Torrent Pharma gets USFDA EIR for Indrad facility

Ahmedabad: Torrent Pharma has informed in a BSE filing that the U.S. Food and Drug Administration (USFDA) has issued Establishment Inspection Report (“EIR”) with Voluntary Action Indicated (“VAI”) classification for the manufacturing facility at Indrad, Gujarat. The inspection has now been successfully closed by the USFDA.

VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action

The USFDA had conducted inspection at the facility from 03-Jun-24 to 12-Jun-24 and issued five observations. 

Read also: Torrent Pharma gets 5 USFDA observations for Indrad facility

Torrent Pharma is an Indian multinational pharmaceutical company headquartered in Ahmedabad, India. The company specializes in therapeutic segment of cardiovascular (CV), central nervous system (CNS), gastro-intestinal (GI) and women healthcare (WHC).

Read also: Torrent Pharma is said to seek raising USD 3 billion for KKR stake in JB Chemicals: Report

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Madhya Pradesh HC directs Govt to submit report on Doctors’ safety measures

Jabalpur: At a time when the resident doctors at RG Kar Medical College are still protesting over the brutal rape and murder of PG trainee doctor in Kolkata, the Madhya Pradesh High Court in Jabalpur has ordered the state government to submit a comprehensive report within 14 days on the actions it has taken to enhance the safety of doctors in medical colleges across the state.

The court, led by Acting Chief Justice Sanjeev Sachdeva, was addressing a public interest litigation (PIL) filed by RTI activist Ansul Tiwari. The petition highlighted the urgent need for improved safety measures for doctors, prompted by the disturbing incident in Kolkata.

Also read- Violence at Prayagraj Hospital: Senior doctor suffers vision loss in left eye after mob attack

Advocate Mahendra Pateria, representing the medical community, informed the court that the state must present a detailed strategy during the proceedings. The required blueprint should cover several critical areas, transport for duty doctors, the establishment of a state grievance committee, setting up police posts, securing campus areas, implementing an attendants policy, enforcing restrictions on photography and videography, and managing bed occupancy.

“HC has asked the state government to come up with a strategy and planning for the safety and security of women doctors in hospitals and medical colleges and how it is planning to ensure their safety. Fourteen days time has been given to the state government to submit the report,” said Pateria as quoted by Free Press Journal

Medical Dialogues had earlier reported that after taking suo motu cognisance of the incident of rape and murder of a PG trainee doctor at RG Kar Hospital, the Supreme Court constituted a National Task Force to frame effective recommendations to remedy the issues of concern regarding safety, working conditions, and well-being of medical professionals and other related matters.

This 15-member committee, comprising nine senior doctors and five ex-officio government officials, shall prepare an action plan to prevent violence against medical professionals and provide safe working conditions for them.

Further, it will provide an enforceable national protocol for dignified and safe working conditions for interns, residents, senior residents, doctors, nurses, and all medical professionals, the Union Ministry of Health and Family Welfare mentioned in an Office Memorandum issued yesterday.

To prevent violence against healthcare workers, the NTF’s job will be to ensure due security in medical establishments, provide a framework for infrastructural development- such as separate duty rooms and restrooms for male/female doctors, nurses, gender-neural common resting space, use of bio-metric or facial recognition for entry to sensitive areas, installing CCTVs, provision of transport from place of stay to place of duty and vice versa.

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Lung cancer drug: Natco Pharma submits ANDA for generic version of Novartis Tabrecta

Hyderabad: Natco Pharma Limited has announced its submission of an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of TABRECTA (Capmatinib hydrochloride) Eq 150mg base and Eq 200 mg base tablets.

TABRECTA is the brand of Novartis.
Natco believes it is the first company to have filed a substantially-complete ANDA containing a paragraph IV certification for this product and expects to be eligible for 180 days of sole marketing exclusivity at the time of potential launch of the product under certain circumstances.
TABRECTA has recorded sales of USD 126 million in the US market for the year 2023.
Capmatinib hydrochloride is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a specific type of mutation.

Read also: Natco Pharma net profit increases 59 percent to Rs 668 crore in Q1

Natco Pharma Limited was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 employees, Natco today has eight manufacturing facilities spread across India with modern research laboratories, capabilities in New Drug Development, etc.

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Kerala battles amoebic brain fever with new research initiative

Kerala: In a pioneering effort to tackle amoebic meningoencephalitis, also known as amoebic brain fever, Kerala has launched a comprehensive research initiative, marking India’s first coordinated approach to combat the disease.

