Monthly Archives: April 2022

New technologies and production processes in the food industry have led to novel foods becoming increasingly important to both food manufacturers and the consuming public worldwide. This is very much the case across a number of jurisdictions in Southeast Asia.

Novel foods refer to new food production processes, foods, and ingredients that have not yet been commonly used for human consumption, so these innovative foods require safety assessments before companies can produce and market them. While rules for these safety assessments are already part of novel food regulations in several other jurisdictionssuch as the novel food regulations in the United Kingdom and European Union adopted in 2003, and the major reform of food safety laws in the United States passed in 2011 under the Food Modernization Actsimilar rules governing the assessment of novel foods are relatively new or yet to be introduced in many parts of Asia.

Nevertheless, it is important to understand the laws and practices that apply to safety assessments and the process of bringing novel foods to market in jurisdictions in the region. This article provides some clarity in this regard by summarizing important practical information on novel foods and the relevant required safety assessments in Indonesia, Thailand, and Vietnam.

Indonesia

Process and Timeline

Before submitting an application for novel food safety assessment, the applicant or a representative should first consult with BPOMs Directorate of Processed Food Standardization. This consultation can help the applicant identify the data requirements for submission.

For obtaining approval of novel foods, applicants must submit the required items through the directorates online submission system. BPOM will then check the application to verify its completeness, and will contact the applicant within five working days either to confirm that the submission is complete or to direct the applicant to rectify any shortcomings.

Once all requirements have been fulfilled, BPOM is to assess the application within 85 working daysor around 46 months in practice.

Required Documents

The application requirements differ depending on the category of novel food. There are two main categories:

Thailand

Process and Timeline

Seeking approval for novel foods consists of two stages.

In this stage, the applicant submits safety data to one of four safety assessment organizations accepted by the FDA. The maximum or estimated duration of this step depends on the organization:

Novel foods that contain any ingredient derived from a genetically modified organism (GMO) must undergo a BIOTEC review.

To apply for the FDAs approval of a novel food, the applicant must submit the letter from the safety assessment organization, along with other relevant documents, to the FDA via their online system. The FDA will consider the application and make a determination within 40 business days.

Required Documents

Vietnam

A genetically modified food contains one or several genetically engineered ingredients. New food additiveswhile not legally definedinclude new combinations of permitted food additives, food additives not included in the permitted list, and food additives included in the permitted list but used outside of the permitted categories.

A genetically modified food contains one or several genetically engineered ingredients. New food additiveswhile not legally definedinclude new combinations of permitted food additives, food additives not included in the permitted list, and food additives included in the permitted list but used outside of the permitted categories.

Self-declaration: None

Registered product declaration: USD 70

Process and Timeline

Conventional Foods. Every food product sold in Vietnam must have a declaration that it meets regulatory standards. For many types of food, a self-declaration procedure covers this requirement. However, some foods also require additional inspection and approval from the Ministry of Health via a registered product declaration.

GMOs. Food products based on GMOs that are on the Ministry of Agricultural and Rural Developments list of edible GMOs undergo the same approval procedure as other conventional food products. However, food products based on GMOs not on this list must first obtain certification of the GMOs eligibility for use as food before undergoing the approval procedure for conventional food products.

In order to apply for certification, Vietnams Council of Food Safety must have concluded that the GMO has no inordinate risks for human health, or the GMO must have been approved for use as food by at least five developed countries, with no adverse incidents having occurred.

If one of these conditions is met, the application can be submitted to the relevant department in the Ministry of Agricultural and Rural Development. Within seven working days of receiving a submission, the department will acknowledge the validity of the application or request additions.

Valid applications will then be appraised by the Genetically Modified Food Safety Councilan advisory council composed of representatives of the Ministries of Industry and Trade; Science and Technology; Agriculture and Rural Development; Natural Resources and Environment; and Health, in addition to other experts. For GMOs that have already been approved for use as food by at least five developed countries, without any recorded adverse incidents, appraisal of the application takes 60 days. For other GMOs, the maximum appraisal duration is 180 days.

Within 30 days of obtaining the appraisal results, the minister of the Ministry of Agricultural and Rural Development will either certify the GMOs eligibility for use as food, or issue a refusal clearly stating the reason.

