Glenmark Gets CDSCO Panel Nod to Study ISB 2001 in Multiple Myeloma

New Delhi: The drug major Glenmark has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the clinical study of the anticancer drug ISB 2001 in relapsed/refractory multiple myeloma.

This came after the drug major Glenmark presented Phase 1 clinical study protocol No. ISB 2001-101 version 2.0 amendment 01 dated 07/April/2023. This study is a first-in-human, Phase 1, open-label study that will evaluate the safety and anti-myeloma activity of ISB 2001 in participants with relapsed/refractory multiple myeloma.

Multiple myeloma is a cancer that forms in a type of white blood cell called a plasma cell. Healthy plasma cells help fight infections by making proteins called antibodies. Antibodies find and attack germs. In multiple myeloma, cancerous plasma cells build up in the bone marrow.

ISB-2001 is under development for the treatment of relapsed or refractory multiple myeloma. The drug candidate is a tri-specific monoclonal antibody, which is being developed based on TREAT (Tri-specific engagement by antibodies based on T cell receptor) technology. It acts by targeting BCMA, CD3, and CD38 and it is being developed based on BEAT platform. It is administered through the parenteral route.

ISB 2001 is a triple-target antibody, meaning the therapy has three arms — each one reaching out and interacting with a different target. Those targets are CD38, BCMA, and CD3.

CD38 and BCMA are proteins highly present at the surface of myeloma cells, while CD3 is a cell surface molecule found in T-cells, a type of immune cell with cancer-killing abilities.

By simultaneously targeting two cancer-specific proteins and a T-cell protein, the treatment candidate is expected to redirect immune cells to CD38 effectively- and BCMA-positive myeloma cells, triggering a cancer-destroying attack.

At the recent SEC meeting for oncology held on the 7th and 8th of February 2023, the expert panel reviewed the Phase I clinical study protocol No. ISB 2001-101 version 2.0 amendment 01 dated 07/April/2023.

After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.

Also Read:GSK gets CDSCO Panel Nod To study Anti-cancer Drug Belantamab mafodotin

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Either Pay or don’t have internship: Supreme Court on medical colleges not paying stipend to MBBS interns

While considering the plea filed by medical students flagging the issue of non-payment of stipend, the Supreme Court recently noted that even after charging crores of rupees for the MBBS course, the medical colleges are not adequately paying stipends to the MBBS interns.

The top Court bench comprising Justice Sudhanshu Dhulia and Prasanna B Varale expressed concerns at the complaints of MBBS interns in this regard. Justice Dhulia orally expressed his discontent over the stand of the medical colleges charging hefty fees on one hand and not being ready to pay stipend on the other.
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2 crore OPD tokens generated using ABHA-based scan and share service

New Delhi: The National Health Authority (NHA) yesterday achieved a significant milestone of generating over 2 Crore tokens for Out-Patient-Department (OPD) registrations through the ABHA-based Scan and Share service.

Launched under the Ayushman Bharat Digital Mission (ABDM) in October 2022, this innovative paperless service has revolutionized the patient experience, particularly benefiting vulnerable groups such as the elderly, pregnant women, and those with mobility challenges, by eliminating the need to wait in long queues for appointments.

The ABHA-based Scan and Share service enables patients to conveniently register for OPD appointments by scanning a QR code displayed at the OPD registration counter, thereby instantaneously sharing their ABHA profile for registration.

Also Read:AB PM-JAY: 30 crore Ayushman Cards issued, With 4.8 crore Uttar Pradesh tops the list

The Scan and Share service is presently operational in over 3,860 healthcare facilities across 465 districts in 33 States and Union Territories of India. On an average, one lakh patients use the scan and share service daily and save time spent in the queues.

Leading the adoption journey are Uttar Pradesh, Andhra Pradesh, Karnataka, and Jammu & Kashmir, with impressive statistics showcasing their commitment to leveraging technology for citizen welfare. 

