iProov Dynamic Liveness Is the First and Only Solution to Achieve CEN/TS 18099 High and Ingenium Level 4 for Injection Attack Detection




iProov Dynamic Liveness Is the First and Only Solution to Achieve CEN/TS 18099 High and Ingenium Level 4 for Injection Attack Detection

Establishes New Benchmark for High Identity Assurance Based on Accredited Testing of Industry Standard

LONDON–(BUSINESS WIRE)–iProov, the world’s leading provider of science-based biometric identity verification solutions, today announced that its Dynamic Liveness technology is the first and only solution to successfully achieve an Ingenium Level 4 evaluation and the CEN/TS 18099 High technical specification for Injection Attack Detection, following an independent evaluation by the ISO/IEC 17025-accredited, Ingenium Biometric Laboratories. Ingenium Level 4 builds on the requirements outlined in CEN/TS 18099, providing an increased level of assurance with an extended period of active testing and inclusion of complex, highly-weighted attack types.

As AI-generated deepfakes and injection attacks rapidly evolve, CEN/TS 18099 is helping organizations to move beyond vendor-led claims with accredited, standards-based benchmarks that provide real comparability and trust. While many biometric providers point to independent testing, too often these evaluations are conducted against proprietary frameworks that have not been developed by industry standards groups. As a result, the testing requirements are inconsistent and cannot be meaningfully compared across vendor solutions.

“In the age of deepfakes, biometric security must be proven, not promised,” said Andrew Bud, founder and CEO of iProov. “CEN/TS 18099 is the first true benchmark for injection attack detection, a requirement now included in NIST 800-63-4. Achieving Ingenium Level 4 through accredited testing sets iProov apart as the highest-assurance facial biometric provider independently validated today.”

During 40 days of intensive evaluation by Ingenium, no successful Injection Attack Method could be established, and iProov successfully blocked all attempts. Critically, this highest tier of protection was achieved while maintaining a Bona Fide Presentation Classification Error Rate (BPCER) of just 1.3%, demonstrating that statutory-grade resilience does not require sacrificing usability.

CEN Level High represents a significant benchmark for injection attack detection under the CEN/TS 18099 framework and provides organizations with a clear, accredited reference point when assessing biometric providers. Exceeding the CEN High level demonstrates that iProov is delivering a highly secure solution independently validated against one of the most demanding standards-based evaluations currently in the market.

Ingenium’s Level 4 Injection Attack Detection evaluation establishes iProov among the leading benchmark solutions for organizations looking to align with the latest NIST 800-63-4 Digital Identity Guidelines and provides a clear path for those requiring phishing-resistant, digital injection-aware security. By combining these results with FIDO Face Verification Certification, iProov provides the only independently established audit trail for the world’s most demanding regulatory environments, including the UK National Cyber Plan and the EU’s EUDI Wallet frameworks. Its solution also conforms to the Web Content Accessibility Guidelines (WCAG) 2.2 Level AA, including Section 508, delivering an inclusive user experience while achieving high performance.

For further information on iProov’s industry certifications, click here.

About iProov

iProov provides science-based biometric solutions that enable the world’s most security-conscious organizations to streamline secure remote onboarding and authentication for digital and physical access. Its award-winning liveness technology and iSOC offer unmatched resilience against deepfakes and generative AI threats while ensuring effortless, scalable user experiences. Trusted by leading governments and enterprises, including the U.S. Department of Homeland Security, U.K. Home Office, GovTech Singapore, ING, and UBS, iProov sets the standard in biometric identity assurance. Learn more at www.iproov.com.

