Prof Pradeep Kumar Prajapati takes over as Director of All India Institute of Ayurveda

New Delhi: Professor Pradeep Kumar Prajapati formally assumed charge as the Director of the All India Institute of Ayurveda (AIIA), New Delhi, recently.

Prior to this appointment, Prof. Prajapati served as the Vice-Chancellor of Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur. He has also been associated for a long period with Gujarat Ayurved University, Jamnagar, contributing significantly to research and academic development. He began his academic career as an Assistant Professor at the National Institute of Ayurveda (NIA), Jaipur.

A formal welcome ceremony was organized at AIIA to mark the occasion. The event began with the lighting of the ceremonial lamp and a Dhanvantari Vandana. The institute’s former Executive Director, Prof. (Dr.) Manjusha Rajagopal, Dean (PhD) Prof. (Dr.) Mahesh Vyas and a large number of academic, medical, administrative, and nursing staff were present. All attendees extended a warm welcome to the new Director by presenting floral bouquets.

Also Read:AYUSH Ministry Launches Initiatives to Integrate Ayush Medicine with Allopathic System

In his first address as Director, Prof. Prajapati said:

“It is a matter of great pride and honour for me to have the opportunity to serve Ayurveda at this esteemed institution. With the government’s vision of taking Ayurveda to the masses, I am confident that, with the collective support of all, AIIA will achieve global recognition in the years to come.”

Former Executive Director Prof. (Dr.) Manjusha Rajagopal, in her welcome remarks, expressed gratitude to all and reaffirmed her commitment to team spirit and collaborative work. Dean Prof. (Dr.) Mahesh Vyas highlighted that Prof. Prajapati’s experience with premier institutions in the country will help take AIIA to new heights.

Immediately after assuming charge, Prof. Prajapati participated in the valedictory session of a Continuing Medical Education (CME) program organized for faculty at the institute, where he also performed the ceremonial lamp lighting.

Prof. Prajapati holds a BAMS degree from Gurukul Kangri University and obtained his MD and PhD from Banaras Hindu University (BHU).

It is noteworthy that his appointment as Director of AIIA was approved by the Union Cabinet. As per the terms, he will serve for a period of five years from the date of assuming charge or until the age of superannuation, whichever is earlier.

Also Read:9th Ayurveda Day: PM Modi launches Rs 12,850 crore healthcare projects, Lays Foundation stone of 7 ESIC projects

Powered by WPeMatico

Higher Semaglutide Doses Safely Boost Weight Loss and Health in Adults with Obesity, Confirm Two Clinical Trials

A higher weekly dose of semaglutide (7.2 mg) can significantly improve weight loss and related health outcomes in adults living with obesity, including those with type 2 diabetes (T2D), according to the results of two large-scale, international phase 3 clinical trials. The findings, published in The Lancet Diabetes & Endocrinology journal, suggest that a higher dose of semaglutide offers a promising new option for people with obesity, including those with T2D, who have not achieved sufficient weight loss with existing treatments.

The STEP UP and STEP UP T2D clinical trials are the first to investigate whether increasing the dose of semaglutide from the currently approved dose of 2·4 mg to 7·2 mg is safe and leads to additional weight reduction. Trial participants were randomised to receive either the higher 7·2 mg dose of semaglutide, the currently approved 2.4 mg dose, or placebo over 72 weeks. All participants-regardless of treatment group-received lifestyle interventions such as dietary counseling and increased physical activity recommendations.

In adults without diabetes, a 7·2 mg dose of semaglutide led to an average weight loss of nearly 19%, surpassing the 16% loss seen with 2·4 mg and 4% with placebo. Nearly half of the participants on the higher dose lost 20% or more of their body weight, with about one-third losing at least 25%. Participants also experienced improvements in waist circumference, blood pressure, blood sugar, and cholesterol levels, all key factors in reducing obesity-related health risks. Similarly, in adults with obesity and T2D, the 7·2 mg dose resulted in an average 13% weight loss compared to 10% with 2.4 mg and 3.9% with placebo, along with significant reductions in blood sugar levels and waist size.

