Latest news with #ProjectOrbis
Toronto Star
13-05-2025
- Health
- Toronto Star
Ontario government aims to fast-track cancer drugs in new pilot project
The province is planning to pilot a new program to get the latest cancer drugs to patients at least nine months faster. Premier Doug Ford had been urging other provincial and territorial leaders to join Ontario in trying to fast-track life-saving drugs. Canada has one of the slowest rates of getting new medications to patients because of the length of time for approval as well as negotiations with pharmaceutical companies — which in some cases can be up to two years longer than other countries. ARTICLE CONTINUES BELOW Last summer, Ford said the issue would be a priority for him as chair of the Council of the Federation, but is now saying Ontario will go it alone with a new, three-year pilot that in essence will combine the approval and negotiation stages. 'Ensuring timely patient access to new and life-saving medicines is a fundamental priority we all share,' Health Minister Sylvia Jones wrote in a letter to her provincial and territorial counterparts. While other provinces are on board with the idea, there are 'jurisdictional concerns' so Ontario plans to move ahead on its own, she said. 'For Ontario, this was a very clear priority identified by Premier Doug Ford at the 2024 Summer Council of the Federation (COF) meeting in Nova Scotia. Since then, my officials have explored multiple implementation options, guided by a patient-first approach. With this in mind, Ontario intends to proceed with the pilot project beginning in Spring 2025,' Jones wrote. 'Patient access to life-saving medicines remains our paramount concern. At the same time, we are committed to ensuring that appropriate guardrails are in place to address any concerns and uphold shared standards of safety, cost-effectiveness and equity.' Ontario's move comes amid promises from Ottawa to also address the delay. During the election, Prime Minister Mark Carney pledged that, if elected, his government would 'significantly reduce wait times for life-saving medications … Canadian patients wait too long for public access to medicines following Health Canada approval, putting us behind other G7 countries' and promised to cut red tape without compromising safety. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW The Ontario pilot will include 'select high priority cancer drugs' that are approved and part of Project Orbis, an international effort to co-ordinate efforts between countries to get medications approved and fast-tracked out to patients. In Canada, it can take up to two years to get medications approved and out to the public, when other countries can do it in half the time. In a letter last year to the pan-Canadian Pharmaceutical Alliance, founded by the country's premiers, Ford noted that 'Canada currently ranks last in the G7 in the time it takes to approve and provide patients access to innovative and often life-saving medicines.' 'This needs to change,' Ford wrote. 'We owe it to Canadians to do everything we can to give them the same timely access to life-changing treatments as patients in the rest of the world.' Ontario Ontario hospitals spent over $9B on agency staff over 10 years, study finds The Canadian Centre for Policy Alternatives study, released Monday, examined financial Experts, however, have said the holdup is often pharmaceutical companies, who choose when to apply for a drug to enter a market, and given Canada's size — it is the ninth largest market after counties such as the U.S., Europe and Japan — it is often not a priority. After Health Canada approval, provincial governments negotiate a price together through a lengthy assessment process. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW Experts had said more resources to ensure priority approval could help ease that wait time. Cancer groups have been urging governments to act, saying patients are desperate for life-saving treatments. The issue is personal for Ford, who lost his younger brother Rob Ford, a former Toronto mayor, to cancer almost a decade ago. Politics Headlines Newsletter Get the latest news and unmatched insights in your inbox every evening Error! Sorry, there was an error processing your request. There was a problem with the recaptcha. Please try again. Please enter a valid email address. Sign Up Yes, I'd also like to receive customized content suggestions and promotional messages from the Star. You may unsubscribe at any time. By signing up, you agree to our terms of use and privacy policy. This site is protected by reCAPTCHA and the Google privacy policy and terms of service apply. Politics Headlines Newsletter You're signed up! You'll start getting Politics Headlines in your inbox soon. Want more of the latest from us? Sign up for more at our newsletter page.
