Intas Pharma Gets Expert Panel Nod For PMS Data On Tofacitinib Ointment In Atopic Dermatitis

New Delhi: Intas Pharma has received approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) for the results of its Post-Marketing Surveillance (PMS) study on Tofacitinib 2% w/w ointment in adult patients with mild to moderate atopic dermatitis, including those experiencing flare-ups.

The update was discussed during the SEC’s 7th meeting held on 23rd July 2025 at the CDSCO headquarters in New Delhi. The firm presented the report of an active PMS study, which was conducted to assess the real-world effectiveness and safety of the topical Janus kinase (JAK) inhibitor formulation.

The PMS study focused on adult patients diagnosed with mild to moderate atopic dermatitis, particularly those suffering from flare-ups of the condition. The firm submitted its findings before the committee for evaluation, which included real-world data collected under post-marketing conditions.

After a comprehensive review and detailed deliberation, the committee acknowledged the results submitted by the company and recommended acceptance of the data presented in the PMS study.

Tofacitinib, a JAK inhibitor, is more commonly used in oral form for autoimmune conditions. However, its topical formulation for dermatological use in atopic dermatitis represents a growing area of interest in India, especially for patients seeking localized and non-systemic treatment options.

The committee’s acceptance of the PMS study results reflects regulatory confidence in the product’s post-marketing safety and real-world efficacy in the Indian population. This could pave the way for broader clinical adoption of Tofacitinib 2% ointment as a therapeutic option in dermatology.

“After detailed deliberation, the committee recommended to accept the results of active PMS study presented by the firm.”

Also Read: Health Ministry Notifies Cosmetics Rules 2025, Empowers States To Suspend Licences

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CM Siddaramaiah pays surprise visit to Victoria Hospital, calls for expansion

Bengaluru: Karnataka Chief Minister Siddaramaiah pays a surprise visit to the government-run Victoria Hospital on Wednesday. He stressed the urgent need to expand the capacity of the hospital, amid the growing number of patients arriving from across the country.

He paid a surprise visit to the hospital along with Medical Education Minister Sharan Prakash Patil after his tour to Koppal and Raichur was cancelled due to bad weather.

The CM interacted with the patients, including a few from Bihar. 

“People from across the country come to Victoria Hospital. There is overcrowding. So there is a need to increase its capacity,” Siddaramaiah told reporters, news agency PTI reported.

The CM said that he has asked the medical team to treat patients with compassion.

Also Read: Govt Organ Transplant and Retrieval Centre to come up in Bengaluru

“Since people are getting free treatment here, there will be too much pressure on the doctors. I have told them to be patient,” Siddaramaiah said.

He further said that he had given strict instructions that no one should take even a rupee from patients.

“I noticed that liver transplant in private hospitals costs about Rs 40 lakh to Rs 50 lakh, but here it is done free of cost. The demand is to increase the capacity,” Siddaramaiah said.

According to the CM, presently, there are 120 beds available in the gastroenterology department. There is a proposal to make it a 300-bed facility, which the government will consider, he added.

Siddaramaiah said during his interaction, patients told him that the doctors took good care of them and proper food was given to them.

When reporters highlighted that private ambulance drivers are running a racket here since government ambulances are not available, Siddaramaiah said by dailing 108, people can avail the government service.

The 108 services will be restarted, Minister Patil said, without elaborating further.

The CM said he also visited the Vani Vilas Hospital. More than 40 deliveries take place daily, he said.

Also Read:Karnataka Plans Organ Transplant Centres in 22 Medical Colleges

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Genomics-guided tool helps guide immunotherapy choices for advanced kidney cancers

A study led by Roswell Park Comprehensive Cancer Center helps explain why a rare and hyper-aggressive subtype of kidney cancer is susceptible to immunotherapy—information that helped researchers create a first-of-its-kind tool to guide treatment decisions for advanced kidney cancers.