Both trials reported that the higher dose of semaglutide was safe and generally well tolerated. Gastrointestinal side effects like nausea and diarrhoea, and some sensory symptoms like tingling, were the most common. However, most side effects were manageable, resolved over time, and did not lead to participants dropping out of the trial. No increase in serious adverse events or severe hypoglycaemia was observed with the higher dose.

By delivering greater weight reduction and metabolic benefits while maintaining a favourable safety profile, the authors say this higher dose could help more people reach their health goals and reduce the burden of obesity-related complications worldwide. However, they highlight that further research is needed to fully understand the long-term benefits and risks.

Reference:

Wharton, Sean et al., Once-weekly semaglutide 7·2 mg in adults with obesity (STEP UP): a randomised, controlled, phase 3b trial, The Lancet Diabetes & Endocrinology, DOI: 10.1016/S2213-8587(25)00226-8 

Powered by WPeMatico

Undiagnosed Sleep-Disordered Breathing Worsens Heart Function in HCM Patients: JAMA

UK: Researchers have found in a new study that sleep-disordered breathing (SDB) is highly prevalent in hypertrophic cardiomyopathy (HCM) patients and is linked to adverse myocardial remodeling, greater diastolic dysfunction, and elevated troponin-T levels, indicating subclinical myocardial injury. The findings support further trials on treating SDB to improve outcomes in HCM.

The study, published in JAMA Cardiology by Shahid Karim, William Harvey Research Institute, NIHR Barts Biomedical Centre, Queen Mary University London, London, United Kingdom, and colleagues evaluated the burden of SDB in patients with HCM and its association with cardiac function and injury.
A total of 154 adults with HCM, identified from an institutional registry between 2018 and 2024, underwent overnight polysomnography, the gold standard for diagnosing sleep-disordered breathing. Participants with a prior diagnosis of SDB or pregnancy were excluded. Researchers assessed echocardiographic measures, biomarker levels, and functional status, with data analysis conducted independently of sleep study results.
The study led to the following findings:
  • Sleep-disordered breathing (SDB) was identified in nearly 60% of patients, with most cases previously undiagnosed.
  • Patients with SDB showed higher left ventricular mass, greater diastolic dysfunction, and elevated baseline troponin-T levels, along with larger overnight rises in troponin, pointing to subclinical myocardial injury.
  • Over half of the HCM patients with SDB reported New York Heart Association class II or III symptoms, compared with only one-fourth of those without SDB.
  • Hypertension and diabetes were more common in patients with SDB, while rates of atrial fibrillation and prior myectomy were comparable between groups.
The authors highlighted that SDB may play a key role in worsening the structural and functional abnormalities seen in HCM, adding to the overall disease burden. As SDB is often silent and under-recognized, its presence in this population may go unnoticed without systematic evaluation.
The researchers noted certain limitations, including the single-center design, predominantly European cohort, and reliance on routine echocardiograms, which may have introduced variability. Classifying all hypopneas as obstructive could also have underestimated the true burden of central sleep apnea.
The study highlights the importance of considering SDB as a comorbidity in patients with HCM, particularly in those with unexplained worsening of symptoms or evidence of diastolic dysfunction. The authors stressed the need for randomized clinical trials to determine whether treating SDB can improve remodeling, arrhythmic risk, and long-term outcomes in this patient population.
Reference:
Karim S, Chahal A, Venkataraman S, et al. Prevalence and Clinical Implications of Sleep Apnea in Hypertrophic Cardiomyopathy. JAMA Cardiol. Published online September 03, 2025. doi:10.1001/jamacardio.2025.2877

Powered by WPeMatico

Study Links Metabolic Syndrome to Adverse Coronary Plaque Profiles in T2DM

China: A new study has found that metabolic syndrome (MS) independently contributes to more severe and unfavorable coronary artery plaque characteristics in patients with type 2 diabetes mellitus (T2DM). These include higher rates of mixed, noncalcified, and nonobstructive plaques, as well as spotty calcification and extensive plaque burden.           

