The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised a new drug today (1 November) to treat severe alopecia areata.
Litfulo is the new hard capsule medicine with a recommended dosage of just 50 mg per day.
It contains an active ingredient, ritlecitinib, an enzyme inhibitor treatment for patients over 12 years.
Ritlecitinib works by reducing the activity of enzymes in the body called JAK3 and TEC kinases that cause hair follicle inflammation.
This reduction in inflammation leads to hair regrowth in patients with alopecia areata.
Alopecia areata is an autoimmune disease, where the body's own immune system attacks hair follicles leading to hair loss on the scalp and other parts of the body.
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.
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 (MHRA) has authorised an innovative and first-of-its-kind gene-editing treatment for sickle-cell
disease and transfusion-dependent β-thalassemia.
Known as Casgevy (exagamglogene autotemcel), the treatment is based on the innovative gene-editing tool CRISPR, for which its inventors were awarded the Nobel
Prize in 2020.
Casgevy is the first medicine to be licensed that uses CRISPR, and it is to be used for treating patients aged 12 and over.
To date, a bone marrow transplant has been the only permanent treatment option for these life-long conditions, which in some cases can be fatal.
The MHRA's authorisation came after a rigorous assessment of its safety, quality and effectiveness.
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.
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 Healthcare products Regulatory Agency (MHRA) has reminded healthcare professionals prescribing aripiprazole to alert patients about its
possible side effects, following a rise in the number of reports of gambling disorder associated with the drug.
Patients taking aripiprazole, which is used for the treatment of schizophrenia and bipolar disorder, are at risk of developing unusual urges or cravings that they
cannot resist, including behaviours such as addictive gambling, excessive eating or spending, or an abnormally high sex drive.
The regulator has received 69 reports of gambling or gambling disorder suspected to be caused by aripiprazole in the last 14 years via the Yellow Card Scheme, out
of which 32 were received between 1 January and 31 August this year.
Alison Cave, MHRA Chief Safety Officer, said: "The number of reports for suspected gambling and other impulsive behaviours associated with aripiprazole are small
in comparison to the frequency with which it is prescribed, but the consequences for any patient developing these conditions can be significant."
Pharmaceutical Services Negotiating Committee (PSNC) has expressed its support for alterations in the Human Medicines Regulations 2012 to enable original pack dispensing (OPD) and supply of medicines containing sodium valproate by pharmacists.
PSNC's support for changes was in response to the consultation on OPD, initiated by the Department of Health and Social Care (DHSC).
The consultation had proposed regulatory changes to allow pharmacists to dispense (up to 10 per cent) more or less than the prescribed quantity of a given medicine in the manufacturer's original packs.
Key aims of the proposal are to "support increased patient safety by ensuring patients receive the necessary information that is included in the original manufacturer's packaging about the safe and effective use of a product," DHSC said.
GlaxoSmithKline and Sanofi said on Wednesday (December 15) they expect data from late-stage clinical trials of its booster dose of their Covid-19 vaccine candidate in the first quarter, instead of this year, another delay for the potential shot.
The news came as two companies said preliminary data from trials showed the single-dose booster provided strong immune responses. They added that they need more
time to test the booster on more people who have not been infected by the virus before they can submit data to regulators.
The Phase III trial for the recombinant adjuvanted Covid-19 vaccine recruited most participants in the third quarter, coinciding with a significant increase in the number of people infected globally due to the Delta variant, it said.
"To provide the necessary data to regulatory authorities for the booster vaccine submission, the trial will continue to accrue the number of events needed for analysis, with results expected in Q1, 2022."
No safety concerns were identified.
This is the latest delay for the vaccine's development, putting the companies further behind rivals in the race for Covid-19 shots.
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."
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.
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) has launched a public consultation on plans to reclassify a locally-applied hormone replacement
therapy product to treat the cause and relieve the symptoms of vaginal atrophy.
The MHRA is proposing that Gina 10 microgram vaginal tablets, containing oestradiol, be made available over the counter as a "self care" product, under the
supervision of a pharmacist.
The Commission on Human Medicines too has advised that the application by Novo Nordisk, which is used to treat vaginal dryness, caused by oestrogen deficiency in
postmenopausal women, can be made available as a pharmacy (P) medicine.
