Latest news with #PSMA
Malaysian Reserve
3 days ago
- Business
- Malaysian Reserve
Telix's Illuccix® PSMA-PET Imaging Agent Approved in Portugal
MELBOURNE, Australia, June 4, 2025 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, 'Telix', 'the Company') today announces that its prostate cancer PET[1] imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in Portugal by INFARMED[2] for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enhances the options available to healthcare providers across Portugal for PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical. Illuccix, after radiolabelling with gallium-68, is indicated in Portugal for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high-risk PCa prior to primary curative therapy. Suspected recurrent PCa in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy. Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated. PSMA-PET imaging represents a significant advancement in prostate cancer management, largely replacing conventional imaging methods such as bone scans and CT[4] scans as the standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines recognise its superior accuracy in staging primary disease and assessing BCR[5]. Illuccix® PSMA-PET will help address an important clinical need by supporting timely and effective diagnosis, as well as identifying patients who may benefit from PSMA-targeted therapy. Illuccix's broad approval is supported by robust clinical data, including the largest Ga-68-based PSMA data set from the VISION trial[6]. Despite the proven benefits of PSMA-PET imaging, patients in Portugal have faced long wait times due to tracer shortages and infrastructure constraints. Dr. Fernando Abreu, Director of Nuclear Medicine at the Santa Maria Local Health Unit, commented, 'PSMA-PET imaging has significantly enhanced the accuracy and confidence in the detection and monitoring of prostate cancer. However, Portugal is currently facing a shortage of gallium-68 tracers, which has resulted in a national waiting list of up to six months. This delay has an impact on the timely diagnoses and treatments impacting patient care. The approval of Illuccix® in Portugal will be welcomed by physicians and patients as it allows hospitals and clinics to conduct PSMA-PET scans more efficiently, and with shorter wait times.' With its broad indication, Illuccix® is designed to support healthcare providers in delivering efficient and reliable imaging. The approval comes as demand for PSMA-PET continues to grow across Europe, reinforcing the need for solutions that fit within existing hospital workflows. Illuccix® will be distributed in Portugal by Sociedade Avanço, Unipessoal, LDA (Avanço), a specialist distributor of nuclear medicine, radiotherapy technologies and urology biopsy products. 'The approval of Illuccix® in Portugal marks an important milestone, providing healthcare professionals with access to a gallium-based PSMA-PET imaging agent supported by strong clinical validation. Our partnership with Avanço will help address the current shortages of gallium tracers and enable more efficient scanning processes. This collaboration reflects Telix's ongoing commitment to expanding access to high-quality prostate cancer imaging across Europe and reducing the barriers that currently delay diagnosis and treatment.' said Raphaël Ortiz, Chief Executive Officer, Telix International. Mr. Diogo Marcos, Managing Director of Avanço added: 'We are delighted to partner with Telix for the distribution of Illuccix® in Portugal. As the official distributor of the GalliaPharm®[7] generator, currently the only generator with marketing approval in the country, we are uniquely positioned to help address the national shortage of gallium-68. Our established distribution network ensures nationwide access, and our collaboration with Telix will enable us to support physicians in delivering timely and accurate PSMA-PET imaging.' Healthcare professionals in Portugal interested in ordering Illuccix® or learning more about availability can contact comercial@ or call (+351) 214 380 690. Prostate Cancer in Portugal Prostate cancer is the most common cancer in men in Portugal, with just over 7,500 new cases diagnosed annually, and a significantly higher incidence in men than either bowel (6,092 new cases) or lung cancer (4,253 new cases). Prostate cancer is also the third most common cause of cancer death in men, with just over 2,080 men dying from their disease in Portugal in 2022[8]. About Illuccix® Telix's prostate imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the United States Food and Drug Administration (FDA)[9], by the Australian Therapeutic Goods Administration (TGA)[10], by Health Canada[11], by the Brazilian Health Regulatory Agency (ANVISA)[12], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[13], by the French National Agency for the Safety of Medicine and Health Products (ANSM)[14] and in multiple countries within the European Economic Area (EEA)[15] following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM[16]. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX). Visit for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook. Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as 'may', 'expect', 'intend', 'plan', 'estimate', 'anticipate', 'believe', 'outlook', 'forecast' and 'guidance', or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix's business; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2025 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country. [1] Positron emission tomography. [2] National Authority of Medicines and Health Products, I.P. [3] Imaging of prostate-specific membrane antigen with positron emission tomography. [4] Computed tomography. [5] European Association of Urology (EAU) Guidelines. Edn. presented at the EAU Annual Congress Paris 2024. ISBN 978-94-92671-23-3.: Prostate cancer: European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for diagnosis, treatment and follow-up. 2023: [6] ID: NCT03511664. VISION study sponsored by Endocyte, a Novartis company. Telix provided Illuccix (TLX591-CDx) for PSMA-PET imaging. [7] GalliaPharm® is a registered trademark of Eckert & Ziegler SE. [8] Global Cancer Statistics 2022: GLOBOCAN survey. Published August 2024. [9] Telix ASX disclosure 20 December 2021. [10] Telix ASX disclosure 2 November 2021. [11] Telix ASX disclosure 14 October 2022. [12] Telix ASX disclosure 18 March 2025. [13] Telix ASX disclosure 13 February 2025. [14] Telix media release 29 April 2025. [15] Czech Republic, Denmark, Finland, Ireland, Luxembourg, Malta, the Netherlands, Norway, Portugal and Sweden at time of release. [16] Telix ASX disclosure 17 January 2025. Logo – View original content:
Wall Street Journal
5 days ago
- Business
- Wall Street Journal
Novartis's Cancer Treatment Pluvicto Shows Positive Results in Trial
Novartis said Pluvicto demonstrated positive results in patients with PSMA-positive metastatic hormone-sensitive prostate cancer. The Swiss pharmaceutical company on Monday said Pluvicto showed statistically significant and clinically meaningful benefits—including combined with hormone therapy versus hormone therapy alone—with positive trend in overall survival.
