SC revokes ban on sale of Saridon

Agencies
September 18, 2018

New Delhi, Sep 18: The Supreme Court has temporarily revoked the ban imposed on the sale of Saridon, an analgesic for headaches.

Saridon was one among 328 drugs, which were banned by the Central government recently. These were Fixed Dose Combinations (FDCs) which were banned by the Centre to stop irrational use.

A bench of Justice Rohinton Nariman and Justice Indu Malhotra temporarily allowed the sale of Saridon, and two other drugs after the drug makers challenged recent notification issued by the Centre prohibiting the manufacture and sale of 328 FDCs.

On September 7, the Ministry of Health and Family Welfare had issued a notification prohibiting the manufacture and sale of FDCs, which has a fixed dose combination of two or more compounds. 

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Agencies
July 2,2020

The American pharmaceutical giant Pfizer Inc. and the European biotechnology company BioNTech SE have conducted an experimental trial of a COVID-19 vaccine candidate and found it to be safe, well-tolerated, and capable of generating antibodies in the patients.

The study, which is yet to be peer-reviewed, describes the preliminary clinical data for the candidate vaccine -- nucleoside-modified messenger RNA (modRNA), BNT162b1.

It said the amount of antibodies produced in participants after they received two shots of the vaccine candidate was greater than that reported in patients receiving convalescent plasma from recovered COVID-19 patients.

"I was glad to see Pfizer put up their phase 1 trial data today. Virus neutralizing antibody titers achieved after two doses are greater than convalescent antibody titers," tweeted Peter Hotez, a vaccine scientist from Baylor College of Medicine in the US, who was unrelated to the study.

Researchers, including those from New York University in the US, who were involved in the study, said the candidate vaccine enables human cells to produce an optimised version of the receptor binding domain (RBD) antigen -- a part of the spike (S) protein of SARS-CoV-2 which it uses to gain entry into human cells.

"Robust immunogenicity was observed after vaccination with BNT162b1," the scientists noted in the study.

They said the program is evaluating at least four experimental vaccines, each of which represents a unique combination of mRNA format and target component of the novel coronavirus, SARS-CoV-2.

Based on the study's findings, they said BNT162b1 could be administered in a quantity that was well tolerated, potentially generating a dose dependent production of immune system molecules in the patients.

The research noted that patients treated with the vaccine candidate produced nearly 1.8 to 2.8 fold greater levels of RBD-binding antibodies that could neutralise SARS-CoV-2.

"We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, topline findings," said Kathrin U. Jansen, study co-author and Senior Vice President and Head of Vaccine Research & Development, Pfizer.

"We look forward to publishing our clinical data in a peer-reviewed journal as quickly as possible," Jansen said.

According to Ugur Sahin, CEO and Co-founder of BioNTech, and another co-author of the study, the preliminary data are encouraging as they provide an initial signal that BNT162b1 is able to produce neutralising antibody responses in humans.

He said the immune response observed in the patients treated with the experimental vaccine are at, or above, the levels observed from convalescent sera, adding that it does so at "relatively low dose levels."

"We look forward to providing further data updates on BNT162b1," Sahin said.

According to a statement from Pfizer, the initial part of the study included 45 healthy adults 18 to 55 years of age.

It said the priliminary data for BNT162b1 was evaluated in 24 subjects who received two injections of 10 microgrammes ( g) and 30 g -- 12 subjects who received a single injection of 100 g, and 9 subjects who received two doses of a dummy vaccine.

The study noted that participants received two doses, 21 days apart, of placebo, 10 g or 30 g of BNT162b1, or received a single dose of 100 g of the vaccine candidate.

According to the scientists, the highest neutralising concentrations of antibodies were observed seven days after the second dose of 10 g, or 30 g on day 28 after vaccination.

They said the neutralising concentrations were 1.8- and 2.8-times that observed in a panel of 38 blood samples from people who had contracted the virus.

In all 24 subjects who received two vaccinations at 10 g and 30 g dose levels, elevation of RBD-binding antibody concentrations was observed after the second injection, the study noted.

It said these concentrations are 8- and 46.3-times the concentration seen in a panel of 38 blood samples from those infected with the novel coronavirus.

At the 10 g or 30 g dose levels, the scientists said adverse reactions, including low grade fever, were more common after the second dose than the first dose.

According to Pfizer, local reactions and systemic events after injection with 10 g and 30 g of BNT162b1 were "dose-dependent, generally mild to moderate, and transient."

It said the most commonly reported local reaction was injection site pain, which was mild to moderate, except in one of 12 subjects who received a 100 g dose, which was severe.

The study noted that there was no serious adverse events reported by the patients.

Citing the limitations of the research, the scientists said the immunity generated in the participants in the form of the T cells and B cells of their immune system, and the level of immunity needed to protect one from COVID-19 are unknown.

With these preliminary data, along with additional data being generated, Pfizer noted in the statement that the two companies will determine a dose level, and select among multiple vaccine candidates to seek to progress to a large, global safety and efficacy trial, which may involve up to 30,000 healthy participants if regulatory approval to proceed is received.

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News Network
June 20,2020

Washington, Jun 20: Pregnant and postpartum women are usually at a high risk of depression and anxiety - one in seven women struggle with symptoms in the perinatal period and the coronavirus pandemic is exacerbating those struggles according to a recent study.

The study was published in Frontiers in Global Women's Health, which found that the likelihood of maternal depression and anxiety has substantially increased during the health crisis.

