Page 34 - Health Medical Pharma
FDA issues form 483 with 9 observations to Natco's Kothur unit
: Natco Pharma Limited Thursday said the US Food and Drug Administration has issued nine observations under Form 483 for its formulation facility in Kothur Village, near here. According to a press release from the city-based drug-maker, the inspection was conducted between May 30 and June 5 and the company would provide due justifications and corrective actionplan within the next 15 working days to address the USFDA observations. At the end of the inspection, the facility received nine observations, with no repeat observations and mostly procedural in nature. The company believes that none of the observations were related to data integrity and that all of the observations can be addressed within a short period of time, the release said. Visual inspection of products carried out as part of investigation was not properly documented, the FDA said in one of the observations. As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection ...
USFDA completes inspection of Natco's formulations facility in Kothur
At the end of the inspection, the facility received nine observations, with no repeat observations and mostly procedural in nature. The company believes that none of observations are related to data integrity and that all of the observations can be addressed within a short period of time.
Alembic Pharmaceuticals receives USFDA approval for Carbidopa and Levodopa Extended-Release Tablets
Carbidopa and Levodopa Extended-Release Tablets USP, 25 mg/100 mg and 50 mg/200 mg have an estimated market size of US$ 24 million for twelve months ending December 2018 according to IQVIA.
Alembic Pharma gets USFDA nod for Parkinson's disease treatment drug
Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator for Carbidopa and Levodopa extended-release tablets, used for treatment of Parkinson's disease. The approved product is therapeutically equivalent to the reference listed drug Sinemet CR tablets of Merck Sharp & Dohme Corp. The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application Carbidopa and Levodopa extended-release tablets in the strengths of 25 mg/100 mg and 50mg/200 mg, Alembic said in a BSE filing. Quoting IQVIA sales data, the company said the Carbidopa and Levodopa extended-release tablets had an estimated market size of USD 24 million for 12 months ended December 2018. The company said it now has a total of 94 abbreviated new drug application (ANDA) approvals from the USFDA. Shares of Alembic Pharmaceuticals were trading at Rs 511.05 apiece, down 0.08 per cent, on the BSE.
New AI tool can tell babies' cries apart
Scientists have developed a new artificial intelligence (AI) based tool that can identify and distinguish between normal cry signals of babies and abnormal ones, such as those resulting from an underlying illness. The method, described in the IEEE/CAA Journal of Automatica Sinica (JAS), promises to be useful to parents at home as well as in healthcare settings, as doctors may use it to discern cries among sick children. Experienced health care workers and seasoned parents are able to pretty accurately distinguish among a baby's many needs based on the crying sounds it makes. While each baby's cry is unique, they share some common features when they result from the same reasons, said researchers from Northern Illinois University in the US. Identifying the hidden patterns in the cry signal has been a major challenge, and AI applications have now been shown to be an appropriate solution within this context. The new research uses a specific algorithm based on automatic speech recognition .
1 patient tests positive, 6 negative for Nipah Virus: Kerala Health Minister
Out of the seven patients who were admitted to the hospital suspecting Nipah virus infection, one has been tested positive while the other six have been tested negative.Kerala Health Minister KK Shailaja said at a press briefing here on Thursday, "7 patients are admitted to hospital, one patient's result is positive for Nipah virus. 6 patients' results are negative. No one has been discharged from the isolation ward. Source of the virus is not confirmed yet."On the other hand, two persons suffering from high fever were put under observation at Trivandrum Medical College on Thursday. Their samples have been sent for examination.On June 4, a 23-old-man had tested positive for Nipah virus infection, which killed 17 people in Kerala last year.As of now, a total of 15 people are under observation in the state.Union Minister for Health and Family Welfare Dr Harsh Vardhan had on June 4 said that the Centre had rushed a team of doctors to Kerala for investigation in the wake of the scare of ..
Home-based weight management benefits kids, parents
Researchers have found that home-based weight management programmes may be beneficial for both kids as well as parents.
