Latest news with #AustralianTherapeuticGoodsAdministration
Business Times
18-07-2025
- Health
- Business Times
How safe are the chemicals in sunscreen?
LAST week, the Australian Therapeutic Goods Administration (TGA) released its safety review of seven active ingredients commonly used in sunscreens. It found five were low-risk and appropriate for use in sunscreens at their current concentrations. However, the TGA recommended tighter restrictions on two ingredients – homosalate and oxybenzone – to reduce how much can be used in a product. This is based on uncertainty about their potential effects on the endocrine system, which creates and releases hormones. This news, together with recent reports that some products may have inflated their claims of SPF coverage, might make consumers worried about whether their sunscreen products are working – and safe. But it's not time to abandon sunscreens. In Australia, all sunscreens must pass a strict approval process before going on the market. The TGA tests the safety and efficacy of all ingredients, and this recent review is part of the TGA's continuing commitment to safety. The greatest threat sunscreen poses to people's health is not using it. Australia has the highest incidence of melanoma and non-melanoma skin cancer worldwide, and approximately 95 per cent of melanoma cases in Australia are linked to ultraviolet (UV) exposure. Still, it's understandable people want to know what's in their products, and any changes that might affect them. So let's take a closer look at the safety review and what it found. A NEWSLETTER FOR YOU Friday, 2 pm Lifestyle Our picks of the latest dining, travel and leisure options to treat yourself. Sign Up Sign Up What are the active ingredients in sunscreen? There are two main types of sunscreen: physical and chemical. This is based on the different active ingredients they use. An active ingredient is a chemical component in a product that has an effect on the body – basically, what makes the product 'work'. In sunscreens, this is the compound that absorbs UV rays from the sun. The other ingredients – for example, those that give the sunscreen its smell or help the skin absorb it – are 'inactive'. Physical sunscreens typically use minerals, such as titanium dioxide and zinc oxide, that can absorb the sun's rays but also reflect some of them. Chemical sunscreens use a variety of chemical ingredients to absorb or scatter UV light, both long wave (UVA) or short wave (UVB). The seven active ingredients in this review are in chemical sunscreens. Why did the TGA do the review? Australia's current limits for the concentrations of these chemicals in sunscreen are generally consistent with other regulatory agencies, such as the European Union and the US Food and Drug Administration. However, safety is an evolving subject. The TGA periodically reexamines the safety of all therapeutic goods. Last year, the TGA revised its method of estimating sunscreen exposure to more closely model how skin is exposed to sunscreens over time. This model considers how much sunscreen someone typically applies, how much skin they cover (whole body versus face and hands, or just face) and how it's absorbed through the skin. Given this new model – along with changes in the EU and US approaches to sunscreen regulation – the TGA selected seven common sunscreen ingredients to investigate in depth. Determining what's safe When evaluating whether chemicals are safe for human use, testing will often consider studies in animals – especially when there is no or limited data on humans. These animal tests are done by the manufacturers, not the TGA. To take into account any unforeseen sensitivity humans may have to these chemicals, a 'margin of safety' is built in. This is typically a concentration 50 to 100 times lower than the dose at which no negative effect was seen in animals. The sunscreen review used a margin of safety 100 times lower than this dose as the safety threshold. For most of the seven investigated sunscreen chemicals, the TGA found the margin of safety was above 100. This means they're considered safe and low-risk for long-term use. However, two ingredients, homosalate and oxybenzone, were found to be below 100. This was based on the highest estimated sunscreen exposure, applied to the body at the maximum permitted concentration: 15 per cent for homosalate, 10 per cent for oxybenzone. At lower concentrations, other uses – such as just the hands and face – could be considered low-risk for both ingredients. What are the health concerns? Homosalate and oxybenzone have low acute oral toxicity – meaning you would need to swallow a lot of it to experience toxic effects, nearly half a kilogram of these chemicals – and don't cause irritation to eyes or skin. There is inconclusive evidence about oxybenzone