Glenmark Pharmaceuticals appears to have stolen a march over its peers after it received regulatory clearance in India for and launched its version of favipiravir, the antiviral currently being evaluated as part of treatment options for COVID-19 in several countries including Japan.To get more news about 259793-96-9, wisepowder official website is the best place for you.

Glenmark’s product, to be sold as FabiFlu, has received emergency use authorization in India for the treatment of mild to moderate COVID-19, the disease caused by the coronavirus. The manufacturing and marketing go-ahead was granted as part of an accelerated approval process, which takes into account disease severity, rarity and the availability of alternative treatments, the firm explained in a presentation. Patients will be required to provide informed consent before initiation of treatment.
Glenmark said the approval terms also require the company to submit updated safety and efficacy data to India’s drug regulator on “a periodic basis. Further, we will be submitting postmarketing surveillance of the first 1,000 patients who access the drug. The CDSCO [Central Drugs Standard Control Organization] has given us three months to submit a final clinical trial report, which we expect to complete in about four weeks from now,” Glenmark told Generics Bulletin sister publication Scrip.

Glenmark’s chair and managing director Glenn Saldanha noted that since FabiFlu is orally administered, it serves as a more convenient treatment option over other intravenously administered medications. “Glenmark will work closely with the government and medical community to make FabiFlu quickly accessible to patients across the country,” Saldanha added.

The product, which acts as an RNA polymerase inhibitor, is available as a 200mg tablet and priced at INR3,500 ($45.90) for a pack of 34 tablets. While pricing may appear rational, some industry experts said that treatment entails a significant pill burden, given the day-one dose requirement of 1,800mg twice-daily and then 800mg twice-daily from day two onwards, for a maximum 14 days.

“This would imply 18 tablets are to be taken on day one, and that’s a challenge, but higher-dose tablets may be on the anvil,” one expert told Scrip.Glenmark has been conducting Phase III trials with favipiravir as a monotherapy option for COVID-19. The study evaluated efficacy and safety plus standard of care versus standard of care alone in mild to moderate disease and involved 150 patients at 11 sites across India.

On how the clinical improvement/recovery rate in the study compared to other global trials, the Mumbai-based firm said that, globally, COVID-19 patients treated with favipiravir have shown positive outcomes such as reduced clinical symptoms and quicker disease recovery within one week. “Glenmark’s clinical trial findings are in line with global data, with most patients showing clinical improvements within the first seven days of treatment initiation,” the company said.

There is significant global development activity around favipiravir for COVID-19 and Glenmark highlighted that around 18 clinical trials involving over 3,000 subjects are underway in countries including India, the US, Canada, Italy, China, France and the UK.

As Glenmark Pharmaceuticals launched antiviral drug Favipiravir for the treatment of mild to moderate COVID-19 cases, medical experts on Saturday cautioned against seeing it as a "magic bullet" to treat the deadly virus but said it will be helpful as it can be orally administered and reduce viral load.To get more news about 259793-96-9, wisepowder official website is the best place for you.
They said the drug's real efficacy would be known in the coming months.

Glenmark Pharmaceuticals said it has launched antiviral drug Favipiravir, under the brand name FabiFlu, for the treatment of patients with mild to moderate COVID-19 at a price of about Rs 103 per tablet.FabiFlu is the first oral Favipiravir-approved medication in India for the treatment of COVID-19, it said in a statement.

"This drug was already being used in Japan for influenza. They have been using it in COVID-19 patients also. Even China was using it and Russia had also given permission in May to use it. Antiviral drugs like Remdesivir and Favipiravir are not specific to COVID-19 but were being used for influenza," said Dr Vikas Maurya, Director, Department of Pulmonology and Sleep Disorders, Fortis Hospital, Shalimar Bagh.

He said studies found that there was some benefit of Favipiravir in COVID-19 treatment and that is why it has now been launched in India as well.Dr Maurya said with COVID-19 cases rising, the launching of the drug comes as a relief.

"It is not a magic bullet as it is not the only thing we have to give. This is not a specific drug made for COVID-19 and has been found to be useful, but how much it will be useful we will have to see. Real efficacy will be known when administered on a large scale," he told PTI.

"Best thing is that it is an oral drug, while Ramdesiver is an intravenous drug. It (Favipiravir) can be even taken at home. So even if it is giving some benefit, it will be quite useful," Dr Maurya said.

