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Pfizer said on Thursday (June 1) data from late-stage trials showed its experimental combination of antibiotics was effective in treating deadly infections caused by drug-resistant bacteria. Deaths from antibiotic-resistant bacteria, also known as superbugs, have been on the rise globally, and health regulators have called for the development of newer treatments as resistance to older antibiotics grows. The late-stage studies compared the experimental combination of the antibiotics aztreonam-avibactam (ATM-AVI) and existing generic drug metronidazole with a combination of two older antibiotics - meropenem and colistin - to treat complicated intra-abdominal infections and types of hospital-acquired pneumonia. Hospital-acquired pneumonia occurs in patients at least two to three days after being admitted, or in those who have life-threatening lung infections with high mortality rates and who are on mechanical breathing machines. Pfizer said the data from the studies shows the antibiotic combination of ATM-AVI is effective and well-tolerated in treating infections caused by gram-negative bacteria. The cure rate in patients with complicated intra-abdominal infections with Pfizer's combination therapy, along with existing generic drug metronidazole, was 76.4%, versus 74% using the other antibiotics.

The current structure of global incentives to develop new antibiotics is insufficient and requires urgent resolution revealed a new report 'Incentivising new antibiotics' by the Office of Health Economics (OHE). OHE analysis demonstrates that on a global level, it is estimated that an effective 10-year incentive would require £3.5bn ($4.2bn) to adequately cover the entire research and development process for a new antibiotic. The report considers how health systems in the UK and around the world can stimulate the research and development (R&D) of new antibiotics. In 2020, the National Institute for Health and Care Excellence (NICE) and NHS England initiated an Antimicrobial Resistance pilot with the aim of incentivising pharmaceutical companies to develop new antibiotics by addressing the issues associated with reimbursement, which historically has deterred companies from pursuing AMR research.

The Association of the British Pharmaceutical Industry (ABPI) has welcomed the National Institute for Health and Care Excellence's leadership in introducing a new approach to the evaluation of antibiotics. On Tuesday (12 April), NICE published a draft guidance to tackle antimicrobial resistance under which two new antimicrobial drugs - cefiderocol and ceftazidime-avibactam - became the first to be made available as part of the UK's innovative subscription-style payment model. Commenting on the announcement of the new draft guidance, Richard Torbett, chief executive of the ABPI, said: "This is an important milestone in the UK's global leadership on AMR. Antibiotics underpin modern medicine, but the increasing threat of antibiotic resistance remains one of the biggest global health challenges we face. "To tackle this, it is critical that the appropriate frameworks are in place for companies to invest the billions of pounds required to discover the new antibiotics needed for patients.

The NHS has launched plans to expand pioneering subscription-style drug contracts to develop lifesaving antibiotics of the future. It is building on its world-first pilot to incentivise the pharmaceutical industry to develop new antibiotics that could be offered to NHS patients when they need them the most. The consultation has launched almost a year to the day that contracts for two superbug-busting drugs were rolled out as part of a world-first pilot. Cefiderocol and ceftazidime-avibactam, new antibiotics manufactured by Shionogi and Pfizer respectively, were awarded world-first subscription contracts which provided the companies with a fixed annual fee based primarily on the availability of the drugs and their value to the NHS, as opposed to the volumes used. By breaking the link between the payments companies receive and the number of their antibiotics prescribed, the NHS is removing any incentive to overuse antibiotics, decreasing the risk of life-threatening infections, such as sepsis and pneumonia, becoming resistant to treatment.

Britain's drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) on Monday announced that fluoroquinolone antibiotics must only be administered when no other antibiotics are appropriate for use. It elaborated that fluoroquinolones given systemically (by mouth, injection, or inhalation) should only be prescribed "when other recommended antibiotics have failed, will not work due to resistance, or are unsafe to use in an individual patient." Previous regulations on fluoroquinolones stated that this class of antibiotics should not be prescribed for mild to moderate or self-limiting infections, or non-bacterial conditions. Further restrictions have been introduced after receiving reports from patients who have experienced long-lasting or disabling reactions following use of fluoroquinolones, the MHRA revealed. Dr Alison Cave, MHRA Chief Safety Officer, said: "Patient safety is our top priority. We have listened to the experience of patients regarding long-lasting and potentially irreversible adverse reactions following use of fluoroquinolone antibiotics, in some cases prescribed for mild-to-moderate infections.

The UK Health Security Agency (UKHSA) has published the latest national surveillance data on antibiotic prescribing and resistance. The English surveillance programme for antimicrobial utilisation and resistance (ESPAUR) report showed an increase in antibiotic use in all settings (apart from dental) in 2022. According to the report, antibiotic prescribing rose by 8.4 per cent in 2022 compared with 2021, although the number remains below 2019 pre-pandemic levels. "There are many reasons behind the increase in prescribing, one of which is likely related to decreased immunity and exposure to infections during the COVID-19 pandemic that may have underpinned the increased transmission in co-circulating infections, namely: influenza (flu), respiratory syncytial virus (RSV) and group A streptococcus (GAS)," the report stated.