Business Recorder
24-05-2025
- Business
- Business Recorder
Appeals by PSMA, member mills: CAT remands case to CCP for fresh hearing
ISLAMABAD: The Competition Appellate Tribunal (CAT), while deciding the appeals filed by the Pakistan Sugar Mills Association (PSMA) and its member mills, has remanded the case to the Competition Commission of Pakistan (CCP) for a fresh hearing in the case of cartelisation, price fixing and market manipulation. In its short order on Friday, the Tribunal directed that the matter be reheard by either the Chairperson or any other member of the Commission who was not a signatory to either of the earlier conflicting opinions, and that a final decision be issued preferably within 90 days. After the fresh hearing, the decision of the Chairperson or the assigned member will settle the matter and determine the violations of competition law by PSMA and its member sugar mills. The CCP's original 2021 order was issued by a four-member bench that was evenly split in its opinion. Two members, including former Chairperson Ms Rahat Kaunain Hassan and Member Mujatba Lodhi, supported the imposition of the penalty, while the remaining two members including Ms Bushra Naz Malik and Shaista Bano issued a dissenting opinion. To break the deadlock, the then Chairperson Rahat Kaunain exercised a casting vote under Subsection 5 of Section 24 of the Competition Act, 2010, through a note dated August 13, 2021—effectively converting the stalemate into a majority ruling that upheld the penalty. The legality of this casting vote became the central issue in the appeals. The Tribunal has now ruled that the Chairperson has no authority to exercise a casting vote in quasi-judicial proceedings under the Competition Act, 2010. As a result, the Chairperson's opinion based on the casting vote has been set aside. In its 2021 order, the CCP stated that the sugar mills were found to be collectively deciding the quantum of exports, eventually controlling the domestic supply of sugar in the relevant market during the period 2012 to 2020. The order said, 'It has been observed that there was an absence of independent, timely, and accurate information-gathering framework to provide quantitative support in the government's price controls mechanisms for essential commodities.' In August, 2021, the CCP imposed the highest-ever penalty of Rs 44 billion on PSMA and its member sugar mills for cartelisation, price fixing and market manipulation. The penalty has been imposed on the calculation of turnover of 55 sugar mills for the financial year 2019, with the PSMA facing a maximum penalty of Rs 300 million. For each of the four violations committed by the association, a penalty of Rs 75 million was imposed, resulting in a total of Rs 300 million. Meanwhile, a fixed penalty of Rs 50 million has been imposed on each of 22 sugar mills for collusively participating in the tender issued by the Utility Stores Corporation (USC) in 2010. The Commission initiated an enquiry into alleged cartelization and price in sugar industry in December 2019, which found that PSMA and its members were controlling domestic sugar supplies by coordinating on sales, stock positions, production quotas, and sharing sensitive commercial information. The CCP also found that certain mills used PSMA's platform to collectively decide on sugar supply for government tenders and even decided to cease crushing activities in a coordinated manner. The CCP conducted raids at PSMA offices and the premises of certain sugar mills, and impounded a number of evidentiary material including smart phones, computers, documents and files. The enquiry committee on examination of impounded data found that PSMA and its member mills were actively involved in discussions related to cartelization, collusive activities, and future planning to keep sugar supply limited. The Commission also found that PSMA Punjab Zone, particularly 16 sugar mills were indulged in collective decisions pertaining to purchase of sugarcane, production of sugar and sale or trade of sugar, which have restricted competition in the relevant market. Evidence available with the CCP showed that from 2012 to 2021, PSMA devised a collective strategy to reduce domestic sugar stocks through exports with the purpose to achieving desired domestic price levels. Whenever exports were allowed, price of sugar in the market increased. This is especially notable in the consecutive four months from March to June 2019 when as a consequence of sizeable export volumes, per kg price of sugar increased by Rs3/kg each month. Overall, during 2019 the cumulative price hike was Rs18/kg. Further evidence revealed that PSMA and its member mills were cognizant that exports would lead to two pronged benefits for them, export earnings and subsidy payments, and achieving desired price levels in the domestic market. Meanwhile, price data suggested that whenever the exports were made, domestic prices faced an upward pressure. Calculations showed that the benefit accrued to mills on account of rise in domestic prices due to exports alone was approximately Rs 40 billion in revenue during the period Feb-19 to Sep-19. It would relevant to add that an amount Rs 29.22 billion was also paid