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 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 Department of Health and Social Care (DHSC) and NHS England last month issued a "safety critical" national patient safety alert, warning about
the UK-wide shortage of a life-saving drug used to treat patients with chronic breathing issues.
NHS trusts, health authorities, ambulance services, GP practices, private healthcare providers, and community pharmacy contractors were informed that
salbutamol 2.5mg and 5mg nebuliser liquid unit dose vials are in short supply, with the latter likely to remain "out of stock" until mid-April 2024.
As per the alert, the shortage of the drug resulted from a combination of manufacturing issues, leading to heightened demand for alternative suppliers.
It was mentioned that while terbutaline, salbutamol with ipratropium, and ipratropium nebuliser liquids remained available, they could't meet the increased demand.
Global healthcare company Mundipharma and Vectura, an inhalation contract development and manufacturing organization, have entered into a collaboration
agreement aimed at reformulating an asthma inhaler as part of their commitment to reducing the product's carbon footprint.
The companies will be working together on incorporating an environmentally friendly propellant into the formulation of flutiform, a pressurised metered-dose
inhaler (pMDI) used for asthma treatment, to achieve a near-zero-emissions product.
Currently, the product uses the approved apaflurane hydrofluoroalkane 227 (HFA-227), a type of fluorinated greenhouse gas, as its propellant.
The European Union's regulation on these types of greenhouse gases targets a two-thirds reduction in their usage and subsequent emissions by 2030.
In a joint statement, companies revealed that work is already in progress to find an alternative to the HFA-227 gas.
Yuri Martina, Chief Development and Medical Officer at Mundipharma, said: "This is the first step in our long-term plan to develop a near-zero-emissions asthma
inhaler.
For the first time, Covid-19 vaccines will be available for purchase from pharmacies in Britain from April 1.
As revealed by The Times, Boots is set to launch a private vaccination service next week to ensure that people "remain ready to respond to this constantly
evolving and unpredictable virus."
Under the NHS national immunization programme (NIP), Covid booster vaccines are only offered to those at high risk, including over-65s or patients with weakened
immune systems.
From April 1, anyone aged 12 or over can get the Pfizer-BioNTech Covid-19 vaccine at 50 Boots stores for £98.95.
While it's highly unlikely for healthier young adults to experience severe Covid-19, getting the single-dose vaccine can protect them from discomforting symptoms
like coughs and sore throats.
A spokesperson for Boots told the publication that their private service is the extension of their existing delivery of Covid-19 vaccinations for the NHS.
Campaigners have submitted an open letter to the Department of Health and Social Care (DHSC), urging the Minister for Primary Care and Public Health to
freeze prescription charges to keep people with long-term conditions alive and well.
The campaign is led by the Prescription Charges Coalition, which represents over 50 organisations, including Royal Pharmaceutical Society (RPS) and Pharmacists'
Defence Association (PDA).
Currently, the prescription charge is £9.65 per item, and campaigners have asked the government to freeze it for 2024 and 2025 as people living with long-term
health conditions in England are "being forced to choose between heating, eating, and taking their vital medication on a daily basis."
In 2023, a study conducted by the Prescription Charges Coalition revealed that almost 10 per cent of survey participants had skipped medication in the previous
year due to the cost of prescriptions. This led to increased physical and mental health problems, as well as impacted the time they took off work.
Laura Cockram, Chair of the Prescription Charges Coalition and Head of Campaigns at Parkinson's UK, expressed deep concern that a further rise in the charge this
year will lead to people skipping or not taking the full dose of their medication, which will affect their health and put more pressure on the already under
pressure NHS.
Many people with advanced Parkinson's disease are currently required to take more than 20 pills a day to manage their symptoms, while some necessitate
treatment through a permanent feeding tube.
Soon, patients will only be required to wear a portable kit to get a continuous dose of the medication delivered into their bloodstream 24 hours a day.
This innovative treatment, called Produodopa, will now be made available on the NHS, providing benefit to nearly 1,000 people with advanced Parkinson's disease,
according to a BBC report.
James Palmer, NHS England's medical director for specialised services, told the publication that the drug's rollout will offer "a vital new option on the NHS for
those who aren't suitable for other treatments such as deep brain stimulation."
He added that the new therapy will help patients manage their symptoms "more effectively" and improve their quality of life.
Covid-19 vaccine maker Novavax on Wednesday said it expects revenue this year to be flat or lower as it works to improve its commercial performance and
pick up market share from much larger rivals, Pfizer and Moderna.
The company posted a larger-than-expected fourth-quarter loss as revenue lagged analysts' estimates.
Chief executive John Jacobs said Novavax claimed just a low-single-digit percentage market share in the US during the most recent vaccination campaign, as demand
for Covid vaccines was smaller than hoped and the company got its protein-based shot to market later than its messenger RNA-based rivals.
"We were disappointed with that US performance," Jacobs said in an interview.
He said the company's sales force was not targeted enough toward retail pharmacy chains, and that its 5-dose vials were not as convenient for use as rivals'
pre-filled syringes.
Pfizer on Thursday said a single dose of its new respiratory syncytial virus (RSV) vaccine Abrysvo maintained its ability to protect against the illness
through a second year of respiratory disease season.
The company said in a press release that the vaccine's efficacy against RSV-associated lower respiratory tract disease with three or more symptoms was 77.8 per cent
through season two, compared with efficacy of 88.9 per cent after the first RSV season, which led to the shot's US approval.
The data is from a late-stage trial of more than 37,000 participants being conducted in both the Northern and Southern hemispheres.
