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The Wire
5 days ago
- Health
- The Wire
Antibiotics, Diabetes and BP Drugs, Vitamin Supplements Found to Be Not of Standard Quality in June
Health Banjot Kaur Issues that Union and state regulators detected during their monthly inspections include contamination and incorrect labelling. Representative image of tablet drugs. Photo: New Delhi: Batches of as many as 185 drugs were found to be not of standard quality (NSQ) by Union and state drug regulators during their monthly inspection in June. The results of their inspections were released on Friday (July 18). A drug is labelled NSQ if it does not meet the quality standards laid down in the Indian laws governing drugs. The Central Drugs Standard Control Organisation (CDSCO) found batches of 55 drugs NSQ, with batches of the remaining 130 being flagged by various state drug regulators. The CDSCO is India's drug regulator at the Union government level. This is not a one-off list. It is a monthly document that the CDSCO publishes. The exercise became regular about a year ago. 'As part of the continuous regulatory surveillance, drug samples are picked from sales/distribution point and analysed, and the list of spurious [NSQ] drugs are displayed on the CDSCO portal on a monthly basis,' the CDSCO said. The purpose of displaying the list is to make stakeholders aware about the NSQ batches identified in the market, it added. The drugs that the CDSCO and state regulators most commonly found to be NSQ were mainly antibiotics, vitamin and calcium supplements, and anti-hypertensives (used for controlling blood pressure) in oral and injectable forms. The companies mentioned in this article are not the only ones whose products were found to be NSQ. We have only considered companies that made either multiple batches of a given drug that were found sub-par, or those that have manufactured various drugs that were found sub-par. It must be mentioned here that the CDSCO's and the states' labs only test a certain batch(es) of a particular medicine. If one batch of any drug has been red-flagged, it does not necessarily mean that all its batches would be substandard. Common 'errors' One of the most serious risks associated with NSQ drugs is improper sterility. This means that the drug contains harmful microorganisms that can lead to infection in a patient's body after ingestion. This could potentially cause extremely serious complications in patients, like sepsis or even death due to acute infection. The other common problem that some drugs have is that they contain 'particulate matter' – particles that inadvertently enter the drug during the manufacturing process. These particles can contaminate the drug. A 'description' error is one in which a drug's physical appearance does not match its prescribed appearance as per regulation. For example, if a tablet is described in regulation as having a white colour but a patient finds it to be orange, the tablet would have a description error. Several medicines were reported as experiencing 'loss on drying'. This error reflects the lack of moisture in drugs, which may cause microbial growth in them, potentially causing infection if ingested. A drug is labelled as having assay errors when an ingredient in it is found in a quantity that is higher or lower than what is mentioned on its label. A higher amount would mean an overdose and a lower amount would result in an underdose – the latter would lead to a situation where a patient even after consuming the prescribed strength of a drug ends up ingesting a lower quantity of some ingredient. This can lead to their disease getting worse. 'Extractable volume' errors usually occur with vials. If the liquid that is to be extracted from a vial using a syringe is present in a quantity greater or lower than as labelled, this can again lead to an overdose or underdose of the drug given in injectable form. 'Dissolution' errors can adversely affect the absorption of a drug. What did the CDSCO find? Six drugs manufactured by Paksons Pharmaceuticals Private Limited were found to be NSQ. These include a dexamethasone sodium phosphate injection – an antibiotic; an ascorbic acid injection, used as a vitamin C supplement; an adrenaline bitartrate injection, used during cardiac arrest; an ondansetron injection, used for treating nausea caused by cancer medicines; and a gentamicin injection, used for treating bacterial injections. The company's diclofenac sodium injection, used as a pain killer, had extractable volume issues in its vials. Four batches of Phaex Polymers Private Limited's colestyramine (used to treat high cholesterol) and three batches of its sodium polystyrene sulfonate (for regulating potassium levels) reported 'loss of drying' mistakes. Zee Laboratories' tranexamic acid