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In a pioneering study conducted by Renalis University Hospitals in Cleveland, Ohio, a novel approach to treating overactive bladder (OAB) has emerged with the use of a digital conversational agent named CeCe. They found that CeCe’s role as a digital conversational agent emerged as a promising solution, effectively alleviating the severity of OAB symptoms and enhancing the overall quality of life for patients.
The study results were published in the journal UroGynecology.
Overactive bladder (OAB) syndrome stands as a persistent medical condition significantly impacting the quality of life for a considerable portion of the population. It disrupts the activities of daily living and many individuals refrain from seeking medical assistance. As conservative therapy is effective in the management of overactive bladder, researchers conducted a prospective observational trial to evaluate the efficacy of digital conversational agents for the treatment of Overactive bladder.
In this prospective observational trial, a digital conversational agent developed by Renalis University Hospitals in Cleveland, Ohio, was employed for OAB treatment. Patients accessed CeCe over 8 weeks, receiving guidance on bladder training, pelvic floor exercises, and comprehensive information on bladder health. The primary objective was to assess a reduction in the International Consultation on Incontinence—Overactive Bladder Quality-of-Life Questionnaire (ICIQ-OAB-QoL) score from week 1 to week 8. Additionally, patients completed the 36-item Short-Form Health Survey and Generalized Anxiety Disorder Questionnaire at the same intervals, along with voiding diaries at weeks 1, 4, and 8. A power analysis indicated that a total of 30 patients were necessary to demonstrate a significant difference in symptom scores post-CeCe use, with 80% power and an α error of 5%.
Findings:
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Hyderabad: Aurobindo Pharma has announced that Unit VI-B, a Formulation manufacturing facility of the Company, situated at Chitkul Village, Patancheru Mandal, Sangareddy District, Telangana, has received Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) classifying the facility as “Voluntary Action Indicated” (“VAI”).
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 inspected the facility from September 22 to September 29, 2023 and issued one observation.
Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded speciality pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 25 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA. The company’s product portfolio is spread over seven major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.
Read also: Aurobindo Pharma arm bags USFDA nod for Posaconazole Injection
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Published in the latest December issue of JAPI, the survey included 1007 health care professionals (HCPs) from across India. Based on consensus results, panelists recommended five commandments.
1. Perform a thorough clinical evaluation before prescribing PPIs (level 1)
2. Prescribe PPIs for a short-term duration (≤8 weeks). If long-term therapy is prescribed, reassess the need for continuation periodically and attempt to taper or discontinue if possible (level 2)
3. Educate patients about potential side effects associated with long-term PPI use, especially abnormal bowel habits, bloating, micronutrient deficiencies, flatulence, and abdominal pain (level 2)
4. Co-prescribe pre- and probiotics with PPIs when managing patients with Antibiotic-associated diarrhoea, and those experiencing abnormal bowel habits, bloating (level 1), micronutrient deficiencies, flatulence, and abdominal pain (level 2)
5. Consider co-prescribing pre- and probiotics for >3 months to achieve favorable outcomes and improve overall quality of life (level 1), while monitoring and assessing their effectiveness regularly.
PPI: proton-pump inhibitor
Level 1: >50% agreed; level 2: 30-50% HCPs agreed
Adapted from:
Kalra S et al. The Scope of Pre- and Probiotics as an Add-on to Proton-pump Inhibitors in Various Clinical Indications. J Assoc Physicians India 2023;https://doi.org/10.59556/ japi.71.0409
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Chandigarh: In response to receiving multiple complaints against a doctor accused of having a nexus with a local pharmaceutical company/ brand, the UT health department on Friday repatriated a medical officer at Government Multi-Specialty Hospital (GMSH), Sector 16.
The doctor serving in the Department of Orthopaedics was sent back to his home cadre in Haryana after accusations emerged that he had prescribed medicines of a pharmaceutical company/brand to patients at the hospital for commission.
A private news channel recently uncovered this incident through a sting operation conducted at the hospital, which exposed the nexus between the accused doctor and a medical representative.