as subsidy. According to the CCP enquiry report, despite the depressed picture of the industry portrayed by PSMA financial statements of various companies suggested that they were making profits. Published accounts of a sample of 16 sugar mills, from 2017 to 2019, revealed that the sugar mills were earning profits from their operations. Average gross profit margins were 11%, 8% and 13% in 2017, 2018 and 2019 respectively. Average net profit margins were 2.8%, 0.4% and 2.4% respectively. It is worth mentioning that the CCP has been giving policy level recommendations time and again for a better, more efficient and competitive sugar sector in Pakistan. In its policy notes issued in 2009, 2012, and 2021, the CCP recommended the federal and provincial governments to deregulate the sugar sector, abolish minimum support, allow market forces to determine prices, and lifting restrictions on the establishment or expansion of sugar mills to encourage competition. Copyright Business Recorder, 2025
Express Tribune
24-05-2025
- Business
- Express Tribune
Tribunal overturns ruling in sugar case
Listen to article The Competition Appellate Tribunal, while deciding the appeals filed by the Pakistan Sugar Mills Association (PSMA) and its member mills, has sent back the case involving a penalty of Rs44 billion to the Competition Commission of Pakistan (CCP) for a fresh hearing. In its short order, the tribunal directed that the matter be reheard by either the chairperson or any other member of the commission who was not a signatory to the earlier conflicting opinions and a final decision should be made preferably within 90 days. The CCP's original 2021 order was issued by a four-member bench that was evenly split. Two members, including the then chairperson Rahat Kaunain Hassan and member Mujatba Lodhi, supported the imposition of the penalty while the remaining two including Bushra Naz Malik and Shaista Bano wrote a dissenting note. To break the deadlock, the then chairperson exercised the "casting vote" under sub-section 5 of Section 24 of the Competition Act 2010 through a note dated August 13, 2021, effectively converting the stalemate into a majority ruling that upheld the penalty. The legality of the casting vote became the central issue in the appeals filed by millers. The tribunal has ruled that the chairperson has no authority to exercise a casting vote in quasi-judicial proceedings under the Competition Act. As a result, the chairperson's opinion based on the casting vote has been set aside. After fresh hearing, the decision of the chairperson or the assigned member will settle the matter and determine the violation of competition law by the PSMA and its member mills. The appellate tribunal has recently become fully functional following the federal government's appointment of a new chairman, allowing the tribunal to resume hearing on several long-pending appeals. In the sugar cartel case, the CCP had imposed penalties of Rs44 billion on the millers' association and 81 of its members. PSMA and its members had allegedly formed a cartel to manipulate prices and had collectively decided to export the sweetener. The CCP passed the order for violating Section 4 of the Competition Act.
Business Recorder
23-05-2025
- Business
- Business Recorder
Rs44bn penalty on sugar mills: CAT remands case to CCP for rehearing
The Competition Appellate Tribunal (CAT) remanded on Friday the Pakistan Sugar Mills Association (PSMA) and its member mills case to the Competition Commission of Pakistan's (CCP) for a fresh hearing. As per CCP, the decision was taking while hearing the appeals filed by PSMA and its member mills. In its order, the CAT directed that the matter be reheard by either the Chairperson or any other member of the Commission who was not a signatory to either of the earlier conflicting opinions. It also directed that a final decision be issued preferably within 90 days. Following the tribunal's order, the decision of the Chairperson or the assigned member will settle the matter and determine the violations of competition law by PSMA and its member sugar mills. In 2021, the CCP imposed the largest amount of penalty of nearly Rs44 billion (approximately above US$265 million) on 55 sugar mills and the PSMA for allegedly committing cartelisation, carrying out anti-competitive activities, collectively deciding the quantum of exports, etc. The CCP's four-member bench had issued its order that was evenly divided in its opinion. Chairperson Rahat Kaunain Hassan and Mujatba Lodhi supported the imposition of the penalty, while Bushra Naz Malik and Shaista Bano issued a dissenting opinion. In order to break the deadlock, the then Chairperson exercised a casting vote under Subsection 5 of Section 24 of the Competition Act, 2010, through a note dated August 13, 2021—effectively converting the stalemate into a majority ruling that upheld the penalty. The legality of this decision by Rahat became the central issue in the appeals. In its order today, the CAT has ruled that the chairperson has no authority to exercise a casting vote in quasi-judicial proceedings under the Competition Act, 2010. As a result, the Chairperson's opinion based on the casting vote has been set aside.
