The U.S. health regulator has approved a therapy developed by Johnson & Johnson and its China-focused partner Legend Biotech Corp to treat a type of white blood cell cancer, the U.S. healthcare company said on Monday.
The Food and Drug Administration‘s decision paves the way for Legend’s first approved product in the United States, at a time when the regulator has stepped up its scrutiny of drug trials conducted in China. The Legend-J&J therapy was tested initially in China, and then in the United States and Japan.
“This is the first of many cell therapies we plan to bring to patients as we continue advancing our pipeline across disease states,” said Ying Huang, Legend’s chief executive officer and chief financial officer.
The treatment, Carvykti/Cilta-cel, belongs to a class of drugs known as CAR-T therapies, or chimeric antigen receptor T-cell therapies.
CAR-T drugs work by harvesting a patient’s own disease-fighting T-cells, genetically engineering them to target specific proteins on cancer cells, and replacing them to seek out and attack cancer.
Legend and J&J will sell the drug in Greater China at 70-30 split in profit, and in all other countries in a 50-50 split in profit. https://bit.ly/3C1cfnsA decision on the CAR-T therapy was initially expected to come by the end of November after it was given priority review six months earlier, but this was extended by three months to allow sufficient time to review information submitted by J&J following an FDA request.
Legend, which initiated the development, signed an agreement with Janssen Biotech Inc, an arm of J&J, in 2017, to jointly develop and commercialize the drug, with Legend getting $350 million in upfront payment.
Besides the United States, Carvykti/Cilta-cel is also being reviewed by health authorities in Japan and Europe. A Marketing Authorisation Application (MAA) for the therapy in China is yet to be filed.
(This story clarifies in paragraph 6 that Legend and J&J will sell the drug in Greater China at “70-30” split in profit, corrects last paragraph to say an MAA is yet to be filed in China)
(Reporting by Leroy Leo, Shivani Tanna and Sneha Bhowmik in Bengaluru; additional reporting by Bhargav Acharya; Editing by Sriraj Kalluvila, Subhranshu Sahu and Sherry Jacob-Phillips)
Nunavut admits to large tuberculosis outbreak in Pangnirtung months later – The Globe and Mail
Pangnirtung, a small hamlet on Baffin Island, is grappling with the largest tuberculosis outbreak in Nunavut since 2017, according to data the territorial government released on Thursday after refusing for months to reveal the extent of the disease’s spread.
The Nunavut Department of Health said on Thursday that 139 cases of TB have been identified in Pangnirtung in the past 18 months, 31 of which were active, meaning the patients were sick and infectious. The rest were cases of latent or “sleeping” TB, an asymptomatic version of the bacterial infection that isn’t contagious, but that puts patients at risk of developing active TB in the future.
The Globe and Mail travelled to Pangnirtung earlier this month as part of a continuing investigation into health care in Canada’s youngest territory. In interviews, community leaders have expressed frustration at the lack of official information about the TB outbreak, which Michael Patterson, the territory’s chief public-health officer, first declared on Nov. 25 without providing a tally of cases.
The size of the outbreak came as a surprise to Pangnirtung Mayor Eric Lawlor who, along with the rest of the hamlet’s elected council, wasn’t privy to official statistics on the ballooning health problem in his own community.
“The information should have been provided to us regularly to begin with,” Mr. Lawlor said on Thursday. “This is more concerning than COVID, actually. With the numbers being so high, it’s kind of worrisome and bothersome that we haven’t been addressing it more seriously from the government side.”
The Nunavut Department of Health published the figures in a news release a week after receiving a list of questions from The Globe about the ongoing tuberculosis outbreak in Pangnirtung, a community of about 1,600 people an hour’s flight north of Iqaluit, the territorial capital.
“I don’t know why they’re so secretive,” said Madeleine Qumuatuq, Pangnirtung’s community wellness co-ordinator. “You can’t be secretive and then do prevention. I mean, they’ve got to be truthful to us.”
Ms. Qumuatuq was one of several Pangnirtung residents who raised concerns about the pace of the government’s response to the TB outbreak. She pointed out that the health department rented the community hall – one of Pangnirtung’s few public spaces – beginning March 1 for a satellite TB clinic that still isn’t up and running.
“We’re missing out on a lot of age groups that would normally be coming here to play checkers, pool, whatever it might be. And the teenagers hang out here,” she said. “All that is taken away because they’ve rented the space. But they’re not even here yet.”
Danarae Sommerville, a spokesperson for the Nunavut Department of Health, said by e-mail that the delay has been caused by a shortage of skilled workers “required to ensure the Hamlet building has the appropriate wiring and network to set up workstations for staff.” Those workers were waylaid responding to the aftermath of a fire that consumed a government building in another hamlet, she added.
In responses to earlier questions about the outbreak, she pointed out that the Department of Health sent extra nurses and other front-line staff to Pangnirtung to help manage the outbreak – no easy feat during a national nursing shortage exacerbated by the pandemic.