The findings published in Frontiers in Endocrinology emphasize the importance of early detection and control of MS components to reduce cardiovascular risk in this vulnerable population. 
The research, led by Yu-shan Zhang and colleagues from the Department of Radiology, West China Hospital, Sichuan University, assessed the effect of MS on coronary atherosclerotic plaques in patients with T2DM. Using coronary computed tomography angiography (CCTA), the investigators analyzed plaque type, stenosis severity, high-risk plaque features, and measures of plaque extent, such as segment involvement score (SIS) and segment stenosis score (SSS). A total of 2,431 patients with T2DM who underwent CCTA between January 2015 and February 2022 were retrospectively enrolled and grouped based on the presence or absence of MS.
The key findings of the study were as follows:
  • 61.5% of the cohort (1,496 patients) had metabolic syndrome (MS).
  • Patients with MS showed a higher prevalence of noncalcified and mixed plaques.
  • They also had a greater occurrence of nonobstructive stenosis.
  • SIS (Segment Involvement Score) and SSS (Segment Stenosis Score) values were significantly higher in patients with MS.
  • The number of MS components correlated directly with worsening plaque features, including higher proportions of patients with noncalcified or mixed plaques, SIS ≥4, and SSS ≥7.
  • Multivariate logistic regression confirmed MS as an independent predictor of adverse plaque profiles.
  • MS was associated with higher odds of noncalcified plaques (OR=1.232).
  • MS increased the likelihood of mixed plaques (OR=1.307).
  • MS was linked with more nonobstructive stenosis (OR=1.615).
  • Patients with MS had greater odds of SIS ≥4 (OR=1.529).
  • MS was associated with SSS ≥7 (OR=1.387).
  • MS significantly increased the risk of spotty calcification (OR=1.870).
  • All associations remained significant even after adjusting for potential confounding factors.
The study concludes that metabolic syndrome plays a pivotal role in shaping the coronary artery disease profile of patients with T2DM. Among the individual components of MS, hypertension appeared to exert the greatest influence on coronary atherosclerosis in this group. This suggests that aggressive blood pressure management, along with broader MS control, could be essential in slowing plaque progression and reducing future cardiovascular events.
Despite its strengths, the authors acknowledged several limitations. The cross-sectional design prevents causal inference, and certain confounders, such as detailed lipid-related variables, were not captured. Moreover, the single-center setting and the exclusively Chinese patient population may limit generalizability. Nonetheless, the large sample size and comprehensive imaging analysis lend strong support to the conclusions.
Overall, this study highlights the pressing need for systematic screening and early intervention for metabolic syndrome in individuals with type 2 diabetes. By targeting modifiable risk factors such as hypertension, obesity, and dyslipidemia, clinicians may be able to reduce coronary plaque burden and improve long-term cardiovascular outcomes in this high-risk group.
Reference:
Zhang, Y., Shi, R., Jiang, Y., Gao, Y., Wang, J., Li, Y., & Yang, Z. (2025). Effect of metabolic syndrome on coronary artery atherosclerotic plaque in type 2 diabetes mellitus patients. Frontiers in Endocrinology, 16, 1595475. https://doi.org/10.3389/fendo.2025.1595475

Powered by WPeMatico

Cardiac MRI Workflow Improves Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy: Study Shows

China: A new cardiac MRI-based workflow has shown promise in improving the prediction of sudden cardiac death (SCD) among individuals with nonischemic dilated cardiomyopathy (DCM), offering clinicians refined tools for risk stratification and personalized treatment strategies. By establishing specific cutoff values for late gadolinium enhancement (LGE) and extracellular volume fraction (ECV), the study demonstrates a more precise approach to identifying both high-risk and low-risk patient groups.