How Nipah infection is different from swine flu, bird flu
With the return of the Nipah infection in Kerala, the need for awareness about zoonotic diseases has increased, especially in view of the spread of misinformation about these diseases.
TN to screen Nipah patients on Kerala borders
The Tamil Nadu government has set up medical teams at the checkposts in the seven districts bordering Kerala to screen for Nipah virus infected persons, said a senior official of the Public Health Department.
Nipah: K'taka sounds alert after man infected with virus in Kerala
Days after a 23-year-old student was diagnosed with the potentially deadly Nipah virus in Kerala, the Karnataka government has sounded alert in eight districts, including those on the borders of the neighbouring state. The condition of the college student, diagnosed with Nipah infection, is stable, hospital authorities said. A total of 314 persons who were in touch with the infected person have been kept under observation, officials said. Following the Nipah outbreak report, the Health Department in Karnataka issued a circular asking administration in Chamarajanagar, Mysuru, Kodagu, Dakshina Kannada, Uttara Kannada, Udupi, Shivamogga and Chikkamagaluru districts to immediately convene inter-departmental coordination committee meetings, including veterinary department, Indian Medical Association and Indian Academy of Pediatrics. Authorities in these eight districts have been directed to identify two isolation beds to quarantine suspected human cases. They have been asked to keep all ...
Nipah: Samples of 6 test negative; Ker Health Min says big relief for us
Samples of six people, including three nurses and a nursing assistant, who had attended on a college student infected with Nipah virus have tested negative and indicate the virus has not spread, Kerala Health Minister K K Shailaja said Thursday. The results of the blood tests of the six have come as a huge relief for Kerala authorities trying to stop the spread of the highly infectious virus that had left 17 people dead in the state last year. The condition of the college student, diagnosed with Nipah infection, is stable and a total of 314 persons who were in touch with the infected person have been kept under observation, a Union Health Ministry official said in New Delhi. Shailaja said the six of them, who tested negative, had direct contact with the Nipah-infected patient. "They have tested negative for Nipah. This indicates that the virus has not spread. It is a matter of big relief for us," the minister told reporters here. Result of the sample of the seventh person is awaited,
Mystery of deep-sea dragonfish's see-through teeth solved
Scientists have found what makes the teeth of deep-sea dragonfish transparent, a unique adaptation which helps camouflage the predatory creatures from their prey. According to the study published in the journal Matter, the adaptation results from their teeth having an unusually crystalline nanostructure mixed with amorphous regions. The findings could provide "bioinspiration" for researchers looking to develop transparent ceramics. Deep-sea creatures have evolved some fascinating adaptations such as bioluminescence, eyes that can see in low light, and mouths that can engulf much larger prey. Some species, such as the deep-sea dragonfish (Aristostomias scintillans), have transparent teeth. "It's an adaptation that, to our knowledge, has not yet been explored in detail," said Audrey Velasco-Hogan, a PhD student at the University of California San Diego in the US. "By studying why these teeth are transparent, we can better understand deep-sea organisms like the dragonfish and the ...
USFDA issues 9 observations to Natco Pharma's Kothur facility
Natco Pharma Thursday said the US health regulator has made nine observations after the completion of inspection of its Kothur formulation facility in Telangana. The United States Food and Drug Administration (USFDA) conducted inspection at Kothur facility between May 30-June 5, 2019. "At the end of the inspection, the facility received 9 observations, with no repeat observations and mostly procedural in nature," Natco Pharma said in a BSE filing. The company believes that none of the observations are related to data integrity and that they can be addressed within a short period of time, it added. Natco Pharma said it will provide due justifications and corrective action plan within next 15 working days to address the USFDA observations. Shares of Natco Pharma were trading 0.67 per cent lower at Rs 543.30 apiece on BSE.
Six test negative for Nipah in Kerala
Samples of six patients suffering from fever were tested negative for Nipah virus, Kerala Health Minister K.K. Shailaja announced on Thursday. She said there was no need to panic as the situation was under control.
