amidst the rapid spread of the Omicron variant. The vaccine, Nuvaxovid, was approved as a first and second dose as it met the required safety, quality and effectiveness standards, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement. The British approval for Nuvaxovid comes days after the drugmaker filed for US authorisation of the vaccine following months of struggles with development and manufacturing problems, and follows a German backing earlier in the day. "We are continuing our vital safety work in monitoring the use of all Covid-19 vaccines, to ensure that their benefits in protecting people against Covid-19 disease continue to outweigh any risks," MHRA chief executive June Raine said.

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Committees of Advertising Practice (CAP) have issued a joint enforcement notice about the 'illegal' advertising of Kenalog injections on digital platforms. The notice warns all organisations offering Kenalog as a 'hay fever treatment' to stop advertising it in any of their social media or website advertising. "Kenalog is a prescription-only medicine (POM), which must not be directly or indirectly advertised to the public. Kenalog is not licensed for the treatment of hay fever in the UK, although it is offered by some beauty and aesthetics clinics, under the personal responsibility of an individual prescriber, and advertised widely on social media," said MHRA. "Now, advertisers must ensure that all references to Kenalog in the text, images or emojis on social media are removed, as well as commonly-used descriptive phrases for the jab such as 'hay fever injection' or hay fever jab' or any account names, testimonials or memes by 29 August 2022." After this date, the CAP's compliance team will remove non-compliant ads using targeted software and those who continue to promote it may be referred to the MHRA for further enforcement action.

The Department of Health and Social Care (DHSC) has issued a medicine supply notification for Temazepam 10mg and 20mg tablets. "Temazepam 10mg and 20mg tablets are in limited supply until w/c 5th December 2022. Alternative benzodiazepines and non-benzodiazepine hypnotics remain available and will be able to support increased demand," said DHSC. Temazepam 10mg/5ml oral solution remains available but cannot support an uplift in demand. DHSC suggested: "Where the above options are not suitable, unlicensed supplies of temazepam 10mg tablets may be sourced, lead times vary." The department confirmed that Target Healthcare, a specialist importers, have confirmed they can source unlicensed Temazepam 10mg tablets. "If there is currently no listing on dm+d for the imported product for prescribers to select using their prescribing systems an EPS prescription for unlicensed Temazepam 10mg tablets cannot be issued."

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised the public to exercise caution when buying anti-choking devices online, ensuring these products are purchased from reputable sellers. As estimated by the regulator, more than 10,000 counterfeit or unbranded anti-choking devices have been purchased by the public within the last two years through listings on online marketplaces such as Amazon and eBay, as well as drop-shipping websites. People are cautioned that the use of such products poses a substantial risk of failure in clearing blockages and could exacerbate the situation by pushing obstructions further down into the airway passage. Dr Alison Cave, MHRA Chief Safety Officer, said: "Buying anti-choking devices that do not have a valid UKCA or CE mark increases the risk of receiving a product which does not include appropriate instructions and is either fake or does not meet the UK's regulatory requirements. "These products do not meet our strict quality standards and may put your health and safety at significant risk by failing to resolve or even worsening choking incidents."

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication of semaglutide (Wegovy), authorising its use to reduce the risk of serious heart problems and strokes in adults who are obese or overweight. Semaglutide, a GLP-1 receptor agonist, was previously approved for use in the treatment of obesity and weight management, to be used alongside diet, physical activity and behavioural support. The latest approval establishes it as the first weight loss drug to be prescribed to prevent cardiovascular events, such as cardiovascular death, non-fatal heart attack and non-fatal stroke, in people with established cardiovascular disease and a Body Mass Index (BMI) higher or equal to 27 kg/m2. Novo Nordisk, the manufacturer of Wegovy, received this authorisation on 23 July following compelling evidence from a recent post-approval clinical study involving over 17,600 participants. The study demonstrated that Wegovy, administered at a dose of 2.4 mg once weekly via subcutaneous injection for up to five years, significantly lowers the incidence of major adverse cardiovascular events (MACE) by 20 per cent compared to a placebo.

Supply of all Champix products, used for smoking cessation, will remain out of stock until further notice from the Medicines and Healthcare products Regulatory Agency (MHRA). The announcement follows a medicine recall order initiated by the MHRA for "all strengths of Champix® tablets" on October 14, 2021 at pharmacy and wholesaler level. Pfizer, the sole supplier of Champix tablets, stopped the distribution of 0.5mg and 1mg tablets in early June 2021. The company is currently unable to confirm when supplies will resume amid global regulatory investigations relating to the presence of nitrosamine impurities above the Pfizer's acceptable level of daily intake in several lots.

The Medicines and Healthcare products Regulatory Agency (MHRA) has recalled Labetalol 200mg tablets (Tillomed Laboratories Ltd) directed to pharmacies and wholesalers. Manufacturer, Tillomed Laboratories is recalling one batch of Labetalol 200mg tablets due to an error on the foil blister packaging. The incorrect aluminium foil blister packaging states Labetalol 100mg tablets, however it should be labelled as Labetalol 200mg Tablets. This error has occurred at the primary packing operation. Tillomed Laboratories Limited has confirmed the actual tablet contained in the blister is Labetalol 200mg Tablets, which is the strength stated on the outer carton. This error is limited to the packaging of the batch with 100mg aluminium foil blister and does not impact the lot (batch) number or expiry as printed on the outer carton and aluminium foil blister. Healthcare professionals has been advised to stop supplying the batches immediately. Quarantine all remaining stock and return it to supplier using supplier's approved process.

