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Medical Voice 2nd January 2020

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Dr KK Aggarwal    02 January 2020

Ocean climate patterns linked to diarrhea epidemic outbreaks: Study

The study, published in the journal Nature Communications, noted that diarrhea is the second leading cause of death in children younger than five years of age in low- and middle-income countries, with 72 percent of the deaths occurring in the first two years of life.

NEW YORK: Spikes in cases of life-threatening diarrhea in young children across the world may be associated with climate conditions linked to the oceans, according to a study which may lead to new early-warning systems to prepare for diarrhea epidemics.

The study, published in the journal Nature Communications, noted that diarrhea is the second leading cause of death in children younger than five years of age in low- and middle-income countries, with 72 percent of the deaths occurring in the first two years of life....read more

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USFDA slaps 19 warning letters to Indian pharma firms in 2019; highest in 4 years

India Today- PB Jayakumar

The Indian pharmaceutical companies have received 19 warning letters, out of the 41 (46 per cent) issued by the Office of Manufacturing Quality of the US Food and Drug Administration (USFDA) in 2019, the most in four years. This reversed the recent trend wherein Indian companies had been increasingly complying with the standards and resolving their manufacturing quality issues quickly that had cropped up over the last four-five years. If the Indian drug manufacturers accounted for nearly 50 per cent of the current good manufacturing practices (cGMP)-related warning letters in 2015, it reduced to less than 30 per cent in 2016. This number further reduced to 24 per cent in 2017. In 2018, none of the top ten domestic firms were in the cGMP warning letter list, though many firms were struggling to get out of the trouble. Out of 68 warning letters issued by the USFDA in 2018, 10 were related to India. In 2017, Indias share of warning letters was 17 out of 79. According to a study by the Indian Pharmaceutical Alliance (IPA) and consultancy firm McKinsey, a couple of years ago, the number of FDA inspections in India declined from 272 in 2017 to 192 in 2015, but the share of plants receiving a clearance without adverse observations increased from 32 per cent to 51 per cent.

FDA grants ODD to pancreatic cancer drug candidate by OBI Pharma

BioSpectrum

OBI Pharma, Inc., a Taiwan biopharma company has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for OBI-999 for the treatment of Pancreatic Cancer. OBI-999 is a first-in-class antibody drug conjugate targeting Globo H, a glycolipid antigen. A Phase 1/2 clinical trial of OBI-999 has commenced enrollment at the University of Texas M.D. Anderson Cancer Center, with Dr. Apostolia M. Tsimberidou as the Principal Investigator, in patients with locally advanced or metastatic solid tumors, including Pancreatic, Gastric, Colorectal and Esophageal Cancers (ClinicalTrials.gov Identifier: NCT04084366). The objective of the trial is to verify the safety and preliminary efficacy profile of OBI-999 in these patient populations. Tillman Pearce, MD, CMO, OBI Pharma noted, "We are very excited about the potential value that OBI-999 may provide to patients with pancreatic cancer given both the high potency we have observed using OBI-999 in pancreatic cancer xenograft models and because many pancreas cancers highly overexpress Globo H, the glycolipid target of OBI-999, using the validated IHC assay that will be available for selecting patients for the Phase 2 portion of this first-in-human clinical trial."

Increase in patients at Delhi hospitals due to extreme cold weather

The Times of India- PTI

Hospitals across Delhi reported a surge in the number of patients suffering from respiratory complications and other ailments with the national capital experiencing an intense spell of cold wave over the past one week and the pollution touching "severe" levels. Delhi recorded its coldest day ever in the month of December on Monday, with the maximum temperature being at just 9.4 degrees Celsius. According to AIIMS director Randeep Guleria, there has been a rise of 15-20 per cent in the number of patients visiting out-patient departments (OPDs) or emergencies with respiratory and cardiac ailments. "The cold in Delhi at present is more severe than the hilly regions and with the mercury dipping, there is an increase of almost 15-20 per cent in the number of patients in OPD," Guleria said. He said people should take precautions as in such extreme weathers one may develop bronchitis and young children and older people may also get pneumonia. Patients suffering from heart problems also are at risk. Some may even face hypothermia, a medical emergency when the body loses heat faster than it can produce heat, causing a dangerously low body temperature. Guleria said extreme cold also leads to increased cases of influenza, viral infections among others and advised people to keep themselves properly covered while going out and go for morning walks when the temperatures go higher. The Centre-run RML and Safdarjung hospitals also saw around 20 per cent increase in the number of patients in OPDs. "Patients are coming with complaints of influenza, hypertension, cardio-vascular diseases, exacerbation of asthma, bronchitis and other respiratory ailments," said Minakshi Bharadwaj, medical superintendent of RML hospital, adding children and those above the age of 60 are the worst affected.

Kota infant deaths: Broken windows, shortage of staff, pigs inside hospital campus, says NCPCR report

India Today- PTI

Broken windows and gates, pigs roaming inside hospital campus and acute shortage of staff were among the findings of the apex child rights body NCPCR during inspection of J K Lon Hospital in Kota where 940 children died this year. A team from the National Commission for Protection of Child Rights team visited the hospital after which its chairperson Priyank Kanoongo issued a show cause notice to Vaibhav Galtiya, Secretary of Medical Education Department in Rajasthan government, and sought an action taken report from him on its findings. "It is evident that there was no glass in windows panes, gates were broken and as a result the admitted children were suffering with extreme weather condition," Kanoongo said. He also said that the general upkeep and maintenance of the hospital is in the "worst condition". "Pigs were found roaming inside the campus of the hospital," he said in the notice. Kanoongo also said that there was acute shortage of staff. He has sought the action taken report within three working days.

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