Nipah virus: Six suspected patients test negative
Six persons admitted to a quarantine facility at the Government Medical College in Kerala's Ernakulam have tested negative for the potentially deadly Nipah virus, a senior Health Ministry official said Thursday. The condition of thecollege student, diagnosed with Nipah infection, is stable and a total of 314 persons who were in touch with the infected person have been kept under observation, the official said. "The bloodand serum samples of all six suspected patients have tested negative for Nipah virus infection," the official said. The Union Health Ministry has deployed a six-member team comprising an epidemiologistto conduct contact tracing for early detection of suspects and review of isolation facilities. Union Health Minister Harsh Vardhan, who reviewed the public health measures put in place in Kerala on Wednesday, said the situation is under control and people need not panic. During the review meeting, the Centre also discussed SOPs for quarantine of symptomatic contacts, ...
Natco Pharma rises after filing ANDA for Bosentan tablets
Natco Pharma rose 0.88% to 551.75 at 9:25 IST on the BSE after the company announced filing of ANDA with the US drug regulator for generic version of Bosentan tablets.
DHFL in focus after credit ratings downgrade
Dewan Housing Finance Corporation (DHFL) will be watched. ICRA, CRISIL, CARE Ratings (CARE) and Brickwork Ratings (Brickwork) have downgraded credit ratings on commercial papers of DHFL to 'D' (Default) owing to liquidity concerns.
Pramila Jayapal re-introduces legislation addressing South Asian heart disease
Indian-American Congresswoman Pramila Jayapal on Wednesday re-introduced a bipartisan legislation in the US House of Representatives that aims to raise awareness about the alarming rate of heart disease in the South Asian community, including Indians, and invest in reversing this trend. Co-sponsored by Republican Congressman Joe Wilson from South Carolina, the bill known as "South Asian Heart Health Awareness and Research Act" will create South Asian heart health promotion grants at the Centers for Disease Control to develop a clearinghouse and web portal of information on South Asian heart health, develop culturally appropriate materials to promote heart health in the community members. "Heart disease in the South Asian community has risen to an alarmingly disproportionate level. Our bill will fund research and analysis to identify solutions to these preventable circumstances and ultimately save more lives," said Congresswoman Jayapal, 53, introducting the Bill. "Not only will we ...
Trump administration cuts funding for fetal tissue research
The Trump administration on Wednesday discontinued a multi-million-dollar research contract with a university involving the use of fetal tissue to test new HIV treatments, arguing it was "promoting the dignity of human life." The use of fetal tissue is supported by many scientists who say it is essential for finding cures for diseases from Alzheimer's to spinal cord injuries. But it is sharply criticized by anti-abortion activists who brand such research "immoral" and say it might encourage more people to terminate their pregnancies. They also say researchers should instead focus on alternatives such as stem cells harvested from adults or umbilical cords. The administration's decision comes as several conservative-leaning US states have adopted extremely restrictive laws on abortion in the hope that the Supreme Court will opt to revisit a landmark 1973 ruling establishing abortion rights nationwide. President Donald Trump has declared himself "strongly Pro-Life" as he seeks to rally ..
Number of measles cases in US this year surpasses 1,000
The number of measles cases in the United States this year has reached 1,001, health officials said Wednesday, as they vowed to stop the spread of misinformation about vaccines. The announcement comes days after authorities declared the US was in danger of losing its "elimination status" on the contagious respiratory disease if the current outbreaks continue. "The 1,000th case of a preventable disease like measles is a troubling reminder of how important" it is to ensure that people understand that vaccines are safe, Health and Human Services (HHS) Secretary Alex Azar said in a statement. Azar vowed to "continue our efforts to support local health departments and health care providers in responding to this situation, with the ultimate goal of stopping the outbreak and the spread of misinformation about vaccines." "We cannot say this enough: Vaccines are a safe and highly effective public health tool that can prevent this disease and end the current outbreak." The previous record ...