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Walking Faster and Farther Reduces CV Risk among People with High Blood Pressure: Study

Analysis of over 36,000 people with high blood pressure has shown that taking more steps, even below the recommended daily target of 10,000 steps, and walking faster, is associated with a significant reduction in the risk of major problems of the heart and blood vessels.

The study, published in the European Journal of Preventive Cardiology, found that compared to a daily step count of 2,300 steps, every extra 1,000 steps was linked to a 17% reduction in the risk of developing a major adverse cardiovascular event (MACE), up to 10,000 steps. Additional steps above 10,000 were associated with a lower risk of stroke.

Approximately 1.28 billion people worldwide are living with high blood pressure, and it places them at increased risk of heart disease (49% increase), stroke (62% increase) and heart failure (77-89% increase). Until now, it has been unclear how much people with high blood pressure need to increase their physical activity in order to see a reduction in their risk of MACE.

Professor Emmanuel Stamatakis, Director of the Mackenzie Wearables Research Hub at the University of Sydney, Australia, who supervised the study, said: “This study is one of the first to demonstrate a dose-response relationship between daily step count and major problems of the heart and blood vessels. In a nutshell, we found that, if you live with high blood pressure, the more you walk with greater intensity, the lower your risk for future serious cardiovascular events.

“These findings support the message that any amount of physical activity is beneficial, even below the widely recommended daily target of 10,000 steps.”

The study analysed data obtained from 32,192 people who had enrolled in a sub-study of the UK Biobank study. They had been diagnosed with high blood pressure and agreed to wear an accelerometer on their wrist for seven consecutive days to measure how far and how fast they walked. Data from the accelerometers was collected between 2013 and 2015. The average age was 64 and the participants were followed up for nearly eight years, providing the researchers with data for 283,001 person-years. During this time 1,935 cases of heart problems or stroke occurred.

In addition to a 17% reduction in overall risk for every extra 1,000 steps a day, the researchers found a 22% reduction in heart failure, 9% reduction in risk of heart attack, and 24% reduction in risk of stroke. This means that every increase of 1,000 steps a day was associated with:

• an average reduction in the absolute risk of MACE of 31.5 events per 10,000 person-years

• an average reduction in the absolute risk of 7.2 heart failure events per 10,000 person-years

• an average reduction in the absolute risk of 9.9 myocardial infarctions (heart attacks) per 10,000 person-years

• an average reduction in the absolute risk of 10.4 strokes per 10,000 person-years.

The average (mean) intensity of the 30 minutes of fastest walking per day was 80 steps a minute and this was associated with a 30% reduced risk of MACE. There was no evidence of harm in people whose 30 minutes of fastest walking or running was over 130 steps a minute. [2]

The researchers found similar results when they looked at 37,350 people without high blood pressure. Every 1,000-step increase in daily step count led to an average lower risk of MACE, heart failure, myocardial infarctions and stroke of 20.2%, 23.2%, 17.9%, and 24.6%, respectively.

Prof. Stamatakis said: “Our findings offer patients accessible and measurable targets for heart health, even below 10,000 steps daily. Clinicians should promote physical activity as standard care, especially in patients with high blood pressure. Our results can inform new, tailored public health recommendations for these patients. Future recommendations on walking in people with high blood pressure could consider promoting higher stepping intensity.”

Strengths of the study include the large number of patients, the use of accelerometers to provide detailed information on numbers of steps and speed, and the use of data from national records in England, Wales and Scotland on deaths and causes of death.

Limitations include the fact that physical activity was measured only when people first joined the study and did not include any subsequent changes in behaviour. In addition, the researchers point out that their findings can show only that there is an association between walking further and faster and better health outcomes, not that it causes these better outcomes. However, they conducted extensive analyses to minimise the risk of what is called ‘reverse causation’ (in which, in this case, health problems could be causing both a reduction in physical activity and an increase in heart disease events). Most UK Biobank participants are White, are less likely to be obese, to smoke or drink alcohol, and to be better educated, and so they may not be representative of the general UK population.