potentially causing cancer in rats and mice – but only at concentrations to which humans will never be exposed via sunscreens. The key issue is whether the two ingredients affect the endocrine system. While effects have been seen at high concentrations in animal studies, it is not clear whether these translate to humans exposed to sunscreen levels. No effect has been seen in clinical studies on fertility, hormones, weight gain and, in pregnant women, fetal development. The TGA is being very cautious here, using a very wide margin of safety under worst-case scenarios. What are the recommendations? The TGA recommends the allowed concentration of homosalate and oxybenzone be reduced. But exactly how much it will be lowered is complicated, depending on whether the product is intended for adults or children, specifically for the face, or the whole body, and so on. However, some sunscreens would need to be reformulated or warning labels placed on particular formulations. The exact changes will be decided after public consultation in Australia. Submissions close on Aug 12. What about benzophenone? There is also some evidence that benzophenone – a chemical produced when sunscreen containing octocrylene degrades – may cause cancer at high concentrations. This is based on studies in which mice and rats were fed benzophenone well above the concentration in sunscreens. Octocrylene degrades slowly over time to benzophenone. Heat makes it degrade faster, especially at temperatures above 40 deg C. The TGA has recommended restricting benzophenone to 0.0383 per cent in sunscreens to ensure it remains safe during the product's shelf life. The Australian Cancer Council advises storing sunscreens below 30 deg C. The bottom line The proposed restrictions are very conservative, based on worst-case scenarios. But even in worst-case scenarios, the margin of safety for these ingredients is still below the level at which any negative effect was seen in animals. The threat of cancer from sun exposure is far more serious than any potential negative effect from sunscreens. If you do wish to avoid these chemicals before new limits are imposed, several sunscreens are available that provide high levels of protection with little or no homosalate and oxybenzone. For more information, check product labels. THE CONVERSATION The writer is a senior lecturer in pharmacology at the University of Adelaide
Yahoo
26-05-2025
- Business
- Yahoo
Australia Delivers Certainty for US Biotechs in 2025: Avance Clinical Offers Fast Start-Up, Regulatory Predictability, and R&D Rebates
ADELAIDE, Australia, May 26, 2025 (GLOBE NEWSWIRE) -- As regulatory uncertainty grows in the United States, US biotechs are increasingly looking to Australia as a stable and predictable launchpad for early-phase clinical trials. With its globally accepted regulatory framework, accelerated timelines, and 43.5% R&D rebate, Australia offers a compelling advantage — and Avance Clinical, Australia's leading early-phase specialist CRO, is delivering the GlobalReady solution to help biotechs de-risk, conserve capital and accelerate their programs. 'In today's capital-constrained biotech environment, sponsors need solutions that deliver speed, predictability, quality, and capital efficiency,' said Ben Edwards, Chief Operating Officer at Avance Clinical. 'Australia is a smart strategic choice — it allows biotechs to start faster, control costs, reduce burn rate, and generate FDA-accepted data without the delays and complexity of the US IND process in a Phase I setting.' Through its GlobalReady program, Avance Clinical enables biotech sponsors to rapidly initiate early phase trials in Australia — often within 5 to 6 weeks — without the need for an open IND. The company's deep regulatory and scientific expertise ensures that data generated under the Australian Therapeutic Goods Administration (TGA) framework is accepted by the FDA and other major regulatory agencies worldwide. In addition to regulatory speed and data quality, Australia offers a unique fiscal advantage with its 43.5% R&D tax rebate, significantly reducing early clinical trial costs — a major incentive for venture-backed biotech companies managing limited runway. As part of its GlobalReady model, Avance Clinical also facilitates expansion into Asia, where its newly signed partnerships with leading Taiwanese and South Korean clinical sites offer biotechs access to large, treatment-naïve patient populations — essential for fast Phase II and III recruitment. For later-phase trials, Avance Clinical also provides a seamless expansion to its US-based operational and regulatory teams, ensuring continuity, quality oversight, and alignment with sponsor expectations throughout the development lifecycle. "Our model is built specifically for biotechs — agile, science-driven, capital