"The social and physical isolation measures that are critically needed to reduce the spread of the virus are taking a toll on the physical and mental health of many of us," said Dr. Margie Davenport of the University of Alberta, Canada, who co-authored the study.

For new moms, those stresses come with side effects.

"We know that experiencing depression and anxiety during pregnancy and the postpartum period can have detrimental effects on the mental and physical health of both mother and baby that can persist for years," said Davenport.

Such effects can include premature delivery, reduced mother-infant bonding, and developmental delays in infants.

The study surveyed 900 women - 520 of whom were pregnant and 380 of whom had given birth in the past year - and asked about their depression and anxiety symptoms before and during the pandemic.

Before the pandemic began, 29 percent of those women experienced moderate to high anxiety symptoms, and 15 percent experienced depressive symptoms. During the pandemic, those numbers increased - 72 percent experienced anxiety and 41percent experienced depression.

Because lockdown measures have affected daily routines and access to gyms, researchers also asked women whether their exercise habits had changed. Of the women surveyed, 64 percent reduced their physical activity since the pandemic began, while 15 percent increased and 21 percent experienced no change.

Exercise is a known way to ease depression symptoms, so limited physical activity may result in an uptick in depressive symptoms. Indeed, the study found that women who engaged in at least 150 minutes of moderate physical activity a week had significantly lower symptoms of depression and anxiety.

The findings are somewhat limited given the fact that researchers could not survey women before the pandemic began (since they could not know a pandemic would occur). The women surveyed could only offer their pre-pandemic symptoms in hindsight.

Also, while the researchers asked women about their symptoms using validated measures, only mental health care professionals can validly diagnose an individual with depression or anxiety.

The study was specifically interested in the impact of COVID-19 on new moms, but Davenport says maternal mental health is a critical issue no matter the time.

"Even when we are not in a global pandemic, many pregnant and postpartum women frequently feel isolated whether due to being hospitalized, not having family or friends around or other reasons," she said.

"It is critical to increase awareness of the impact of social (and physical) isolation on the mental health of pregnant and postpartum women," Davenport added.

Increased awareness makes diagnosis and treatment - the ultimate goal - more likely.

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Agencies
February 7,2020

Birmingham, Feb 7: According to a new study, social media users are more likely to eat healthy or junk food after getting influenced by their peer group.

The research published in the scientific journal 'Appetite' found that study participants ate an extra fifth of a portion of fruit and vegetables themselves for every portion they thought their social media peers ate. So, if they believed their friends got their 'five a day' of fruit and veg, they were likely to eat an extra portion themselves.

On the other hand, Facebook users were found to consume an extra portion of unhealthy snack foods and sugary drinks for every three portions they believed their online social circles did.
The findings suggested that people eat around a third more junk food if they think their friends also indulge in the same.

The Aston University researchers said the findings provide the first evidence to suggest our online social circles could be implicitly influencing our eating habits, with important implications for using 'nudge' techniques on social media to encourage healthy eating.

Researchers asked 369 university students to estimate the amount of fruit, vegetables, 'energy-dense snacks' and sugary drinks their Facebook peers consumed on a daily basis.

The information was cross-referenced with the participants' own actual eating habits and showed that those who felt their social circles 'approved' of eating junk food consumed significantly more themselves. Meanwhile, those who thought their friends ate a healthy diet ate more portions of fruit and veg. Their perceptions could have come from seeing friends' posts about the food and drink they consumed, or simply a general impression of their overall health.

There was no significant link between the participants' eating habits and their Body Mass Index (BMI), a standard measure of healthy weight, however. The researchers said the next stage of their work would track a participant group over time to see whether the influence of social media on eating habits had a longer-term impact on weight.

The most recent figures from the NHS's Health Survey for England showed that in 2018 only 28 percent of adults were eating the recommended five portions of fruit and vegetables per day. In Wales, this was 24 percent, in Scotland 22 percent and in Northern Ireland around 20 percent. Children and young people across the UK had even lower levels of fruit and veg consumption.

Aston University health psychology Ph.D. student Lily Hawkins, who led the study alongside supervisor Dr. Jason Thomas, said: "This study suggests we may be influenced by our social peers more than we realize when choosing certain foods. We seem to be subconsciously accounting for how others behave when making our own food choices. So if we believe our friends are eating plenty of fruit and veg we're more likely to eat fruit and veg ourselves. On the other hand, if we feel they're happy to consume lots of snacks and sugary drinks, it can give us a license to overeat foods that are bad for our health. The implication is that we can use social media as a tool to 'nudge' each other's eating behavior within friendship groups, and potentially use this knowledge as a tool for public health interventions."

"With children and young people spending a huge amount of time interacting with peers and influencers via social media, the important new findings from this study could help shape how we deliver interventions that help them adopt healthy eating habits from a young age and stick with them for life," said professor Claire Farrow.

A dietitian called Aisling Pigott further mentioned that "Research such as this demonstrates how we are influenced by online perceptions about how others eat. The promotion of positive health messages across social media, which are focused on promoting healthy choices and non-restrictive relationships with food and body, could nudge people into making positive decisions around the food they eat."

"We do have to be mindful of the importance of 'nudging' positive behaviors and not 'shaming' food choices on social media as a health intervention. We know that generating guilt around food is not particularly helpful when it comes to lifestyle change and maintenance," Aisling added.

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