Active tuberculosis infections, which are caused by bacteria that spread through the air and usually lodge in the lungs, can cause fever, weight loss, night sweats, fatigue and a chronic, sometimes bloody cough. Antibiotics can cure active TB and prevent latent cases from turning into serious disease. The infection can be fatal if left untreated.
Tuberculosis is a disease that most Canadians think of as a scourge of the past. But it remains a scourge of the present in Indigenous communities, particularly Inuit communities, where deep-seated poverty, overcrowded housing and limited access to medical care make residents particularly vulnerable.
The federal Liberal government, along with Inuit Tapiriit Kanatami, a national Inuit organization, promised in 2018 to eliminate TB in Inuit communities by 2030.
The most recent data from the Public Health Agency of Canada show there were 72.2 active cases of TB per 100,000 population among Inuit people in 2020, compared with a national case rate of 4.7 per 100,000.
Despite being 15 times higher than the national average, the TB rate among Inuit in 2020 was down significantly, from 188.7 cases per 100,000 in 2019 and from a 10-year annual average of 184.14 per 100,000 from 2010 to 2019. The decline likely reflects cases of TB going undiagnosed in the first year of the pandemic, experts on the disease have said.
Nunavut, which is home to the majority of Inuit in Canada, recorded 34 active cases across the territory in 2020, or 86.40 per 100,000, down from an average of 66 active cases per year territory-wide over the previous four years.
In February, Nunavut’s privacy commissioner ruled in The Globe’s favour after the newspaper appealed the territorial government’s refusal to release TB case counts by community, age and gender.
But privacy commissioner decisions aren’t binding in Nunavut. Health Minister John Main rejected the call to release community-level data, saying at the time that doing so could risk identifying patients and stigmatizing entire communities.
Neither Mr. Main nor Dr. Patterson were available for interviews Thursday.
Chris Puglia, another spokesperson for the Nunavut Department of Health, said in an e-mail that the department doesn’t plan to release TB data by hamlet, except during outbreaks. “Community level data outside an outbreak does not offer additional protection to public health and could further stigmatize the disease and create hesitancy in people seeking testing,” he wrote.
He added that Dr. Patterson’s office decided to compromise in the case of Pangnirtung and release updates every three months that “might assist in outbreak management.” The Department of Health released community-level data during Nunavut’s last major TB outbreak, in Qikiqtarjuaq in 2017-2018. A 15-year-old girl died in that outbreak.
Nunavut Privacy Commissioner Graham Steele said the government should go further and follow his ruling on TB data.
“I continue to believe that the law requires that community-level numbers be released, and not only at a time and place selected by the government,” he said Thursday. “It’s hard to hold the government to account for tuberculosis policy when it holds all the numbers in secret.”
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Monkeypox stigma can spread ‘like a virus,’ LGBTQ advocates say – Global News
Advocates warn that stigma could pose a public health threat as a cluster of monkeypox cases stokes concern in the queer community.
Health authorities are investigating more than two dozen confirmed monkeypox cases in Canada as part of an unprecedented outbreak of the rare disease that seldom spreads outside Africa.
Twenty-five infections have been confirmed in Quebec, in addition to one in Ontario, the Public Health Agency of Canada said Thursday, predicting the tally will rise in coming days.
While everyone is susceptible to the virus, clusters of cases have been reported among men who have sex with men, officials say.
For some LGBTQ advocates, this raises the spectre of sexual stigmatization that saw gay and bisexual men scapegoated for the rise of the HIV-AIDS epidemic.
Others say the early detection of the monkeypox cases by sexual health clinics shows how the queer community has mobilized to dismantle shame and promote safe practices.
Quebec confirms 25 cases of monkeypox, plans to administer vaccine
Canada’s deputy chief public health officer said he’s mindful of the potential for stigma and discrimination, reiterating that the virus’s spread isn’t limited to any specific group or sexual orientation.
But as early signs suggest that the virus is circulating in certain communities, authorities are working to raise awareness among those at elevated risk of exposure, Dr. Howard Njoo told a news conference Thursday.
The disease can be contracted through close contact with a sick person, including but not limited to sexual activity, said Njoo. Scientists are still working to determine what’s driving cross-border transmission of the virus.
Aaron Purdie, executive director of the Health Initiative for Men in B.C., said he worries that the spread of fear and stigma could present a greater threat than the disease itself.
“Stigma spreads like a virus,” Purdie said. “Yes, it’s treatable. Yes, it’s containable. But it spreads nonetheless.”
Stigma can be a major hurdle to effective disease prevention and treatment, particularly for gay men who have suffered systemic discrimination by the health-care system, said Purdie.
Dane Griffiths, director of the Gay Men’s Sexual Health Alliance of Ontario, said silence tends to perpetuate stigma, so one of the best strategies to combat it is to provide timely and accurate information without “shame or blame.”
The identification of monkeypox cases in men who have sex with men speaks to the success of community-led efforts to improve access to sexual health testing and care, said Griffiths.