The Medicines and Healthcare products Regulatory Agency (MHRA) has cautioned people to stop using certain eye gels, highlighting a potential risk of microbial contamination that can cause an infection. As a precaution, the agency on Friday announced recall of specific batches of carbomer-containing lubricating eye gels branded Aacarb, Aacomer and Puroptics, which are generally used to relieve the symptoms of dry eye. Burkholderia cenocepacia is suspected to have caused the microbial contamination, and the issue was raised after an ongoing investigation conducted by UK Health Security Agency (UKHSA) identified a small number of cases of infection. Investigations are on to determine if there is a link between these products and the infections which have been identified. Meanwhile, retailers have been told to withdraw the affected products, and users are asked to return their product to the place of purchase immediately.

HRA Pharma is celebrating the 1st anniversary of Hana, the first type of daily oral contraception available in the UK without a prescription. The launch of Hana in 2021 followed the historic decision of the Medicines and Healthcare products Regulatory Agency (MHRA) to grant a marketing authorisation and marked a significant step forward in the women's contraception category. The company reports that pharmacists have embraced the reclassification and have found merit in using emergency contraception consultations as an opportunity to educate women on their over-the-counter contraception options. Alison Slingsby, innovations project manager at HRA Pharma, commented: "We have been delighted with Hana's reception - within weeks of launch, it quickly became the best-selling mini-pill without prescription, with more than 95 per cent market share, and has maintained this market leading position ever since. We previously had the experience of switching emergency contraceptive ellaOne to a P medicine, Hana is on track to match and eventually exceed the ellaOne volumes.

The Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday authorised a Covid-19 vaccine for infants as young as six months, opening the door for vaccinating the country's youngest children once the UK's Joint Committee on Vaccination and Immunisation (JCVI) agrees. The regulator authorised the vaccine - made by Pfizer and BioNTech - for children aged six months to four years old, after it was deemed safe and effective based on an ongoing clinical trial involving 4,526 participants. Whether the vaccine is eventually deployed in this age group depends on a recommendation from the JCVI, which advises UK health departments on which shots should be used as part of the national vaccination programme. The vaccine is tailored for use in this age group - it is a lower dose version than the one used in children aged five to 11 years. It is given as three injections in the upper arm, with the first two doses given three weeks apart, followed by a third dose administered at least two months after the second dose.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a second "bivalent" vaccine as a Covid-19 booster. The updated booster vaccine made by Pfizer/BioNTech, targeting two coronavirus variants, has been approved for use in individuals aged 12 years and above. In each dose of the booster vaccine, 'Comirnaty bivalent Original/Omicron', half of the vaccine (15 micrograms) targets the original virus strain and the other half (15 micrograms) targets Omicron (BA.1). Dr June Raine, MHRA chief executive said: "I am pleased to announce that we now have a second approved vaccine for the UK Autumn booster programme. The clinical trial of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against the Omicron BA.1 variant as well as the original strain. Bivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against Covid-19 variants. We have in place a comprehensive safety surveillance strategy for all UK-approved Covid-19 vaccines, and this will include the updated booster we approved today."

The life cycle management company, Pharmanovia, has appointed Nivedita Valentine as associate vice president of Product Innovation. Ms Valentine will oversee the company's product innovation operations and decision-making as Pharmanovia continues to focus efforts on both, identifying new prospects to enhance lifecycle management of its brands through incremental innovation. She will report to interim chief scientific officer Stephen Deacon and help bridge unmet patient needs with the help of novel therapies, originating both from in-house development and through partnerships. Ms Valentine currently holds positions on the value-added medicines committee within Medicines for Europe and the International Rare Diseases Research Consortium (IRDiRC) Task Force on Drug Repurposing Guidebook. Pharmanovia CEO Dr James Burt commented: "Digitalisation and utilising the latest technological innovation are notable areas of acceleration within the pharma industry and Nivedita's appointment will ensure iconic brands will continue to be improved, supported, and used sustainably.

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.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis. On the start of World Allergy Week (19 June), an annual initiative led by the World Allergy Organization, aiming to raise awareness of allergies, their management and prevention, the MHRA has collaborated with allergy awareness advocates to share an easy step-by-step infographic guide and video outlining the latest advice from the CHM's working group on the safe and effective use of AAIs. Steve Barclay, Secretary of State for Health and Social Care said: "A severe allergic reaction can be life-threatening. One in five people in the UK suffer with at least one allergy, so it's vital people are equipped with the knowledge to keep themselves safe. Adrenaline auto-injectors - also known as AAIs or by their brand names such as EpiPen - are highly effective and convenient for the immediate treatment of anaphylaxis. If you have been prescribed one, please carry it with you at all times and make sure you are up to date on the latest safety guidance - it could save your life."