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Alembic Pharmaceuticals Ltd on Thursday said it has received final approval from the US health regulator for its generic version of Loteprednol Etabonate and Tobramycin ophthalmic suspension used for treatment of eye infection. The approval granted by the US Food & Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) Loteprednol Etabonate and Tobramycin Ophthalmic Suspension of strength 0.5 per cent/0.3 per cent (5 mL and 10 mL), Alembic Pharmaceuticals Ltd said in a regulatory filing. Alembic was granted a Competitive Generic Therapy (CGT) designation for this application. With this approval, Alembic is eligible for 180 days of CGT exclusivity upon commercialisation, it added. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5 per cent/0.3 per cent, of Bausch & Lomb Incorporated, the company said. Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5 per cent/0.3 per cent, is ...
A team at the Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, has reported a significant rise in infections caused by a lesser-known bacterium that mimics whooping cough in north India, officials said on Thursday. Pertussis, commonly known as whooping cough, is a highly contagious respiratory illness that has historically been a major cause of childhood mortality, with fatality rates reaching 10 per cent in the early 20th century, a PGIMER statement noted. The study, titled 'Emergence of Bordetella holmesiiAssociated Pertussis-Like Illness, Northern India, 20192023', was published in the Emerging Infectious Diseases journal (of the Centers for Disease Control and Prevention, USA) and analysed 935 suspected pertussis cases. Researchers discovered that nearly 37 per cent of infections were caused by Bordetella holmesii (bacterium), surpassing the number of infections from Bordetella pertussis, which used to be relatively more common. The most significan
Only about eight per cent of bacterial infections detected in 2019 in India were treated appropriately, according to an analysis of low- and middle-income countries. Findings published in The Lancet Infectious Diseases journal show that in 2019, there were nearly 15 lakh bacterial infections resistant to carbapenems -- a common antibiotic -- across eight countries that were under study. Carbapenems are used for treating severe infections -- such as those acquired from being inside a hospital, where bacteria resistant to antibiotics are abundant. Of the 15 lakh bacterial infections, only over a lakh treatment courses were procured -- the resulting treatment gap meant that only 6.9 per cent of the patients were treated appropriately, researchers, including those from the Global Antibiotic Research and Development Partnership (GARDP), Switzerland, found. "India procured most of the treatment courses (80.5 per cent; 83,468 courses), with 7.8 per cent of infections treated appropriately
Affecting around a tenth of rural populations in India every year, 'scrub typhus' infection, spread by the bite of an infected larval mite (chigger), could be an "under-recognised" leading cause of hospitalisations for fever, a study has suggested. The study, conducted by the Christian Medical College, Vellore, and London School of Hygiene and Tropical Medicine (LSHTM), looked at over 32,000 people from across 37 rural villages in Tamil Nadu, with its results published in the New England Journal of Medicine. Chiggers are found on grass, plant litter and bare soil across rural areas of Asia, and usually feed on small mammals such as rats and shrews. Scrub typhus is caused by the bacterium 'Orientia tsutsugamushi', which belongs to the rickettsia family. Severe illness due to the infection can lead to Acute Respiratory Distress Syndrome (ARDS), shock, meningitis and kidney failure. Rural areas in India are among the most affected by the potentially life-threatening infection, along w
Bharat Biotech on Wednesday announced a collaboration with Alopexx Inc for development and commercialisation of the latter's broad-spectrum anti-microbial vaccine in India and other low income countries. As part of the collaboration, the companies will co-develop and commercialise the vaccine -- AV0328, in India and other licensed territories, Bharat Biotech said in a statement. Alopexx would be entitled to a one-time upfront payment and milestone payments, as well as royalties on future sales of AV0328 in the licensed territories, it added. "Our goal is to develop solutions to reduce anti-microbial resistance through vaccination. This collaboration aligns with our mission to provide safe, affordable, and high-quality vaccines to combat infectious diseases globally," Bharat Biotech Executive Chairman Krishna Ella said. Alopexx CEO Daniel Vlock said, this collaboration brings the company one step closer to addressing the critical need for affordable, broad-spectrum antimicrobial ..