“There are gay and bisexual men who have been showing up around the world at clinics and doctor’s offices and are being seen and therefore counted,” said Griffiths. “That’s a good thing, and it’s actually to be encouraged within our community.”
© 2022 The Canadian Press
Monkeypox: Canada likely to see more cases – CTV News
With 26 confirmed cases of monkeypox in Canada, health officials warn there will likely be more cases reported in the coming days and weeks. However, one expert says the outbreak can be stopped if the country works quickly to get it under control.
Infectious disease expert Dr. Isaac Bogoch says that Canada will “definitely” see more cases of the virus in the “few days and weeks ahead.”
“This outbreak is going to crumble along unfortunately for a bit of time,” Bogoch told CTV’s Your Morning on Friday.
However, if health officials act quickly, Bogoch said the outbreak in Canada can be stopped.
“Currently, there’s only 26 people in a country of 38 million people and the risk of the general population today is extremely, extremely small. But let’s play our cards right. Let’s deal with this quickly and effectively so that no one else needs to get this infection and that we just get this under control,” he said.
The Public Health Agency of Canada announced on Thursday there are now 25 confirmed cases of monkeypox in Quebec, and one confirmed case in Ontario. However, the health agency says several suspected and probable cases are still being investigated.
Prior to this month, monkeypox had never been detected in Canada.
Despite the unexplained rise in cases in Canada, and a growing number in other countries such as the U.S., Spain, Portugal, and the U.K., Bogoch says Canada has the tools to “quell this quickly,” if federal and provincial health officials take a co-ordinated approach to vaccinating those at high risk.
“We have an outbreak of this right now, but there’s no reason to let this run amok and there’s no reason to have this infect many people,” he said.
PHAC said they are focusing on a “targeted approach to vaccination and treatment” amid the current outbreak, and do not believe a mass vaccination campaign is necessary.
There is no proven treatment for the virus infection, but the smallpox vaccine is known to also protect against monkeypox, with a greater than 85 per cent efficacy. Because the smallpox vaccine eradicated the disease, however, routine smallpox immunization for the general population ended in Canada in 1972.
PHAC has already supplied Quebec with 1,000 doses of the smallpox vaccine Imvamune from Canada’s National Emergency Strategic Stockpile. Because of the limited supply, it is not yet clear who will be eligible for the vaccines, but Bogoch said they will likely be reserved for close contacts and health-care workers.
Bogoch said if vaccines are issued to high-risk groups quickly, officials “can certainly prevent the spread of this and fewer Canadians need to be impacted.”
WHAT TO KNOW ABOUT MONKEYPOX
First discovered in 1958, monkeypox is a rare disease caused by a virus that belongs to the same family as the one that causes smallpox. The disease was first found in colonies of monkeys used for research.
The disease has primarily been reported in central and western African countries, with the first case outside the continent reported in 2003 in the United States.
The virus is transmitted through contact with an infected animal, human or contaminated material. Transmission between people is thought to primarily occur through large respiratory droplets, which generally do not travel far and would require extended close contact. Transmission from an animal can happen through bites or scratches, contact with an animal’s blood or body fluids.
Monkeypox symptoms are similar to those for the smallpox, but generally milder. The first signs are fever, headache, muscle aches, backaches, chills, and exhaustion.
The incubation period — the span of time between initial infection and seeing symptoms — for monkeypox is generally 6-13 days, but can range to as many as 21 days, according to PHAC.
The “pox” develops after the onset of a fever and usually occurs between one to three days later, sometimes longer. A rash usually begins on the face and spreads to other parts of the body, developing into distinct, raised bumps that then become filled with fluid or pus.
Dr. Howard Njoo, Deputy Chief Public Health Officer, said Canadians should be aware of these symptoms, and seek medical attention particularly if they have an unexplained rash.
He added that people can avoid infection by “maintaining physical distance from people outside their homes.”
“As well, wearing masks, covering coughs and sneezes, and practicing frequent handwashing continues to be important, especially in public spaces,” Njoo said.
While the overall risk of monkeypox to the general public is low, Njoo said it is important to remember that everyone is susceptible, despite most cases in the country and others appearing to be spread through sexual contact between men.
He added that more guidance on case identification and contact tracing, along with infection prevention, will be released shortly.
Monkeypox is endemic in animals in regions in Western Africa, and while cases have popped up in countries where it is not endemic before, the cases typically involved people who recently travelled from a country in Africa.
What is unusual right now is that officials in numerous countries that don’t usually deal with monkeypox are seeing cases where the patient has no travel history, Njoo said.
Due to the unexpected nature of the current outbreak, Njoo said health officials in Canada and abroad are looking at whether there are any changes from what was previously known about the rare illness, including incubation period and method of transmission.
He said global cases are “not all similar in how they’re presenting,” and said milder cases may even go undetected.
“Our understanding of the virus is still evolving, but I want to emphasize this is a global response,” Njoo said.
With files from CTVNews.ca’s Alexandra Mae Jones and Solarina Ho
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