Contacts

Louise Burke

Global PR Manager

iProov

Louise.burke@iproov.com

We Are All Sculptra: First-of-its-Kind Galderma Initiative to Demonstrate How Everyone Can Benefit from Sculptra’s Regenerative Properties




We Are All Sculptra: First-of-its-Kind Galderma Initiative to Demonstrate How Everyone Can Benefit from Sculptra’s Regenerative Properties

• Galderma unveils We Are All Sculptra, a global campaign capturing the clinical performance of Sculptra^® across nine diverse patient profiles and journeys, over two years¹
• Backed by over 25 years of clinical use, Sculptra continues to prove its versatility as a regenerative treatment that works across all three layers of the skin^2-6
• The campaign captures the patients’ clinical and emotional experiences – including before & after treatment imagery – highlighting Sculptra’s adaptability and reinforcing its role in tailored, science-backed regenerative aesthetic care¹

ZUG, Switzerland–(BUSINESS WIRE)–Galderma (SIX: GALD), the pure-play dermatology category leader, today unveiled We Are All Sculptra, a unique program designed to capture the clinical impact of Sculptra^® across nine diverse patients – who were all new to injectable aesthetics – over two years.¹ This innovative initiative will offer a rare and authentic real-life perspective on the power of regenerative biostimulation to deliver personalized outcomes, and demonstrate how Sculptra adapts to different skin types, life stages, and aesthetic goals.¹

Sculptra is the first proven regenerative biostimulator, backed by over 25 years of clinical use.^2-6 With a unique poly-L-lactic acid (PLLA-SCA™) formulation, Sculptra re-engages the skin’s renewal process, stimulating collagen and elastin for healthy looking skin.^3,7-11 Over the decades, it has evolved into a versatile treatment that delivers regenerative benefits across all three skin layers, helping to gradually restore volume, firmness, radiance and skin quality, and smoothing wrinkles and folds over time.^2,3,7-14

Through self-recorded video diaries and clinical check-ins, We Are All Sculptra will follow nine patients – who were all new to injectable aesthetics – over two years, offering a long-term view of how Sculptra performs over time.¹ Its launch captures the patients’ personal reflections, results, and before & after treatment imagery, offering a powerful lens into both clinical outcomes and emotional impact.¹

The campaign highlights the rich diversity of real patients, spanning age, gender identity, ethnicity, and skin biology.¹ Grounded in Galderma’s AART™ (Assessment, Anatomy, Range, and Treatment) methodologies and HIT™ (Holistic Individualised Treatment) protocols, it demonstrates the extent to which regenerative aesthetics can be tailored to individual goals and skin needs, by combining structured clinical assessment with holistic, individualized treatment planning.¹

Whether renewing natural volume, improving skin quality, or repositioning tissue for a lifted appearance, each case will highlight Sculptra’s adaptability across diverse indications and patient needs.¹ As well its natural, long-lasting clinical outcomes, the campaign captures the emotional resonance of treatment, with improved confidence, self-recognition, and wellbeing seen throughout the group, while also leaving them with a positive first impression of aesthetic treatments.¹

Learn more about We Are All Sculptra here.

About Sculptra

Sculptra is the first proven regenerative biostimulator, with a unique poly-L-lactic acid (PLLA-SCA™) formulation, to provide progressive and sustained regenerative effect across all three skin layers.^2-6 Sculptra reverses aging processes in the skin, including degradation of the extracellular matrix, which results in volume loss, laxity, and the appearance of wrinkles.^2,15-18 Sculptra progressively rebuilds the skin’s structural foundation by encouraging the remodeling of components of the extracellular matrix, such as elastin and collagen, helping to gradually restore volume, firmness, radiance and skin quality, and the look of fullness to wrinkles and folds over time.^8-11 Sculptra has been shown to provide visible improvements as early as one month after treatment, with results lasting up to two years.^2,17,19,20

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References

Contacts

For further information:
Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com
+41 76 315 26 50

Richard Harbinson

Corporate Communications Director

richard.harbinson@galderma.com
+41 76 210 60 62

Céline Buguet

Franchises and R&D Communications Director

celine.buguet@galderma.com
+41 76 249 90 87

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

emil.ivanov@galderma.com
+41 21 642 78 12

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com
+41 21 642 76 43

Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC)




Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC)

Approval expands PD-L1 testing to support treatment decisions with KEYTRUDA® (pembrolizumab)^{1, 2}

SANTA CLARA, Calif.–(BUSINESS WIRE)–$A #BringGreatScienceToLife—Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration (FDA) has approved PD-L1 IHC 22C3 pharmDx, Code SK006, as the only FDA-approved companion diagnostic indicated to aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC), whose tumors express PD-L1 and who may be eligible for treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy.

