Group items tagged

British health agencies have secured funding to develop a standardised approach to test the performance of vaccines being used or in development against monkeypox, days after the World Health Organization labelled the growing outbreak a global health emergency. The Coalition for Epidemic Preparedness Innovations (CEPI) said it would give up to $375,000 to the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Security Agency (UKHSA) to develop standard tools to assess the strength and duration of immune responses generated by current vaccines, and for tests used to detect monkeypox antibody levels. Apart from administration fees, these tools will be made freely available to the global scientific community, paving the way for a common standardised assessment between countries documenting vaccine performance against monkeypox, CEPI said. Until this year, the viral disease has rarely spread outside Africa where it is endemic. But reports of a handful of cases in Britain in early May signalled that the outbreak had moved into Europe. So far, there have been more than 16,000 confirmed cases of monkeypox in more than 75 countries.

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.

Monkeypox appears to be spreading from person to person in England, the UK Health Security Agency (UKHSA) said on Wednesday (June 1). The usually mild viral disease, which is endemic in west and central Africa, is understood to spread through close contact. Until early May, cases rarely cropped up outside Africa and were typically linked to travel to there. "The current outbreak is the first time that the virus has been passed from person to person in England where travel links to an endemic country have not been identified," the agency said. According to the UKHSA, the majority of cases in the United Kingdom - 132 - are in London, while 111 cases are known to be in gay, bisexual, or other men who have sex with men. Only two cases are in women. Recent foreign travel to a number of different countries in Europe within 21 days of symptom onset has been reported by 34 confirmed cases, or about 18 per cent of the 190 cases of the disease that have been confirmed by the United Kingdom as of May 31.

To complete the evaluations of Lateral Flow Device (LFD) test kits, the UK Health Security Agency (UKHSA) will approach pharmacies and send 15 combined kits to pharmacies in December. The combined kits will contain a standard LFD pack, one PCR test along with comprehensive instructions. For the evaluation, a part of meeting Medicines and Healthcare products Regulatory Agency (MHRA) obligations, UKSHA needs "dual swabbing through the community pharmacy Covid-19 lateral flow device distribution service." Pharmacies receiving these kits need to finish the current open carton of LFD packs and then open the next standard carton. Pharmacy negotiator PSNC has advised pharmacies to be mindful of "the expiration date of the kit and ensure these are handed out in sufficient time."

Two new subvariants of Omicron - BA.4 and BA.5 - are spreading much faster than other corovanirus variants in Europe, which could lead to more hospitalisations and deaths as they become dominant, the EU's disease prevention agency said on Monday (June 13). Most EU countries have so far detected low rates of the two subgroups. But in countries where the proportion has risen - such as Portugal, where BA.5 accounted for 87 per cent of cases by May 30 - there have been surges in overall cases, according to the European Centre for Disease Prevention and Control (ECDC). The two sublineages were added to the World Health Organization's monitoring list in March and have also been designated as variants of concern by the ECDC. Variants BA.4 and BA.5 do not appear to carry a higher risk of severe disease than other forms of Omicron.But an increase in case numbers from higher transmission rates risks leading to an increase in hospitalisations and deaths, the agency said. "The growth advantage reported for BA.4 and BA.5 suggest that these variants will become dominant," ECDC said in a statement on its website.

The Food Standards Agency (FSA) has launched a campaign to caution people with food allergies about the risk of products labelled as 'vegan'. People who have an allergy to milk, eggs, fish and crustaceans or molluscs are encouraged to always check for a precautionary allergen statement such as 'may contain' on products labelled 'vegan' before consuming the food. The launch of the campaign comes in the wake of recent research findings by the FSA that 62 per cent of individuals with reactions to animal-based products or who buy for someone with allergies were confident that products labelled 'vegan' are safe to eat. This is "incorrect" and may put them at risk, the agency said. The FSA study found that 54 per cent of people who experience reactions to animal-based products and 53 per cent of those purchasing for someone with a food hypersensitivity to animal-origin products have used vegan labelling to determine the safety of packaged food on at least some occasions.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is considering the reclassification of Aquiette 2.5mg tablets contains oxybutynin hydrochloride that is used to treat women with milder symptoms of overactive bladder from Prescription-Only-Medicine (POM) to Pharmacy (P) medicine. The agency is encouraging pharmacists, GPs and other health care professionals, the public and women to take part in the reclassification consultation to make a treatment for overactive bladder available for women without the need for a prescription. Public consultation on a set of proposals to make Aquiette 2.5mg Tablets (oxybutynin hydrochloride) available from pharmacies will close on 13 May, 2022. It would be the first time a medicine for the treatment of overactive bladder would be available without prescription, if the reclassification consultation receives positive responses. After the decision is made to reclassify this treatment, pharmacists will have access to training materials and a checklist to enable them to identify women who can be supplied this medicine safely.