Required Documents

Applications for certification of a food product as an edible GMO must include the following items:

If the applicant has any other unpublished reference or research materials, assessments, test reports, or scientific figures concluding that the genetically modified organisms do not negatively affect human health, those items should be included in the application.

Conclusion

New foods and ingredients are highly regulated in countries around the world, regardless of whether a jurisdiction has specific laws on novel foods. There are some common regulatory approaches and practices, but even in a single region such as Southeast Asia the rules and processes can vary. Indonesia, Thailand, and Vietnamthree especially active and well-developed regulatory regimes for food in the region, offer compliant food producers and importers a chance to access local consumers and markets. By first recognizing the requirements and regulations in these jurisdictions, and then seeking local expertise that can ensure the process is done correctly, businesses and investors can avoid costly interruptions or delays as they bring their products to market.

Here is the original post:
Novel Food Safety Assessments in Indonesia, Thailand, and Vietnam - Lexology

We went on a hunt for the coolest (and spookiest) stories about bringing vulnerable animals back from the brink of extinction or, in some cases, bringing them back from the dead.

De-extincting the Tassie tiger: an Australian Jurassic Park?

In a stunning announcement in March, the University of Melbourne announced it had received $5 million in funding for a new research lab, the Thylacine Integrated Genomics Research Lab (TIGRR), which will primarily look to bring back the extinct thylacine (Tasmanian tiger) using genetic engineering and cloning techniques.

Once abundant in Tasmania, the tigers were hunted to extinction by European settlers who thought they were killing their livestock.

The ambitious new project will take a thylacine genome, salvaged from a preserved specimen, and use it as a map to re-engineer the genome inside a living cell from the creatures closest living relative, the Dunnart. Then, it will in theory clone a living thylacine from that living cell.

But, to paraphrase Jeff Goldblum, is this a case of spending so much time wondering whether they could, they never stopped to think whether they should?

Read more here.

Lost South American wildflower named extinctus rediscovered (but still endangered)

In a rare but beautiful case of redemption, the orange tropical wildflowerGasteranthus extinctus,endemic to the Andean foothills in Ecuador, was thought to have gone extinct 40 years ago.

But in a stroke of luck, a team of researchers who set out in hopes of rediscovering the plant managed to find a specimen growing, proving that its still clinging on (though still perilously endangered).

We walked into Centinela thinking it was going to break our heart, and instead we ended up falling in love, said one of the lead researchers.

Get an update of science stories delivered straight to your inbox.

Read the full article here.

Bringing back the iconic woolly mammoth

Back in 2017, scientists from Harvard University stunned the world when they announced plans to bring back the iconic woolly mammoth.

These iconic, massive elephant-like creatures had shaggy fur that helped them brave the frosty wilds of the last Ice Age.

De-extincting the mammoths, the scientists said, would be possible because mammoth DNA remains in frozen carcasses found buried in the permafrost in places like Siberia. They say theyre going to use elephant DNA to help patch up the holes, and create a living mammoth cell, which they will implant into an elephant to carry to term, giving birth to a real life woolly mammoth.

But, why do it?According to Revive and Restore, a genomic research and restoration project, the absence of the woolly mammoths from the tundra stopped the compaction of snow, meaning extreme winter cold didnt penetrate the soil, leading to the accelerated melting of the permafrost.

So, the theory goes, these new mammoths will help reverse the melting of these ice stores that are full of greenhouse gases.

Read on for more.

Bringing back the Christmas Island rat

It might be a slightly less iconic species, but the Christmas Island rat was yet another fatality of European expansion, vanishing from the island 119 years ago because of diseases brought from the strange, foreign land.

This rat still has many living relative species, making it potentially a model species for this kind of de-extinction.

Read on for more.

Read the rest here:
Wrap: four organisms that could be brought back from the brink of extinction (and beyond) - Cosmos

GMO debate is not over

In his op-ed Saving the planet one bite at a time, (April 7), Prof. Sylvain Charlebois says the new United Nations Intergovernmental Panel on Climate Change (IPCC) report is worth the read but it seems he did not actually read it himself. Charlebois says, The report sees global trade and genetic engineering as part of the solution, but the report doesnt even mention genetic engineering (genetically modified organisms or GMOs). Yet he then states, it is time to put the anti-GMO rhetoric to rest. Whatever reason he has for making this passionate statement, the IPCC is not it, and readers deserve correct information. Falsely reporting on the IPCC content trivializes the serious challenge before us. Furthermore, this attempt to shut down debate over GMOs comes at a time when we need more debate, not less: as the Canadian Food Inspection Agency and Health Canada are proposing to remove environmental and food safety assessments for some genetically engineered seeds and foods.

