Powered by WPeMatico
Powered by WPeMatico
Vadodara: Alembic Pharmaceuticals Limited today announced that the Company has received
tentative approval from the US Food & Drug Administration (USFDA) for its
Abbreviated New Drug Application (ANDA) for Bosutinib
Tablets, 100 mg and 500 mg.
The approved ANDA is therapeutically equivalent to the
reference listed drug product (RLD), Bosulif Tablets, 100 mg and 500 mg, of PF Prism
C.V. (PF Prism).
Bosutinib tablets are indicated for the treatment of a certain type of
leukemia called Philadelphia chromosome-positive chronic myelogenous leukemia. It is a type of cancer that affects the blood and bone marrow. It is characterized by the presence of a specific genetic abnormality known as the Philadelphia chromosome.
Bosutinib Tablets, 100 mg and 500 mg have an estimated market size of US$ 275
million for twelve months ending March 2024 according to IQVIA.
Alembic has a cumulative total of 206 ANDA approvals (179 final approvals and 27
tentative approvals) from USFDA.
Read also: Alembic Pharma secures USFDA okay for Doxycycline Capsules for inflammatory lesions of rosacea
Headquartered in India, Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company. Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Its state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
Read also: USFDA nod to Alembic Pharma stroke and blood clots drug Dabigatran Etexilate
Powered by WPeMatico
Guwahati: After a doctor couple was arrested last year for allegedly abusing and torturing their adopted 4-year-old girl, a POCSO Court has framed charges against the accused doctor couple under Section 6 of the Protection of Children from Sexual Offences (POCSO) Act, 2012.
If convicted, the couple could face the most severe penalties under the Act, which deals with aggravated penetrative sexual assault and mandates rigorous imprisonment for a minimum of 20 years, extending up to life imprisonment.
Besides the court pressing additional charges on them, the male doctor has been facing multiple charges under the Indian Penal Code (IPC). The specific charges include Section 376 AB of the IPC Pertaining to the rape of a woman under 12 years of age, which carries a minimum punishment of 20 years of rigorous imprisonment, extendable to life, Sections 466 and 471 of the IPC (Related to forgery of court records and using forged documents as genuine, punishable by up to 7 years of imprisonment and fines) and Section 370 (5) of the IPC (Concerning trafficking of more than one person, punishable with a minimum of 10 years of rigorous imprisonment, which may extend to life).
Also read- Assam Doctor Couple Held For Allegedly Torturing, Abusing Adopted 4-Year-Old
Similarly, the female doctor was charged under the IPC including Section 376 AB of the IPC (Punishment for raping a woman under the age of 12), Section 326 A of the IPC (Pertaining to causing grievous hurt by acid attack), Sections 466 and 471 of the IPC (Forgery and use of forged documents), Section 370 (5) of the IPC (Trafficking of more than one person), The Sentinel reports.
Both the doctors are also charged under Sections 75, 80, and 81 of the Juvenile Justice (Care and Protection of Children) Act, which deals with cruelty to children, using children for illegal activities, and exploitation of children for labour. These offences carry severe penalties, including imprisonment and fines.
Medical Dialogues team in May 2023 reported that the doctor couple was arrested for allegedly abusing and torturing a 4-year-old girl after being rescued in a state of dehydration with hands tied to a pole on the terrace at their house.
The duo include a Psychiatrist from Meghalaya’s Ri-Bhoi district who was arrested a day after her husband, a gastrointestinal and advanced general surgeon, was held from his residence in the capital city of Assam.
Additional Deputy Commissioner of Police (Central) Nandini Kakati said that police received information that a 4-year-old minor girl’s hands were tied to a pole on the terrace and police immediately rushed to the spot and rescued the minor girl.
During the interrogation, the doctor confessed that he used to hit the minor with an iron rod and even poured hot water on her body. After the police caught their caretaker, she alleged that the doctor had asked her to punish the kid on the terrace as punishment for the child’s disobedience.
Powered by WPeMatico
Researchers have found in a new study that exposure to brighter light at night significantly increases the risk of developing type 2 diabetes. This conclusion, based on a large prospective cohort study involving UK Biobank participants, emphasizes the importance of maintaining dark environments during nighttime to mitigate diabetes risk. The study was published in The Lancet by Daniel P. and colleagues.