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised healthcare professionals to stop supplying a specific batch of Paroxetine 40mg Film Coated Tablets immediately. Crescent Pharma Limited is recalling a specific batch of Paroxetine 40mg Film Coated Tablets as a precautionary measure due to out of specification results for dissolution during routine stability testing. "Quarantine all remaining stock of the said batch and return it to your supplier, using your supplier's approved process," said MHRA. The agency alerted the patients that this is a precautionary Pharmacy and Wholesaler level recall, therefore no further action is required by patients.

A news report suggests the Department of Health and Social Care is aiming to be ready to start charging for Covid-19 tests which are currently free at the end of June. Britain has been increasingly dependent on rapid testing to try to tackle the more-transmissible Omicron variant, which has spread rapidly through the population but is less severe. The government has previously said it will end the universal free provision of easy-to-use lateral flow devices (LFDs) at a "later stage", with individuals and businesses bearing the cost. The Department of Health has declined to say what the tests cost, citing commercial contracts. One source has told the Reuters news agency they can run to £30 for a pack of seven. Free pick up from pharmacies The tests have been made freely available to order online or pick up from local pharmacies since April. The UK Health Security Agency said that between December 30 and January 5 more than 8 million LFDs were conducted, the highest weekly figure on record.

The UK's Health Security Agency (UKHSA) said mistakes at a testing laboratory led to misreporting of tens of thousands of positive COVID-19 cases as negative and may have resulted in the deaths of about 20 people. Britain has one of the highest coronavirus death tolls in the world, with more than 177,000 deaths since the pandemic started in 2020. Many experts have said the contact tracing programme fell well short of the "world-beating" system the government had promised. An investigation by the government agency responsible for responding to public health emergencies said the Immensa laboratory in central England was found to have misreported around 39,000 tests as negative when they should have been positive between September 2 and October 12 last year.

A polio vaccine booster campaign is being launched for almost a million children in London aged between 1 and 9 after confirmation that poliovirus is spreading in the capital for the first time since the 1980s. The UK Health Security Agency has identified 116 polioviruses from 19 sewage samples this year in London, after first sending an alert about finding the virus in June. The levels of poliovirus found and genetic diversity indicated that transmission was taking place in a number of London boroughs, the agency said on Wednesday (Aug 10). Health secretary Steve Barclay said: "I recognise parents and guardians will be concerned about the detection of polio in London, however I want to reassure people that nobody has been diagnosed with the virus and the risk to the wider population is low… "Vaccines offer the best defence to children, and those around them, so I would encourage families to ensure they are up to date with their routine jabs, and to come forward for the polio booster as soon as they are contacted by the NHS."

Health authorities in India have launched an inquiry into an allegation that a local pharmaceutical regulator, in return for a bribe, helped switch samples of cough syrups that the World Health Organization (WHO) had linked to the deaths of children in Gambia before the samples were tested at an Indian laboratory, according to two government officials and documents reviewed by the Reuters news agency. In an April 29 letter to the Anti-Corruption Bureau (ACB) in Haryana state reviewed by the news agency, a lawyer named Yashpal accused the state's drug controller, Manmohan Taneja, of taking a bribe of 50 million rupees (£481,600 approx.) from local manufacturer Maiden Pharmaceuticals to help it switch the samples before an Indian government laboratory tested them. Maiden's factory is based in Haryana state. Reuters points out that it was unable to independently establish that any bribes were paid. Taneja did not respond to phone calls, messages or emails seeking comment. Maiden did not respond to requests for comment. The WHO said it had no knowledge of the allegation. Yashpal - who like some Indians uses only one name - did not say in the letter where he got the information, or provide evidence for his claim about the syrups made by Maiden. Reuters was unable to independently establish that any bribes were paid.

