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Tetra Bio-Pharma expands into Australia with new research subsidiary

The Canadian company is establishing research company Tetra Bio-Pharma Australia Pty Ltd.

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Tetra Bio-Pharma expands into Australia with new research subsidiary
Home » News » International » Tetra Bio-Pharma expands into Australia with new research subsidiary

Tetra Bio-Pharma has announced the launch of its new wholly owned subsidiary Tetra Bio-Pharma Australia Pty Ltd, an Australian-based research company focused on the execution of clinical trials in Australia.

The new subsidiary follows the recent announcement of Tetra‘s partnership with Cannvalate Pty Ltd for the performance of clinical trials of Tetra’s drug candidates in Australia. Accordingly, TBP-AU will benefit from a 43.5 per cent tax credit on all money spent on clinical trials in Australia.

The development represents Tetra’s second foreign subsidiary and is in line with the company’s global expansion strategy for QIXLEE – a botanical inhaled investigational new drug with a fixed ratio of THC and CBD that meets USA cGMP regulatory requirements – and other future drug candidates.

Read more: Tetra Bio-Pharma receives European orphan drug designation for novel CBD cream

Tetra Bio-Pharma CEO, Dr Guy Chamberland, commented: “We look forward to working with our strategic partners and building value for our current and future investors.

“These are very exciting times for us as we continue to drive scientific excellence and deliver on the promise of cannabinoid-derived transformative medicines to improve patient health and quality of life.”

The company has also announced it has completed the Annual Licence Review process for its Health Canada Drug Establishment Licence (DEL), meeting the regulatory requirements of C.01A.009 of the Food and Drug Regulations to maintain its DEL for the distribution of pharmaceuticals, like REDUVO, in Canada.

Tetra Bio-Pharma has also stated that it submitted its first New Drug Submission (NDS) for REDUVO – a soft gel capsule used to treat chemotherapy-induced nausea and vomiting (CINV) and weight loss and severe nausea in people living with HIV infection – to Health Canada to obtain a Drug Identification Number (DIN) for the prescription drug. The company is now in discussions with Health Canada to address final commentary on the submission.

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Luxembourg delegates visit medical cannabis facility in Portugal

The delegation visited Tilray’s EU-GMP facility in Cantanhede.

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Luxembourg delegates visit medical cannabis facility in Portugal
Tilray Medical Hosts Luxembourg Delegation at Tilray's EU-GMP-certified medical cannabis facility in Portugal.
Home » News » International » Tetra Bio-Pharma expands into Australia with new research subsidiary

Tilray Medical recently welcomed the Government of Luxembourg delegation on its visit to the company’s European Campus in Portugal.

In October 2021, global cannabis company Tilray was named as the supplier of cannabis products for Luxembourg’s medical cannabis programme by the country’s Ministry of Health.

For the programme, Tilray is supplying a variety of its pharmaceutical-grade medical cannabis products, including extracts and dried flower with different levels of THC and CBD for patients with a range of medical conditions.

The recent visit to Tilray’s EU-GMP medical cannabis cultivation and manufacturing facility was organized to give the Luxembourg Delegation a firsthand view of Tilray’s operations in Portugal.

Read more: Tilray launches first medical cannabis oil in Malta market

Tilray’s managing director in Europe, Sascha Mielcarek, commented: “We are honoured to host the Luxembourg Ministry of Health Delegation at our state-of-the-art cannabis facility in Cantanhede, Portugal. 

“Demand for cannabis legalisation in Europe is growing rapidly and we are incredibly proud to service the patients in Luxembourg and around the world with the high-quality medical cannabis products they rely on and in the formats they prefer.”

The delegation included: Paulette Lenert, Deputy Prime Minister and Minister of Health of Luxembourg; H. E. Conrad Bruch, Ambassador of Luxembourg to Portugal; Alain Origer, National Drugs Coordinator; Laura Valli, International Affairs Coordinator; Bob Lessel, Social Health Department; and, Sven Back, Department of narcotics and medicinal cannabis.

At the time of the announcement that Tilray would act as supplier for Luxembourg’s medical cannabis programme, chairman and chief executive officer, at Tilray, Irwin Simon said the company believes its growth potential in the European Union represents a $1bn opportunity, noting that: “We’re proud to be building this unrivaled global platform and will continue to advocate for patient access in Europe and countries around the world.”

Tilray was the first to successfully export medical cannabis from North America and import medical cannabis products into the EU in 2016, and its branded medical cannabis products are now available in 20 Countries around the world as the firm continues to expand its footprint in Europe.

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Thailand becomes first country in Asia to decriminalise cannabis

Under the new law change, people incarcerated on cannabis-related charges will be released from prison.