Lucy Sharratt, co-ordinator, Canadian Biotechnology Action Network (CBAN)

Brott deserves a statue

The sudden recent death of Boris Brott in such a tragic manner is truly heartbreaking. That it should happen on a street in Hamilton, the city he loved so well, is especially painful.

Boris Brott was a world renowned maestro, and a strong proponent of this city. The enthusiasm and obvious joy he brought to his performances was always uplifting to witness.

I was lucky to see him perform here in Hamilton and more recently at the National Arts Centre in Ottawa. His enthusiasm, energy and sense of fun was always evident.

I think a fitting and appropriate tribute to Boris Brott would be to have his likeness in a statue erected in Gore Park, honouring his decades long musical contributions to Hamilton. Honouring him this way would also promote his legacy of a love for music.

Perhaps it might replace the contentious statues of John A. Macdonald or Queen Victoria. The loss of a person of Brotts stature deserves a monument at the centre of this city.

Marion Shynal, Stoney Creek

Standardize traffic lights

Who knows when a green light with a red flashing hand signal is going to yellow and one second later to red? Or countdown lights some turn red at 0; other countdowns go from 0 to a red hand signal for you to guess at how long you have to go through the intersection safely. A quick glance into your review mirror tells you that the car behind you is on your bumper; to make a quick decision to stop could end up in a collision. Split second decision. I hate it! You slow down nearing an intersection not knowing weather you can safely make it through the light only having to speed up as the light hasnt yet changed and the guy behind you is honking his horn pushing you through. Then you worry if this was a red-light camera intersection. I ask myself every day, why cant Hamilton synchronize all the traffic lights for continuity, so that every driver knows when to slow down to stop?

Saving mine for buck-a-beer

The letter writers complaining about getting a refund on the licence stickers are getting tiring. Really? I never got a red cent back from their beloved Liberals, in fact I was gouged enough on everything from electricity to public services to make up for a centurys worth of overpayment to their provincial coffers.

I, for one, appreciate that I dont have to spend money on stickers for my vehicles and was grateful to get my refund. You want to donate your refund to Del Duca or any other cause, knock yourself out. Im saving mine for buck-a-beer.

In praise of journalists

If not for journalists, we would not have found out that the abundance of rapid tests in Ontario were given to private schools. In fact they were given more tests than LTC homes and paramedics put together. I am a proud supporter of my local newspaper and thankful for the truth seekers out there. Keep up the good work the general public needs to know the truth

Robin Magder Pierce, Hamilton

Depraved Russian soldiers

For the children, written in Russian, on the side of an exploded missile, in the midst of dozens of Ukrainian dead. Unarmed civilian, women, children and aged. Can we imagine much that is more barbaric, uncivilized and depraved? We wonder if this dedication was the sick humour of the commanding officer, or was a suggestion from petulant Putin personally. It certainly leaves no doubt as to their evil intentions. I shall never visit Russia.

Edward A. Collis, Burlington

Superrich of the world, unite!

Regarding Liberal-NDP deal will mean major tax hikes (April 1): The manifesto of the 21st century: Superrich of the world, unite!

Nicholas Christoforou, Ancaster

See more here:
Opinion | April 16: Russian barbarism, a statue of Boris, standardize traffic lights and other letters - Hamilton Spectator

Chinese leader Xi Jinping helda grand ceremonyon April 8 to celebrate the success of the Beijing Olympics. Perhaps it is just because of the success Xi was bragging about thatmodern Olympism, once admired by generations of people from around the world, is dead.

The cause of death of modern Olympism is twofold: corruption and hyper-and-unfair-politicization which includes the ascendance of nationalism.

Few people are so naive as to believe that the Olympics are, or could ever be, devoid of politics. Indeed, since its inception, the modern Olympic Games have become part of geopolitical history, often reflecting political tensions between nation-states.

