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Showing posts from October, 2024

Study highlights Dental Safety Concerns: Anaphylaxis Linked to PEG-Infused Endodontic Materials in dental Patients

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Norway: Recent case reports in the Journal of Endodontics have highlighted the rare but serious risk of anaphylaxis following treatment with endodontic materials containing polyethylene glycol (PEG). Two patients experienced severe allergic reactions after dental procedures involving these materials, raising important concerns within the dental community. "While rare, clinicians should be aware that PEG in endodontic filling materials can trigger anaphylaxis. It is important to conduct a PEG allergy assessment when anaphylaxis is suspected," the researchers wrote. Anaphylaxis is a life-threatening allergic reaction that can occur rapidly, making early recognition and treatment critical. While anaphylactic reactions to PEG are uncommon, they are likely underreported and can lead to severe consequences for patients, especially those who remain undiagnosed. These cases emphasize the need for heightened awareness among dental professionals regarding the potential for PEG to ...

Droxidopa Effective as Adjunct Therapy for Vasopressor Weaning in ICU Patients, finds study

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USA: A recent multicenter, retrospective, single-arm observational study has unveiled promising results for the use of droxidopa in critically ill patients experiencing persistent hypotension. The study, published in the Journal of Intensive Care Medicine, suggested that droxidopa may be a valuable adjunct therapy for facilitating vasopressor weaning, with comparable effects observed in patients receiving the medication through feeding tubes. Persistent hypotension is a significant challenge in the management of critically ill patients, often leading to prolonged reliance on vasopressor agents. These medications can have adverse effects and complications, underscoring the need for alternative strategies to facilitate safe withdrawal. According to the study authors, persistent reliance on vasopressors is a frequent factor contributing to delays in patient discharge from the intensive care unit (ICU). They note that adjunct oral agents can accelerate the timeline for discontinuing ...

Study Links Hormone Dosage in Intrauterine Systems to Increased Depression Risk in First-Time Users

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Denmark: A recent study has highlighted a concerning association between the dosage of hormones in levonorgestrel-releasing intrauterine systems (LNG-IUS) and the risk of developing depression among first-time users. The research, published in the American Journal of Psychiatry, reveals that the likelihood of experiencing depression increases with higher dosages of the hormone, suggesting a dose-dependent relationship. The findings revealed that the first-time use of an LNG-IUS was associated with an increased risk of developing depression in a dose-dependent manner across low, medium, and high-dose options.  "While the observational nature of the study does not allow for causal conclusions, the identified dose-response relationship adds to the growing body of evidence indicating a link between levonorgestrel exposure and depression risk," the researchers wrote. Levonorgestrel, a synthetic progestin commonly used in various contraceptive methods, has been the subject of...

Shilpa Pharma Lifesciences receives CEP from EDQM for API, Desmopressin

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Karnataka: Shilpa Medicare Limited's 100% subsidiary, Shilpa Pharma Lifesciences Limited has received certificate of suitability (CEP) from EDQM (European Directorate for the Quality of Medicines & Healthcare) for API, Desmopressin. Desmopressin is synthetic peptide manufactured by Shilpa Pharma Lifesciences through solid phase synthesis. Desmopressin helps to reduce frequent urination and excessive thirst. This is used to treat central diabetes insipidus and bedwetting. “We at Shilpa have always been investing in challenging chemical synthesis. With unwavering commitment and belief in our technical capabilities, we have invested in developing a versatile peptide portfolio over past few years and Desmopressin is the first peptide molecule to receive CEP from the European Regulators. This CEP showcases our proficiency in quality-oriented development as well as commercial manufacturing capabilities that meet the expectations of global quality standards paving way for more suc...

CENTAC Releases BSMS, BHMS, BUMS Seat Matrix, Draft Merit List, Counselling on October 8

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Puducherry- The Centralised Admission Committee (CENTAC) has recently published the schedule and Draft Merit list for BSMS, BHMS and BUMS courses on its official website. The draft Merit list is prepared based on the National Eligibility and Entrance Test-Undergraduate (NEET UG) 2024 score. In this regard, CENTAC has published a notice informing that the objections if any, may be submitted through Grievances in the login dashboard or email on or before 07 October 2024, 11.00 am. No, objections will be allowed after the last date. After disposing of the objections, if any, the Final Merit List will be published on 07 October 2024. Meanwhile, physical Counselling for BSMS, BHMS and BUMS courses is scheduled on Tuesday, 08 October 2024 at 11.00 a.m. at CENTAC Office, Puducherry. Along with this, CENTAC has also released the seats available for the BSMS, BHMS and BUMS courses. As per the seats matrix, a total of 5 seats are available in the said courses for the academic year 2024. Of...