Noted city-based lung surgeon Dr Arvind Kumar said he does not believe that any of these antiviral drugs like Remdisiver or Favipiravir will be game changers.

"If at all ''game changer'' can be used, it is for dexamethasone which has shown a significant reduction in mortality and is available cheaply," he said.There are so many medications available and Favipiravir will also help some patients, added Dr Kumar, who works at Sir Ganga Ram Hospital.

The Favipiravir drug will be available as a 200 mg tablet at a maximum retail price of Rs 3,500 for a strip of 34 tablets, Glenmark Pharmaceuticals said.It is a prescription-based medication with recommended dose being 1,800 mg twice daily on day one, followed by 800 mg twice daily up to day 14, it added.The tablets are being produced by the company at its Baddi facility in Himachal Pradesh. The drug will be available both through hospitals and the retail channel, Glenmark said.

Fujifilm is ramping up production of its antiviral treatment favipiravir, one of many approved drugs being tested as a possible treatment for COVID-19. Phase III clinical trials are ongoing in Japan, and the government has ordered 2 million treatment courses. In the US, Fujifilm started Phase II trials earlier this month.To get more news about Favipiravir, wisepowder official website is the best place for you.
Favipiravir, which Fujifilm sells under the brand name Avigan, has been approved in Japan since 2014 to treat influenza and other viral strains that don’t respond to other drugs. “Avigan tablets are expected to have efficacy against infection with the new coronavirus in view of its characteristic mechanism of action,” says a Fujifilm spokesperson,although the company has yet to present evidence of efficacy.
The Japanese government stated its preference for Avigan to be made in Japan using domestically produced materials. Toyama Chemical, the Fujifilm subsidiary that developed Avigan, will fulfill part of its requirement for a key intermediate, diethyl malonate, from the chemical producer Denka. The firm will restart a plant in Niigata Prefecture that it had closed in 2017 because of global oversupply of the material. The facility was not dismantled and should be able to resume full operations in late May, according to a Denka spokesperson.In addition, Fujifilm will boost production of intermediates at its Wako Pure Chemical subsidiary and establish partnerships with other raw material suppliers.
Fujifilm expects to complete small Phase III trials in Japan, involving 100 people, in June. In the US, Phase II trials with 50 people will be conducted at Brigham and Women’s Hospital, Massachusetts General Hospital, and the University of Massachusetts Medical School. Italy and China launched clinical trials of the antiviral in March.
According to the Fujifilm spokesperson, human trials so far have not uncovered any adverse reactions. The drug has not been tested on pregnant women, however, because preclinical studies indicated possible harm to fetuses.
Like Gilead Sciences’ remdesivir, another antiviral being tested against COVID-19, favipiravir is a selective inhibitor of the RNA polymerase involved in viral replication. Animal studies showed that it’s effective against influenza as well as West Nile virus, yellow fever, foot-and-mouth disease, and other viruses, Fujifilm says.
The firm notes that thus far the Japanese government is the only group that has ordered large quantities of favipiravir to use against COVID-19. The World Health Organization did not include favipiravir among the four existing drugs it is testing against the disease in a multinational trial.

Introduction An outbreak of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) was reported in Wuhan, China in mid-December 2019, and declared a pandemic by the World Health Organization (WHO) on March 11, 2020. Due to the unknown nature of the disease and the lack of specific drugs, several potential treatments were used for patients. This systematic review and meta-analysis will evaluate studies of the effects of Favipiravir in COVID-19 pneumonia. Methods and analysis We will search electronic databases including LitCovid hub, PubMed, Scopus, ISI web of Sciences, Cochrane, and Embase using keywords related to COVID-19 and Favipiravir. To get more news about Favipiravir, wisepowder official website is the best place for you.
We will search the reference lists of all included studies and reviews. We will also search for clinical trial registries, such as clinicaltrial.gov for the ongoing clinical trials. Two investigators (MAZ and SH) will independently screen titles, abstracts, and full-text of included studies based on eligibility criteria. These investigators will also independently extract data and appraise the quality of studies. All potential discrepancies will be resolved through consultation with the third reviewer. Data synthesis will be conducted using the Review Manager software (version 5.3) or CMA (version 2). Statistical heterogeneity will be assessed using a standard I2 test. A funnel plot, Egger test, and Begg test will be used for asymmetry to explore possible publication bias. Ethics and dissemination The findings of this systematic review with proportional meta-analysis will help to identify the safety and efficacy of Favipiravir for COVID-19 patients. Knowledge gained from this research will also assist physicians in selecting better treatment options and developing a guideline in this field.

