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FDA Approves Trials to Test the Effectiveness of Anti-Malarial Drugs Against COVID-19

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As touted by President Donald Trump, on Sunday, an emergency authorization was issued by the Food and Drug Administration (FDA) in Washington. It was regarding the use of chloroquine and hydroxychloroquine – both anti-malaria drugs, for experimental coronavirus treatments, despite the inconclusive clinical proof of their efficacy.

However, on Sunday, the Department of Health and Human Services had announced that distribution of hydroxychloroquine and chloroquine products can be done by doctors, and they may prescribe these drugs to hospitalized teen and adult patients that are infected with COVID-19, as appropriate, in the situation where the availability or feasibility of a clinical trial are not seen.

According to HHS, 30 million doses of hydroxychloroquine has already been given by Germany’s Sandoz, to the Strategic National Stockpile – the inventory of medical supplies for public health emergencies, of the Federal Government. Meanwhile, Bayer has reported having donated a million doses of chloroquine, according to the international media.

HSS further added that the issuance of the emergency authorization was due to the potential benefits of the product that seemed to outweigh the risks. HHS further acknowledged that some benefit in the treatment of hospitalized COVID-19 patients may be offered by these drugs, as suggested by the anecdotal reports. However, HSS cautioned the need for clinical trials, so that the effectiveness of these treatments can be backed up with scientific evidence.

Amidst the ambiguity, some Americans have attempted to seek over-the-counter replacements. An example was the man from Arizona who had bought a nonpharmaceutical form of chloroquine phosphate – a common chemical used for the cleanliness of fish tanks, which ultimately killed him, landing his now-widow in intensive care.

Consumption of non-pharmaceutical chloroquine phosphate without a prescription and supervision of a certified health care provider is warned by the CDC due to the dangers of it causing serious health consequences, including death.

While President Donald Trump continues his support and praise for anti-malarial drugs in daily press briefings, Fox news has released separate segments specifically devoted to the drugs’ potential benefits. Chloroquine and hydroxychloroquine as coronavirus cures have been further promoted by others, including the President’s personal lawyer Rudy Guiliana, and Turning Points USA founder Charlie Kirk.

Furthermore, a tweet by Giuliani was removed by Twitter, since Giuliani had falsely claimed hydroxychloroquine to have a 100% effective treatment rate for COVID-19, despite no scientific proof.

However, scientists hope the decade-old drugs – chloroquine and hydroxychloroquine, may show effectiveness as a treatment for COVID-19, despite early studies providing mixed evidence regarding their effectiveness, due to the potential associated risks such as vision problems or cardiac arrest.

Prescription limiting rules have been issued by some state pharmacy boards including Texas, Louisiana, Ohio, and North Carolina.

A nationwide trial is underway to test the effectiveness of the drug hydroxychloroquine as a vaccine for COVID-19, while a second trial will test the effectiveness of the drug in the treatment of COVID-19.

David Boulware, an infectious disease scientist at the University of Minnesota, is currently running trials. According to Boulware, the rationale for trying it as a vaccine for COVID-19 is based on laboratory studies that would have shown the capability of the drug of keeping COVID-19 from entering cells. Boulware and his team are currently looking for people that have recently been in contact with a COVID-19 infected case, such as health workers or people living with an infected person, and are recruiting online.

To avoid the placebo effect, the trial will be double-blind. Furthermore, Boulware says the trial is approved by the FDA.

An initial look at the results will be taken next week by a committee of independent experts known as the data safety and monitoring board.

Masters in Biotechnology, the author loves to write about health and fitness in her spare time.

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Cannabis

Are You Planning To Get A Cannabis Business License In Connecticut? Read To Begin Planning

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Cannabis Connecticut

The cannabis business in Connecticut is likely to develop new opportunities for people. It will be beneficial for the state and the public. The business community is excited to begin marijuana involving operations as the state has legalized pot for recreational purposes.

 

Entrepreneurs, investors, and growers; are developing business plans and gathering information to obtain a license to begin cannabis businesses. Specific licensing criteria and application deadlines have not been established by the authorities yet. However, Connecticut law provides some guidance to entrepreneurs and investors to begin planning about their pot business. 

 

Applicants For Cannabis Business Licenses In Connecticut

 

According to the law, two groups of applicants can apply to access a pot businesses license. The two groups are the Social Equity Group and general applicants. 

ALSO READ: Cannabis Giant – Canopy Growth Losses Mega Money And Execs Earns Bonuses

A Social Equity Group may consist of an individual or multiple individuals. It must be 65 percent owned and controlled by an individual or individuals of specific qualities. The individual(S) in this group can be from an average household with a revenue of less than 300% of the state median household income and had been taxpayers.  