injection, used for controlling excessive loss of blood during surgery in patients suffering from hemophilia, reported assay problems. On the other hand, its glipizide & metformin tablets, used for treating high blood sugar, had a description error. Two batches of Overseas Health Care Pvt Ltd's calcium aspartate, calcium orotate, calcitriol minerals and vitamin tablets, which are used to supplement calcium and micronutrients like zinc and vitamins to treat deficiencies, had compromised assays for almost all of their ingredients. Martin & Brown BioSciences Pvt Ltd's calcium gluconate injection had particulate matter and description errors along with extractable volume issues. Three batches of its rabeprazole sodium injection – used to treat acid reflux – also had particulate matter and assay problems. Two batches of E.G. Pharmaceuticals' vitamin C injection and vitamin B12, folic acid and niacinamide injection had particulate matter and description errors. Two batches of Healers Lab's telmisartan tablets (used to manage blood pressure) had dissolution issues. What did state drug regulators find? State drug regulators too found serious errors in some drugs. Five batches of Puniska Injectables's sodium chloride injection had serious sterility problems. These injections have multiple purposes. They are primarily given in cases of dehydration to restore electrolytes (sodium and chlorine). Similarly, Paschim Banga's dextrose injection, which is used to normalise blood sugar levels, and its sodium chloride injection, had sterility issues. Thirteen batches of Martin & Brown BioSciences' calcium and vitamin D3 tablets had description errors. Vivek Pharmachem's paracetamol and ciprofloxacin hydrochloride tablets had description and dissolution issues respectively. Safe Care Life Sciences's mecobalamin 2,500 mg injection, which is used for vitamin B12 supplementation, had 2.38 mg per ml of mecobalamin against the labelled claim of 2,500 mg per ml in its vial. Two batches of Oscar Remedies's ciprofloxacin & dexamethasone eye/ear drops had 943.33% more ciprofloxacin than the labelled amount. The full lists of NSQ drugs made by the CDSCO and state regulators can be found here and here respectively. The Wire is now on WhatsApp. Follow our channel for sharp analysis and opinions on the latest developments.
Edinburgh Reporter
15-07-2025
- General
- Edinburgh Reporter
How SmartHappyKids Montessori Boards Support Cognitive Growth in Toddlers and Preschoolers
Did you know what processes occur in a child's brain in the first years of life? Today, we will reveal this issue from the point of view of the benefits of Montessori boards for cognitive growth. Do you still think that a child does not understand anything and is not capable of leaps in development at 2 years old? Our article, based on the opinions of experts, will prove you otherwise. Montessori Boards for Cognitive Growth and Interesting Facts What are the best Montessori boards for toddler learning? It is a valuable and exciting toy that allows kids to solve many tasks simultaneously. On websites like SmartHappyKids, you will find dozens of examples and models made of wooden parts. They are eco-friendly, and kids are always delighted with them. An interesting fact about the busy board is that the percentage of interested little users reaches almost 100%. After all, regardless of interests, every child will find something to do on a busy board. Photo by Photo By: Facts about cognitive development to convince you that such toys are worth buying: A baby's brain forms up to 1 million new neural connections per second. Wow? Yes, this is the figure the Harvard Center on the Developing Child provided. Montessori boards for cognitive growth can stimulate growth. Developing fine motor skills stimulates the development of literate speech and logical thinking. Finger coordination is closely connected to the correct functioning of speech centers. Babies are capable of minimal mathematical operations with such toys. Learning through play has a more effective and demonstrable effect on development. With educational Montessori boards for cognitive skills, learning becomes natural and exciting. Mirror neurons allow your baby to learn through imitation. The child repeats the actions of adults – he twists, opens, and presses. Are you still unsure about the need to buy such a toy? Below are two more points that will convince you. Early development studies show that the prefrontal cortex and attentional islets are activated when a child is deeply immersed in an activity. This leads to an increase in dopamine production, and attention and self-regulation functions are strengthened. How Montessori tools help child development? First of all, they affect the active development of the brain, which is the basis of everything. Conclusions The aspects above show how Montessori educational boards combine neuroscientific approaches, new cognitive psychology, and the experience of many educators into a single system. So, try to find your option among many models. Like this: Like Related