Light exposure at night disrupts circadian rhythms, a known risk factor for type 2 diabetes. While previous research has established this link, this study is the first to demonstrate how personal light exposure patterns predict diabetes risk in a large-scale cohort. The study involved 84,790 participants, aged 62.3 ± 7.9 years, with 58% being female, who wore light sensors for one week to record their day and night light exposure.
The participants’ circadian amplitude and phase were modeled from the weekly light data. The study excluded individuals with diabetes prior to light tracking and followed up for 7.9 ± 1.2 years, during which 1,997 incident type 2 diabetes cases were recorded. The analysis adjusted for variables including age, sex, ethnicity, socioeconomic status, lifestyle factors, and polygenic risk.
The study findings were as follows:
Compared to participants with dark nights (0–50th percentiles), those exposed to brighter night light had incrementally higher diabetes risk.
The hazard ratios (HR) were:
50–70th percentiles: HR = 1.29 [1.14–1.46]
70–90th percentiles: HR = 1.39 [1.24–1.57]
90–100th percentiles: HR = 1.53 [1.32–1.77]
Lower modeled circadian amplitude was associated with higher diabetes risk (aHR = 1.07 [1.03–1.10] per standard deviation).
Early or late circadian phases also increased diabetes risk (aHR range: 1.06–1.26).
Both night light exposure and polygenic risk independently predicted higher diabetes risk.
The increased risk from bright night exposure was similar to the risk difference between low and moderate genetic predisposition.
The findings suggest that brighter night light disrupts circadian rhythms, leading to higher diabetes risk. This disruption occurs regardless of genetic predisposition, indicating that environmental factors play a crucial role. The similarity in risk levels between those with bright night light exposure and moderate genetic risk highlights the potential of light management in diabetes prevention.
Avoiding light at night emerges as a simple, cost-effective strategy to reduce diabetes risk. This recommendation holds particular significance for individuals with high genetic risk, who may benefit greatly from minimizing night light exposure. The study concludes that brighter night light exposure and disrupted circadian rhythms significantly increase the risk of type 2 diabetes.
Reference:
Windred, D. P., Burns, A. C., Rutter, M. K., Ching Yeung, C. H., Lane, J. M., Xiao, Q., Saxena, R., Cain, S. W., & Phillips, A. J. K. (2024). Personal light exposure patterns and incidence of type 2 diabetes: analysis of 13 million hours of light sensor data and 670,000 person-years of prospective observation. The Lancet Regional Health. Europe, 100943, 100943. https://doi.org/10.1016/j.lanepe.2024.100943
Powered by WPeMatico
In the management of patients with acute coronary syndrome (ACS) who have undergone high-risk percutaneous coronary intervention (PCI), a recent study published in the Journal of American Medical Association revealed that routine stress testing 12 months post-procedure does not offer additional benefits over the standard care.
The POST-PCI trial compared routine functional testing follow-up strategies with standard care alone. The patients were selected from 11 different sites in South Korea and recruited for this experiment between November 2017 and September 2019. Data analysis was carried out in 2022. 12 months following high-risk PCI, this study compared clinical outcomes between the two groups, one which underwent routine stress testing and other group received standard care without routine testing. The primary measure from the study was a composite of death from any cause, myocardial infarction, or hospitalization for unstable angina within two years following randomization.
The key findings of this study were:
The hazard ratio (HR) for the primary outcome in ACS patients was 1.55, with a 95% confidence interval (CI) of 1.03-2.33 and a P-value of .03. This elevated risk calls for the the critical need to effectively follow-up this patient group.
The mean age in the patient population was 64.7 (10.3) years, with 350 patients were female that accounted for 20.5%. Out of the 1706 patients, 526 individuals (30.8%) had ACS upon presentation. The patients with ACS had a 55% higher risk of the main outcome compared to those without ACS because of increased first-year incident rates.
In individuals with ACS and in patients without ACS, the 2-year occurrences of the main outcome were comparable whether using regular functional testing or standard therapy alone.
The formal relationships among ACS status and a combination of invasive angiography or repeat revascularization were not significant, despite a major study suggesting that the rates of invasive angiography and repeat revascularization were higher after 1 year in the regular functional testing group. At 12 months, regular monitoring and stress testing did not provide any additional benefit over standard care for ACS patients who had undergone high-risk PCI, despite their higher risk of serious complications in the first year following PCI.