The MHRA has been asking GPs, pharmacists and members of the public for their opinions on whether the tablets can be made available to women aged 50 and over who
have not had a period for at least a year.
If the reclassification goes ahead, pharmacists will be given training materials and a checklist to help them supply the medicine safely.
Covid-19 vaccine makers are shifting gears and planning for a smaller, more competitive booster shot market after delivering as many doses as fast as they
could over the last 18 months.
Executives at the biggest Covid vaccine makers including Pfizer and Moderna said they believe most people who wanted to get vaccinated against Covid have already done so - more than five billion people worldwide.
In the coming year, most Covid vaccinations will be booster shots, or first inoculations for children, which are still gaining regulatory approvals around the world, they said.
Pfizer, which makes its shot with Germany's BioNTech and Moderna still see a major role for themselves in the vaccine market even as overall demand declines.
Upstart US vaccine maker Novavax and Germany's CureVac, which is working with GlaxoSmithKline, are developing vaccines they hope to target at the booster market.
The roles of AstraZeneca and Johnson & Johnson, whose shots have been less popular or effective, are expected to decline in this market.
The Royal Pharmaceutical Society (RPS) has published a new professional guidance for prescribing practice on Monday (June 6) which it says will be "for the
benefit of all independent prescribers across the UK".
Based on collaboration with multi-professional stakeholders, the document is a guidance tool for prescribers wanting to expand their prescribing scope of practice.
Commissioned by the Welsh government, the document was developed through an expert group with representatives from many healthcare professions, including from Higher Education institutions, professional bodies, regulatory bodies, the National Institute for Health and Care Excellence, NHS Education for Scotland, Health Education
and Improvement Wales, and representatives from hospital, community and GP practice.
RPS president Claire Anderson said: "It's fantastic to see the growth in prescribing, both across the profession and more widely, to improve patient care.
Following concerns raised about cracked cartridges and insulin leaks, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued a national
patient safety alert for the NovoRapid PumpCart prefilled insulin cartridge and the Roche Accu-Chek Insight Insulin pump system.
The regulator have asked patients to check the pre-filled glass insulin cartridge for cracks before use. It advised against using the cartridge if it has been dropped even if no cracks are visible and urged to closely follow the updated handling instructions in the pump user manual when changing pre-filled glass insulin
cartridges.
In some of the reported leakage incidents, the cartridges were found to be cracked and provided an inadequate supply of insulin to patients. Leakages also occurred in cases where no cracks in the cartridge were visible, the regulator said.
In some patients there were consequences of not receiving enough insulin from their pump system, including reports of severely high blood sugar and diabetic ketoacidosis, a serious complication of diabetes when the body produces high levels of blood acids called ketones.
Healthcare professionals are being advised to contact patients over the next six months using said device to discuss their individual needs and source an alternative pump where appropriate.
"Because of the rare risk of insulin leakage from the Roche Accu-Chek Insight Insulin Pump, patients should check the pre-filled glass insulin cartridge for any cracks prior to usage," Dr June Raine, MHRA chief executive, said.
The Pharmaceutical Services Negotiating Committee (PSNC) has expressed disappointment as the government continued to refuse to "a much-needed broader funding uplift" for the community pharmacies in England.
This follows conclusion of the first Annual Review of the progress of the five-year Community Pharmacy Contractual Framework (CPCF) deal by PSNC, the Department of Health and Social Care (DHSC) and NHS England & NHS Improvement (NHSE&I).
"We remain deeply frustrated by government's refusal to agree a much-needed broader funding uplift for the sector, but we are determined to continue to look for
better ways forward for the sector throughout 2022 and beyond," said Bharat Patel, PSNC vice-chair, negotiating team member and an independent contractor.
Patel noted that despite some important wins such as recognition of key challenges faced by pharmacies, the commitment to consider these as part of our Year 4
negotiations, and agreement to take forward work on service fee and other regulatory changes, the PSNC is disappointed that the review did not lead to "immediate and tangible outcomes and improvements for contractors."
The negotiator had put forward data and analysis showing the capacity and cost constraints faced by pharmacies.
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.
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.