The findings were published on September 9 in Radiology by Di Zhou, MD, and colleagues from the Department of Magnetic Resonance Imaging, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Their work highlights how quantitative cardiac MRI markers can outperform traditional visual assessments when estimating the risk of SCD in patients with DCM.
Dilated cardiomyopathy leads to enlargement of the heart chambers and, without timely management, can result in sudden death. While cardiac MRI with LGE is already recognized as a marker of myocardial scarring, its clinical use has been constrained by qualitative interpretation, especially in cases where LGE appears with intermediate signal intensity. To address this gap, the research team investigated whether quantitative thresholds could offer greater prognostic accuracy.
The study analyzed data from 1,105 patients with DCM who underwent cardiac MRI across four centers. The development cohort included 837 individuals enrolled between 2012 and 2019, while an external validation cohort of 268 patients was added from 2019 to 2021. Patients were followed for a median of 58.3 months, with primary endpoints including SCD, implantable cardioverter-defibrillator (ICD) shocks, and resuscitated cardiac arrest. Secondary endpoints consisted of death related to heart failure, heart transplantation, or the use of a ventricular assist device.
The study revealed the following findings:
  • An LGE extent of at least 7.2% of left ventricular mass was identified as a strong and independent predictor of sudden cardiac death (SCD)-related events, with a hazard ratio of 4.75.
  • This quantitative cutoff offered superior predictive performance compared to qualitative distribution assessments (C statistic: 0.783 vs. 0.732).
  • In patients with LGE below 7.2%, an extracellular volume fraction (ECV) threshold of 31.8% provided additional discriminatory value.
  • Individuals with preserved ejection fraction (>35%), LGE less than 7.2%, and ECV under 31.8% showed a very low annual SCD event rate of 0.2%.
  • Patients with LGE ≥7.2% demonstrated a significantly higher annual risk of 4.65%, independent of ECV or LGE distribution pattern.
By incorporating LGE, ECV, and ejection fraction into a single workflow, the investigators proposed a practical model for clinicians to tailor preventive interventions. “The proposed comprehensive workflow empowers clinicians to implement personalized strategies, which may ultimately lead to improved patient outcomes in this vulnerable cohort,” Zhou and colleagues wrote.
In an editorial accompanying the study, Hajime Sakuma, MD, PhD, of Mie University in Japan, emphasized the clinical value of these thresholds. He noted that they can help physicians identify not only patients who require aggressive intervention, such as ICD implantation, but also those for whom such measures may be unnecessary. Sakuma added that the straightforward design of the workflow makes it feasible for real-world practice.
The study’s insights advance the role of cardiac MRI in guiding precision care for nonischemic DCM, bridging the gap between imaging biomarkers and individualized patient management.
Reference:
Risk Stratification of Sudden Cardiac Death in Nonischemic Dilated Cardiomyopathy: Arrhythmogenic Substrate Assessment in Cardiac MRI Di Zhou, Huaying Zhang, Wenjing Yang, Yining Wang, Leyi Zhu, Mengdi Jiang, Jing Xu, Fei Teng, Xinxiang Zhao, Shaocheng Zhu, Doudou Liu, Qiang Zhang, Arlene Sirajuddin, Andrew E. Arai, Shihua Zhao, and Minjie Lu. Radiology 2025 316:3

Powered by WPeMatico

Vasectomy More Cost-Effective Than Salpingectomy for Permanent Contraception, Reveals Research

USA: Researchers have found in a new cost-effectiveness analysis that vasectomy is a more cost-effective permanent contraceptive option. While salpingectomy prevented more unintended pregnancies and reduced ovarian cancer risk, it only became the more cost-effective option at higher willingness-to-pay levels.