Cumulative efficacy over both seasons after around 16.4 months of disease surveillance was 81.5 per cent, Pfizer said.
The data is similar to the efficacy of GSK's rival RSV shot Arexvy over two seasons, which was released in June.
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.
Bambuterol 10mg tablet, used in the treatment of asthma and chronic obstructive pulmonary disease, is facing supply disruption as sole supplier of the medicine, Astra Zeneca, is discontinuing its production, according to an update by the Department of Health and Social Care (DHSC).
The available stock of the medicine is expected to be exhausted by the end of June 2022.
Meanwhile, other oral β2-agonists, which are the preferred route of administration, remain available, DHSC said.
Existing Covid-19 inoculations will struggle against the fast-spreading Omicron variant, the head of vaccine manufacturer Moderna warned on Tuesday (November 30), as countries ramp up vaccination programmes and impose further restrictions in an effort to curb growing concern.
First reported to the World Health Organization in South Africa less than a week ago, the new strain has rapidly spread from Africa to the Pacific, and from Europe
to North America as dozens of countries have announced travel restrictions.
While no deaths have yet been reported from Omicron, and it could take weeks to know how infectious and how resistant the strain may prove to vaccines, its emergence underscores how besieged the world remains by Covid-19, nearly two years after the first cases were recorded.
Stephane Bancel, the head of US vaccine manufacturer Moderna, told the Financial Times in an interview published today that data would be available on the effectiveness of vaccines in the two weeks' time, but that scientists were pessimistic.
Superdrug Online Doctors has made travelling easy ahead of Easter by introducing jet lag 'melatonin' tablets into its travel services portfolio to help those
taking long haul flights.
The company has seen an 287 per cent increase in demand for its travel services and products. Malaria treatment is up by 272 per cent, gut health products up by
317 per cent, jet lag melatonin tablets increasing by 900 per cent since launch and Period Delay services which offer more choice when it comes to the timing of
periods up by 195 per cent year-on-year.
Dr Sara Kayat, Superdrug's medical ambassador, comments: "Jet lag is a temporary sleep problem that affects people who travel across different time zones. It can
occur when your internal clock, the function that lets your body know when to stay awake and when to sleep, is disrupted by a new time zone and puts your internal
clock out of sync. Melatonin is a hormone we produce to help regulate our sleep cycles, and a synthetic version can be taken in the short term to manage jet lag."
The MHRA's Criminal Enforcement Unit (CEU), working with other law enforcement partners, has seized more than two million "illegally traded medicines" this
year, with a total value of £5 million.
The products confiscated in the UK were prescription-only medicines including anti-depressants, pain medication and human growth hormones.
The MHRA launched an initiative, Operation Pangea, 15 years ago to combat "illegal internet trade in medical" products.
Andy Morling, the Deputy Director of Criminal Enforcement of MHRA, spoke about Operation Pangea's 15-year anniversary.
"Fifteen years ago, the MHRA started Operation Pangea, combining our knowledge and resources with those of international partners to disrupt and bring to justice
the criminal gangs responsible for selling medicines illegally and causing harm around the world.
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 NHS on Thursday (May 5) said it has rolled out the arthritis drug baricitinib for seriously ill Covid patients.
The Recovery trial, conducted by the NHS and University of Oxford, found that 13 per cent fewer severely ill patients died of Covid when treated with the drug compared to existing treatment options.
Typically used to treat arthritis to reduce pain and inflammation, baricitinib can now be given to hospitalised Covid patients in addition to current treatments, and clinical studies show that this can provide benefits on top of existing treatment.
The NHS has led the rollout of Covid medicines, from the discovery of dexamethasone as the world's first effective treatment, to the first vaccination outside of a clinical trial in December 2020.
The NHS said baricitinib works by reducing inflammation caused by Covid-19 by blocking signals to the immune system that are causing it to attack the body.
The Department of Health and Social Care (DHSC) has issued a further five new Serious Shortage Protocols (SSPs) for Phenoxymethylpenicillin (Pen V) to enable
the continued supply of antibiotics to patients.
"The new SSPs, introduced with immediate effect, allow community pharmacists to consider different oral antibiotic preparations, to enable the continued supply of
antibiotics to patients and mitigate the ongoing supply disruptions affecting Phenoxymethylpenicillin," said DHSC.
On Friday (16 December) SSP043-SSP047 has been authorised by the Secretary of State to provide pharmacists with procedures to follow in providing suitable alternative
oral antibiotics to substitute Phenoxymethylpenicillin.
"For each SSP, DHSC has included specific patient counselling points which must be taken into account when deciding whether supply in accordance with an SSP is
suitable for a patient."
The business landscape worldwide is undergoing a significant transformation, shifting from a sole focus on profitability to incorporating a broader spectrum
of considerations. Today, Environmental, Social, and Governance (ESG) criteria are integral to business operations, reflecting a commitment to sustainable and
ethical practices alongside financial growth.
ESG stands for three interconnected pillars: Environmental, focusing on reducing a company's ecological footprint; Social, addressing the impact on employees,
diversity, equity, inclusion, and the broader community; and Governance, which ensures responsible management practices, ethical behavior, and compliance with
regulations.
This holistic approach is becoming a critical foundation for long-term success in various industries, including healthcare. For the UK healthcare and pharmacy
sectors, integrating ESG not only aligns with global sustainability goals but also offers substantial benefits. This article delves into the specific implications
of ESG for UK pharmacies, highlighting how they can leverage these practices to foster both community well-being and business success.