New York Times
25-04-2025
- Health
- New York Times
David Paton, Creator of Flying Eye Hospital, Dies at 94
David Paton, an idealistic and innovative ophthalmologist who started Project Orbis, converting a United Airlines jet into a flying hospital that took surgeons to developing countries to operate on patients and educate local doctors, died on April 3 at his home in Reno, Nev. He was 94. His death was confirmed by his son, Townley. The son of a prominent New York eye surgeon whose patients included the Shah of Iran and the financier J. Pierpont Morgan's horse, Dr. Paton (pronounced PAY-ton) was teaching at the Wilmer Eye Institute at Johns Hopkins University in the early 1970s when he became discouraged by increasing cases of preventable blindness in far-flung places. 'More eye doctors were needed,' he wrote in his memoir, 'Second Sight: Views from an Eye Doctor's Odyssey' (2011), 'but equally important was the need to beef up the existing doctors' medical education.' But how? He considered shipping trunks of equipment — almost the way a circus would — but that presented logistical challenges. He pondered the possibility of using a medical ship like the one that Project Hope, a humanitarian group, sent around the world. That was too slow for him. 'Shortly after the first moon landing in 1969, thinking big was becoming a reality,' Dr. Paton wrote. And then a moonshot idea struck him: 'Could an aircraft be the answer? A large enough aircraft could be converted into an operating theater, a teaching classroom and all the necessary facilities.' All he needed was a plane. He asked the military to donate one, but that was a nonstarter. He approached several universities for the money to buy one, but administrators turned him down, saying the idea wasn't feasible. 'David was willing to take risks that others wouldn't,' Bruce Spivey, the founding president of the American Academy of Ophthalmology, said in an interview. 'He was charming. He was inspiring. And he didn't quit.' Dr. Paton decided to raise funds on his own. In 1973, he founded Project Orbis with a group of wealthy, well-connected society figures like the Texas oilman Leonard F. McCollum and Betsy Trippe Wainwright, the daughter of the Pan American World Airways founder Juan Trippe. In 1980, Mr. Trippe helped persuade the United Airlines chief executive Edward Carlson to donate a DC-8 jet. The United States Agency for International Development contributed $1.25 million to convert the plane into a hospital with an operating room, recovery area and a classroom equipped with televisions, so local medical workers could watch surgeries. Surgeons and nurses volunteered their services, agreeing to spend two to four weeks abroad. The first flight, in 1982, was to Panama. The plane then went to Peru, Jordan, Nepal and beyond. Mother Teresa once visited. So did the Cuban leader Fidel Castro. In 1999, The Sunday Times of London's magazine sent a reporter to Cuba to write about the plane, now known as the Flying Eye Hospital. One of the patients who arrived was a 14-year-old girl named Julia. 'In developed nations, Julia's condition would have been little more than an irritation,' The Sunday Times article said. 'It is almost certain she had uveitis, an inflammation inside the eye, which can be cleared with drops. In Britain, even cats are easily treated.' Her doctor was Edward Holland, a prominent eye surgeon. 'Holland uses tiny knives to make openings that allow him to get his instruments into the eye, and soon he is pulling at Julia's scar tissue,' The Sunday Times article said. 'As the tissue is pulled away, a dark and liquid pupil, unseen for a decade, is revealed. It is an intimate and moving moment; this is medicine's chamber music. Next, he breaks up and removes the cataract, and implants a lens so that the eye will keep its shape.' The Cuban ophthalmologists watching in the viewing room applauded. But after the surgery, Julia still couldn't see. 'And then a minor miracle begins,' the article said. 'As the swelling begins to go down, she makes discoveries about the world around her. Minute by minute she can see something new.' David Paton was born on Aug. 16, 1930, in Baltimore, and grew up in Manhattan. His father, Richard Townley Paton, specialized in corneal transplants and founded the Eye-Bank for Sight Restoration. His mother, Helen (Meserve) Paton, was an interior designer. In his memoir, he described growing up 'among the fine, intellectually sharp, widely traveled persons of the Establishment.' His father practiced on Park Avenue. His mother threw parties at their home on the Upper East Side. David attended the Hill School, a boarding school in Pottstown, Pa. There, he met James A. Baker III, a Texan who later became secretary of state for President Ronald Reagan. They were roommates at Princeton University and lifelong best friends. 'David came from a very privileged background, but he was down to earth and just a very likable guy,' Mr. Baker said in an interview. 