The investigation, published in Obstetrics & Gynecology by Jill Brown, MD, MPH, of the Department of Gynecologic Surgery and Obstetrics at the Uniformed Services University in Bethesda, Maryland, compared the long-term economic value of the two procedures for couples seeking permanent contraception. Using a decision-tree model created in TreeAge, the researchers analyzed outcomes for a hypothetical cohort of 800,000 individuals—the approximate number of Americans who undergo permanent contraception each year.
Effectiveness was measured in quality-adjusted life-years (QALYs), with a willingness-to-pay (WTP) threshold of $100,000 per QALY gained or lost. Cost estimates, probabilities, and utility values were sourced from existing medical literature.
The analysis calculated the incremental cost-effectiveness ratio (ICER) between salpingectomy and vasectomy and included a probabilistic sensitivity assessment with 10,000 simulations. A cost-effectiveness acceptability curve was then generated for WTP thresholds ranging from $0 to $200,000. Secondary outcomes included the number of unintended pregnancies as well as ovarian cancer cases and deaths.
The study revealed the following findings:
  • Salpingectomy had an incremental cost-effectiveness ratio (ICER) of $143,769 per QALY gained compared with vasectomy, exceeding the standard $100,000 threshold.
  • Vasectomy was more cost-effective in 81.5% of simulations at a willingness-to-pay (WTP) level of $100,000.
  • The cost-effectiveness advantage of vasectomy dropped to 14.7% when the WTP threshold increased to $200,000, indicating salpingectomy may be more attractive when higher costs are acceptable.
  • Salpingectomy was linked to 1,215 fewer unintended pregnancies annually compared with vasectomy.
  • It was also associated with 6,085 fewer ovarian cancer cases each year.
  • The procedure further resulted in 4,921 fewer ovarian cancer deaths, highlighting its broader public health benefits.
The authors concluded that, at a WTP threshold of $100,000, salpingectomy does not meet standard benchmarks for cost-effectiveness relative to vasectomy, despite its ability to lower both unintended pregnancy rates and the societal burden of ovarian cancer. They emphasized the importance of shared decision-making between healthcare providers and couples considering permanent contraception. According to the research team, counseling should incorporate not only the financial and contraceptive aspects of each procedure but also the long-term health benefits—particularly the reduction in ovarian cancer risk—associated with salpingectomy.
“The analysis highlights the nuanced balance between economic considerations and broader health outcomes when choosing a permanent contraceptive method, offering valuable insights for clinicians and couples making these critical decisions,” the authors wrote.
Reference:
Pearson, Amy BS; Shvartsman, Katerina MD; Zeng, Wu MD, PhD; Brown, Jill MD, MPH. Cost Effectiveness of Salpingectomy Compared With Vasectomy for Permanent Contraception. Obstetrics & Gynecology ():10.1097/AOG.0000000000006042, August 28, 2025. | DOI: 10.1097/AOG.0000000000006042

Powered by WPeMatico

Keeping Medicines Without Licence Amounts to ‘Offer for Sale’, HC Upholds Chemist’s Conviction

Shimla: The Himachal Pradesh High Court has upheld the conviction of a chemist under the Drugs and Cosmetics Act, 1940, for stocking allopathic medicines without a valid licence, stressing that such offences affect public health and must be dealt with strictly.

Justice Rakesh Kainthla rejected Sanjay K. Maanav’s challenge and affirmed the trial court’s 2007 conviction order as well as the appellate court’s 2012 judgment, holding that no case was made out for interference.

The case clearly clarifies that simply possessing unlicensed medicines can allow the Court to presume intent to sell, placing the burden on the accused to prove otherwise. It also underscores that such offences will attract deterrent punishment, as stocking drugs without authorization is viewed as a serious threat to public health.

The case dates back to June 15, 2001, when Drugs Inspector Navneet Marwaha, accompanied by police officials, conducted a raid at Maanav Health Clinic in McLeodganj. During the raid, the High Court recorded, “the accused was present in the clinic, and he had displayed a variety of allopathic drugs for sale.”