Reference:
Lee, J., Kang, D.-Y., Kim, H., Choi, Y., Jo, S., Ahn, J.-M., Kim, S., Yoon, Y.-H., Hur, S.-H., Lee, C. H., Kim, W.-J., Kang, S. H., Park, C. S., Lee, B.-K., Suh, J.-W., Choi, J. W., Kim, K.-S., Lee, S. N., Park, S.-J., & Park, D.-W. (2024). Routine Stress Testing After PCI in Patients With and Without Acute Coronary Syndrome. In JAMA Cardiology. American Medical Association (AMA). https://doi.org/10.1001/jamacardio.2024.1556
Powered by WPeMatico
A study led by the Barcelona Institute for Global Health (ISGlobal), a centre supported by the ”la Caixa” Foundation, provides new evidence on the adverse effects of prenatal exposure to ethylene oxide (EO) on foetal development.
The results, published in Epidemiology, show that increased EO exposure in utero is associated with a reduction in birth weight and head circumference in newborns.
Ethylene oxide is a chemical used in various industrial processes and in hospitals, is known for its mutagenic and carcinogenic properties. Human exposure to EO is mainly through inhalation of tobacco smoke and air pollution produced from various household products, including cleaning and personal care products.
Workers in the healthcare and chemical industries are particularly exposed to this substance, which is commonly used in sterilisation processes. Previous studies have found that women exposed to higher levels of EO at work during pregnancy had a higher risk of miscarriage and premature birth than those with lower exposure.
This new study focused on pregnant women and newborns in the general population, rather than a specific population with known high levels of EO exposure. The research team looked at the levels of EO hemoglobin (Hb) adducts in the cord blood of 1,106 newborns from 5 countries: Greece, Spain, Norway, UK and Denmark. This measurement provides valid information on the amount of EO the foetus was exposed to during the last three months of pregnancy, which may help to better understand potential adverse effects on foetal development and birth outcomes.
The study used data from the NewGeneris project, which aimed to study genotoxic exposures in the environment on children’s health by measuring several biomarkers in cord blood. Information on birth weight, head circumference, sex and gestational age was obtained from maternity records.
Higher exposure, lower birth weight and smaller head circumference
The results of the study showed that median levels of EO-Hb adducts in the umbilical cord were higher in smoking mothers compared to non-smoking mothers. Higher levels of hemoglobin adducts were associated with lower birth weight. Specifically, mean birth weight decreased by 3.30 grams with each 10 pmol/g increase in hemoglobin adducts. Increasing levels of hemoglobin adducts were also associated with a decrease in head circumference.
“Reduced head circumference has been linked to delayed neurodevelopment, and reduced birth weight increases the risk of cardiovascular disease, type 2 diabetes mellitus and osteoporosis,” says Barbara Harding, ISGlobal researcher and first author of the study.
The team found no evidence of an association between EO Hb adduct levels and the risk of being small for gestational age (SGA), a condition that can compromise a baby’s short and long-term health.
“The study results highlight the importance of addressing EO exposure in both occupational and non-occupational settings. Policy changes to reduce EO exposure in vulnerable populations, such as women of childbearing age, could protect foetal health and improve birth outcomes,” says Manolis Kogevinas, ISGlobal researcher and senior author of the study.
Reference
Harding BN, Agramunt, S., Pedersen, M., Knudsen, LE., Nielsen, JKS, Wright, J, Vafeiadi, M., Merlo, DF., Stayner, L., Kelly-Reif, K., Espinosa, A., Bustamante, M., Gützkow, KB., Granum, B., von Stedingk, H., Rydberg, P., Alexander, J., Törnqvist, M., Kogevinas, M. Ethylene oxide hemoglobin adducts in cord blood and offspring’s size at birth: The NewGeneris European Cohort Study. Epidemiology. 2024. DOI: 10.1097/EDE.0000000000001767
Powered by WPeMatico
Researchers have found that a novel device inspired by the unique structure of python teeth significantly enhances the strength of rotator cuff repairs. A research team from Columbia University, led by Stavros Thomopoulos, PhD, came to this conclusion while seeking to improve post-operative outcomes for patients undergoing common orthopedic surgery. The study was published in the journal Science Advances.