The ABDM Public Dashboard (https://dashboard.abdm.gov.in/abdm/) provides insights into the service’s utilization, with notable usage recorded across AIIMS in Delhi, Bhopal, Raipur, and Bhubaneswar. Remarkably, sixteen hospitals from Uttar Pradesh, Andhra Pradesh, and Jammu and Kashmir feature prominently in the top-performing facilities for the overall number of OPD tokens generated using ABHA-based Scan and Share service, exemplifying their dedication to enhancing healthcare accessibility and efficiency.

Among all the OPD tokens generated using ABHA, 75% are done by first-time users, while 22% return for subsequent OPD visits after availing the token facility once, highlighting its widespread adoption and usefulness. The service usage data also gives an interesting fact that over 25% users are above the age of 45 years. This signifies that the service is simple to use and adds convenience to the routine OPD registrations.

Speaking on the importance of digital healthcare services, CEO, NHA said, “ABDM leverages digital technology to provide accessible and high-quality healthcare for all citizens of India. The Scan and Share facility is one such initiative through which ABDM promotes seamless patient registration by cutting down the waiting time significantly. It has ensured accuracy of data entry into the systems, enhancing efficiency and empowering healthcare providers with comprehensive patient information. By such innovation, we aim to create a healthcare system where every individual can instantly access their health records and take charge of their health journey.”

To drive further adoption of the Scan and Share service among hospitals and Digital Solution Companies (DSCs) providing technology to healthcare facilities, NHA offers financial incentives through the ABDM’s Digital Health Incentive Scheme (DHIS) for ‘Scan and Share’ transactions and the generation of electronic health records. More information about DHIS is accessible at https://abdm.gov.in/DHIS.

The NHA is also dedicated to leveraging technology to enhance patients’ access to healthcare services. The ‘Scan and Share’ service is now being implemented in pharmacies and plans are underway to extend it to diagnostic laboratory centres as well.

Additionally, upcoming services like ‘Scan and Send’ and ‘Scan and Pay’ will soon allow patients to conveniently scan a QR code at a facility (hospital or pharmacy) to send their health records, (including prescriptions or lab reports). Similarly, the patients will have the convenience of making payments for tests or medicines prescribed to them directly through their app, eliminating the need to wait in lines for payment at healthcare facilities.

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Doctor flags fake video claiming to treat diabetes in 48 hours

Senior diabetologist Dr. V Mohan has denounced a video circulating on social media, depicting a figure resembling him endorsing a diabetes cure within 48 hours, as “fake.” This incident highlights the alarming potential of such AI-generated clips as emerging health hazards.

Originally posted on the Facebook pages of the Indian Medical Association of Tirunelveli, the video rapidly gained traction. However, Dr. Mohan, who does not speak Hindi, immediately recognized the manipulation. In November 2023, he reported the video to Tamil Nadu police’s cyber security cell, resulting in its removal. Nevertheless, the video resurfaced.

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Psychosocial therapies could be effective treatment for non-physical symptoms of menopause

Interventions such as mindfulness and cognitive behavioral therapy (CBT), could be an effective treatment option for menopause-related mood symptoms, memory and concentration problems, finds a new study by UCL researchers.

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Concerted efforts urgently needed to meet 2030 Global Alcohol Action Plan targets

Concerted international efforts are urgently needed to meet the targets set out in the 2030 Global Alcohol Action Plan (GAAP) and avert “dire consequences” for low and middle income countries, where alcohol markets are expanding, warn health scientists in the open access journal BMJ Global Health.

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How AI could improve speed, accuracy of response to infectious disease outbreaks in hospitals and even prevent them

A new research review to be given at a pre-congress day for this year’s European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2024) will highlight the potential artificial intelligence (AI) has to improve the speed and accuracy of investigations into infectious disease outbreaks in hospitals, and potentially provide real-time information to stop or prevent them. The talk will be by Dr. Jonas Marschall, Division of Infectious Diseases, Washington University School of Medicine, St. Louis, MO, U.S.

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Sinusitis linked to 40% heightened risk of rheumatic disease

The common inflammatory condition sinusitis is linked to a 40% heightened risk of a subsequent diagnosis of rheumatic disease, particularly in the five to 10 years preceding the start of symptoms, according to research published in the open access journal RMD Open.