efficient and globally integrated," said Edwards. "From Australia to Asia to the US, we provide a single CRO partner to guide clinical programs from first-in-human to regulatory submission." Avance Clinical will be showcasing its GlobalReady capabilities at two major US conferences: the 2025 ASCO Annual Meeting in Chicago, 30 May – 3 June, and BIO International 2025 in Boston, 16 – 19 June. To schedule a meeting with the team, please visit About Avance Clinical Avance Clinical is a leading full-service CRO offering biotech companies faster, more flexible, and higher-quality clinical trial services. Headquartered in Australia, Avance Clinical delivers globally accepted data across Australia, New Zealand, Asia, North America, and Europe. With over 30 years of experience and expertise in more than 250 indications, the company specializes in early to late-phase clinical trials, providing comprehensive support from pre-clinical consulting through to Phase I-II studies. Discover Avance Clinical's Australian Advantage and Asia Advantage Get into clinic faster with Avance Clinical's ClinicReady service Learn about Avance Clinical's GlobalReady model for biotechs Speak with our scientific experts about your upcoming study Book a meeting or request a proposal For media enquiries, email media@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
22-05-2025
- Health
- Yahoo
Lilly's Kisunla marketing for Alzheimer's authorised in Australia
Eli Lilly and Company has received marketing authorisation from the Australian Therapeutic Goods Administration (TGA) for Kisunla (donanemab) to treat mild cognitive impairment and mild dementia due to Alzheimer's disease in the adult population. This authorisation allows for the intravenous infusion of Kisunla every four weeks to treat the condition. The drug is specifically indicated for those who are Apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. Kisunla is be the first amyloid-targeting therapy for Alzheimer's registered in the country. Kinsunla can reduce amyloid plaques, created by the clumping of naturally occurring amyloid proteins, potentially slowing the functional and cognitive decline in those with early symptomatic Alzheimers's. The decision to register the therapy was supported by data from the Phase III TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 trials. The TRAILBLAZER-ALZ 2 trial showcased the therapy's efficacy, slowing cognitive and functional decline against a placebo at 18 months and minimising disease progression risk by 39% over the same time. The approved titration schedule in the country, based on the TRAILBLAZER-ALZ 6 trial, significantly minimises the incidence of amyloid-related imaging abnormalities (ARIA) with oedema/effusion at 24 weeks against the original dosing schedule while maintaining Kisunla's plaque-reducing and plasma P-tau217-lowering abilities. Eli Lilly has also submitted this modified schedule for regulatory review in other countries. Kisunla has been approved in Australia, Bahrain, Brazil, China, Japan, Kuwait, Mexico, Qatar, Singapore, Taiwan, the UK, the United Arab Emirates and the US. Eli Lilly and Company executive vice-president and Lilly International president Ilya Yuffa stated: "It is exciting to see Kisunla's marketing authorisation in Australia, marking it as the 13th regulatory authorisation. 'In our TRAILBLAZER-ALZ 2 Phase III study, results showed that Kisunla significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer's, which allowed them more time to do things that mattered most to them, like remember information, make meals, manage finances and maintain independence.' Eli Lilly had previously announced an expansion of its partnership with Purdue University, with a planned investment of up to $250m over the next eight years to accelerate innovation across the pharma pipeline. "Lilly's Kisunla marketing for Alzheimer's authorised in Australia" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
21-05-2025
- Health
- Yahoo
Lilly's Kisunla (donanemab) receives marketing authorization in Australia for the treatment of early symptomatic Alzheimer's disease