When asked to produce a valid drug licence or a registered medical practitioner’s certificate, Maanav instead produced photocopies of certificates from Akhil Bhartiya Ayurvedic Vidyapeeth, Agra and N.E.H.M. Investigations later confirmed these to be invalid since electro-homoeopathy is not recognised by either the State or Central Medical Councils. The drugs were seized and sealed on the spot.

In 2007, the trial court convicted Maanav under Section 27(b)(ii) of the Drugs and Cosmetics Act, sentencing him to one month’s simple imprisonment and a fine of ₹5,000, with a default imprisonment of 15 days. The appellate court upheld this in 2012.

In his revision petition, Maanav argued that he never stocked allopathic medicines, only electropathy preparations. His counsel claimed that the prosecution failed to prove intent to sell, an “essential requirement under Section 27(b)(ii).”

In support of his argument, Maanav relied on the Supreme Court’s ruling in Mohammad Shabir v. State of Maharashtra (1979), which had held that “mere possession” of medicines was not sufficient to attract penal provisions.

Alternatively, he pleaded for leniency, pointing out that more than two decades had passed since the incident and the accused had already undergone “the agony of trial, appeal and revision.”

The State opposed the revision strongly. Additional Advocate General Lokender Kutlehria argued that the accused kept large stocks of medicines openly displayed on racks, which itself proved intent to sell.

“The accused had no license or degree, yet he possessed a huge quantity of allopathic drugs. He was playing with the lives of the people, and no sympathy should be shown to him,” the State submitted.

The Himachal Pradesh High Court pointed out that the position had changed after the 1982 amendment to Section 18(a) of the Drugs and Cosmetics Act, which introduced the phrase “offer for sale” into the law. The Court referred to a Karnataka High Court judgment (State of Karnataka v. Kannika Stores, 1992) which clarified that once this amendment came into effect, keeping medicines on the racks of a shop amounted to an offer for sale and was prohibited under the Act.

The High Court, after reviewing the evidence, upheld the reasoning of the trial court. It noted:

“In the present case, the drugs were found on the rack inside the clinic and learned Trial Court had rightly held that this violated Section 27 of the Drugs and Cosmetics Act.”

“Thus, there is no infirmity in the judgments and order passed by learned Courts below convicting the accused of the commission of an offence punishable under Section 27(b)(ii) of the Drugs & Cosmetics Act.”

The Court stressed that subsequent amendments to the Act had made even “stocking” or “exhibiting” medicines without a licence a punishable offence. As the order explained:

“When possession is with the accused and when there is no consent, it is for him to say for what purpose he has stored them. A presumption of fact has to be drawn by the Court, and the gist of the evidence and complaint has to be taken together; the accused was not taken by surprise when the charge clearly mentions the purpose of storing for sale only. Therefore, I have no hesitation in holding that the Court can draw a valid presumption, particularly so when there is no proof of purchase of the drugs or need for storing them by the accused. The offence under Section 18(C) read with 27(b) (ii) of the Act has been squarely made out, and the accused has to be convicted.”

On the plea for reduction of sentence, Justice Kainthla was categorical:

“Learned Trial Court sentenced the accused to undergo simple imprisonment for a period of one month, pay a fine of ₹5,000/- and in default of payment of fine to undergo further simple imprisonment for 15 days. The accused was found in possession of allopathic medicines, and he had no certificate/ licence to possess them. Learned Trial Court had rightly noticed that the possession of these drugs adversely affected public health and should be seriously viewed. The Court cannot ignore the impact of the crime while imposing the sentence, and the learned Trial Court was justified in considering the same. Keeping in view the impact on public health, the sentence of one month cannot be said to be excessive. The plea on behalf of the accused to reduce it cannot be accepted because of the lapse of time since the incident. The Court has to impose a deterrent sentence to dissuade people from playing with the lives of others by stocking the allopathic drugs for sale. Therefore, there is no justification for the reduction of the sentence.”