According to the PTI report, as the initial step, a technical workshop was organised by the Kerala Health Department here, with the participation of experts from the state and institutions such as the Indian Council of Medical Research (ICMR), Indian Association of Virology (IAV), Pondicherry EV Institute, Indian Institute of Science, and Pollution Control Board.

Also Read:Kerala Govt to release special guidelines for amoebic meningoencephalitis

Health Minister Veena George inaugurated the workshop. She said that Kerala will undertake research on amoebic meningoencephalitis.

“This will be the first such effort at the global level. When a cluster was formed in Thiruvananthapuram, we were able to detect the first case and subsequently identify other infected individuals. All of them are recovering,” the minister said.

George said the Health Department has decided to find out why cases are increasing in the state.

“Based on this, we have decided to launch research activities in collaboration with expert organisations like ICMR and the Indian Institute of Science,” the minister said, news agency PTI reported.

In an official statement, the Health Department said the participants in the workshop praised Kerala’s efforts.

According to their evaluation, the state’s excellent measures were able to detect very rare diseases like amoebic meningoencephalitis early and save a few people from a disease with a mortality rate of 97 per cent.

The team extended full support to Kerala’s efforts to prevent amoebic meningoencephalitis.

Globally, only 11 people have recovered from amoebic meningoencephalitis. In 2024, Kerala reported 19 cases, with five fatalities.

“Kerala has managed to increase the recovery rate. So far, four people in the state have recovered. All those who contracted the disease in Kerala had contact with contaminated water, either directly or indirectly,” the statement said.

To determine why only some people who used the same water source contracted the disease, a case-control study will be conducted with the help of ICMR and the National Institute of Epidemiology, it said.

The statement also said the Environment Engineering Department of Kerala University and the Pollution Control Board jointly presented a detailed study report on the biological and non-biological factors that aid the growth of amoeba.

“It was decided to assess such conditions in Kerala’s water bodies. Through this, a detailed study will be conducted on the biological and non-biological factors that aid the growth of amoeba, and an action plan will be formulated based on a unified approach,” the release added.

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Goa Medical College establishes task force for safety of medical professionals

Panaji: Goa Medical College has established a Task Force dedicated to the welfare and safety of its medical professionals. The Task Force will be led by Professor SN Bandekar, the Dean of Goa Medical College, with various department heads and directors serving as members.  

The Medical Superintendent of the college has been appointed as the Member Secretary.  

According to an ANI report, the official order from the office of the Dean reads, “The Dean, Goa Medical College is pleased to constitute a Task Force for medical professionals’ welfare and safety at the Goa Medical College and Hospital.

Also Read:Goa Medical College resident doctor assaulted by two women, Doctors association demands action

This development comes amid the uproar over the brutal rape and murder of a woman trainee doctor on the R G Kar Medical College and Hospital premises which sparked outrage all over the country.

Meanwhile, earlier today, BJP called for a ’12 hour Bengal Bandh’ after Kolkata police resorted to lathi charge, use of water cannons and tear gas against the protestors in Nabnna Abhiyaan’ Rally, which aimed to protest the recent rape and murder of a woman trainee doctor in Kolkata upon which West Bengal Chief Minister Mamata Banerjee condemned BJP’s 12-hour ‘Bengal Bandh’ and called it an attempt to “defame” Bengal, news agency ANI reported.

Mamata Banerjee’s scathing attack on BJP comes after the latter held a 12-hour ‘Bengal Bandh’ protest, following the ‘Nabanna Abhijan’ violence. Mamata Banerjee claimed that TMC government wants justice for the victims of R G Kar Hospital and College incident.

“We have dedicated this day to the RG Kar doctor. We want justice but BJP today called for a bandh. They don’t want justice, they are only trying to defame Bengal,” Mamata Banerjee said.  

She further criticised the ‘Bandh’ and supported the police actions on the protestors of Nabanna Abhijan rally.  

“We don’t support this bandh. BJP never demanded the resignations of the CMs of UP, MP and even Manipur. We saw pictures from yesterday (Nabanna Abhiyan rally), I salute the police for handling the situation well.” she said. 

Meanwhile, Union Minister and West Bengal BJP President Sukanta Majumdar led a sit-in protest in Baguiati, Kolkata, during the BJP’s 12-hour bandh. Majumdar described the protest as a “people’s movement” demanding the resignation of Chief Minister Mamata Banerjee.  

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SGLT2 Inhibitors might prevent dementia in Diabetes Patients, reveals research

Sodium-glucose cotransporter-2 (SGLT-2) inhibitors used to treat type 2 diabetes might prevent dementia, providing greater benefits with longer treatment, suggests a large study from Korea published by The BMJ today.