All relevant ethical guidelines have been followed; any necessary IRB and/or ethics committee approvals have been obtained and details of the IRB/oversight body are included in the manuscript.

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Today I'm going to be talking to Armand Balboni, MD, PhD, chief executive officer of Appili Therapeutics, about favipiravir, a potential COVID-19 treatment for elderly and long-term care populations.To get more news about Favipiravir, wisepowder official website is the best place for you.
A recent analysis showed a surge in prescription pills for hydroxychloroquine and chloroquine, likely due to off-label prescribing. The JAMA study analyzed prescription patterns and found that hydroxychloroquine/chloroquine fills increased by 1977% since last year.

States are slowly easing their barriers to pharmacists-provided COVID-19 testing. In early April, the US Department of Health and Human Services (HHS) authorized licensed pharmacists to order and administer COVID-19 tests approved by the FDA. By mid-May, about two-thirds of states had adjusted regulations for pharmacists-provided testing, but just a handful of pharmacies have managed to navigate the maze of federal, state, and supply-chain practicalities.
The company was founded in 2015 as a singly focused company, and the idea was to tackle infectious diseases in a way that others don't or can't. What we do is we look for unmet need first. So, is there a disease out there in the infectious disease world where folks are not able to readily find a solution, and we really try and match programs then with the disease, and we do that in a way that's agnostic to where something was created. And I think that's what's a little bit different here. We're all scientists, either by training, or experience, or both. We don't necessarily make the things in-house. Instead, we go and find solutions to problems, which means that we have antifungals, 2 antibiotics, and now an antiviral program. For me, the daily mission is one of trying to keep the team moving forward with the portfolio of products which really touches on a number of really important diseases. I like to say that we're a socially conscious biotech. We both do good and we do well, and I know people roll their eyes when they hear that you need to be a socially conscious biotech company. But we really are. We really try and find those tough problems and then we really relish the challenge to go find solutions.
So that's specifically looking at the antiviral program that we have been working with Fujifilm Toyama Chemical. It's a drug called favipiravir. It's a broad-spectrum antiviral. The long-term-care setting, as many of us have seen and know, even though the pandemic has not been going on for really that long, has disproportionately affected those in the long-term-care setting-the elderly. It doesn't mean that others can't get it, but we see a particular real serious problem there, and in fact, in many places, including Ontario, where our first clinical trial is being run for favipiravir in the long-term-care setting, 80% of the morbidity and mortality has been associated with the elderly, and so that that is really an unmet need, and it really fits into our wheelhouse.

I think the other reason we're focusing on that group is just the properties of the of the drug. Favipiravir is particularly well-suited for that population based on its properties, which are: it's oral, it's a tablet, unlike remdesivir, which is injected in an IV. And also, in the elderly, even when a vaccine becomes available, and we all certainly hope one will and I'm confident there will be one, the elderly don't necessarily respond to vaccines in the same way that everyone else does. Their immune system tends to be a bit more challenged. We think that there will be a place for this drug. And then finally, we focused on this group because nobody else was. We have the only randomized control trial, looking at this population for prophylaxis, meaning we're giving it soon-after infection as soon as possible, very early on in course of the disease. And, you know, it’s the only trial in the world to look at this really important population. So for all those reasons, we thought that it was a good fit for us.

It has been reported that EGT dosage of up to 30 mg/day for adults and 20 mg per day for children has no genotoxicity by EFSA panel report.To get more news about l-ergothioneine supplements, wisepowder official website is the best place for you.

In a human study, l-ergothioneine 5 mg and 25 mg/day dosage for 7 days were found to have no adverse effects.

L-Ergothioneine (EGT) Research
L-Ergothioneine (EGT) became a popular focus of study when it was discovered in red blood cells of animals in 1928. Due to its accumulation in the erythrocytes and its natural antioxidant properties, ERGO was proposed as a possible therapeutic treatment for red blood cell disorders which were predisposed to oxidative damage.

Many advances in research of EGT have been achieved in recent years including the identification of a highly specific transporter in higher organisms and humans and also better understanding of its distribution. Although, the true physiological role of EGT is yet to be fully determined, EGT has been shown to possess numerous antioxidant and cytoprotective effects in vitro and a few in vivo, including free radical scavenger activity, radio protective properties, anti-inflammatory actions and protection against UV radiation or neuronal injuries.