PD-L1 IHC 22C3 pharmDx, Code SK006, enables pathologists to assess PD-L1 expression at the time of diagnosis, supporting informed treatment decisions in a disease where therapeutic options remain limited for many patients. This approval marks the seventh FDA approved companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006, for use with KEYTRUDA.

Nina Green, vice president and general manager of Agilent’s Clinical Diagnostics Division, stated: “Delivering effective precision oncology requires close collaboration between diagnostics and therapeutics, and this FDA approval reflects Agilent’s long-standing industry partnership in companion diagnostics. We are proud to enable pathologists to identify patients with EOC who may benefit from immunotherapy. As the first immuno-oncology approval for this disease, this milestone underscores our commitment to advancing precision medicine and expanding access to innovative cancer treatments worldwide.”

PD-L1 expression in EOC was evaluated using PD-L1 IHC 22C3 pharmDx, Code SK006, in the KEYNOTE-B96 clinical trial supporting its use in identifying patients who may benefit from KEYTRUDA.

In the U.S., ovarian cancer caused approximately 12,730 deaths in 2025 and has a 5-year survival rate of 51.6% between 2015 to 2021³.

In addition to EOC, PD-L1 IHC 22C3 pharmDx, Code SK006, is indicated in the U.S. to help physicians identify patients with non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), cervical cancer, head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), and gastric or gastroesophageal junction (GEJ) adenocarcinoma who may benefit from treatment with KEYTRUDA.

PD-L1 IHC 22C3 pharmDx, Code SK006, was developed by Agilent in partnership with Merck & Co. (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Corrected on Feb. 11, 2026: Amended press release to align with FDA-approved KEYTRUDA indication language. See KEYTRUDA full prescribing information.

About Agilent Technologies

Agilent Technologies, Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers’ most challenging questions. The company generated revenue of $6.95 billion in fiscal year 2025 and employs approximately 18,000 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn and Facebook.

References:

1. PD-L1 IHC 22C3 pharmDx, Code SK006 [Instructions for Use]. Santa Clara, CA: Agilent Technologies, Inc.; 2026.
2. KEYTRUDA® (pembrolizumab) Merck Sharp & Dohme LLC, Rahway, NJ, USA; 2026.
3. National Cancer Institute. https://seer.cancer.gov/statfacts/html/ovary.html, accessed 8 January 2026.

Contacts

MEDIA CONTACT:
Kate Coyle

+1 302-633-7490

kate.coyle@agilent.com

New Blood Test Helps GPs Manage Brain Scan Delays, Brings Field Forward




New Blood Test Helps GPs Manage Brain Scan Delays, Brings Field Forward

GLASGOW, Scotland–(BUSINESS WIRE)–Dxcover, a global leader in innovative AI-enabled technologies, today announced the availability of its UKCA¹-approved, blood-based brain cancer early detection test in the UK.

The new validated test has demonstrated a 99.3% negative predictive value² (NPV), enabling GPs to provide earlier reassurance to symptomatic patients, inform referral into imaging, and reach an earlier diagnosis. UK-based GPs and private specialists are invited to register their interest to enable access to the test and integrate it into existing referral workflows for the triage of symptomatic patients into imaging or specialist assessment.

“To date, blood-based detection of brain malignancies has been out of reach, with too many technical challenges for other technologies,” said Matthew J. Baker, CEO and co-Founder of Dxcover. “But now a minimally invasive clinical test can help improve outcomes for patients and enable treatment developments to move faster in this space.”