'He had his objectives in life straight. He was a hell of a lot better student than I was.' After graduating from Princeton in 1952, David earned his medical degree from Johns Hopkins University. He worked in senior positions at the Wilmer Eye Institute and served as chairman of the ophthalmology department at the Baylor College of Medicine in Houston. In 1979, while still trying to procure a plane for Project Orbis, he became the medical director of the King Khaled Eye Specialist Hospital in Riyadh, Saudi Arabia. 'Among my duties,' he wrote in his memoir, 'was providing eye care for many of the princes and princesses of the kingdom — about 5,000 of each, I was told — and it seemed that all of them insisted on being treated exclusively by the doctor in charge, no matter how minor their complaint.' Dr. Paton's marriages to Jane Sterling Treman and Jane Franke ended in divorce. He married Diane Johnston in 1985. She died in 2022. In addition to his son, he is survived by two granddaughters. Dr. Paton left his role as medical director of Project Orbis in 1987, after a dispute with the board of directors. That year, President Ronald Reagan awarded him the Presidential Citizens Medal. Although his official connection with the organization had ended, he occasionally served as an informal adviser. Now called Orbis International, the organization is on its third plane, an MD-10 donated by Federal Express. From 2014 to 2023, Orbis performed more than 621,000 surgeries and procedures, according to its most recent annual report, and offered more than 424,000 training sessions to doctors, nurses and other providers. 'The plane is just such a unique venue,' Dr. Hunter Cherwek, the organization's vice president of clinical services and technologies, said in an interview. 'It was just an incredibly bold and visionary idea.'
![Norgine welcomes TGA registration in Australia of IFINWIL® (eflornithine) for adults and children diagnosed with high-risk neuroblastoma (HRNB)[1]](/_next/image?url=https%3A%2F%2Fall-logos-bucket.s3.amazonaws.com%2Fapnews.com.png&w=48&q=75){kind=small}
Associated Press
17-04-2025
- Business
- Associated Press
Norgine welcomes TGA registration in Australia of IFINWIL® (eflornithine) for adults and children diagnosed with high-risk neuroblastoma (HRNB)[1]
UXBRIDGE, England, April 17, 2025 /CNW/ -- Norgine is pleased to announce that the Australian Therapeutic Goods Administration (TGA) has approved the registration of IFINWIL® (eflornithine) for the treatment of adults and paediatric patients with high-risk neuroblastoma (HRNB), who have responded to prior multiagent, multimodality therapy.1 Neuroblastoma Australia welcomed the news today: 'On behalf of all families of children impacted by neuroblastoma, we welcome the TGA's decision to approve IFINWIL®. We urgently need treatments for children diagnosed with neuroblastoma and this milestone marks a step in the right direction towards a better future for children and their families. We thank the Federal Government for taking action to ensure access and we look forward to continued support for children with aggressive cancers.' said Lucy Jones, CEO Neuroblastoma Australia. High Risk Neuroblastoma is a rare but aggressive form of cancer, predominantly affecting children and most commonly presenting in the first 5 years of life2. Each year in Australia, approximately 50 children are diagnosed with neuroblastoma, with about half of these cases being classified as high risk neuroblastoma3,4. Neuroblastoma originates in the body's nerve cells (neuroblasts) and typically presents as a primary tumour in the adrenal glands5. It is considered an aggressive tumour because it often spreads to other parts of the body (metastasizes). In most cases, it has spread by the time it is diagnosed5. 'We are committed to improving the lives of children and their families living with high-risk neuroblastoma' said Gus Rudolph, General Manager, Norgine, Australia. 'This rare childhood cancer has devastating consequences for those impacted and while more needs to be done to improve treatment outcomes, we would like to recognise the TGA for their work to-date on this approval. Norgine will continue to engage with the relevant stakeholders to bring IFINWIL® to patients as quickly as possible.' 'This approval, as part of the Project Orbis initiative, represents a vital step forward in ensuring access to innovative cancer treatments for patients around the world,' said Dr. David Gillen, Chief Medical Officer, Norgine. 