The authorization in Australia is for adult patients who are Apolipoprotein E-ε4 heterozygotes or non-carriers INDIANAPOLIS, May 21, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the Australian Therapeutic Goods Administration (TGA) has granted marketing authorization for Kisunla (donanemab), an injection for intravenous infusion every four weeks to treat mild cognitive impairment and mild dementia due to Alzheimer's disease in adults who are Apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. Kisunla is the first amyloid-targeting therapy for people with Alzheimer's registered in Australia and the only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed. Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. Kisunla can help remove the excessive buildup of amyloid plaques and help slow the cognitive and functional decline in patients with early symptomatic Alzheimer's disease. "It is exciting to see Kisunla's marketing authorization in Australia, marking it as the 13th regulatory authorization. In our TRAILBLAZER-ALZ 2 Phase 3 study, results showed that Kisunla significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer's disease, which allowed them more time to do things that mattered most to them like remember information, make meals, manage finances, and maintain independence," said Ilya Yuffa, executive vice president and president of Lilly International, Eli Lilly and Company. "As our data showed, the earlier patients are identified, diagnosed, and treated with Kisunla, the greater their response to treatment." It's estimated that 600,000 Australians are currently living with Alzheimer's disease,1 with approximately 450,000 of these individuals in the early stages of the disease who could be assessed to determine eligibility for treatment with Kisunla.4 Alzheimer's disease is the third leading cause of death in Australia.1 The registration of Kisunla in Australia was based on the TRAILBLAZER-ALZ 2 Phase 3 and TRAILBLAZER-ALZ 6 clinical trial data. The TRAILBLAZER-ALZ 2 study demonstrated that Kisunla significantly slowed cognitive and functional decline — characterized by more significant memory and thinking deficits, with related impacts on daily functioning and requiring higher levels of caregiver support—by up to 35% compared to placebo at 18 months and reduced the risk of progressing to the next clinical stage of disease by 39% over the same period.3 Amyloid-related imaging abnormalities (ARIA) with edema/effusion (ARIA-E) and with hemorrhage/ hemosiderosis (ARIA-H) are side effects within the class of therapies that are usually asymptomatic, although serious and life-threatening events can rarely occur.2 Because ARIA-E can cause focal neurologic deficits that can mimic ischemic stroke, the product information in Australia includes a boxed warning that notes treatment to dissolve blood clots should be carefully considered by the patient's doctor. The titration schedule approved in Australia is based on TRAILBLAZER-ALZ 6, which demonstrated that the incidence of ARIA-E at 24 weeks was significantly lowered versus the original dosing schedule, while preserving Kisunla's ability to reduce amyloid plaque and plasma P-tau217.2 The modified titration schedule has been submitted for regulatory review in other countries. Donanemab is now approved in the United States, Japan, China, United Kingdom, UAE, Qatar, Kuwait, Bahrain, Singapore, Taiwan, Brazil, Mexico and Australia. About Kisunla In Australia, Kisunla is an amyloid-targeting treatment for people with mild cognitive impairment and mild dementia due to Alzheimer's disease in adult patients who are ApoE ε4 heterozygotes or non-carriers. Kisunla can cause serious side effects, including amyloid-related imaging abnormalities (ARIA), and infusion-related reactions. Donanemab is a prescription medicine administered intravenously every four weeks. About TRAILBLAZER-ALZ 2 StudyTRAILBLAZER-ALZ 2 (NCT04437511) was a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia due to Alzheimer's disease) with the presence of confirmed Alzheimer's disease neuropathology. The trial enrolled 1,736 participants, across 8 countries, selected based on cognitive assessments in conjunction with evidence of Alzheimer's disease pathology. The Phase 3 TRAILBLAZER-ALZ 2 study results were published in the Journal of the American Medical Association (JAMA). About TRAILBLAZER-ALZ 6 study and the TRAILBLAZER-ALZ programTRAILBLAZER-ALZ 6 (NCT05738486) was a Phase 3b, multicenter, randomized, double-blind study to investigate different dosing regimens and their effect on ARIA-E in adults with early symptomatic Alzheimer's disease. The trial enrolled 843 participants ages 60-85 selected based on cognitive assessments in conjunction with amyloid plaque imaging by PET scan. The primary endpoint results were published in Alzheimer's and Dementia. Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ 3, focused on reducing risk of progression to symptomatic AD in participants with preclinical Alzheimer's disease; and TRAILBLAZER-ALZ 5, a registration trial for early symptomatic Alzheimer's disease currently enrolling in China, Korea, Taiwan, and other geographies. INDICATION AND SAFETY SUMMARY WITH WARNINGS Kisunla (kih-SUHN-lah) is used to treat adults with early symptomatic Alzheimer's disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease. Warnings - Kisunla can cause Amyloid-Related Imaging Abnormalities or "ARIA." This is a common side effect that does not usually cause any symptoms, but serious symptoms can occur. ARIA can be fatal. ARIA is most commonly seen as temporary swelling in an area or areas of the brain that usually goes away over time. Some people may also have spots of bleeding on the surface of or in the brain and infrequently, larger areas of bleeding in the brain can occur. Although most people do not have symptoms, some people have: Headache Dizziness Nausea Difficulty walking Confusion Vision changes Seizures Some people have a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor. You may be at higher risk of developing bleeding in the brain if you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving Kisunla. Talk to your healthcare provider to see if you are on any medicines that increase this risk. Your healthcare provider will do magnetic resonance imaging (MRI) brain scans before and during your treatment with Kisunla to check you for ARIA. You should carry information that you are receiving Kisunla, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above. There are registries that collect information on treatments for Alzheimer's disease. Your healthcare provider can help you become enrolled in these registries. Warnings - Kisunla can cause serious allergic and infusion-related reactions. Do not receive Kisunla if you have serious allergic reactions to donanemab-azbt or any of the ingredients in Kisunla. Symptoms may include swelling of the face, lips, mouth, or eyelids, problems breathing, hives, chills, irritation of skin, nausea, vomiting, sweating, headache, or chest pain. You will be monitored for at least 30 minutes after you receive Kisunla for any reaction. Tell your healthcare provider right away if you have these symptoms or any reaction during or after a Kisunla infusion. Other common side effects Headache Tell your healthcare provider right away if you have any side effects. These are not all of the possible side effects of Kisunla. You can report side effects at 1-800-FDA-1088 or Before you receive Kisunla, tell your healthcare provider: About all medicines you take, including prescription and over-the-counter medicines, as well as vitamins and herbal supplements. Especially tell your healthcare provider if you have medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin). About all of your medical conditions including if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed. Kisunla has not been studied in people who were pregnant or breastfeeding. It is not known if Kisunla could harm your unborn or breastfeeding baby. How to receive KisunlaKisunla is a prescription medicine given through an intravenous (IV) infusion using a needle inserted into a vein in your arm. Kisunla is given once every 4 weeks. Each infusion will last about 30 minutes. Learn more For more information about Kisunla, call 1-800-LillyRx (1-800-545-5979) or go to This summary provides basic information about Kisunla. It does not include all information known about this medicine. Read the information given to you about Kisunla. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Kisunla. Your healthcare provider is the best person to help you decide if Kisunla is right for you. DN CON BS APP Please see full Prescribing Information including boxed warning for ARIA and Medication Guide for Kisunla. Trademarks and Trade NamesAll trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. About LillyLilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit and or follow us on Facebook, Instagram and LinkedIn. P-LLY Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Kisunla (donanemab-azbt) as a treatment for people with early symptomatic Alzheimer's disease, the supply and commercialization of Kisunla, and future readouts, presentations, and other milestones relating to Kisunla and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study findings to date, that Kisunla will receive additional regulatory approvals or that Kisunla will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. References Diagnosis to Dignity – A Vision for Alzheimer's Disease in Australia. Evohealth. October 2024. Wang, H., Nery, E. S. M., Ardayfio, P., Khanna, R., Svaldi, D. O., Gueorguieva, I., Shcherbinin, S., Andersen, S. W., Hauck, P. M., Engle, S. E., Brooks, D. A., Collins, E. C., Fox, N. C., Greenberg, S. M., Salloway, S., Mintun, M. A., & Sims, J. R. (2025). Modified titration of donanemab reduces ARIA risk and maintains amyloid reduction. Alzheimer S & Dementia, 21(4). Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023;330(6):512-527. doi:10.1001/jama.2023.13239. Eli Lilly Australia. Data on file. Refer to: Gina Goodenough, 463-304-2167 (Media) Michael Czapar; czapar_michael_c@ 317-617-0983 (Investors) View original content to download multimedia: SOURCE Eli Lilly and Company Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