Reference:

Sonia Wing Mei Cheng, Prospective associations of daily step count and stepping intensity with overall and type-specific major adverse cardiovascular events in people with hypertension, European Journal of Preventive Cardiology, https://doi.org/10.1093/eurjpc/zwaf441.

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Study shows people overestimate hill steepness based on their eye level

People’s perceptions of the world are easily impacted by the angle at which they view objects in it, suggests a new study.

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Did you walk or cycle to school as a child? Your children are likely to follow in your footsteps

If you used physically active modes of commuting to school, your children are likely to do the same. A study published in the European Journal of Public Health by the University of Jyväskylä, Finland, reveals an intergenerational link between parents’ and their children’s school commuting habits. The researchers emphasize that active commuting to school is a simple and practical way to incorporate more physical activity into daily life.

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User-friendly tool streamlines transcriptomic data analysis for precision medicine applications

The Barcelona Institute for Global Health (ISGlobal) has launched HTGAnalyzer, a new, easy-to-use, fast and reproducible bioinformatics tool for advanced transcriptomic data analysis. Designed within the R statistical environment, this package simplifies complex analytical processes, making them accessible to professionals without specific expertise in bioinformatics.

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Report ties to child mental health crisis to immigration enforcement

Aggressive immigration practices—such as detention, deportation, and workplace raids—are contributing to widespread emotional trauma among both immigrant and U.S.-born children living in mixed-status households, according to a report published by a team of mental health professionals in the School of Medicine at the University of California, Riverside.

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CGM Metrics Strongly Predict 5-Year Mortality Risk in Diabetes, Study Shows

USA: A new long-term analysis published in Diabetes Care has highlighted the potential of continuous glucose monitoring (CGM) metrics to predict the risk of death among individuals with type 1 or type 2 diabetes. The study, led by Tomoki Okuno from the Department of Biostatistics at the University of California, Los Angeles, in collaboration with colleagues, suggests that CGM data may provide a more nuanced assessment of risk than traditional HbA1c measurements.

The research examined 2,752 adults aged 21 years or older with diabetes, 65% of whom had type 2 diabetes, from the Veterans Affairs Healthcare System. All participants had used Dexcom CGM devices between 2015 and 2020 and had at least 10 days of CGM data within landmark periods of 14 days, three months, or six months. These glucose readings were linked with electronic health records, and participants were followed for up to five years from the start of CGM use to assess all-cause mortality.

At the time of CGM initiation, the average age of participants was 64 years, and the median duration of CGM use was almost three years. Over the follow-up period, 407 participants died. The analysis evaluated multiple CGM-derived metrics—mean glucose (MG), time in range (TIR), time above range (TAR), coefficient of variation (CV), and glycemic risk index (GRI)—using multivariable Cox models adjusted for known mortality risk factors.

The study led to the following findings:

  • Higher mean glucose (MG), time above range (TAR), coefficient of variation (CV), and glycemic risk index (GRI) during the six-month observation period were significantly associated with an increased risk of death over the following five years.
  • Spending more time in the target glucose range (TIR) was linked to a lower mortality risk.
  • Hazard ratios were MG (1.18), TAR (1.20), CV (1.18), GRI (1.23), and TIR (0.83), all with P-values ≤ 0.01.
  • These associations remained significant even after adjusting for HbA1c levels recorded during the same period.
  • The link between glucose variability (CV) and mortality persisted independently of other CGM metrics, with the strongest association seen in individuals with lower HbA1c levels.
  • Similar associations were observed with shorter CGM observation periods, supporting the consistency of the results.

The researchers noted that while HbA1c remains a cornerstone in diabetes management, it provides an average glucose estimate and does not reflect fluctuations or the duration of hypo- and hyperglycemic episodes. CGM-derived data, on the other hand, offer a more dynamic picture of glycemic control, potentially enabling clinicians to identify high-risk individuals who might be missed using HbA1c alone.