As this study was observational, the researchers note that the effect size could have been overestimated and say randomised controlled trials are now needed to confirm these findings.

According to the World Health Organization, the number of people with dementia globally is expected to reach 78 million by 2030 and type 2 diabetes is associated with a greater risk of developing dementia.

A recent study of over 65s with type 2 diabetes suggested a decreased risk of dementia associated with SGLT-2 inhibitors versus another type of diabetes drug, dipeptidyl peptidase-4 (DPP-4) inhibitors. But the effects on younger people and specific types of dementia (eg, Alzheimer’s disease, vascular dementia) remains unclear.

To address this, researchers used the Korea National Health Insurance Service database to identify 110,885 pairs of adults with type 2 diabetes aged 40-69 years who were free of dementia and started taking either an SGLT-2 inhibitor or a DPP-4 inhibitor between 2013 and 2021.

All participants (average age 62; 56% men) were matched by age, sex, use of the diabetes drug metformin, and baseline cardiovascular risk and were followed up for an average of 670 days to see who developed dementia.

Potentially influential factors including personal characteristics, income level, underlying risk factors for dementia, other conditions and related medicine use, were also taken into account.

Over the follow-up period, a total of 1,172 participants with newly diagnosed dementia were identified.

Dementia rates per 100 person years were 0.22 for those using SGLT-2 inhibitors and 0.35 for those using DPP-4 inhibitors, corresponding to a 35% reduced risk of dementia associated with use of SGLT-2 inhibitors compared with DPP-4 inhibitors.

The researchers also found a 39% reduced risk for Alzheimer’s disease, and a 52% reduced risk for vascular dementia associated with SGLT-2 inhibitors compared with DPP-4 inhibitors.

What’s more, the effect of SGLT-2 inhibitors seemed more pronounced with longer treatment duration. A 48% reduced risk of dementia was seen for more than two years of treatment versus a 43% reduced risk for two years or less.

This is an observational study so no firm conclusions can be drawn about cause and effect, and the authors note that details of health behaviours (eg, smoking and alcohol consumption) and duration of type 2 diabetes were not fully available.

However, they point out that this was a large study based on nationally representative data that included relatively younger people with type 2 diabetes, and results were highly consistent across subgroups.

As such, they say SGLT-2 inhibitors might prevent dementia, providing greater benefits with longer treatment, and they call for randomised controlled trials to confirm these findings.

This study reports promising results that have important implications for clinical practice as well as from a public health perspective, say researchers from Taiwan in a linked editorial.

They agree that further trials are needed to confirm these findings, and suggest that studies are also needed “to explore the underlying mechanisms of any neuroprotective effects of SGLT-2 inhibitors.”

As no cure currently exists for dementia and few effective treatment options are available, strategies that can potentially prevent onset are critically important, they write.

Given the substantial socioeconomic and public health burdens associated with both dementia and type 2 diabetes, they also recommend that clinical guidelines and healthcare policies should be updated regularly to incorporate latest best evidence on the potential benefits of SGLT-2 inhibitors, including reduced dementia risk.

Reference:

Shin A, Koo B K, Lee J Y, Kang E H. Risk of dementia after initiation of sodium-glucose cotransporter-2 inhibitors versus dipeptidyl peptidase-4 inhibitors in adults aged 40-69 years with type 2 diabetes: population based cohort study BMJ 2024; 386 :e079475 doi:10.1136/bmj-2024-079475

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Simple blood test may predict higher cancer risk among type 2 diabetes patients, suggests Danish study

Individuals with type 2 diabetes who are at higher risk of certain cancers could be identified by a simple blood test, this year’s Annual Meeting of the European Association for the Study of Diabetes (EASD) (Madrid, 9-13 September) will hear.

People with type 2 diabetes are known to be at higher risk of developing cancers associated with obesity (OR cancers), including breast, kidney, womb, thyroid and ovarian cancer, as well as gastrointestinal cancers, including colorectal and pancreatic cancer, and multiple myeloma.

It is thought that chronic low-grade inflammation, which is prevalent in both obesity and type 2 diabetes, plays a significant role in cancer development in both conditions.

Mathilde Dahlin Bennetsen, of the Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark and colleagues explored whether differences in levels of proinflammatory cytokines, immune system proteins that heighten inflammation, would help identify individuals with type 2 diabetes who are particularly at risk of OR cancers.

“Understanding which individuals are at higher risk for these cancers would allow for more targeted and effective monitoring and early detection, potentially improving outcomes through earlier intervention and personalised treatment,” says Ms Bennetsen.