Subsequently, the Court held;

“In view of the above, there is no reason to interfere with the judgments and order passed by the learned Courts below. Hence, the present revision fails, and the same is dismissed. Pending application(s), if any, also stand(s) disposed of.”

Also Read: CDSCO Criminal Prosecution Against IndiaMART Put on Hold by Delhi HC Till Sept 17

To view the official order, click the link below:

Powered by WPeMatico

FDA Approves INLEXZO™ for BCG-Unresponsive Bladder Cancer

The U.S. FDA has approved Johnson & Johnson’s INLEXZO™ (gemcitabine intravesical system) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. This new therapy offers an alternative for patients who decline or are ineligible for bladder removal surgery (radical cystectomy).

Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.

Full prescribing information for Inlexzo will be posted on Drugs@FDA.

Efficacy was evaluated in Cohort 2 of SunRISe-1 (NCT04640623), a single-arm, multi-center trial enrolling 83 patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors following transurethral resection. Patients received the gemcitabine intravesical system into the bladder every 3 weeks for 6 months, followed by once every 12 weeks for up to 18 months.

Tumor status was assessed with cystoscopy and urine cytology every 12 weeks during the initial two years of treatment, after which cystoscopy was performed at least every 24 weeks. Mandatory biopsies were performed at 24 and 48 weeks after treatment initiation.

The major efficacy outcome measures were complete response (CR) at any time (defined as negative results for cystoscopy [with TURBT/biopsies as applicable] and urine cytology) and duration of response (DOR). CR assessment at each timepoint was based on central pathology review.

The CR rate was 82% (95% CI: 72, 90) and 51% of patients with a CR had a DOR ≥ 12 months.

The prescribing information includes warnings and precautions describing risks of administering gemcitabine intravesical system in patients with a perforated bladder, risk of metastatic bladder cancer with delayed cystectomy, magnetic resonance imaging (MRI) safety, and embryo-fetal toxicity.

The gemcitabine intravesical system delivers 225 mg of gemcitabine into the bladder, with an indwelling period following each insertion of 3 weeks prior to removal. The gemcitabine intravesical system is inserted once every 3 weeks for up to 6 months (8 doses), followed by once every 12 weeks for up to 18 months (6 doses), or until persistent or recurrent high-grade NMIBC, disease progression, or unacceptable toxicity.

This review used the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

This application was granted priority review. The gemcitabine intravesical system received breakthrough therapy designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Powered by WPeMatico

Biologic Therapy may Lower Malignancy Risk in Psoriasis,suggests study

A new study has investigated the impact of biologic therapies on cancer risk among patients with psoriasis and found that these treatments may offer protective benefits compared to traditional topical therapies. Psoriasis is a chronic immune-mediated condition that often requires long-term management, and concerns about the potential for systemic therapies to influence malignancy risk have persisted among clinicians and patients alike. This research focused on comparing patients receiving biologic treatments, such as tumor necrosis factor inhibitors and interleukin-targeted agents, with those using only topical monotherapies. The study revealed that patients treated with biologic therapies experienced a lower incidence of malignancies over the observation period. While topical monotherapy is often considered safe and effective for managing mild disease, it does not provide systemic immunomodulatory effects that may influence the immune surveillance mechanisms associated with cancer development. Biologic therapies, by modulating specific inflammatory pathways implicated in both psoriasis and cancer progression, may reduce the risk of malignancy while simultaneously controlling skin disease. The findings underscore the importance of considering personalized treatment strategies for patients with psoriasis, especially those at elevated risk for cancer due to age, family history, or comorbidities. Clinicians are encouraged to weigh both dermatologic benefits and systemic protective effects when recommending biologic therapy. Furthermore, the study highlights the need for ongoing surveillance and long-term follow-up to better understand the relationship between immune-targeted treatments and malignancy risk in this population. While biologic therapies have previously been scrutinized for their immunosuppressive potential, this research provides reassurance that, when appropriately selected and monitored, these treatments may confer additional systemic benefits beyond skin clearance. Patients and healthcare providers should engage in shared decision-making, considering both disease severity and individual risk factors for malignancy, to optimize treatment outcomes and overall health.