The pharmaceutical industry is one of the most important and valuable industries in the world. It is responsible for developing and producing medicines that improve and save lives. However, there are some things you may not know about this fascinating industry. In this blog post, we will discuss six interesting facts about the pharmaceutical industry! 1. THE MANUFACTURING PROCESS OF PHARMACEUTICALS IS HIGHLY REGULATED All pharmaceutical products must go through a rigorous manufacturing process before they can be made available to patients. This process is heavily regulated by various government agencies to ensure that the medicines are safe and effective. The pharmaceutical manufacturing process usually involves multiple steps, including the preparation of raw materials, the manufacturing of active pharmaceutical ingredients (APIs), and the packaging and labeling of finished products. To ensure patient safety, all pharmaceutical companies must adhere to strict regulations set by government agencies such as the Food and Drug Administration (FDA). These regulations are designed to protect patients by ensuring that medicines are safe and effective.

The world has never been in a better position to end the Covid-19 pandemic, the head of the World Health Organization said on September 14, his most optimistic outlook yet on the years-long health crisis which has killed over six million people. "We are not there yet. But the end is in sight," WHO Director-General Tedros Adhanom Ghebreyesus told reporters at a virtual press conference. That was the most upbeat assessment from the UN agency since it declared an international emergency in January 2020 and started describing Covid-19 as a pandemic three months later. The virus, which emerged in China in late 2019, has killed nearly 6.5 million people and infected 606 million, roiling global economies and overwhelming healthcare systems. The rollout of vaccines and therapies have helped to stem deaths and hospitalisations, and the Omicron variant which emerged late last year causes less severe disease. Deaths from Covid-19 last week were the lowest since March 2020, the U.N. agency reported.

The global company in information and data analytics, Elsevier launched a platform, PharmaPendium for drug candidates. It is an effective tool that provides data including complete Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval packages for drug development. The platform is supported by the FDA, the Medical Devices Agency (PMDA) and the top 20 global pharma companies. Olivier Barberan, Director of Translational Medicine Solutions spoke about how "improved access to highly relevant data plus predictive tools enhances regulatory success, safeguarding the massive investments of pharma companies." "Translation of preclinical research findings to humans in an efficient but safe way is one of the greatest challenges facing drug developers. We designed the new PharmaPendium to solve this," he added.

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.

The World Health Organization said on Sunday (May 29) that monkey pox constitutes a "moderate risk" to overall public health at global level after cases were reported in countries where the disease is not typically found. "The public health risk could become high if this virus exploits the opportunity to establish itself as a human pathogen and spreads to groups at higher risk of severe disease such as young children and immunosuppressed persons," WHO said. As of May 26, a total of 257 confirmed cases and 120 suspected cases have been reported from 23 member states that are not endemic for the virus, the health agency said in a statement. There has been no reported fatalities so far. WHO also said that the sudden appearance of monkeypox at once in several non-endemic countries suggests undetected transmission for some time and recent amplifying events. The agency added that it expects more cases to be reported as surveillance in endemic and non-endemic countries expands. Monkeypox is an infectious disease that is usually mild, and is endemic in parts of west and central Africa. It is spread by close contact, so it can be relatively easily contained through measures such as self-isolation and hygiene.

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.

Polio has been detected in sewage samples in London, the first sign since the 1980s that the virus could be spreading in the UK, but no cases have been found, authorities said. The risk of infection from the disease, which causes paralysis in children in under one per cent of cases, was also low because of high vaccination rates, the UK Health Security Agency (UKHSA) said. The agency nevertheless encouraged parents to make sure their children were vaccinated after the discovery of the virus during routine wastewater surveillance - particularly those who may have missed shots during the Covid-19 pandemic. Nationwide vaccination levels are above the 90 per cent needed to prevent outbreaks, but London's coverage rates among the under-twos has dipped below that in recent years. NHS England will begin contacting parents of children under five who are not immunised. Polio, spread mainly through contamination by faecal matter, used to kill and paralyse thousands of children annually worldwide. There is no cure, but vaccination brought the world close to ending the wild, or naturally occurring, form of the disease.

Medicines and Healthcare products Regulatory Agency (MHRA) has urged the healthcare professionals to share their views on the consultation on 'how MHRA communicate with healthcare professionals to improve medicines and medical devices' safety'. Through this consultation the agency wants to review its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices. "We want to ensure that healthcare professionals are receiving actionable information and guidance on safe use of medicines and medical devices that they can take into their working practice, providing timely advice to patients," said MHRA. "We need to improve the way we communicate with healthcare professionals. We want to hear from you to enable us to transform how we communicate with you and how we work together on our common goal of greater patient safety."