 

An individual with residency in a disproportionately impacted area for not less than five of ten years immediately preceding the application can apply as a Social Equity Group applicant. An applicant with 65% ownership and who had been a resident of a disproportionately impacted area for not less than nine years before turning 18 can also apply. 

 

The Connecticut Department of Consumer Protection will not award a license to any lottery applicant who has two or more licenses, of the same type at the same time of lottery until June 30, 2025. An applicant may submit as many applications as desire. It is because the legislature has not set any limitations on the number of applications by an applicant.

 

License Types And Application Expenses

 

Cannabis business licenses are of seven types. General applicants and Social Equity Group; both can apply for any license type. The retailer and hybrid retailer license, lottery entry fee is $500, the fee for provision license is $5000 and renewing this type of license costs $25000. 

 

The lotter entry fee, provision license fee, and renewal fee of a cultivator license type are $1000, $25000, and $75000, respectively. The third type of license is Micro-cultivator. The entry fee, fee for provision license, and final fee for Micro-cultivator are $250, $500, and $1000, respectively. 

 

Product manufacturer license, entry fee is $750, its provision fee is $5000, and the final charge is $25000. Cannabis food and beverage manufacturer license, entry fee is $250, provision fee is $1000, and renewal or final fee is $5000. The product packager license type, entry fee costs $500, the provision fee costs $5000, and the final fee is $25000.

 

Are There Any Discounts 

 

Individuals who qualify as Social Equity Group applicants will receive a 50% discount from the Connecticut government for the first three renewal cycles. Moreover, people who meet qualifications will get substantial financial savings. Doing so will allow them to begin operations effectively. 

ALSO READ: Explosion Caused By Invercargill Couple During Cannabis Oil Production

 

Individuals who have medical cannabis business licenses and desire to transform into another license type can do so after paying some fee. 

 

If an applicant desires to convert their medical cannabis dispensary license into a hybrid retailer license, they must pay $1000000 as a fee. Likewise, an existing medical pot producer can convert their license, to include recreational marijuana production by paying $3000000. 

 

Already established cannabis businesses in Connecticut will not receive a 50% discount even if they belong to the Social Equity Group. However, they can become eligible for discounted license fees if they show dedication to creating equity joint ventures. 

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Cannabis Giant – Canopy Growth Losses Mega Money And Execs Earns Bonuses

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Cannabis industry growth

Canopy Growth is a cannabis and cannabinoid-based consumer-product company. The marijuana giant experiences huge losses CA$1.7 billion, and there have been some profits. Ups and downs in sales and profits are part of trade and business activities. 

 

Canopy Growth executives received more than 4 million Canadian dollars (equivalent to $3.2 million) in cash. According to a regulatory filing, executives receive bonuses after making solid progress in the year. The company lose CA$1.7 billion and reduces its labor force by laying off hundreds of workers. 

 

Compensation Packages Of Ontario-based Cannabis Company

 

According to Smith Falls, the annual general meeting was scheduled for September 14 via webcast. Executive compensation figures were disclosed before the meetings. The compensation packages for executives consist of salaries and bonuses. 

ALSO READ: Is Tobacco Industry Shifting To Cannabis

 

Canopy Growth company also provides long-term and short-term incentives as it is their policy. Five of the executives of the cannabis giant company will be receiving bonuses as short-term incentives. The company grants long-term bonuses annually in March. But in 2021, these were awarded on June 9. 

 

The LTI bonuses were not awarded in the total compensation table. However, they were issued after the end of the fiscal year. The proxy noted that the company is determined to fix the regular timing of annual LTI grants. Moreover, from the beginning of Fiscal 2022, annual LTI grants will occur in June of each year. In Fiscal 2021 no LTI awards were granted by the cannabis company.

 

Canopy Growth Performance Measures 

 

The world-leading marijuana company uses four measures to evaluate performance. Depending upon performance related to corporate objectives, executives get cash rewards or annual bonuses. 

 

Performance in maintaining free cash flow has the highest weighting in the four performances measures. It weighs 50%. Net revenue weightage is 20%, adjusted EBITDA contributes 20 percent, and an individualized objective contributes 10% in performance measures. 

 

In the fiscal 2021 year, the company could not meet its net revenue and adjusted EBITDA. However, the company was bale to meet goals for free cash flow. Free cash flow was half the shortfall the company predicted. 

 

Adjusted EBITDA is a measure of profitability, and in the 2021 fiscal year, the adjusted EBITDA came in a negative $258 million. The cannabis company had an objective of negative $246 million. There were slight changes in net revenue and other performance measures. 

 

Bonuses Allocation

 

Canopy Growth announces to give David Klein a cash bonus worth CA$2.2 million. David Klein is the CEO of the company. The chief financial officer of the marijuana company Mike Lee will receive a cash bonus of CA$579,000. 