L-ergothioneine (EGT) is a naturally occurring sulfur-containing amino acid only biosynthesized by fungi and mycobacteria in the soil. It is avidly taken up from the diet by humans and other animals through a transporter, OCTN1. Ergothioneine then accumulates to high levels in certain tissues undergoing relatively high levels of oxidative stress, such as erythrocytes, airway epithelium, liver, and kidneys.To get more news about l-ergothioneine, wisepowder official website is the best place for you.

Ergothioneine is not rapidly metabolised, or excreted in urine and is present in many, if not all, human tissues and body fluids. It is a stable antioxidant molecule and does not degrade at high temperature and high pH.

While mushrooms are the richest dietary source of ergothioneine, other ergothioneine rich foods include black beans, red meat and oats. Mushrooms are also a good dietary source of glutathione which together with ergothioneine are excellent dietary antioxidants. However, ergothioneine mushroom species show variations in the levels of these antioxidants.

Conjugated linoleic acid (CLA) can be referred to a group of positional and geometric isomers of linoleic acid. Naturally, the most abundant isomer is cis-9, trans-11 (c9, t11), while in supplement forms CLA is typically sold as an equal mix of the 2 predominant isomers c9, t11 and t10, c12.To get more news about Conjugated Linoleic Acid (CLA), wisepowder official website is the best place for you.

In animal studies, CLA has been found to reduce body fat in several ways. In several studies involving mice, it was found to reduce food intake, increase fat burning, stimulate fat breakdown and inhibit fat production.

In humans, CLA has also been found to cause a significant fat loss. However, the fat burning potential of CLA is much stronger in animals than in humans. Research shows that conjugated linoleic acid weight loss is only modest in humans.

It was found that trans-10, cis-12 CLA attenuates human adipocyte TG content and differentiation. CLA act to reduce adiposity through modulating properties in the lipid metabolism. The action of conjugated linoleic acid on the lipid metabolism is associated with the inhibition of the entry of glucose into the adipocytes.

A review of studies published shows that conjugated linoleic acid for weight loss, taken at a dose of 3.2 grams per day, produces a minor loss in body fat (average 0.05kg) compared to a placebo.

In a study it was found that supplementation of a CLA mixture in overweight and obese people (3 to 4 g/day for 24 weeks) decreased body fat mass and increased lean body mass.

It’s worth noting that some people experience better results than others due to factors including: CLA isomer combination versus individual isomers, CLA dose and duration of treatment, gender, weight, age and metabolic status of the subjects.

One of the possible potential mechanisms by which CLA reduces body fat mass may be that it decreases energy intake or increases energy expenditure.

One study demonstrated that mice supplemented with a CLA mixture for four weeks reduced their food intake and experienced liver function improvements, although studies haven’t proved this same effect yet in humans.

Yes, PEA provides numerous Weight loss benefits. We have discussed some of the benefits below.To get more news about palmitoylethanolamide supplement, wisepowder official website is the best place for you.

i. Palmitoylethanolamide(PEA) prevents against pain and inflammation during and after a weight loss workout

Obesity causes the appearance of an inflammatory process that may be initiated even after a moderate weight gain. Palmitoylethanolamide acts as an endogenous lipid that has shown numerous anti-inflammatory properties.

A research study was carried out to investigate the anti-inflammatory effect of Palmitoylethanolamide supplement on human adipocytes. The study demonstrated that PEA inhibits the LPS stimulated secretion of TNF-alpha by human adipocytes. It was also proved that Palmitoylethanolamide showed a great anti-inflammatory activity as the chemical can completely stop the high increase in the levels of TNF-alpha in the serum which had been treated with a high dose of LPS.

Scientists found out that when PEA binds to PPAR-α, the receptor is stimulated and this enhances the ability of your body to regulate breakdown of fats, weight management, anti-inflammatory activity, and pain-relieving responses. Because of its lack of toxicity, PEA proved to be very efficient in the prevention against obesity-associated insulin resistance.