Rotator cuff tears are among the most prevalent orthopedic injuries, affecting approximately 40% of Americans over 65 years old. With around 600,000 repair surgeries performed annually in the U.S., current techniques, which primarily rely on sutures to reattach tendons to shoulder bones, often fail. The sutures can slice through tendons over time, especially where stress is highest, leading to failure rates ranging from 20% in younger patients to a staggering 94% in elderly patients with severe tears. The “cheesewiring effect,” wherein sutures cut through tendons, significantly contributes to these high failure rates.
The inward-curving teeth of pythons, which prevent prey from escaping without tearing flesh, Thomopoulos and colleagues developed a 3D-printed device to improve tendon-bone attachment. The device is composed of small biocompatible plastic rectangles studded with curved teeth, optimized through experimentation with different curvature ratios, tooth arrangements, and spacing.
The researchers conducted trials using five paired shoulder joints from human cadavers. They simulated rotator cuff tears and performed conventional double-row suture repairs on some, while others were repaired using the python-tooth device. The devices, measuring 15.5-17.5 mm by 6-8 mm and carrying 13 teeth each about 3 mm high, were tested for their ability to withstand strain.
Repairs incorporating the python-tooth device exhibited an average increase in maximum force (strength) of 83% compared to conventional suture repairs.
The optimal tooth curvature ratio was found to be 2.5, which prevented cutting while effectively grasping bovine tendon samples.
The customizability of 3D printing allows for patient-specific designs, enhancing the fit and effectiveness of the device.
The significant improvement in repair strength suggests that this device could dramatically reduce the high rerupture rates currently observed in rotator cuff surgeries. The python-tooth device’s ability to gently yet firmly grasp tendons addresses the mechanical failures associated with traditional suturing techniques.
This innovative approach, holds great potential for improving the durability and success of rotator cuff repairs. By nearly doubling the repair strength, the python-tooth device could significantly enhance postoperative outcomes and reduce the high rates of rerupture seen with current techniques.
Reference:
Kurtaliaj, I., Hoppe, E. D., Huang, Y., Ju, D., Sandler, J. A., Yoon, D., Smith, L. J., Betancur, S. T., Effiong, L., Gardner, T., Tedesco, L., Desai, S., Birman, V., Levine, W. N., Genin, G. M., & Thomopoulos, S. (2024). Python tooth–inspired fixation device for enhanced rotator cuff repair. Science Advances, 10(26). https://doi.org/10.1126/sciadv.adl5270
Powered by WPeMatico
Turkey: Percutaneous nephrolithotomy (PCNL) is a well-established procedure for treating kidney stones, but recent advancements have sparked debate over the best approach. A new study comparing standard PCNL with total tubeless PCNL performed in the supine position offers fresh insights into these techniques.
The study revealed that total tubeless (TT) percutaneous nephrolithotomy in the supine position reduces postoperative pain in selected patients without affecting the complication rates as in prone PCNL. According to the authors, the study was the first to compare TT and standard PCNL in the supine position,” the researchers wrote. The findings were published online in Urolithiasis on June 04, 2024.
Both techniques delivered similar complication and stone-free rates, however, TT PCNL boasted shorter fluoroscopy & operation times. Most notably, TT PCNL emerged as a game-changer for postoperative pain management, significantly reducing visual analog scale scores.
The debate over which method provides superior outcomes continues to evolve, with proponents of each technique advocating based on their respective advantages. While standard PCNL remains a cornerstone in kidney stone treatment, total tubeless PCNL in the supine position presents a compelling alternative for selected patients seeking faster recovery and reduced postoperative complications.
Çağdaş Bildirici, Department of Urology, Bitlis State Hospital, Bitlis, Turkey, and colleagues aimed to compare the safety, efficacy, and advantages of the total tubeless percutaneous nephrolithotomy and standard PCNL in the supine position.
In the study carried out at İzmir Tepecik Health Application and Research Center, 87 patients were examined. Forty-three patients who underwent the TT procedure were defined as Group 1, and 44 patients who underwent the standard procedure with a nephrostomy tube were defined as Group 2.
Two techniques were evaluated with outcome parameters and demographic data. Univariate regression analyses were conducted in these data sets for the parameters that predicted the TT procedure.
The study revealed the following findings:
· The demographic data of the groups and all characteristics of the stones were similar.
· When the results were examined, the stone-free rates detected by non-contrast computed tomography (CT) in the postoperative 1st month were similar between the groups.