Drug Safety Alert: Indian Pharmacopoeia Commission Flags ADR Linked To Tetracycline

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New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of September, has revealed that the popular antibiotic Tetracycline is linked with adverse drug reactions (ADRs) named Fixed Drug Eruption (FDE). In connection with the above, the Indian Pharmacopoeia Commission (IPC) has cautioned healthcare professionals to diligently monitor the potential occurrence of adverse drug reactions (ADRs) when administering tetracycline. This came after a preliminary analysis of adverse drug reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database. Tetracycline is an antibiotic used to treat a wide variety of susceptible infections. Tetracycline is a broad spectrum polyketide antibiotic produced by the Streptomyces genus of Actinobacteria. It exerts a bacteriostatic effect on bacteria by binding reversibly to the bacterial 30S ribosomal subunit and blocking incoming aminoacyl tRNA from binding to the ribosome accept...

Study Highlights Role of Surgical Factors in Post-Laryngectomy Hypocalcemia Management

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Iran: A recent spanning eight years has shed light on the key factors contributing to post-surgical hypocalcemia (< 8.5 mg/dl) in laryngectomy patients. "Although average calcium levels showed no significant change, adjusting for albumin levels revealed a decrease in postoperative calcium. Total thyroidectomy, neck dissection, pre-operative hypocalcemia, and prior radiotherapy emerged as robust predictors of post-laryngectomy hypocalcemia," the researchers reported in the Indian Journal of Otolaryngology and Head & Neck Surgery. Laryngeal cancer represents a prevalent form of advanced head and neck malignancy. Treatment typically involves surgery, radiation therapy, chemotherapy, or a combination thereof, for managing locally advanced cases. Despite its invasive nature, total laryngectomy is commonly recommended for T3-4 laryngeal cancers. Following neck compartment surgeries like laryngectomy, patients are susceptible to post-surgical hypocalcemia due to the poten...

MBBS dropout posing as RMO arrested after Patient's Death at Kerala Hospital

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Kozhikode: In a disturbing case of alleged medical negligence reported in the city, a 60-year-old heart patient lost his life at the hands of an unqualified medical practitioner, who had only completed the 12th grade and had been struggling to pass the second year of his MBBS course since 2011. Despite this, he worked as a Resident Medical Officer (RMO) at TMH Hospital in Kottakadavu, Kozhikode. After gathering evidence that the medical practitioner was a quack who enrolled in a hospital but still failed to complete his medical degree, the Kerala police arrested him under relevant sections of BNS and TMH Hospital dismissed him after acknowledging a lapse in verifying his qualifications. It was found that the fake doctor was working illegally as an RMO in EDs of various hospitals for years even though he was enrolled in KMCT Hospital to complete his medical studies.  Also read- Rajasthan Administrative officer dies after botched hysterectomy at Jodhpur Hospital, family alleges ...

Serum Institute of India gets CDSCO Panel nod to study Dengue Monoclonal Antibody

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New Delhi:  Serum Institute of India has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of dengue monoclonal antibody in children ≥ 5 years and adults with dengue. This came after Serum Institute of India presented the proposal to conduct a Phase III clinical trial titled “A Phase III, double-blind, randomized, placebo-controlled, multicentric study of dengue monoclonal antibody in children ≥ 5 years and adults with dengue” via protocol number: Dengue-mAb-03version 1.0, dated 04 Jul 2024 along with the results of the Phase II study. The Serum Institute of India (SII) is developing a dengue monoclonal antibody drug called Dengushield, which is an antiviral and orphan drug. Dengue monoclonal antibody is an engineered humanised monoclonal antibody that binds to a non-immunodominant epitope on domain III of the envelope protein (EDIII) and has shown potent, speci...