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Poorly controlled asthma emits same quantity of greenhouse gas as 124,000 homes each year in the UK: Study

Patients whose asthma is poorly controlled account for eight times excess greenhouse gas emissions compared with those whose condition is well controlled—equivalent to that produced by 124,000 homes each year in the U.K. This result has been published online in the journal Thorax.

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Pfizer, NIPER Ahmedabad join hands to support healthcare innovation in India

New Delhi: Pfizer has announced a collaboration with the National Institute of Pharmaceutical Education & Research (NIPER), Ahmedabad to encourage and support startups in India and help early-stage innovators advance on their journey. This collaboration will endeavour to support healthcare start-ups in turning their innovative ideas into market-ready solutions. The initiative is being supported by the Department of Pharmaceuticals and Niti Aayog and is being anchored by Social Alpha.

This partnership expands on the successful Pfizer INDovation initiative, through which 34 startups in India have already been supported through funding and incubation to bring their breakthroughs to market. Through this partnership with NIPER Ahmedabad, this initiative will follow a cohort-based approach with the aim of selecting 6 innovators pan-India, that will be incubated at NIPER Ahmedabad. Start-ups with a proof-of-concept that matches the set mandate will be selected for a one-year accelerator program. Each of these startups will receive incubation support in areas of product development, regulatory pathway, pre-clinical testing, tech transfer support through NIPER ecosystem and real-world clinical fitment check. They will also receive funding support of up to Rs. 25 lakhs each.

Together, Pfizer, NIPER Ahmedabad and Social Alpha will be looking for innovations at TRL levels 3 or higher in the areas of deep tech and artificial intelligence for predictive analysis, point-of-care testing, SaaS, informatics and wearables and track and trace solutions.

NIPER Ahmedabad is in the process of setting up a Centre of Excellence in Medical Device. This partnership will further help startups in this domain take advantage of the NIPER Ahmedabad innovation ecosystem in medical devices to advance in their journey towards commercialization.

Dr. Arunish Chawla, Secretary, Department of Pharmaceuticals said, “Encouraging indigenous innovation in healthcare is not merely a priority, but a responsibility shared by all who are a part of this ecosystem. Our support to this collaboration between Pfizer and NIPER-A highlights the potential of startups bringing innovations that can advance the delivery of healthcare in the country.”

Prof Shailendra Saraf, Director, NIPER- Ahmedabad, said, “NIPER-A has long been at the forefront of pharmaceutical research and education. We believe that innovation is vital to address today’s healthcare challenges and this collaboration can empower start-ups to drive transformative healthcare solutions. Collaboration with a leading pharmaceutical organisation like Pfizer will provide a boost for these innovative start-ups and their ideas.”

Meenakshi Nevatia, Managing Director, Pfizer Ltd., said, “Pfizer has been present in India since 1950 and today has one of the most comprehensive presences in the country through large scale manufacturing and state-of-the-art R&D operations. Through the Pfizer INDovation platform, we are proud to have given wing to startups that are addressing important unmet needs in areas of Oncology, Digital Health, Devices and Diagnostics. We sincerely thank Department of Pharmaceuticals for their support in facilitating the partnership with NIPER-Ahmedabad. We look forward to welcoming our latest cohort of startups to this program and being a part of their journey to success.”

Dr. Chintan Vaishnav, Mission Director, Atal Innovation Mission, said, “India’s healthcare ecosystem will be enriched by new digital breakthroughs brought to the market by startups driven by young innovative minds. These innovations will help facilitate broader disease awareness, quicker diagnosis, and better patient outcomes, inching us closer to our goal of a healthier India.”

Dr. Kshama Kothari, Director – Health and Wellness, Social Alpha, said, “Social Alpha believes that contextual innovations can help improve screening, diagnosis and healthcare delivery, furthering progress made towards health equity. In this edition of INDovation, we will support start-ups through the steps of product development and pre-clinical testing.”

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