IOL News
22-06-2025
- Health
- IOL News
French scientists find new blood type in Guadeloupe woman
The new blood type is dubbed "Gwada negative". Image: / Pexels A French woman from the Caribbean island of Guadeloupe has been identified as the only known carrier of a new blood type, dubbed "Gwada negative," France's blood supply agency has announced. The announcement was made 15 years after researchers received a blood sample from a patient who was undergoing routine tests ahead of surgery, the French Blood Establishment (EFS) said on Friday. "The EFS has just discovered the 48th blood group system in the world!" the agency said in a statement on social network LinkedIn. "This discovery was officially recognised in early June in Milan by the International Society of Blood Transfusion (ISBT)." The scientific association had until now recognised 47 blood group systems. Thierry Peyrard, a medical biologist at the EFS involved in the discovery, told AFP that a "very unusual" antibody was first found in the patient in 2011. However, resources at the time did not allow for further research, he added. Scientists were finally able to unravel the mystery in 2019 thanks to "high-throughput DNA sequencing", which highlighted a genetic mutation, Peyrard said. The patient, who was 54 at the time and lived in Paris, was undergoing routine tests before surgery when the unknown antibody was detected, Peyrard said. This woman "is undoubtedly the only known case in the world," said the expert. "She is the only person in the world who is compatible with herself," he said. Video Player is loading. Play Video Play Unmute Current Time 0:00 / Duration -:- Loaded : 0% Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Transparency Opaque Semi-Transparent Background Color Black White Red Green Blue Yellow Magenta Cyan Transparency Opaque Semi-Transparent Transparent Window Color Black White Red Green Blue Yellow Magenta Cyan Transparency Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Dropshadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. Advertisement Next Stay Close ✕ Peyrard said the woman inherited the blood type from her father and mother, who each had the mutated gene. The name "Gwada negative", which refers to the patient's origins and "sounds good in all languages", has been popular with the experts, said Peyrard. The ABO blood group system was first discovered in the early 1900s. Thanks to DNA sequencing the discovery of new blood groups has accelerated in recent years. Peyrard and colleagues are now hoping to find other people with the same blood group. "Discovering new blood groups means offering patients with rare blood types a better level of care," the EFS said. AFP
Yahoo
06-06-2025
- Business
- Yahoo
BofA Hikes Exelixis, Inc. (EXEL) Target Amid CRC Caution
On Thursday, analysts at BofA Securities raised the price target for Exelixis, Inc. (NASDAQ:EXEL) to $46 from $45, with a Neutral rating. This minor change in the price target, reflecting an upside of nearly 8% from the current stock price, signals the company's revised evaluation of the Zanza pipeline asset. The company is all set to begin the STELLAR-311 trial of Zanza in NET, aiming for as many as three new INDs within this year. During the latest earnings call, the management expressed optimism around its Zanza pipeline asset. As the CEO of Exelixis, Inc. (NASDAQ:EXEL), Michael Morrissey, mentioned: "We're excited to advance Zanza to the center stage in 2025 as our next oncology franchise opportunity." White medicinal tablets. Photo by The analysts noted the significance of the upcoming readouts for the Zanza asset, renal cell carcinoma (RCC), and colorectal cancer (CRC). Despite the excitement for Zanza, analysts remain cautious about the prospects of the CRC population, which is considered the most critical. They substantially discount its chances of success here, citing that the recent updates to the statistical analysis cast a shadow over the stock's potential. Without a breakthrough in the CRC intent-to-treat group, analysts believe that Zanza's peak sales will be between $500 million and $1 billion in the years ahead. Exelixis, Inc. (NASDAQ:EXEL) is a California-based biopharmaceutical company that discovers, develops, and markets new cancer solutions. With a focus on oncology, the company has a leading network of drug development, clinical trials, and commercialization of drugs for difficult-to-treat cancer types. While we acknowledge the potential of EXEL as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure. None.