Brain and central nervous system (CNS) tumours are relatively rare, with 300,000 new cases diagnosed globally each year, usually at a very serious stage with few treatment options. Five-year survival is approximately 33%, yet evidence indicates that even a one-month improvement in time to diagnosis could reduce mortality by 18–28%³.

Continued pressure on diagnostic imaging capacity means many patients presenting with neurological symptoms experience delays between initial consultation, scan referral, imaging, and definitive diagnosis. Dxcover’s blood-based test is designed to support referral decisions and prioritisation on suspected tumour pathways while patients await CT or MRI scans.

The Dxcover Liquid Biopsy Platform can deliver results in under 24 hours. For patients with a positive result, the test supports evidence-based escalation, helping to prioritise referrals, justify urgent imaging requests, and align patients more quickly to the appropriate secondary care pathway.

About Dxcover

Dxcover is changing how early, how accurately, and how efficiently cancer can be detected. The company’s platform integrates infrared spectroscopy with proprietary algorithms and other clinical information to support earlier and more actionable clinical insights from a small amount of blood, yielding results in hours instead of weeks. AI-powered insight, delivered at light speed.

Further Information: https://www.dxcover.com.

Contacts

Media Contact: info@dxcover.com

Galderma Expands Restylane® Portfolio in Japan With Launch of OBT™ Hyaluronic Acid Injectables Restylane Defyne™ and Refyne™




Galderma Expands Restylane® Portfolio in Japan With Launch of OBT™ Hyaluronic Acid Injectables Restylane Defyne™ and Refyne™

• Restylane^® Refyne™ and Restylane Defyne^™ are the first Optimal Balance Technology (OBT™) hyaluronic acid injectables ever approved and launched in Japan, bringing advanced flexibility and natural movement to the market^1,2
• This expands Galderma’s Restylane portfolio in Japan to four products, enabling treatment of a wider spectrum of patient and practitioner needs^3,4
• These two new launches underscore Galderma’s accelerating growth across the Japan & Asia Pacific (JPAC) region

ZUG, Switzerland–(BUSINESS WIRE)–Galderma (SIX: GALD), the pure-play dermatology category leader, has announced the launch of Restylane Defyne and Restylane Refyne: the first OBT‑based hyaluronic acid injectables ever authorized in Japan.^1,2 The products – designed for injection into the mid-to-deep dermis for the correction of moderate to severe facial wrinkles and folds – are now commercially available in the market.^1,2

Restylane Defyne and Refyne leverage the unique balance of softness, flexibility, and support delivered by Galderma’s proprietary OBT – designed to move in harmony with facial expressions while maintaining shape and lift – and are the first and only hyaluronic acid injectables clinically proven to restore youthful facial expressions.^1,2,5-11 Restylane Refyne offers a smooth, flexible gel, ideal for delicate, highly expressive areas, while Restylane Defyne provides support for areas such as the jawline and deeper facial folds.^1,2,5-11 These launches mark a major milestone for Galderma and represent an important chapter in its JPAC growth strategy, supporting the company’s continuing expansion in one of the region’s most dynamic aesthetics markets.

The Restylane portfolio in Japan now includes four products in total, with Refyne and Defyne joining NASHA-powered products, Restylane Classyc^™ and Restylane Lyft^™.^1-4 This versatile range enables clinicians to meet diverse patient needs, from soft, flexible formulations that smooth fine lines, to firmer gels that deliver contouring and support.^1-7,12,13

The approvals of Restylane Refyne and Defyne in Japan were based on two pivotal, double-blinded, randomized, active-controlled phase III studies investigating the products in 171 and 162 subjects, respectively. Restylane Refyne and Defyne met the studies’ endpoints, demonstrating a clinically meaningful improvement in wrinkle severity for up to 12 months, with most patients reporting at least a 1-grade improvement in self-assessment scores after six weeks.^1,2

With over 30 years of innovation and more than 77 million treatments administered worldwide, Restylane is highly relevant in addressing some of today’s most significant aesthetic trends and needs, from improving facial harmony following medication-driven weight loss to growing concerns around menopause-related skin health and aging.^5,14-17 The arrival of OBT technology in Japan now aligns the market more closely with global Restylane availability, reinforcing the brand’s position as the world’s most scientifically studied and diverse hyaluronic acid injectables range.