ALSO READ: Everyone Wants More Cannabis At Cheap Price

 

Rade Kovacevic is the president and chief product officer and will receive from the cannabis company a short-term cash bonus worth CA$659000. The chief commercial officer of the pot company is Julious Grant. The company is awarding Julious Grant a bonus of CA$360,000 in cash. Phil Shaer is the legal officer of Canopy Growth and will be receiving a cash bonus of Canadian dollar three hundred and fifty-one thousand. 

 

According to the proxy statement, the executive leadership team put great efforts and performed well in reducing financial losses, maintaining success. Teamwork to help the company revise CPG strategy and improve financially. Dealing with the challenges of the environmental changes caused by the pandemic situation was difficult for everyone. Continuing to work efficiently and perform well in difficult times was a remarkable effort of the company. 

 

Four members of the executive leadership team, received a modest increase in their salary, between CA$14000 to CA$25000. The CEO David Klein will not be receiving any raise in income. He will continue to get CA$1.2 million salaries as the CEO of Canopy Growth cannabis company.

Originally covered on: mjbizdaily

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Can Cannabis-based Drug Treat Brain Tumors? UK Trials Designed To Discover More

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Marijuana cannabis effects on brain

Brain research studies have occurred previously, but the UK-based trial will analyze cannabis-based drug efficacy in treating brain tumors. Thus, this clinical project is different, and its findings can be life-changing for many patients. 

 

The University of Birmingham is planning to coordinate a UK trial. The aim of organizing this trial is to analyze the efficacy of Sativex in treating the most aggressive brain tumors. Sativex is a marijuana-based drug.

ALSO READ: Is Tobacco Industry Shifting To Cannabis

Within the United Kingdom, the NHS has allowed only limited medical marijuana products. Doing so controls the use of medical pot products. It also makes it difficult for all patients to get access to pot-based treatment programs. 

 

Brian tumors are very aggressive sometimes and may remain silent for multiple years. Treatment of such tumors is complex. But there are possibilities of treating them with the marijuana-based drug. The UK trial will help to determine efficacy, safety, and chances of treating neurological tumors. 

 

The UK Trial On Cannabis-Based Drug

 

The Brain Tumor Charity is funding the new phase II trial. The trial involving cannabis-based drugs is going to launch at 15 NHS hospitals. The phase I study in 27 patients has shown promising results, and researchers are hopeful about effectiveness in the new phase II trial. 

 

Glioblastoma is an aggressive brain tumor that has an average survival of fewer than ten months. The treatment is not much effective, and its progression occurs at a faster rate. Due to multiple reasons, patients suffering from glioblastoma are unable to continue living a healthy life. 

 

In the UK trial, patients will receive Sativex together with their chemotherapy. The trial will determine whether or not the cannabis-based drug Sativex increases the survival rate of patients with brain tumors. 

 

Phase I Cannabis Involving UK Trial 

 

Sativex is a marijuana-based drug, it is an oral spray that contains cannabinoids THC and CBD. This drug has shown promising results in phase I trial and improves the condition of people fighting with glioblastoma.

ALSO READ: Explosion Caused By Invercargill Couple During Cannabis Oil Production

The cannabis-based drug has a good efficacy profile in treating patients with multiple sclerosis. During the phase one trial, Sativex was effective when given chemotherapy to patients suffering from a brain tumor. 

 

During the phase, I study the number of patients on Sativex who were observed to live longer than those patients, that were on placebo. However, sufficient data from the phase I study, to show survival impact was not gathered. 

 

Phase II UK Trial To Determine Pot Role In Treating Brain Tumors

 

The phase II trial is called ARISTOCRAT. This trial will continue to research and investigate by observing patients receiving cannabis-based medicine for three years. A placebo group will also be under observation during this time.

 

Professor Susan Short is leading the phase II trial at the University of Leeds. The Cancer Research UK Clinical Trials Unit at the University of Birmingham also co-ordinate the study.

More than 230 patients with brain tumors are to gather from all across the UK nations to conduct the trial. The procedure will begin in early 2022, and the process of funds collection is ongoing.

 

Due to the pandemic, the income of the Brain Tumour Charity decreases by 25 percent last year. As a result, they had to discontinue their research grant funding program. Today the organization launched an appeal to raise £450,000 to open the trial involving the cannabis-based drug.

 

Glioblastomas are one of the most common and aggressive forms of brain cancer. Each year in England alone, about 2200 people are diagnosed with it, with the lowest survival rate. 

 

Moreover, glioblastomas are fast-growing, highly diffusive, have poor boundaries, and extend to multiple parts of the brain. After intensive treatments, including surgery, these brain tumors develop again and again in different areas.

 

Cannabis-based drug effectiveness can give hope and relief in treating and prolonging the life of patients with these aggressive tumors. It is essential to conduct the trial as soon as possible. 

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