Significant proportion of cancer drugs lack proof of added benefit, finds study
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Mumbai: Alkem Labs has announced that US Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (EIR) for the Company’s API manufacturing facility located at Mandva.
The Inspection has been classified as Voluntary Action Indicated (VAI) and was closed accordingly.
Medical Dialogues team had earlier reported that Alkem Labs had received Form 483 with three observations from the USFDA at the end of the inspection conducted at the Company’s API manufacturing facility located at Mandva.
Read also: USFDA Issues 3 Observations For Alkem Labs Mandva Facility
Alkem Laboratories Ltd is an Indian pharmaceutical company engaged in the development, manufacture, and sale of pharmaceutical and nutraceutical products. The company produces branded generics, generic drugs, active pharmaceutical ingredients (APIs) and nutraceuticals in acute and chronic therapeutic areas, such as anti-infective, pain and analgesics, vitamins/minerals/nutrients, cardiac and Diabetology, Gynecology, Ophthalmology, neuro/central nervous system, dermatology, anti-diabetes, anti-osteoporosis, cardiovascular, and muscle relaxants, which are marketed in Indian and International markets. It operates through the pharmaceutical business segment.
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Researchers at Indian Institute of Technology Madras(IIT Madras) and Translational Health Science and Technology Institute (THSTI), Faridabad, as part of ‘Interdisciplinary Group for Advanced Research on Birth Outcomes – DBT India Initiative’ (GARBH-Ini) program, have developed the first India-specific Artificial Intelligence (AI) model to determine the age of a foetus in a pregnant woman in the second and third trimesters precisely.
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Pune: In a remarkable medical achievement, MomStory by Sahyadri Hospitals, led by the expert team of doctors, including Dr Mini Salunkhe, Director & Head of Dept – Obstetrics, Dr Gauri Jagdale, Gynaecologist and Obstetrician and Dr Sunil have successfully treated a 13-year-old schoolgirl, Priya (Name changed), for a rare ovarian condition.
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Kota: The family of a 50-year-old man, who was declared brain dead during a treatment, donated his organs, giving a new lease of life to three patients in Jaipur and Jodhpur.
With this, Jhalawar Government Hospital and Medical College has become the state’s first “non-transplant organ retrieval centre”, its principal Dr Shiv Bhagwan Sharma told PTI on Monday.
On February 18, Bhuria was brought to the hospital with injuries he sustained after falling from the rooftop of his house. He was declared brain dead during the treatment on February 24, following which Jhalawar Chief Medical and Health Officer (CMHO) Dr Sajid Khan and the medical college administration informed the matter to the state government.
Also Read:53-year-old brain-dead woman gifts new life to many through organ donation at AIIMS Delhi
Rajasthan Health Minister Gagendra Singh and Additional Chief Secretary (Health), Shubhra Singh directed the hospital administration to counsel the family to consent for organ donation.
Upon consent of Bhuria’s wife for donation of her husband’s liver and kidneys, a certificate for organ retrieval was issued to the medical college on Saturday and kidneys, liver and cornea were harvested from the brain-dead man on Sunday, Dr Sharma told PTI.
One kidney and liver were allotted to Sawai Man Singh Hospital, Jaipur and other kidney to AIIMS, Jodhpur, he added.
For immediate transportation of these organs to needy patients, a green corridor was created in coordination with traffic police and the organs were on Sunday sent to Jaipur and Jodhpur by four ambulances, Jhalawar CMHO Dr Khan said.
The organs were transplanted to three patients in the two hospitals on Sunday night, giving a new lease of life to them, the CMHO said.
Medical Dialogues team had earlier reported that in a deeply touching display of humanity’s kindness and generosity marked a profoundly moving chapter. A 43-year-old woman has generously donated the chance of life through organ donation.
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The proximal humerus is a common site for both primary and metastatic bone tumors. Although various methods have been developed for reconstruction following resection of the proximal humerus, a consensus on which technique is best has not been established.
Ryuto Tsuchiya et al focused on the sling procedure using a free vascularized fibular graft (FVFG). The study was conducted at National Cancer Center Hospital, Tokyo, Japan.
The authors retrospectively reviewed the data of 19 patients who underwent the sling procedure with use of an FVFG. The median age was 20 years, and the median follow-up duration was 63.1 months. Surgical data, oncological outcomes, the postoperative course, complications, and functional outcomes as measured with use of the Musculoskeletal Tumor Society (MSTS) score were thoroughly reviewed.
Key findings of the study were:
• The median operative duration was 555 minutes, and the median blood loss was 374 mL.
• The median length of the bone defect was 17.0 cm, and the median length of the graft was 20.0 cm.
• With respect to oncological outcomes, 9 patients were continuously disease-free, 9 patients had no evidence of disease, and 1 patient was alive with disease.
• Bone union was present in 13 of the 17 patients for whom it was evaluable.
• The median time to bone union was 4 months.
• Graft growth was observed in 2 pediatric patients.
• Postoperative fracture was a major complication at the recipient site.
• The incidence of pseudarthrosis significantly increased when the FVFG could not be inserted into the remaining humeral bone or was split in half (p = 0.002).
• Although a few patients demonstrated peroneal nerve palsy at the donor site, the symptom was temporary.
• The overall functional outcome was favorable, with an average MSTS score of 66.9%.
“In conclusion, we retrospectively reviewed the largest number of patients to date to undergo the sling procedure using an FVFG. This reconstruction method demonstrated a low complication rate and a favourable functional outcome overall. We therefore conclude that the sling procedure is beneficial for patients in a broad age range who have a wide defect of the proximal humerus” the authors commented.
Level of Evidence: Therapeutic Level IV.
Further reading:
Outcomes of Sling Procedure Using a Free Vascularized Fibular Graft After Resection of the Proximal Humerus
Ryuto Tsuchiya et al
JBJS Open Access 2023:e23.00044.
http://dx.doi.org/10.2106/JBJS.OA.23.00044
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