The study involved 6,466 (40.5% female, median age 60.9 years) members of the Danish Centre for Strategic Research in Diabetes (DD2) cohort, an ongoing study of individuals newly diagnosed with type 2 diabetes.

Levels of proinflammatory cytokines interleukin-6 (IL-6), tumour necrosis factor-alpha (TNF-alpha) and high sensitivity C-reactive protein (hsCRP) were measured at the start of the study. IL-6 and TNF-alpha are released by adipose tissue and they are often found at higher levels in individuals with type 2 diabetes.

The participants were grouped into three categories based on their IL-6 levels: the lowest third (IL6 ≺0.94pg/ml), the middle third (0.94-1.58pg/ml) and the highest third (>1.58pg/ml).

They were then followed for a median of 8.8 years, during which 327 developed an obesity-related cancer.

Higher levels of IL-6 at baseline were associated with a higher risk of developing an OR cancer.

When the results were adjusted for age, sex, diabetes duration, alcohol consumption, waist circumference, physical activity, HbA1c (a measure of how well blood sugar is controlled), triglyceride levels, use of lipid-lowering drugs and use of diabetes medication, those in the highest group had a 51% higher risk of developing an OR cancer compared with those in the lowest group.

TNF-alpha and hsCRP were only weakly associated with OR cancers compared to IL-6.

Factoring in smoking status did not change the results.

When the researchers added baseline IL-6 levels to other factors known to increase the risk of obesity-related cancers, it led to a small but important increase in ability to predict if an individual would go on to develop one of the cancers.

In contrast, the inclusion of TNF-alpha or hsCRP did not improve the predictive models.

The authors conclude that higher IL-6 levels are associated with the development of OR cancers in patients who have recently been diagnosed with type 2 diabetes.

In future, a simple blood test could identify those at higher risk of the cancers, says Ms Bennetsen. However, further research is needed to determine if testing would improve early detection and management of these cancers.

Ms Bennetsen adds: “Understanding that higher levels of inflammation can indicate a greater risk of certain cancers highlights the importance of regular check-ups and effective diabetes management.

“Maintaining a healthy lifestyle and adhering to treatment plans can potentially help manage inflammation and reduce cancer risk.”

Reference:

Individuals with type 2 diabetes who are at higher risk of certain cancers could be identified by a simple blood test, Danish study suggests, Diabetologia, Meeting: Annual Meeting of the European Association for the Study of Diabetes (EASD).

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FINEARTS-HF Study Shows Finerenone Cuts CV death and Heart Failure Events in HFmrEF/HFpEF Patients

USA: Topline results from the FINEARTS-HF trial have revealed that finerenone (Kerendia), a nonsteroidal selective mineralocorticoid receptor antagonist (nsMRA), can lower the risk of cardiovascular (CV) death and total heart failure (HF) events in patients with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF).

Bayer announced that FINEARTS-HF met its primary endpoint, achieving a statistically significant reduction of the composite of CV death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. The trial found no new safety concerns beyond those identified in previous studies with the drug.

Bayer will present the FINEARTS-HF data at the European Society of Cardiology (ESC) Congress 2024 in September and intends to discuss regulatory approval with the U.S. Food and Drug Administration (FDA) thereafter.

KERENDIA, a non-steroidal selective mineralocorticoid receptor antagonist (MRA), has already demonstrated cardiovascular benefits, including reductions in heart failure hospitalizations, cardiovascular death, and non-fatal myocardial infarction in adults with chronic kidney disease (CKD) and type 2 diabetes (T2D). The new topline data shows positive results for a broader patient population, including those with heart failure and a left ventricular ejection fraction (LVEF) greater than 40%, extending its potential benefits beyond CKD in T2D.

The FINEARTS-HF study is a component of the MOONRAKER program for KERENDIA, anticipated to be one of the largest heart failure research initiatives to date. With over 15,000 patients involved, this program aims to provide a thorough understanding of KERENDIA’s effects on heart failure across a wide range of patients and clinical settings.

The FINEARTS-HF trial, a randomized, double-blind, placebo-controlled, parallel-group, multi-center phase III study, assessed the efficacy and safety of KERENDIA (finerenone) for new uses in patients with heart failure and a left ventricular ejection fraction (LVEF) of 40% or higher.

The primary endpoint of the FINEARTS-HF trial was the composite of cardiovascular death and total heart failure (HF) events, which included both first and recurrent HF events such as hospitalizations or urgent HF visits.

In the study, approximately 6,000 patients were randomized to receive either finerenone or a placebo daily for up to 42 months.

Together with other trials in the MOONRAKER clinical program, which includes over 15,000 patients, FINEARTS-HF is part of one of the largest heart failure research initiatives to date. The extensive program aims to build a robust body of evidence for finerenone across a diverse range of patients and clinical situations.