Pharmacists in the UK are reporting significant shortages of a common antibiotic used to treat whooping cough (pertussis), amid rising cases of this bacterial infection. Dr. Leyla Hannbeck, chief executive of the Independent Pharmacies Association (IPA), told BBC Radio 4's Today programme that clarithromycin, one of the key antibiotics for treating whooping cough in children, is "completely out of stock." Clarithromycin is an antibiotic commonly recommended for babies and infants under the age of 1 month. Dr. Leyla said that as pharmacies cannot get the antibiotic, they are being forced to turn patients away or send them back to their doctors to have their prescriptions changed to azithromycin or other antibiotics for treating whooping cough.

Researchers at at an Australian university have developed a new form of antibiotic that can be swiftly re-engineered to avoid resistance to dangerous superbugs. The antibiotic, which was developed by PhD candidate Priscila Cardoso and major supervisor Dr Celine Valery from RMIT's School of Health and Biosciences, has a basic architecture that allows it to be generated quickly and cheaply in a lab. The antibiotic, Priscilicidin, has tiny amino acid building blocks that allow it to be tailored to combat various types of antimicrobial resistance. With the World Health Organization calling antimicrobial resistance "one of the top ten global public health threats facing humanity", developing new antibiotics has become more urgent than ever. Professor Charlotte Conn, one of Cardoso's PhD supervisors, said given that urgency, Priscilicidin was an exciting breakthrough for public health. Priscilicidin is a type of antimicrobial peptide. These peptides are produced by all living organisms as the first defence against bacteria and viruses.

With higher than usual number of cases of scarlet fever, caused by invasive Group A streptococci (iGAS) infections being reported in children across the country, Chief Pharmaceutical Officer for England David Webb has assured pharmacies of sufficient supply of antibiotics. In a letter, shared by the PDA, Webb also urged the pharmacies to order antibiotic stocks sensibly. "Local pharmacy teams may be experiencing a temporary interruption of supply of some relevant antibiotics due to increased demand. On a national level, sufficient stock exists for the NHS," he said. He said NHS is working closely with the Department of Health and Social Care (DHSC) and has taken actions to help ensure medicines continue to be available. He explained that the supplies of antibiotics for the treatment of Group A Strep, particularly phenoxymethylpenicillin presentations, have seen a surge in demand, leading to potential constraints at certain wholesalers and pharmacies,

he Healthcare Distribution Association (HDA) and the Pharmaceutical Services Negotiation Committee (PSNC) have urged the NHS England and the Department of Health and Social Care (DHSC) to issue urgent communications requesting that all those involved in medicines supply do not hoard, stockpile or over-prescribe Strep A antibiotics. In a statement HDA said that the sudden spike in demand for antibiotics used for the treatment of Strep A has meant that there is not enough of these medicines in the supply chain currently to meet this increased demand. As a result, wholesalers are working extremely hard with manufacturers to increase the supply of antibiotics. It added: "As regards pricing, the prices charged to pharmacies by HDA wholesale distributors will directly reflect the increase in prices wholesalers are having to pay for these medicines from manufacturers at the moment, in order to be able to continue supplying these medicines to pharmacies. This will be the case until supply and demand are more in sync."

The PSNC on Friday said it has warned the DHSC about the "very serious impact" of the limited supply of certain antibiotics on pharmacies who are "having to chase stock, purchase without sight of any concession prices, and cope with increasing patient questions and abuse." With higher than usual number of cases of scarlet fever, caused by invasive Group A Streptococci (iGAS) infections, being reported in children across the country, supplies of antibiotics for Group A Strep treatment have seen a surge in demand, leading to limited supply at certain wholesalers and pharmacies. PSNC has urged the DHSC to adopt measures that could help to manage the current crisis, such as allowing pharmacists more freedom to change strengths or formulations without prescriber approval, outside of Serious Shortage Protocols. It has also raised concerns on the significant rise in wholesale prices of many oral antibiotics as a result of the surge in demand and the ongoing supply disruptions. PSNC also said they have received reports of some suppliers putting up their prices for any oral antibiotics they do have in stock.

The Competition and Markets Authority (CMA) has launched an investigation following 'rocketing prices of antibiotics in the wake of Strep A cases', Sky News reported on Wednesday (December 14). On Monday, the Department of Health issued a medicine supply notification for antibiotics for the treatment of Strep A. "Supplies of antibiotics for the treatment of Group A Strep have seen a surge in demand and may be temporarily in limited supply at certain wholesalers and pharmacies. Supplies are available with manufacturers, and deliveries into wholesalers and pharmacies are being expedited and are expected in the coming days" said DHSC. Sky quoted a spokesperson for the CMA as saying: "People have got real concerns about the price of antibiotics used to treat Strep A, and we want companies to be clear about their obligations under the law.