IOL News
04-06-2025
- Business
- IOL News
Artificial blood breakthrough: Japanese scientists develop universal solution for all blood types
Artificial blood isn't just theoretical anymore, it's real, and its potential is astonishing. Image: Imagine a world where blood shortages no longer cost lives. A world where emergencies in rural South African clinics or busy city hospitals aren't derailed by the lack of compatible blood for transfusions. Thanks to revolutionary research by Japanese scientists, this future may be closer than we think. A critical breakthrough in healthcare is unfolding: the development of artificial blood. This innovation, led by Hiromi Sakai and his team at Japan's Nara Medical University, has the potential to save millions of lives globally by addressing one of the most pressing challenges in healthcare, blood shortages. Video Player is loading. Play Video Play Unmute Current Time 0:00 / Duration -:- Loaded : 0% Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Transparency Opaque Semi-Transparent Background Color Black White Red Green Blue Yellow Magenta Cyan Transparency Opaque Semi-Transparent Transparent Window Color Black White Red Green Blue Yellow Magenta Cyan Transparency Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Dropshadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. Advertisement Next Stay Close ✕ Ad Loading The blood supply crisis Blood transfusions are essential in healthcare, saving lives during surgeries, childbirth, trauma, and the treatment of severe illnesses. Yet, maintaining an adequate blood supply is a constant challenge, especially in low- and middle-income countries (LMICs) like South Africa. The demand for O-negative blood, the universal donor type, is particularly high. This blood type can be used in emergencies for patients of any blood group, but its supply is often insufficient. The short shelf life of donated red blood cells makes the situation even more difficult, as they can only be kept for 42 days under refrigeration. The introduction of artificial blood could be a game-changer in ensuring that no patient is turned away due to a lack of compatible blood. A team of scientists in Japan have created artificial blood Image: Pavel Danilyuk/pexels The science behind artificial blood Artificial blood isn't just theoretical anymore; it's real, and its potential is astonishing. According to "Tokyo Weekender", Sakai's team has developed artificial red blood cells by extracting haemoglobin (the iron-rich protein that transports oxygen in the bloodstream) from expired donor blood. Here's how it works: Haemoglobin extraction: Haemoglobin is isolated from expired blood donations, ensuring no waste. Encapsulation: The haemoglobin is encased in a protective shell, creating stable, virus-free artificial red blood cells. Universal compatibility: Because these synthetic cells lack blood type markers, they're compatible with all blood groups; no cross-matching is required. The benefits don't stop there. Unlike donated blood, which requires refrigeration and has a short lifespan, artificial blood can reportedly be stored for up to two years at room temperature and five years when refrigerated. This could transform emergency response systems in remote areas where accessing fresh blood supplies is a logistical nightmare. Early trials have already demonstrated the potential of artificial blood. In 2022, Sakai's team conducted small-scale studies with 12 healthy male volunteers aged 20 to 50. The participants received intravenous injections of haemoglobin vesicles, which mimic the oxygen-carrying function of natural red blood cells. Mild side effects: A few participants reported mild symptoms, but no serious adverse effects were observed. Stable vital signs: There were no significant changes in blood pressure or other vital signs, indicating promising safety levels. Building on this success, the trials have entered a second phase as of March this year, with larger doses (100 to 400 millilitres) being administered to volunteers. If no significant side effects are observed, the research will shift to evaluating the efficacy and safety of artificial blood for practical use. The goal is to make this life-saving innovation widely available by 2030. Early trials have already demonstrated the potential of artificial blood. Image: Ivan Samkov/pexels