At the 1920 Summer Olympics in Antwerp, Belgium the first Games held after World War I nations that lost in the war, such as Germany, were banned from participating. This punitive measure would have violated the principle of political neutrality enshrined in the current version of the Olympic Charter, although early versions of the Charter did not contain such a stipulation.

Sixteen years later, perhaps in part as an act of revenge or vindication, a re-emerging Germany transformed the event into a nationalistic and ideological contest as the host of the 1936 Summer Olympics in Berlin.

During the Cold War, international sports competitions were used as a vehicle for regimes to declare the superiority of their respective political systems. In recent years, the politicization of the Olympic Games has escalated to an unprecedented level, mainly at the hands of Russia and China.

Chinas communist regime exploited the 2008 Beijing Olympics to the fullest extent possible. The Games were a political project designed to demonstrate, both domestically and abroad, the rise of China under the leadership of the Chinese Communist Party (CCP).

The 2014 Sochi Winter Olympics were staged in large part to display the strength of Russian President Vladimir Putin, who used the Games as an opportunity to bolster the image of Russias strength in the lead-up to the authoritarian states annexation of Crimean in February and March of that year.

Thepoliticizationof the Olympic movement was always inevitable, but it is itsunfair politicizationthat has killed modern Olympism.

Such unfair politicization was on full display at the 2022 Beijing Winter Olympics. The Chinese government extensively politicized the 2022 Beijing Olympics while simultaneously slandering dissenting voices of Chinese human rights victims, activists and groups, and the democratic governments of other countries. It claims that such individuals and groups are politicized and contradict the Olympic spirit.

According to the Olympic Charter, the goal of the Games is to place sport at the service of the harmonious development of humankind, with a view to promoting a peaceful society concerned with the preservation of human dignity.

Genocide such as is happening to Uyghurs in Xinjiang is the antithesis of the harmonious development of humankind, and forced labor tramples on human dignity, rather than preserving it.

Ouracts of politicization, meant to defend universal fundamental ethical principles as set forth in the Charter such as peacefully publicizing and protesting the past and present atrocities committed by the CCP were prohibited in Beijing and across China.

The athletes, warned in advance by Chinese officials to remain silent on political matters while in China, literally feared for their freedom and safety if they spoke out.

The modern Olympics have long become a hyper-nationalized event. The Olympic Charter stipulates that the Games are competitions between athletes in individual or team events and not between countries. However, in reality, no Olympic athlete stands alone. Every Olympian is required to be a national of the country of the National Olympic Committee which is entering such competitor.

Olympic athletes are part of teams representing nations. The modern Olympic Games have turned into a competition between nations. Victory, measured by medal count, glorifies and validates the nation and its ruling regime, and is used to purportedly demonstrate the greatness of the nations leader.

Just like Adolf Hitler, Xi wanted the 2022 Beijing Winter Olympic Games to validate and demonstrate Chinese superiority and his own greatness as Chinas leader. He also wanted the Chinese flag, raised and waved around during the Games, to mobilize nationalist sentiment.

The Olympics have become a dangerous instrument of nationalism, which in China means Han chauvinism. As such, anyone in China who might have wanted to politicize the 2022 Games by speaking out about and defending universal ethic principles, such as protesting the genocide of Uyghurs in Xinjiang, would have been deemed an enemy of Xi, the CCP regime, and even the entire nation.

This is the anthesis of fair play, which is a core tenet of the Olympic spirit.

Moreover, the fact that the modern-day Olympics have become a multibillion-dollar business operation virtually ensures that corruption is the rule rather than the exception. This includes doping and, eventually, genetic engineering of competitors especially by depraved, morally-bankrupt totalitarian states like China and Russia.

Compared to democratic nations, authoritarian states like China and Russia also devote vastly more resources to training athletes and bribing the IOC to host the Olympics. These countries give out huge bonuses to medalists who bring glory to their country. And, of course, there are lucrative business opportunities that follow.

The Olympic Games have become one-third politics, one-third money, and one-third competition.

The spirit of modern Olympism has suffered a gradual death of a thousand cuts, due primarily to the intense and ever-increasing politicization of the Games and fueled by the rampant corruption of participating and hosting countries (some more than others) and the IOC itself.