New wearable laser device may monitor brain blood flow to gauge stroke risk, reports research

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Researchers have developed a laser-based device that can be placed on the head to non-invasively monitor changes in brain blood flow and volume. The new device could one day help save lives by offering a direct and simple way to assess stroke risk based on physiological markers rather than indirect markers like lifestyle factors. Strokes occur when blood flow to the brain is blocked or reduced, causing debilitating brain cell damage. With about 15 million people worldwide affected by strokes each year, it is the second leading cause of death and a leading cause of long-term disability. “The lack of a cost-effective and scalable stroke risk assessment system complicates long-term stroke prevention because a physician can’t tell whether a patient’s risk is stable or worsening,” said research team member Simon Mahler, a postdoctoral scholar in Changhuei Yang’s laboratory at the California Institute of Technology. “This new method could help catch early signs of increased stroke risk, w...

Intas Pharmaceuticals Gets CDSCO Panel Nod to Study Recombinant Human Follicle Stimulating Hormone

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New Delhi: Intas Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I clinical trial of the Recombinant Human Follicle Stimulating Hormone 300 IU Solution for Injection. However, this approval is subject to the condition that the firm should have tied up with an IVF center in case of an emergency. This came after the firm presented the protocol to conduct a Phase I clinical study of Recombinant Human Follicle Stimulating Hormone 300 IU Solution for Injection titled " An open label, Phase-I, balanced, randomized, two-treatment, two-period, two-sequence, single subcutaneous dose administration, crossover, bioequivalence study of r-h-FSH (recombinant human follicle stimulating hormone injection), solution for injection of Intas Pharmaceuticals Limited, India with Gonal-f, recombinant human follicle stimulating hormone (r-hFSH) follitropin alfa, solution for injection ...

ICMR invites proposals for Centre for Advanced Research under Extramural Research Program, Details

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New Delhi- Through a notice, the Indian Council of Medical Research (ICMR) has called for concept proposals for the Centre for Advanced Research (CAR), under the Extramural Research Program. The Last Date for concept proposal is November 21, 2024. Under its Extramural Research Programme, the Indian Council of Medical Research (ICMR) funds the Centre for Advanced Research (CAR) to promote advanced research by experienced research teams.   What the CAR is expected to do: Conducting decisive research that helps in solving an important healthcare problem by a research team. It can have single or multiple linked research projects with clear deliverables. It encourages in-depth research, to generate new knowledge and solutions for health problems in multiple aspects of causation, progression, management and prevention. Priority diseases or conditions: Research teams planning to undertake studies in finding solutions for prevention, screening, diagnosis, treatment or rehabilita...

CDSCO Panel grants GSK's Protocol Amendment Proposal To Study Belantamab mafodotin

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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major GlaxoSmithKline's protocol amendment proposal for the clinical trial titled "A Phase 2, Randomized, Parallel, Open-Label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-Agent Belantamab Mafodotin (GSK2857916) in Participants with Relapsed or Refractory Multiple Myeloma (DREAMM-14)." This came after GlaxoSmithKline Pharmaceuticals presented protocol amendment 03 dated 25 June 2024 protocol no. 209628. Belantamab mafodotin is a monoclonal antibody conjugated with a cytotoxic agent for the treatment of relapsed and refractory multiple myeloma. Belantamab mafodotin is a humanized IgG1κ monoclonal antibody against the B-cell maturation antigen (BCMA) conjugated with a cytotoxic agent, maleimidocaproyl monomethyl auristatin F (mcMMAF). The antibody-drug conjugate binds to ...

IRGMA Welcomes CDSCO's New Guidelines, Urges to stop import of substandard gloves

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New Delhi:  Welcoming the updated guidelines detailing the functions and responsibilities of the zonal, sub-zonal, and port offices issued by the Central Drugs Standard Control Organization (CDSCO), the Indian Rubber Gloves Manufacturers Association (IRGMA) has urged the government to take stringent measures to implement the order effectively to stop the import of substandard gloves in the country. The CDSCO issued the new Guidance Document for Functions and Responsibilities of Zonal, Sub-zonal, and Port offices on September 12. The guidelines were last released in 2011, and the recent changes include the introduction of new rules and regulations and the online system through the SUGAM portal, which necessitated the revised order in line with the procedures followed in CDSCO offices. Guidance documents for Zonal, Sub zonal and Port offices were prepared in 2011 and implemented since then. It sets out the nature of work that Zonal, sub-zoneal, and port offices generally carry ...