'By working collaboratively with international regulatory partners, we are able to help bring promising therapies to paediatric patients sooner – a goal that is especially important when time is critical. We're proud to support Project Orbis as we strive to expedite access to high-impact oncology medicines.' Receiving the TGA approval is an important milestone on the path to realising sustainable and equitable access. IFINWIL® is not currently included on the PBS. Please refer to the IFINWIL® Consumer Medicines Information (CMI) for full safety information on risks, side effects and precautions including the risk of low red blood cells (anaemia), low neutrophils (blood cells that fight infection), low platelets (clotting cells), increase in liver enzymes, and hearing loss or problems balancing.1 Notes to Editors: About IFINWIL® IFINWIL® has been investigated for use as a post maintenance treatment for high-risk neuroblastoma (HRNB) in paediatric patients with no active disease (NAD) / no evidence of disease (NED) after first line multiagent, multimodality therapy.6 IFINWIL® is a therapy that blocks an enzyme called ornithine decarboxylase (ODC) responsible for producing polyamines, which are important to tumour growth and development 7. For more information on IFINWIL®, find the CMI here: IFINWIL Consumer Medicine Information (CMI) or the Therapeutic Goods Administration at or speak to your healthcare practitioner. High-Risk Neuroblastoma (HRNB) Treatment Background Children diagnosed with HRNB undergo an intense treatment regimen that still leaves them vulnerable to relapse and death.8 Although there have been some improvements in survival, children with high risk neuroblastoma still face a 30% chance of recurrence (relapse) within the first 5 years post maintenance, and have an extremely poor prognosis and low likelihood of long term survival9 (e.g. estimates as low as 15% of patients will live for five years after relapsing).10 Avoiding relapse is key to long-term survival, and until now, there have been no approved therapies for the post maintenance treatment period in major markets outside of the United States11. About Project Orbis Project Orbis is an initiative (since May 2019) of the US FDA Oncology Center of Excellence (OCE) and provides a framework for concurrent submission and collaborative review of innovative oncology products among international regulatory authorities. It was created with the overarching goal to speed worldwide patient access to innovative cancer therapies. Project Orbis is coordinated by the FDA, and its partners include United Kingdom Medicines and Healthcare Products regulatory Agency (UK MHRA), Australia Therapeutic Goods Administration (TGA), Canada (Health Canada), Singapore (Health Sciences Authority (HSA), Switzerland (Swissmedic), Brazil (Agência Nacional de Vigilância Sanitária (ANVISA), Israel (Ministry of Health). In April 2024, Norgine submitted an application for approval of eflornithine in high-risk neuroblastoma (HRNB), via Project Orbis in Australia, Switzerland and the United Kingdom. This milestone supports Norgine's efforts to deliver patient access to eflornithine and bring a further treatment option in the field of paediatric oncology. About Norgine Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Our commitment to transforming people's lives drives everything we do, and our European experience, fully integrated infrastructure and exceptional partnership approach enable us to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped more than 25 million patients around the world in 2022 and generated €530 million in net product sales, a growth of nearly 5% over 2021. Norgine has a direct presence in 16 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world. NORGINE and the sail logo are trademarks of the Norgine group of companies. References Logo - View original content: SOURCE Norgine
![Norgine welcomes TGA registration in Australia of IFINWIL® (eflornithine) for adults and children diagnosed with high-risk neuroblastoma (HRNB)[1]](/_next/image?url=https%3A%2F%2Fall-logos-bucket.s3.amazonaws.com%2Fkoreaherald.com.png&w=48&q=75){kind=small}
Korea Herald
17-04-2025
- Business
- Korea Herald
Norgine welcomes TGA registration in Australia of IFINWIL® (eflornithine) for adults and children diagnosed with high-risk neuroblastoma (HRNB)[1]
UXBRIDGE, England, April 17, 2025 /PRNewswire/ -- Norgine is pleased to announce that the Australian Therapeutic Goods Administration (TGA) has approved the registration of IFINWIL ® (eflornithine) for the treatment of adults and paediatric patients with high-risk neuroblastoma (HRNB), who have responded to prior multiagent, multimodality therapy. 