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Thailand becomes first country in Asia to decriminalise cannabis
Home » News » International » Tetra Bio-Pharma expands into Australia with new research subsidiary

Thailand has now decriminalised the cultivation and trade of cannabis, however, recreational use will remain illegal. 

The production, trading, import and export of cannabis and hemp products for medicinal use is now legal in Thailand. 

Previously, cannabis is was a category five narcotic, however, cannabis and hemp products have been allowed in the cosmetic and food industries since 2020, and the country was the first in Asia to legalise medical cannabis in 2018. It has also been legal in the country for registered companies to sell cannabis products if they contain less than 0.2 per cent of THC.

The move is a bid to increase economic productivity in the country, with the government valuing the industry in excess of USD£2bn (~£1.60bn) according to Thai Health Minister Anutin Charnvirakul. 

Read more: Thailand to propose removing cannabis from controlled substances list

Small operators will not need to register with the Food and Drug Administration (FDA), however, large cannabis-related businesses need FDA approval to produce and market products.

The move follows the decision from the Thai Government in May to hand out one million free cannabis plants to its citizens. Citizens will now be permitted to cultivate cannabis in their own homes as long as it is medical grade and used for medical purposes only.

The country’s Office of the Judiciary has also confirmed that any ongoing criminal cases related to cannabis will be suspended, and those serving prison sentences related to cannabis charges will also be released on a case-by-case basis.

In an interview with CNN, the Minister highlighted that Thai citizens are keen to become investors and producers in the medical cannabis industry.

However, the smoking or use of cannabis in “non-productive ways” will still be prohibited, Charnvirakul has stated. 

Under Thailand’s Public Health Act, those that use cannabis for recreational purposes will still be subject to penalties such as an $800 fine for public consumption and three months in prison.

Speaking to CNN, Charnvirakul commented: “There has never once been a moment that we would think about advocating people to use cannabis in terms of recreation — or use it in a way that it could irritate others.”

Charnvirakul highlighted that the country would have no problem with tourists who wanted to visit Thailand for medical cannabis treatment, but that the country would not be open for recreational cannabis tourism.

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FDA issues warning over accidental THC ingestion by children

A number of edible THC products in the US are being mistaken for common foods by children.

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FDA issues warning over accidental THC ingestion by children
Home » News » International » Tetra Bio-Pharma expands into Australia with new research subsidiary

The United States Food and Drug Administration (FDA) has issued a warning that accidental ingestion of THC products by children can lead to serious adverse events.

Some edible THC products in the US are being designed to mimic the image of commonly consumed foods. Using similar brand names, colours and logos on packaging, “copycat” cannabis edibles can easily be mistaken for common foods by children.

With the global cannabis-infused edibles market projected to reach USD$9.03bn (~£7.29bn) by 2026 according to Research and Markets, many brands are selling the likes of THC-infused gummies, drinks and candies.

The FDA has confirmed it received over 100 adverse event reports related to children and adults who consumed edible products containing THC from January 2021 to April, 2022. 

Read more: The problem with “copycat” cannabis edibles

The body has warned consumers that these incidents have caused some to experience adverse events such as hallucinations, increased heart rate and vomiting, with a number requiring medical intervention or hospital admission.

The FDA stated: “Some manufacturers are packaging and labeling edible products containing THC to look like popular brands of commonly consumed foods, such as breakfast cereal, candy, and cookies. These products appeal to children and may be easily mistaken for popular, well-recognised foods.

“The FDA is actively working with federal and state partners to further address the concerns related to these products and monitoring the market for adverse events, product complaints, and other emerging cannabis-derived products of potential concern.”

Read more: Over a third of US THC products too strong for legal sale

A recent study carried out by the NYU School of Global Public Health, and published in Drug and Alcohol Dependence, found that out of the 267 edibles revised in the study, 8 per cent closely resembled 13 different popular snack products, consisting of candies or sweet snacks and one salty snack.

It also found that eight out of 13 packages used the exact brand or product name of popular snack products. Five used names that were similar to popular snack products such as “Stoner Patch Dummies” instead of “Sour Patch Kids”, and seven of the packages used the same cartoon or brand character as the original product.

The study authors warned that this problem should be a major concern for the cannabis industry, and that if these products are not stored properly, children can accidentally ingest them.

The FDA has advised consumers to call emergency services for medical help in the event of an adverse reaction and to ensure products are kept in a safe place out of the reach of children. It has also recommended a local poison centre be called, should a product be ingested by a child.

The FDA stated: “Health care professionals, patients and consumers are encouraged to report complaints and cases of exposure and adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.”

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