About the Restylane portfolio

Restylane hyaluronic acid treatments are designed differently to go beyond volumizing for natural-looking results.^4,5,18,19 Our hyaluronic acid is minimally modified and our innovative manufacturing process preserves its biocompatibility while creating individual products designed for a specific purpose.^20-22 Powered by NASHA, NASHA HD™, OBT and SB-NASHA™ technologies, Restylane offers gels with the highest firmness to the highest flexibility, enabling personalized treatments that deliver structural support, natural-looking results, and a healthy glow.^12,13,23,24 Trusted for almost three decades, our hyaluronic acid gels work in sync with your skin for 100% natural-looking results.^5-7

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References

1. Restylane^® Defyne™. IFU. Japan. Available online. Accessed February 2026
2. Restylane^® Refyne™. IFU. Japan. Available online. Accessed February 2026
3. Restylane^® Lyft™. IFU. Japan. Available online. Accessed February 2026
4. Restylane^® Classyc™. IFU. Japan. Available online. Accessed February 2026
5. Di Gregorio C, et al. 25+ years of experience with the Restylane portfolio of injectable HA fillers for facial aesthetic treatment. E-poster presented at AMWC; March 27-29, 2024; Monaco
6. Solish N, et al. Dynamics of HA fillers formulated to maintain natural facial expression. J Cosmet Dermatol. 2019;18(3):738-746. doi: 10.1111/jocd.12961
7. Philipp‐Dormston WG, et al. Perceived naturalness of facial expression after HA filler injection in nasolabial folds and lower face. J Cosmet Dermatol. 2020;19(7):1600-1606. doi: 10.1111/jocd.13205
8. Philipp‐Dormston WG, et al. Evaluating perceived naturalness of facial expression after fillers to the nasolabial folds and lower face with standardized video and photography. Dermatol Surg. 2018;44(6):826-832. doi: 10.1097/DSS.0000000000001419.
9. Galderma. Data on file. MA-43049. xStrain and G’ Global HA filler rheology data. 2023
10. Galderma. Data on file. MA-42769. Restylane Defyne Clinical study report. 2020
11. Öhrlund Å. Evaluation of rheometry amplitude sweep cross-over point as an index of flexibility for HA fillers. JCDSA. 2018;8(2):47-54
12. Galderma Data on file. MA-56724. X-strain and G’ including Shaype
13. Öhrlund Å. Differentiation of NASHA and OBT hyaluronic acid gels according to strength, flexibility, and associated clinical significance. J Drugs Dermatol. 2014;23(1):1332-1336. doi: 10.36849/JDD.7648
14. Galderma. Data on file. MA-57232 [Updated]. 77 Million treated. 2025
15. Galderma. Data on file. MA-55607. Restylane^® 27 years data publications analysis. 2023
16. Fabi G, et al. The potential role of biostimulators/dermal fillers to address menopause-related skin conditions. Poster presented at IMCAS; January 29-31, 2026; Paris, France
17. Lorenc ZP, et al. Synergistic efficacy and safety of poly-L-lactic acid biostimulator and hyaluronic acid filler for facial fullness post weight loss due to glucagon-like peptide-1 receptor agonist medication. Presented at the ASDS 2025 Annual Meeting; November 13-16; Chicago, United States
18. Nikolis A, et al. The role of clinical examination in midface volume correction using hyaluronic acid fillers: should patients be stratified by skin thickness? Aesthet Surg J Open Forum. 2020;2(1):1–12. doi: 10.1093/asjof/ojaa005
19. Talarico S, et al. High patient satisfaction of a HA filler producing enduring full-facial volume restoration: an 18- month open multicenter study. Dermatol Surg. 2015;41:1361–1369. doi: 10.1097/DSS.0000000000000549
20. Edsman K, et al. Gel properties of hyaluronic acid dermal fillers. Dermatol Surg. 2012;38:1170–1179. doi: 10.1111/j.1524-4725.2012.02472.x.
21. Galderma. Data on file. MA-58650. Degree of modification of HA fillers.
22. Seo K. Facial volumization with fillers. Springer. 2021;29–83. doi: 10.1007/978-981-33-6212-3_2
23. Nikolis A, et al. Effectiveness and safety of a new hyaluronic acid injectable for augmentation and correction of chin retrusion. J Drugs Dermatol. 2024;23(4):255–261. doi: 10.36849/JDD.8145
24. Belmontesi M et al. Injectable non-animal stabilized hyaluronic acid as a skin quality booster: an expert panel consensus. J Drugs Dermatol. 2018;17(1):83–88.