· Complication rates and secondary intervention rates were similar.
· Operation and fluoroscopy times were shorter in group 1, which were not statistically significant.
· Postoperative hemoglobin decreased, and creatinine values were similar.
· In Group 1, mean postoperative visual analog scale (VAS) scores and the percentage of VAS reporting > 5 points for pain level measurement were lower and statistically significant.
· In the univariate analysis of the factors predicting the TT procedure, no significant results were found in any parameter.
In conclusion, while both standard and total tubeless PCNL techniques have proven efficacy in treating kidney stones, the choice between them hinges on a nuanced understanding of patient factors and desired outcomes. This study marks a step forward in clarifying the comparative benefits of these procedures, paving the way for informed decision-making in clinical practice.
Reference:
Bildirici, Ç., Çetin, T., Yalçın, M.Y. et al. Comparison of standard percutaneous nephrolithotomy and total tubeless percutaneous nephrolithotomy in the supine position. Urolithiasis 52, 82 (2024). https://doi.org/10.1007/s00240-024-01580-5
Powered by WPeMatico
The caudal block is the commonly employed regional technique in children undergoing hypospadias repair to manage postoperative pain. Recent study evaluated the effectiveness of sacral erector spinae plane block (ESPB) for postoperative analgesia in pediatric patients undergoing hypospadias repair. The study was a randomized controlled trial involving 40 children aged 2–7 years with ASA grade I or II. After general anesthesia induction, group I received ultrasound-guided sacral ESPB with 1 ml/kg of 0.25% bupivacaine, while group II did not receive the block. Pain was assessed using the FLACC scale, and rescue analgesia was given when the FLACC score was ≥4. The primary objective was to compare postoperative analgesic (paracetamol) consumption, and the secondary objective was the time to first rescue analgesia.
The results showed that mean postoperative paracetamol consumption was significantly lower in group I (360 ± 156.60 mg) compared to group II (997.50 ± 310.87 mg), and the time to first rescue analgesia was significantly longer in group I (906 ± 224.51 min) compared to group II (205.00 ± 254.92 min). The study concluded that sacral ESPB effectively reduced postoperative analgesic consumption in pediatric patients undergoing hypospadias repair.
Study Design and Procedure
The study design was a prospective, randomized, and double-blind comparison. The sacral ESPB was found to be safe and effective in all patients, and no complications were observed in any patient. The sacral ESPB was performed using aseptic techniques under ultrasound guidance, and patients remained hemodynamically stable intraoperatively. The study found that the sacral ESPB provided effective pain relief and extended the time to first rescue analgesia, indicating its potential as an alternative to caudal block for pediatric hypospadias repair.
The study’s findings were consistent with previous case reports on the effectiveness of sacral ESPB in various surgeries. The sacral ESPB was observed to have advantages such as ease of administration, widespread local anesthetic spread, and lack of motor block. Overall, the study demonstrated that sacral ESPB is effective at reducing postoperative analgesic consumption and providing prolonged pain relief in pediatric patients undergoing hypospadias repair. This supports the potential use of sacral ESPB as an alternative regional technique in pediatric surgical procedures.
Key Points –
– The study design was prospective, randomized, and double-blind. The sacral ESPB was found to be safe and effective in all patients, and no complications were observed. The procedure was performed using aseptic techniques under ultrasound guidance, and patients remained hemodynamically stable intraoperatively. The sacral ESPB provided effective pain relief and extended the time to first rescue analgesia, suggesting its potential as an alternative to caudal block for pediatric hypospadias repair.
– The findings of the study were consistent with previous case reports on the effectiveness of sacral ESPB in various surgeries. The technique was observed to have advantages such as ease of administration, widespread local anesthetic spread, and lack of motor block. The study demonstrated that sacral ESPB effectively reduced postoperative analgesic consumption and provided prolonged pain relief in pediatric patients undergoing hypospadias repair, supporting its potential use as an alternative regional technique in pediatric surgical procedures.
Reference –
Bansal T, Yadav N, Singhal S, Kadian Y, Lal J, Jain M. Evaluation of USG‑guided novel sacral erector spinae block for postoperative analgesia in pediatric patients undergoing hypospadias repair: A randomized controlled trial. J Anaesthesiol Clin Pharmacol 2024;40:330‑5
Powered by WPeMatico