It was discovered that the accused doctor had allegedly been prescribing locally produced medications in return for a commission. The evidence, captured on camera, included a medical representative’s claim that the doctor had received an advance payment of ₹50,000, HT reports.
According to a TOI news report, the UT health department investigated the allegations of the doctor to gather evidence that revealed repeated transactions of money from a person to the wife of the doctor in GMSH-16. However, an official inquiry into the matter remains pending.
Following this, an official order was released by UT health secretary Ajay Chagti which mentioned: “Dr ***, presently working as medical officer (ortho) in UT health department, on deputation basis from the state of Haryana, is hereby repatriated/relieved to his parent state with immediate effect on administrative grounds.”
“Disciplinary action will be recommended after a detailed inquiry into the matter. I have also requested SP vigilance to probe the case under the Prevention of Corruption Act,” reads the order.
Medical Dialogues team had earlier reported that the Union Government completely curtailed the visits of pharma company Medical Representatives (MRs) to Government Hospital premises. Besides this, the Government strictly stipulated that information about any new launch should be communicated via email.
This action was taken because all doctors across the country were mandated by the erstwhile Medical Council of India (now the National Medical Commission (NMC)) to prescribe generic medicines only. However, the Central Government noted that in various Central Government Hospitals/CGHS Wellness Centers/ Polyclinics there were many doctors (including Residents) who continued to prescribe branded medicines.
The Government has been working on cracking down on the unethical doctor-pharma nexus for long and had earlier suspended two central government health scheme (CGHS) doctors for allegedly prescribing certain medicines in favour of a particular pharmaceutical company.
Speaking to TOI, Chagti further said, “The health department is taking short-term measures at its level. In the medium term, it will contemplate reforms related to transparency.”
Also read- Central Govt Full Stop To Doctor-Pharma Nexus- Curtails MR Visits In Govt Hospitals
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Mumbai: Cipla (EU) Limited, UK a wholly owned subsidiary of Cipla
Limited, hereinafter referred to as Cipla has announced a
strategic collaboration with Kemwell Biopharma Private Limited (through its subsidiary
Kemwell Biopharma UK Limited) and Manipal Education & Medical Group (through its
subsidiary MNI Ventures, Mauritius) to incorporate a joint venture in the United States.
The
primary goal of this joint venture is to develop and commercialise novel Cell therapy
products for major unmet medical needs in the United States, Japan, and EU regions.
Cipla (EU) Limited will secure a 35.2% stake in the joint venture company.
“By capitalizing
on Cipla’s leadership in product development and commercialisation and aligning with
Kemwell’s expertise in biologics and Manipal’s expertise in healthcare delivery, this
strategic collaboration is aimed at expediting development, manufacturing, licensing,
import and export of cutting-edge Cell therapy products to cater to patients globally,” the release stated.
Commenting on this development, Umang Vohra, Managing Director & Global Chief
Executive Officer, Cipla, said, “This joint venture reinforces our concerted efforts to move
up the innovation curve and pioneer transformative treatments in the areas of stem cell
and CAR T-cell therapies, enabled by advances in biotech, mRNA and cell-engineering
research, that can make a difference to patient lives globally. As we steer Cipla into the
future and lead with purpose, our partnership with Kemwell and Manipal Group will be
integral in realising these advancements.”
Commenting on the tie up, Dr Ranjan Pai, Chairman, Manipal Education & Medical
Group, said, “We are very happy to partner with Cipla and Kemwell in bringing the next
generation of biological therapies to address unmet medical needs globally. Physicians
will have accessible, safe, and clinically effective Cell therapies in their hand to fight
against many serious indications. We believe that Cell therapy products will be a gamechanger in offering an advanced therapeutic treatment for millions of patients suffering
with painful diseases.”
Anurag Bagaria, Chairman and CEO, Kemwell added “We believe that Cell therapies will
become a major branch of medical treatment and will become a standard of care for
challenging diseases. Kemwell has built a world-class cGMP facility in Bangalore and
made India an emerging hub for cell therapy development and manufacturing. The
synergistic combinations of Cipla, Manipal and Kemwell will accelerate the
development of novel cell-based products for patients and transform the new JV into a
global player in cell therapeutics.”
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