EMA has recommended granting a marketing authorisation in the European Union (EU) for Emblaveo (aztreonam-avibactam), indicated for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of bacteria (aerobic Gram-negative) where treatment options are limited. Infections due to Gram-negative bacteria that are resistant to many currently available antibiotics are a serious public health problem since patients have limited or sometimes no treatment options. Infections due to multidrug-resistant bacteria are estimated to cause 35,000 deaths in the EU every year. Emblaveo is a fixed-dose combination of two active substances, aztreonam and avibactam. Aztreonam is already authorised for use in the EU on its own and avibactam is authorised for use in combination with another antibiotic (ceftazidime). Aztreonam is an antibiotic that belongs to the group ‘beta-lactams’. It works by attaching to proteins on the surface of the bacteria. This prevents the bacteria from ...
Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections, including neutropenic sepsis—a potentially fatal reaction to infection and a severe complication of chemotherapy. Identifying the signs of neutropenic sepsis can be challenging, leading to a stressful and expensive treatment process. Consequently, all chemotherapy patients feeling ill are advised to seek emergency care to check for neutropenic sepsis. Unfortunately, half of these patients do not receive antibiotics quickly enough, while the other half, not at risk of neutropenic sepsis, unnecessarily visit the emergency department. 52North Health Ltd. (Cambridge UK) has developed NeutroCheck, a groundbreaking approach aimed at enhancing the safety and well-being of cancer patients. This innovation combines a finger-prick blood test with an AI-powered digital platform, allowing patients to evaluate their neutropenic sepsis risk at home. This affordable, ...
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA provided an update on our evaluation of quality and performance issues related to plastic syringes made in China, and announced additional recommendations and actions the FDA is taking to address these issues. The FDA issued warning letters to three entities that describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the U.S. The FDA expects these entities to fully address the violations described in the warning letters and will take additional steps as appropriate. We remain concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance, and our evaluation is ongoing. This is an evolving situation, and we will continue to keep the ...
Bacteria are outpacing scientific advancements, leading to a worrying increase in antibiotic resistance, a situation the World Health Organization has identified as an emerging global health crisis. The key to countering this trend lies in achieving quicker diagnostic results, comprehensive susceptibility testing across various sample types, and the ability to test against a broad range of commercially relevant antibiotics simultaneously. Now, a rapid antibiotic susceptibility testing (AST) system can provide targeted therapeutic results days faster than the current standard of care. Selux Diagnostics (Boston, MA, USA) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary Positive Blood Culture (PBC) Separator. The addition of positive blood culture sample type expands the Selux Next Generation Phenotyping (NGP) System, making this the only FDA-cleared, single-platform technology to deliver rapid AST results for both positive blood culture and isolated colonies. The Selux PBC Separator streamlines the process for ...
Davy James The FDA granted Allecra with a five-year marketing exclusivity extension for Exblifep (cefepime/enmetazobactam) through the Generating Antibiotic Incentives Now Act. The FDA has approved Allecra Therapeutics’ Exblifep (cefepime/enmetazobactam) for the treatment of complicated urinary tract infections (cUTIs), including the kidney infection pyelonephritis, in patients aged 18 years and older.1 The FDA also granted Allecra with a five-year marketing exclusivity extension for the β-lactam/β-lactamase inhibitor combination through the Generating Antibiotic Incentives Now Act (GAIN Act), which is legislation that incentivizes the development of new anti-infective treatments. “Receiving FDA approval is a tremendous achievement for Allecra and a testament to the hard work and dedication of a small, yet highly focused team of individuals. I extend my sincere congratulations to my colleagues Omar Lahlou and Patrick Velicitat for their leadership and oversight throughout this whole process,” Iain Buchanan, supervisory board member of Allecra Therapeutics, said in a press release. “As ...
Globally, an alarming one in every five deaths is attributed to complications related to sepsis, with children accounting for 41% of these fatalities. The urgency in detecting sepsis is paramount since the risk of mortality increases by 4% for each hour the infection remains undiagnosed or treated incorrectly. Common practice involves administering antibiotics to sepsis patients while waiting for blood culture results, which can contribute to antibiotic resistance. Ineffectively treating sepsis can be detrimental, as up to 30% of patients receive incorrect treatments, further elevating their risk of death. The critical nature of timely and accurate diagnosis in sepsis cases is underscored by the fact that the mortality risk escalates by 4% every hour the infection is not properly identified or treated. Now, a new analysis technique offers quicker and more precise pathogen detection in blood samples compared to traditional blood cultures, which are the standard in infection diagnosis. The ...
Taking a One Health approach, which recognises the connection between the health of people and animals, the report presents data primarily collected between 2019 and 2021 on antibiotic consumption and AMR in Europe. For the first time as part of this project, the three agencies analysed trends of antimicrobial consumption and AMR in Escherichia coli (E. coli) from both humans and food-producing animals. They also looked into how these trends were changing in humans and food-producing animals during 2014 – 2021. For example, during this timeframe, antibiotic consumption in food-producing animals decreased by 44%. The analysis performed by the three Agencies found that E. coli bacteria in both animals and humans are becoming less resistant to antibiotics as the overall antibiotic consumption is reduced. This shows that the concerning trends in antibiotic resistance can be reversed with the right actions and policies. The report also shows that, in humans, the ...
Dive Brief The Food and Drug Administration has categorized Smiths Medical’s correction of more than 50,000 syringe pumps in the U.S. as a Class I recall. Smiths Medical, which became part of ICU Medical in a $2.35 billion takeover in January 2022, wrote to customers in December after identifying software problems that could cause its Medfusion 4000 syringe pump to fail. There has been one reported injury linked to the problem. The recall is the latest in a series of regulatory actions related to Smiths Medical. ICU Medical was still working to resolve a warning letter sent to Smiths Medical in 2021 and was facing falling sales of acquired products as of Sept. 30, according to its most recent quarterly results filing. Dive Insight The Class I recall applies to Model 4000 syringe pumps distributed between November 2010 and July 2023. The devices are designed to administer fluids such as ...
Drugdu.com expert’s response: Pharmaceutical intermediates are one or more chemical substances generated during the drug synthesis process, playing a crucial role in the production of the final Active Pharmaceutical Ingredient (API). The variety of pharmaceutical intermediates depends on the chemical structure and synthesis pathway of the target drug. Here are some common types of pharmaceutical intermediates: Benzene Ring Intermediates: Many drugs, especially anticancer and cardiovascular drugs, are based on the benzene ring structure. Heterocyclic Compounds: Such as pyridine, thiophene, imidazole, etc., commonly used in pharmaceutical manufacturing. Amino Acids and Peptides: They are the foundation of many bioactive molecules and drugs, like insulin. Carboxylic Acids and Their Derivatives: Often used in the synthesis of anti-inflammatory drugs and antibiotics. Esters and Ethers: Utilized in the synthesis of various drugs, including painkillers and sedatives. Sulfur Compounds and Thioethers: Play an important role in the synthesis of certain special drugs. Aldehydes and Ketones: Key intermediates ...
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