“Bayer is determined to drive research and innovations that have the potential to become treatment options for diseases with high unmet medical need, including for patients with mildly reduced or preserved ejection fraction,” Dr. Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division, said in a press release.

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Obesity linked to increased susceptibility to COVID-19 infection, reports study

A study finds an increased risk of developing a productive SARS-CoV-2 infection in obese people. Obesity is known to predict worse outcomes and higher mortality for those with COVID-19. Masanori Aikawa and colleagues sought to determine if obesity also affected the likelihood of getting ill in the first place. To investigate, the authors analyzed electronic medical records for 687,813 patients from the Mass General Brigham healthcare system, including 72,613 individuals with suspected SARS-CoV-2 exposure, 18,447 of whom tested positive.

The authors limited their data to a timeframe before vaccination became widespread in Massachusetts, to avoid the possible confounding factor of variable vaccine response. The authors compared the likelihood of testing positive upon suspected exposure for obese individuals with that of non-obese individuals. The authors found significantly increased susceptibility in obese individuals, with 34% higher odds of SARS-CoV-2 positivity in the obese population.

This pattern held across ages and sexes. According to the authors, this knowledge could help communities distribute resources toward individuals at higher risk for SARS-CoV-2 positivity.

Reference:

Joan T Matamalas, Sarvesh Chelvanambi, Julius L Decano, Raony F França, Arda Halu, Diego V Santinelli-Pestana, Elena Aikawa, Rajeev Malhotra, Masanori Aikawa, Obesity and age are transmission risk factors for SARS-CoV-2 infection among exposed individuals, PNAS Nexus, Volume 3, Issue 8, August 2024, pgae294, https://doi.org/10.1093/pnasnexus/pgae294

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Maternal T1D Less Likely Transferred to Child as Compare to Paternal T1D: Study finds

UK: Maternal type
1 diabetes offers long-term protection against type 1 diabetes to offspring as
compared to paternal type 1 diabetes, a recent study finds.

The study presented at the 2024 Annual Meeting of the European Association for the Study of
Diabetes
(EASD) in Madrid suggests that children of mothers with type 1
diabetes are less likely to develop the condition compared to children of
fathers with type 1 diabetes. And found that being exposed to a mother’s type 1
diabetes while still in the womb is very important, in providing long-term
protection against developing type 1 diabetes later in life.

Diabetes is a genetic condition that significantly increases the likelihood
of a child developing diabetes if either or both parents have the disease. Individuals
with a family history of type 1 diabetes (T1D) have an 8 to 15 times higher
risk of developing the condition compared to the general population. The risk
of inheriting T1D from mothers is about half that from fathers.

It remains unclear whether this protective effect
continues beyond childhood and what is the reason for the difference in risk
between maternal and paternal inheritance.

Against the above background, Dr. Lowri Allen of the
Diabetes Research Group at Cardiff University, UK, and colleagues performed a meta-analysis across
5 cohorts of individuals with type 1 diabetes (total n=11,475, diagnosed
age 0-88 years).

They compared the proportion of individuals with type
1 diabetes (T1D) inherited from their fathers versus their mothers and
investigated if this comparison was affected by the age at which the individual
was diagnosed and the timing of the parent’s diagnosis relative to the child’s
birth. Additionally, they analysed the type 1 diabetes genetic risk score
(GRS2) between those with T1D inherited from mothers and those from fathers.

Study findings reveal:

  • Twice
    as many individuals had an affected father compared with mother (overall OR 1.79).
  • The proportion of individuals with type 1
    diabetes who had an affected father was higher than those with an affected
    mother, both for those diagnosed at > 18 years (OR 1.64) and ≤18 years (OR
    1.80)
  • The higher proportion of individuals with
    affected fathers was observed only if the father’s diagnosis occurred before
    the offspring’s birth (OR 1.92 vs OR 1.28).
  • The genetic risk score for type 1 diabetes
    (GRS2) did not significantly differ between individuals with affected fathers
    and those with affected mothers.

“Mother with type 1
diabetes, compared to a father, provides relative protection against developing
the condition and this can help us create new preventive treatments. These
treatments might aim to mimic some of the protective elements present in
mothers,” said the researchers.

Reference: Allen, L. A.,
Taylor, P. N., Carson, A., Oram, R., & Colleagues. (2024). Maternal type 1
diabetes confers long-term relative protection against type 1 diabetes in the
offspring: Results from five cohort studies. Presented at the Annual Meeting of
the European Association for the Study of Diabetes (EASD), Madrid, Spain.

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