Contacts

For further information:

Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com
+41 76 315 26 50

Richard Harbinson

Corporate Communications Director

richard.harbinson@galderma.com
+41 76 210 60 62

Céline Buguet

Franchises and R&D Communications Director

celine.buguet@galderma.com
+41 76 249 90 87

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

emil.ivanov@galderma.com
+41 21 642 78 12

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com
+41 21 642 76 43

Bioscience Association Manitoba Announces 2026 Industry Celebration Winners




Bioscience Association Manitoba Announces 2026 Industry Celebration Winners

Industry Celebration: The DNA of Success takes place March 11, 2026

WINNIPEG, Manitoba–(BUSINESS WIRE)–The Bioscience Association Manitoba (BAM) is pleased to announce the award recipients who will be recognized at the Manitoba Bioscience Industry Celebration: The DNA of Success, in Winnipeg. This annual celebration brings together leaders from industry, academia, government, and the broader community to recognize excellence across Manitoba’s bioscience ecosystem.

The Industry Celebration highlights the people and organizations advancing bioscience, growing companies, and strengthening Manitoba’s position as a hub for bioscience innovation. As part of the evening’s program, BAM will present five awards recognizing achievement across education, leadership, emerging talent, and industry impact.

2026 Manitoba Bioscience Award Recipients

• Most Promising Bioscience Student of the Year | Leena Regi Saleth, University of Manitoba
  
  This award recognizes an outstanding student whose academic achievements and passion for bioscience signal strong potential for future leadership in the sector.

• Outstanding Leadership in Bioscience of the Year | Michelle Di Nella, Seven Oaks Chronic Disease Innovation Centre
  
  This award celebrates an individual who has demonstrated exceptional leadership and vision, contributing meaningfully to the growth and success of Manitoba’s bioscience community.

• Bioscience Educator of the Year | Dr. Samantha Pauls, College of Pharmacy, University of Manitoba
  
  This award honours an educator who has inspired and empowered youth to explore science, helping build curiosity, confidence, and pathways into bioscience careers.

• Emerging Bioscience Company of the Year | PolySense Solutions
  
  This award recognizes a company with extraordinary potential in the bioscience industry, demonstrating innovation, growth, and the ability to make meaningful impact.

• Bioscience Company of the Year | Bausch Health Canada
  
  This award highlights a company that exemplifies leadership, excellence, and long-term impact within the bioscience sector.

“The Industry Celebration is our opportunity to recognize the people and organizations shaping the future of bioscience in Manitoba,” said Andrea Ladouceur, President and CEO at BAM. “These award recipients reflect the depth of talent, innovation, and leadership that continues to strengthen our sector.”

The evening will feature award presentations, networking, and a celebration of achievements driving Manitoba’s bioscience community forward.

For more information about the Industry Celebration: The DNA of Success, visit https://biomb.ca/event/industry-celebration-2026/.