1 Neuroblastoma Australia welcomed the news today: " On behalf of all families of children impacted by neuroblastoma, we welcome the TGA's decision to approve IFINWIL ®. We urgently need treatments for children diagnosed with neuroblastoma and this milestone marks a step in the right direction towards a better future for children and their families. We thank the Federal Government for taking action to ensure access and we look forward to continued support for children with aggressive cancers." said Lucy Jones, CEO Neuroblastoma Australia. High Risk Neuroblastoma is a rare but aggressive form of cancer, predominantly affecting children and most commonly presenting in the first 5 years of life 2. Each year in Australia, approximately 50 children are diagnosed with neuroblastoma, with about half of these cases being classified as high risk neuroblastoma 3,4. Neuroblastoma originates in the body's nerve cells (neuroblasts) and typically presents as a primary tumour in the adrenal glands 5. It is considered an aggressive tumour because it often spreads to other parts of the body (metastasizes). In most cases, it has spread by the time it is diagnosed 5. "We are committed to improving the lives of children and their families living with high-risk neuroblastoma" said Gus Rudolph, General Manager, Norgine, Australia. "This rare childhood cancer has devastating consequences for those impacted and while more needs to be done to improve treatment outcomes, we would like to recognise the TGA for their work to-date on this approval. Norgine will continue to engage with the relevant stakeholders to bring IFINWIL ® to patients as quickly as possible." "This approval, as part of the Project Orbis initiative, represents a vital step forward in ensuring access to innovative cancer treatments for patients around the world," said Dr. David Gillen, Chief Medical Officer, Norgine. "By working collaboratively with international regulatory partners, we are able to help bring promising therapies to paediatric patients sooner – a goal that is especially important when time is critical. We're proud to support Project Orbis as we strive to expedite access to high-impact oncology medicines." Receiving the TGA approval is an important milestone on the path to realising sustainable and equitable access. IFINWIL ® is not currently included on the PBS. Please refer to the IFINWIL ® Consumer Medicines Information (CMI) for full safety information on risks, side effects and precautions including the risk of low red blood cells (anaemia), low neutrophils (blood cells that fight infection), low platelets (clotting cells), increase in liver enzymes, and hearing loss or problems balancing. 1 Notes to Editors: About IFINWIL ® IFINWIL ® has been investigated for use as a post maintenance treatment for high-risk neuroblastoma (HRNB) in paediatric patients with no active disease (NAD) / no evidence of disease (NED) after first line multiagent, multimodality therapy. 6 IFINWIL ® is a therapy that blocks an enzyme called ornithine decarboxylase (ODC) responsible for producing polyamines, which are important to tumour growth and development 7. For more information on IFINWIL ®, find the CMI here: IFINWIL Consumer Medicine Information (CMI) or the Therapeutic Goods Administration at or speak to your healthcare practitioner. High-Risk Neuroblastoma (HRNB) Treatment Background Children diagnosed with HRNB undergo an intense treatment regimen that still leaves them vulnerable to relapse and death. 8 Although there have been some improvements in survival, children with high risk neuroblastoma still face a 30% chance of recurrence (relapse) within the first 5 years post maintenance, and have an extremely poor prognosis and low likelihood of long term survival 9 (e.g. estimates as low as 15% of patients will live for five years after relapsing). 10 Avoiding relapse is key to long-term survival, and until now, there have been no approved therapies for the post maintenance treatment period in major markets outside of the United States 11. About Project Orbis Project Orbis is an initiative (since May 2019) of the US FDA Oncology Center of Excellence (OCE) and provides a framework for concurrent submission and collaborative review of innovative oncology products among international regulatory authorities. It was created with the overarching goal to speed worldwide patient access to innovative cancer therapies. Project Orbis is coordinated by the FDA, and its partners include United Kingdom Medicines and Healthcare Products regulatory Agency (UK MHRA), Australia Therapeutic Goods Administration (TGA), Canada (Health Canada), Singapore (Health Sciences Authority (HSA), Switzerland (Swissmedic), Brazil (Agência Nacional de Vigilância Sanitária (ANVISA), Israel (Ministry of Health). In April 2024, Norgine submitted an application for approval of eflornithine in high-risk neuroblastoma (HRNB), via Project Orbis in Australia, Switzerland and the United Kingdom. This milestone supports Norgine's efforts to deliver patient access to eflornithine and bring a further treatment option in the field of paediatric oncology. About Norgine Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Our commitment to transforming people's lives drives everything we do, and our European experience, fully integrated infrastructure and exceptional partnership approach enable us to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped more than 25 million patients around the world in 2022 and generated €530 million in net product sales, a growth of nearly 5% over 2021. Norgine has a direct presence in 16 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world.