Keywords: Psoriasis, biologic therapy, malignancy risk, cancer prevention, immune modulation, systemic therapy, tumor necrosis factor inhibitors, interleukin inhibitors, personalized medicine, long-term outcomes

Reference:
Zhang, Y., et al. Biologic therapy is associated with reduced malignancy risk in psoriasis: A cohort study. Journal of the American Academy of Dermatology. 2025. https://doi.org/10.1016/j.jaad.2025.07.015

Powered by WPeMatico

Valgus Knee Brace Eases Walking Pain in Osteoarthritis Patients: Trial Shows

Netherlands: Wearing a valgus knee brace can meaningfully reduce walking-related pain in patients with medial compartment knee osteoarthritis (OA), according to a randomized controlled trial published in PLOS One. After six months of use, patients reported both statistically significant and clinically important improvements in pain intensity during walking, along with a reduced reliance on pain medications.

The study, led by Corné J.M. van Loon from the Department of Orthopaedics, Rijnstate Hospital, Arnhem, The Netherlands, and colleagues, aimed to address a gap in prior research by not only assessing clinical outcomes but also incorporating patients’ perspectives on brace use. “Our trial evaluated both the effectiveness and the user experiences of the valgus brace, considering aspects such as wearing time, comfort, and perceived benefits, which are often overlooked in earlier studies,” the authors noted.
In this mixed-method randomized controlled trial, 46 participants with medial compartment knee OA were enrolled. Twenty-three participants in the intervention group received standard care plus a customized valgus brace, while the remaining 23 participants in the control group received regular care but no brace. Outcomes were assessed at baseline, 2 weeks, 3 months, and 6 months, with knee pain during walking, measured on a 10-cm Visual Analog Scale (VAS), being the primary outcome. Secondary measures included walking distance, overall health status, knee functioning, and satisfaction with the brace. To enrich the findings, qualitative interviews were conducted with a subgroup of brace users.
The key findings of the study were as follows:
  • At six months, the intervention group showed a 2.13 cm greater reduction in knee pain after walking compared to the control group.
  • This reduction was both statistically significant and clinically meaningful.
  • No significant improvements were noted for pain at rest or for physical functioning measures.
  • Qualitative findings revealed that many patients experienced benefits beyond pain relief, such as better body function and improved ability to perform activities.
  • Some participants reported mixed or negative views of the brace, while several others described positive overall experiences.
The authors emphasized that although their study demonstrated measurable pain reduction, the relatively small sample size may have limited the ability to detect additional benefits. They highlighted the need for larger, well-powered trials with longer follow-up to better understand the effectiveness of valgus braces. Further exploration of patient factors—such as age, activity level, BMI, and degree of OA—was also recommended, as these could influence both outcomes and user satisfaction.
Importantly, the study highlights that user experience plays a crucial role in determining the success of assistive devices like knee braces. Some participants suggested that factors such as comfort, fit, and wearing duration strongly influenced their perception of benefit. These insights may prove valuable for healthcare providers, manufacturers, and patients alike, guiding future brace design and prescription practices.
“The findings suggest that valgus bracing offers a promising, non-invasive option for alleviating walking-related pain in individuals with medial knee OA. While broader research is required, incorporating patient feedback alongside clinical outcomes could help refine and optimize brace interventions, ultimately improving quality of care for those living with osteoarthritis,” the authors concluded.
Reference:
(2025). Effectiveness and user experiences of a valgus brace in patients with knee osteoarthritis: A mixed-method randomised controlled trial. PLOS ONE, 20(9), e0330157. https://doi.org/10.1371/journal.pone.0330157

Powered by WPeMatico