Therefore, use of palmitoylethanolamide powder may be helpful to active bodybuilders, who are looking to shed off fat, build lean muscle, and prevent work out-induced inflammation that would cause pain during and after heavy exercises.

ii. Palmitoylethanolamide(PEA) causes a decrease in appetite

Science suggests that fatty acid ethanolamides has a big role in the control of feeding behavior. A study was carried out to investigate the role of palmitoylethanolamide (one of the ethanolamides) in weight gain and appetite regulation. Ovariectomized rats showing increased weight gain were treated with palmitoylethanolamide (30 mg/kg sc) for five weeks. After this, blood was collected, and adipose tissue and hypothalamus were removed for cellular, molecular, and histological measurements .

Researchers showed that palmitoylethanolamide (PEA) caused a remarkable reduction in food intake, fat mass, and body weight. Palmitoylethanolamide also transformed adipose tissue macrophages to M2 lean phenotype, associated with a decrease of inflammatory adipokines/ cytokines.

More research on human body shows that activation of PPAR- α by PEA stimulates the feeling of satisfaction and fullness. Maintenance of a healthy weight lowers the occurrence of inflammation and pain after exercise. If you’re an active bodybuilder, experiencing inflammation and pain during or after an exercise due to excess body weight, this may lower the efficiency of your workout or discourage you from working out as often as you’d otherwise want. Taking PEA may eliminate this problem.

Following various documented human studies, user self-reports, user feedbacks such as coluracetam bluelight reviews, as well as animal tests, findings show numerous coluracetam benefits to the body, minds and senses. Here are some of the major potential coluracetam benefits:To get more news about coluracetam dosage, cofttek official website is the best place for you.

1. Working Memory improvement

A Japanese Iwate Medical University study was done on mice to establish the influence of coluracetam supplement on the deficits of working memory as well as reduced hippocampal acetylcholine (ACh) content when administered acutely and chronically. The choline uptake system of the mice has been damaged as a result of nerve toxin administration.

The researchers found out that coluracetam nootropics increased the release of the HACU and Ach, improving the toxin-created working memory deficit and ACh depletion. They observed a remarkable acetylcholine deficit reversal as a result of the administration of the supplement.

2. Improved Learning

People with health issues like Alzheimer’s disease and Schizophrenia normally have abnormally low Acetylcholine levels. As a result, they may experience mind-related symptoms like poor memory and learning. To alleviate the symptoms, something has to be done to increase their levels of acetylcholine, and this is where coluracetam comes in handy.

A Tottori University’s study from the institution’s Department of Neuropsychiatry involved administering recreational drug PCP to inhibit the enzyme that produces acetylcholine and then giving them Coluracetam to see if the supplement would have any effect on the acetylcholine level.

They eventually found out that coluracetam increased ChAT, thus repairing the learning function deficit. As such, they concluded that Coluracetam can be used as a therapeutic drug for those who have learning difficulty due to Schizophrenia or Alzheimer’s disease.

3. Improved memorization and recall abilities

In case you have been experiencing difficulties in comprehending anything you read or memorize things, coluracetam could be of great help for you. Any authentic coluracetam psychonaut will tell you that coluracetam can improve your short-term memory and free recall ability remarkably.

Many users on online threads such as coluracetam bluelight reviews indicate that their coluracetam experience included better memorization, recall capability and reading comprehension. Also, the feedbacks suggest that Coluracetam also boosts information retention, learning speed and thinking ability.

4. Long-term Cognition Improvement

A Yokohama Research Center’s study notes that coluracetam changes choline transporter regulation system, and as a result, positive precognitive affects which last for numerous days after a dose. The effects last for a long time even when the concentration of the nootropic is negligible.

5. Likely to minimize depression that’s resistant to antidepressants

Coluracetam anxiety and treatment-resistant depression relief

Brain Cells Inc. conducted a double-blind randomized controlled trial aimed at establishing coluracetam depression relief capability. The research involved 101 101 people whose depression couldn’t get better even after taking at least two antidepressants. The subjects were given a coluracetam dosage of 80 mg three times per day.

After the trial period, the researchers observed that the subjects responded positively to the supplement as the severity of their depression symptoms had reduced significantly. Being a mood booster by reducing the toxicity of glutamate, coluracetam supplement can be very helpful for people with major depressive disorder (MDD).

From a study similar to the aforementioned but still by Brain Cells Inc. but involving people with comorbid generalized anxiety disorders, coluracetam anxiety relief capability was established. After an 80 mg coluracetam dosage three times a day, the people who were used in the trial had responded positively to the supplement, as their symptoms had reduced.