Overall, the study emphasizes the importance of incorporating CGM metrics—particularly mean glucose, time in range, and measures of glucose variability—into clinical practice for long-term risk assessment. The authors suggest that this approach could pave the way for more targeted interventions aimed at reducing mortality in people with diabetes.

Reference:

Tomoki Okuno, Sharon A. Macwan, Gregory J. Norman, Donald R. Miller, Peter D. Reaven, Jin J. Zhou; Continuous Glucose Monitoring Metrics Predict All-Cause Mortality in Diabetes: A Real-world Long-term Study. Diabetes Care 2025; dc250716. https://doi.org/10.2337/dc25-0716

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SGLT2 Inhibitors Fail to Impact MI Severity or Outcomes in T2DM Patients: Study

Germany: A retrospective cohort study has found that prior use of SGLT2 inhibitors in type 2 diabetes mellitus (T2DM) patients did not reduce myocardial infarction (MI) size or decrease adverse events during hospitalization for MI treated with percutaneous coronary intervention (PCI).

The study, published in BMC Cardiovascular Disorders by Istvan Bojti and colleagues from the Department of Cardiology and Angiology, University Heart Center Freiburg – Bad Krozingen, examined whether ongoing SGLT2 inhibitor therapy influences infarct size and short-term outcomes in T2DM patients experiencing MI.

The research included 681 patients with T2DM who were admitted for MI and underwent PCI between November 2015 and December 2023. Among them, 105 were on SGLT2 inhibitors, while 576 were using other glucose-lowering medications at admission. The primary parameter assessed was infarct size, measured using peak high-sensitive troponin T (hs-TnT) normalized to the endangered myocardial area (EMA).

The analysis revealed the following findings:

  • Analysis showed no significant difference in infarct size between patients on SGLT2 inhibitors and those using other glucose-lowering therapies.
  • Median high-sensitive troponin T (hs-TnT) levels were similar in both groups.
  • Adjusted statistical models indicated that ongoing SGLT2 inhibitor therapy was not associated with a reduction in MI size.
  • Evaluation of in-hospital secondary outcomes, including major adverse events and ICU stay duration, showed no significant benefit linked to SGLT2 inhibitor use.

The authors hypothesize that any potential protective effect of SGLT2 inhibitors may have been offset by more severe coexisting cardiovascular conditions and poorer glycemic control observed in the SGLT2 inhibitor group. They also noted that the evolving prescription patterns during the study period, especially following the positive outcomes of SGLT2 inhibitors in heart failure patients, may have resulted in a higher proportion of patients with advanced cardiovascular disease in the SGLT2 inhibitor cohort.

The study’s real-world design was highlighted as a strength, as it included patients with multiple comorbidities who are often excluded from randomized clinical trials, such as those with prior coronary artery bypass grafting, significant renal impairment, or those on insulin therapy. However, the authors acknowledged several limitations, including the study’s retrospective nature, the absence of data on therapy duration or adherence, and the lack of detailed diabetes-related complications that could influence outcomes. They also emphasized that the method used for estimating infarct size may not be as accurate as cardiac MRI, which is considered the gold standard.

The authors note that while the findings do not demonstrate a significant relationship between ongoing SGLT2 inhibitor therapy and reduced infarct size or adverse in-hospital outcomes, they recommend further prospective studies, ideally incorporating cardiac MRI and diverse patient populations.

“Such investigations are needed to clarify whether SGLT2 inhibitors exert any protective effects in the setting of myocardial infarction, both in patients with and without T2DM,” the researchers concluded.

Reference:

Bojti, I., Bojti, F., Hartikainen, T. et al. SGLT2-inhibition and myocardial infarction size in patients with type 2 diabetes mellitus– Insights from an acute cardiovascular care center. BMC Cardiovasc Disord 25, 566 (2025). https://doi.org/10.1186/s12872-025-04981-5

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