The UK Health Security Agency (UKHSA) has raised alarm over rising cases of extensively antibiotic-resistant Shigella infections, mainly in gay, bisexual, and other men who have physical relationship with men (GBMSM). There has been a 53 per cent increase in cases since the beginning of 2023, mostly driven by a cluster of antibiotic resistant strain called Shigella sonnei, with 97 cases reported this year until November, compared to just four cases last year. According to UKHSA, Shigella sonnei infections are difficult to treat as the strain does not respond to the antibiotics typically used to treat the bacteria. While it has been found across England, cases are concentrated in London (45), the North West (21) and South East (12). Shigella is an infectious gut infection that can cause symptoms like diarrhoea (sometimes mixed with blood), stomach cramps and fever, which are commonly mistaken for food poisoning.

The Department of Health and Social Care (DHSC) has issued a medicine supply notification for antibiotics for the treatment of Group A Strep. "Supplies of antibiotics for the treatment of Group A Strep have seen a surge in demand and may be temporarily in limited supply at certain wholesalers and pharmacies," said DHSC. "Supplies are available with manufacturers, and deliveries into wholesalers and pharmacies are being expedited and are expected in the coming days." If the formulation of antibiotic prescribed is unavailable, DHSC has asked clinicians and local pharmacy teams to consider prescribing an alternative form or strength of the antibiotic where appropriate, ensuring the patient is not intolerant to any of the excipients in the alternative and is counselled on the appropriate dose (and volume) required.

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."

British pharmaceutical giant GSK said on Saturday (April 15) its oral antibiotic drug to treat uncomplicated urinary tract infections (uUTI) in female adults and adolescents met the main goals in late-stage trials. The drug, gepotidacin, in phase III trials, met its primary goals of being on a par or better than nitrofurantoin, the current standard of care for the treatment of uUTIs, the company said. GSK plans to submit results of the trials to the United States Food and Drug Administration for review later in the second quarter. The drug, if approved, could become the first new type of antibiotic, which is critically important for countering drug-resistant infections, to treat uUTIs in 20 years, the company said. "Gepotidacin, if approved, will offer a much-needed additional oral treatment option for patients at risk of treatment failure associated with resistance or recurrence of uUTI," Chris Corsico, senior vice president of development at GSK, said.

Proposed changes to a European Union pharmaceuticals law will include stronger obligations for the supply of medicines and earlier notifications of shortages, EU Health Commissioner Stella Kyriakides said last week (January 17). Kyriakides told a session of the European Parliament that shortages of antibiotics are a growing problem for many European countries. She said the European Commission's proposal to revise the pharmaceuticals legislation is planned for March. "Our objective is and remains to secure access to medicines for all patients in need and to avoid any market disruption of medicines in the EU," Kyriakides said. Shortages of antibiotics have been reported in 26 European countries, the European Medicines Agency says. The unseasonably early upsurge in respiratory infections in Europe this winter and insufficient production capacity are the root causes of the shortages, Kyriakides said. Numerous EU lawmakers speaking at the session said the shortages needed to be tackled urgently. But experts say shortages of essential generic medicines like antibiotics are likely to be recurrent in Europe due to problems in the sector such as the gradual migration of generic manufacturing to Asia.

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The government has launched the Global AMR Innovation Fund (GAMRIF) on Monday (22 May), under which it has announce up to £39 million fund for antimicrobial resistance (AMR) research. Of this new funding package, up to £24 million over four years has been awarded to bolster the UK's partnership with CARB-X - a global AMR research initiative - to support the continued early development of invaluable new antibiotics, vaccines, rapid diagnostics and other products to combat life threatening drug-resistant infections and prevent death and disease across the world. In addition to the CARB-X grant, GAMRIF is investing £5 million over two years into the Global Antibiotic R&D Partnership (GARDP) to develop - and ensure global access to - new antibiotic treatments against major global health priorities. The announcement comes as Health Minister Will Quince attends the World Health Assembly (WHA) in Geneva, Switzerland, and Development Minister Andrew Mitchell participates in an event on health leadership and climate change alongside the WHA. They will announce the launch of the UK government's Global Health Framework for 2023-2025, as part of Minister Quince's address at the WHA. Health Minister Will Quince said: Antimicrobial resistance is a major threat to global health and has led to millions of tragic deaths per year, but the Global AMR Innovation Fund is supporting cutting-edge research and developing vital new treatments to prevent death and disease across the world.

The National Pharmacy Association (NPA) has asked the Secretary of State for Health and Social Care to convene a 'medicines supply taskforce', following weeks of problems with antibiotics supplies. The NPA's chief executive Mark Lyonette wrote a letter to Steve Barclay this week. It cited the precedent of the HRT Taskforce which this summer brought together representatives from across the supply chain after months of supply problems affecting women. "We strongly believe that this situation calls for a similar response from the government. It is imperative that we resolve this supply situation urgently and therefore we request that you convene a Medicines Supply Taskforce, with all the relevant stakeholders in the supply chain, to urgently discuss and agree practical solutions to address the disruptions to the supply of medicines. HRT and antibiotics are the most visible examples of a wider problem with medicines supply which needs to be addressed." NPA board members Olivier Picard and Reena Barai were among the stakeholders joining meetings convened by the HRT Taskforce this summer.