If the integrity of modern Olympism can ever be redeemed, certain changes must take place:

First, competition must be between individual athletes. Naturally, every athlete has his or her own roots, nationality, and citizenship, but none of these factors should be a prominent part of the Games. There should be no national teams, nor should any national flags be raised during the Games.

Second, any politicization of the Games must be carried out in a fair, free, and peaceful manner.

Third, the host country must ensure freedom of expression and freedom of press for all Olympic participants and the media. Any complaints about breaches of these freedoms must be investigated, and, if substantiated, the host country must face severe consequences.

Unless major improvements are made to ensure that the Olympics are about athletic greatness and not political prowess or nationalistic fervor, the trend of declining interest in the Olympic Games will inevitably continue.

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Unfair Politicization, Corruption, and the Death of Modern Olympism - The Globe Post

Shares of Jasper Therapeutics, Inc. (NASDAQ:JSPR Get Rating) have earned a consensus rating of Buy from the six analysts that are presently covering the stock, Marketbeat Ratings reports. One analyst has rated the stock with a hold recommendation and five have assigned a buy recommendation to the company. The average 12-month price target among brokerages that have issued ratings on the stock in the last year is $15.00.

A number of equities research analysts have recently weighed in on the company. Cantor Fitzgerald assumed coverage on Jasper Therapeutics in a report on Monday, February 28th. They set an overweight rating and a $10.00 price target on the stock. Credit Suisse Group cut their price target on Jasper Therapeutics from $15.00 to $10.00 and set an outperform rating on the stock in a report on Friday, February 25th. Finally, Zacks Investment Research raised Jasper Therapeutics from a sell rating to a hold rating in a report on Thursday, January 20th.

JSPR stock traded down $0.13 during midday trading on Tuesday, reaching $2.72. The company had a trading volume of 62,997 shares, compared to its average volume of 85,363. The stocks 50 day moving average price is $3.58. Jasper Therapeutics has a fifty-two week low of $2.70 and a fifty-two week high of $18.88.

Jasper Therapeutics Company Profile (Get Rating)

Jasper Therapeutics, Inc, a clinical-stage biotechnology company, develops therapeutic agents for hematopoietic stem cell transplantation and gene therapies. It focuses on the development and commercialization of conditioning agents and stem cell engineering to allow expanded use of stem cell transplantation and ex vivo gene therapy, a technique in which genetic manipulation of cells is performed outside the body prior to transplantation.

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Jasper Therapeutics, Inc. (NASDAQ:JSPR) Receives Average Recommendation of Buy from Analysts - Defense World

New Delhi (India), April 20: India is preparing to become a global player in the life sciences, fueled by its recent economic boom and a drive to diversify its portfolio with biotechnology. In this article, we look at Indias biological research history, current situation, and expected future growth. Indias greatest difficulty in realizing its ambitions will be to educate, recruit, and support the next generation of scientists. Such issues concern the United States and Europe, but they are especially acute in developing countries that are rushing to achieve scientific brilliance at a rate that may be faster than their current educational and faculty support institutions would allow.

Biotechnology is an important component of Indias national health agenda and a potential source of economic growth. Recognizing the critical role that biology will play in the twenty-first century, the Indian government is expanding and establishing several new biological research institutes, which will result in the creation of several new roles for life science experts. Funds are increasingly becoming accessible for cutting-edge equipment, reducing the formerly significant discrepancy in support facilities between Indias best research institutes and those in the United States and Europe. India is becoming a more attractive site for biological research and a rich base for emerging biotechnology businesses. However, until India attracts and encourages its 6 brightest young people to pursue research, success will not be proportional to the amount of money invested.

Many academic institutions and businesses in the United States and Europe are looking to collaborate with India, the worlds largest democratic country. Having Indian scientists on their faculty or postdoctoral fellows/graduate students in their laboratories has long been beneficial to Western institutions (perhaps benefitting more than India itself). Western scientists, on the other hand, have a limited understanding of Indias scientific and educational systems.

There are about 800 medical and healthcare R&D institutions in India, as well as 575 medical colleges, 350 universities, over 15,000 pharmaceutical and biopharmaceutical enterprises, and an uncountable number of healthcare entities and diagnostics laboratories that handle biomedical material. To govern biotechnology research, there are biosafety committees, a review committee on genetic manipulation, and a genetic engineering advisory group.

Companies are actively working on pharmaceuticals that must be used for an extended period of time, a departure from the conventional idea of minimal medication and quick recovery.

At 2003, USA Today reported on hundreds of diseases caused by humans coming into touch with germs in US biolabs in the US and other parts of the world, including the Middle East, Southeast Asia, CIS countries, and Africa. To evade the gaze of the law, its reasonable to imagine that US biolabs have completely moved such risky operations out of the US and into these other regions.

Given the lack of rules and oversight in India, American biolabs appear to have free reign to undertake trials and experiments. Even from Indian official inspection authorities, most such operations are well guarded and kept secret. Because American biolabs are concerned about public backlash and class action lawsuits in the United States, they have decided to conduct their trials in less regulated third-world nations such as India.

For example, India welcomes foreign investment and is ready to turn a blind eye when biotech companies undertake dangerous trials on an uninformed, ignorant, and illiterate population. Its worth noting that the people chosen for trials are frequently from the poorest parts of society, with little knowledge of the law, the testing procedure, or access to legal counsel.

According to the Indian defence establishment, the Surat plague in 1994, which killed 55 people and forced half of the citys population to flee, was an example of biolab leakage. Various news sources from the time mention the American CDC. There were allegations that CDC labs in Almaty, Kazakhstan, had created a germ with an additional protein ring.

For example, at a cost of $107,000, the US Defense Threat Reduction Agency financed three-year research effort on the highly pathogenic Avian Influenza virus was carried out in Haryana, Kerala, and Odisha. The projects purpose was to gather HPAI positive samples in order to assess the diseases spread and strength.

This isnt a one-off occurrence. At 2019, investigations showed that the US Centers for Disease Control and Prevention (CDC) had secretly financed Nipah Virus research in a BSL2 laboratory in Karnataka. Because the virus is so deadly, these testing can only be performed in a BSL4 level lab.

Between 1967 and 1973, the US Army collaborated with the Bombay Natural History Society in India to perform a Migratory Animal Pathological Survey. The Indian Parliament eventually objected, citing concerns that the study could be used for bio-warfare, forcing the initiative to be halted.

The Northeastern states of Assam, Manipur, Meghalaya, and Tripura were also targeted by American laboratories. The US Ministry of Defenses Defense Threat Reduction Agency conducted an Ebola research project in these areas, collecting human and bat blood. The National Center for Biological Sciences in Bangalore conducted the experiments.

It is all too clear that India, like other third-world and developing countries, is a puppet in the hands of US biopharmaceutical companies that are abusing regulatory procedures and abusing their financial power to do whatever they want, regardless of the repercussions. This must be changed. India should adopt tighter restrictions and control for such facilities conducting trials or research in the country in order to protect India from suffering from potential biological dangers.

Read the original here:
India Biolabs Need Stringent Regulations - ED Times

If you are seeking a naturally lower calorie wine, look for dry wines with a lower ABV, such as Prosecco (brut or extra dry), dry Riesling, or Gamay. These wines typically fall on a spectrum of 80 to 120 calories per glass.

Q: Karen S. from Margate asks, Whats the difference between a natural wine and an organic wine?

A: Hi Karen! Natural wines and organic wines have a lot in common. Most significantly they share a concern for the earth and sustainable practices, but there are also several key differences.

To be certified organic by the USDA, a wine must be made without genetic engineering, and it must undergo a rigorous process of inspections and assessments. The grapes must be grown organically without synthetic fertilizers, and all other ingredients such as yeast and fining agents must be certified organic, as well. While sulfites are commonly added to wines as an additional preserving agent or to enhance flavor, organic wines cannot have added sulfites. Wines labeled as made with organic grapes have slightly less restrictions, but it is still a feat for winemakers to achieve this certification.

Natural wine, on the other hand, is not a legal certification. Rather, its a loose term that refers to wines made with little to no intervention by the winemaker. This means grapes are grown without the assistance of pesticides, grapes are handpicked, and juice is fermented into wine using only native yeasts. These yeasts occur naturally on the fruit, and winemakers allow fermentation to start spontaneously, rather than controlling fermentation with the addition of cultured yeasts. While natural wines wont necessary be certified organic, one could argue that they exemplify the most ancient, non-invasive method of winemaking.

Excerpt from:
What you need to know about natural, organic and vegan wines - Atlantic City Weekly