About Bioscience Association Manitoba (BAM)

Bioscience Association Manitoba (BAM) is a not-for-profit industry association that enables commercial success for Manitoba’s bioscience companies by acting as a catalyst for innovation, expanding the sector’s skills and workforce development, and leading with one unified voice to create local and global engagement.

Contacts

Chloe Gerrard

Communications, Marketing, and IT Manager

Bioscience Association Manitoba

chloe@biomb.ca

THX Pharma and Biocodex Announce a Strategic Licensing Agreement in Batten, Gaucher and Niemann-Pick Type C Diseases




THX Pharma and Biocodex Announce a Strategic Licensing Agreement in Batten, Gaucher and Niemann-Pick Type C Diseases

GENTILLY, France–(BUSINESS WIRE)–THX Pharma (Theranexus) and Biocodex, an independent international pharmaceutical group, today announced the execution of a strategic licensing agreement to advance the development of two drug candidates in three rare diseases with high unmet medical needs: Batten disease with Batten-1, and Gaucher disease and Niemann-Pick type C disease with TX01.

Under the agreement, Biocodex acquires from THX Pharma two licenses: an exclusive worldwide license for the development and commercialization of Batten-1, a drug candidate developed by THX Pharma in juvenile Batten disease (CLN3); and an exclusive license for the United States and Canada for the development and commercial exploitation of TX01, a new formulation of an already approved molecule intended for the treatment of Gaucher disease and Niemann-Pick type C disease.

These genetic diseases, frequently pediatric, cause severe and progressive visceral, hematological or neurological impairments, with a major impact on patients’ quality of life and life expectancy. For some of them, therapeutic options remain nonexistent or very limited, making each development program a considerable scientific and medical challenge. The shared ambition of Biocodex and THX Pharma is to advance therapeutic solutions where needs remain significant, relying on science, partnership and dialogue with all communities, including healthcare professionals and patient organizations.

THX Pharma will receive total payments that may reach €173 million, including an upfront payment of €12 million and up to €161 million in development and commercialization milestone payments, as well as double-digit tiered royalties on net sales. THX Pharma will lead the clinical development of the programs, with financial and scientific support from Biocodex, which will also carry out compassionate access, market access and commercialization activities in the territories covered by the licenses.

Batten-1 is currently in preparation for phase 3 (start planned in 2026). Juvenile Batten disease (CLN3) is an ultra-rare pediatric neurodegenerative disease leading to progressive loss of vision, cognitive and motor functions, followed by death in early adulthood. No treatment is approved to date. Batten-1 aims to become the first available treatment for this condition, with an international launch targeted for 2030. The Batten-1 program was initially developed by the Beyond Batten Disease Foundation.

TX01 is based on an adapted oral formulation of an already approved active substance and is intended for the treatment of two rare lysosomal diseases: Niemann-Pick type C disease and Gaucher disease type 1. This approach aims to improve treatment administration and its suitability for patients’ specific needs.

About Biocodex: Biocodex is an independent French pharmaceutical company present in over 100 countries. Building on decades of commitment in rare diseases, Biocodex works to advance therapies for patients facing high unmet medical needs, alongside its pioneering work in microbiota research and its innovative solutions in women’s health and established products addressing common health needs.

About THX Pharma: THX Pharma (Theranexus) is a biopharmaceutical company specializing in the development of innovative treatments for rare diseases, with a focus on neurological conditions. It is developing Batten-1, targeting the juvenile form of Batten disease, and TX01, a new formulation intended for the treatment of Gaucher disease and Niemann-Pick type C disease.

Contacts

Media:
BIOCODEX / Monet – Anne-Lise Le Vaillant or Florence Desremaux

rpbiocodex@monet-rp.com – +33 1 45 63 12 43

Calla Lily Clinical Care and Merck Announce Strategic Collaboration to Advance Intravaginal Drug Delivery Platform




Calla Lily Clinical Care and Merck Announce Strategic Collaboration to Advance Intravaginal Drug Delivery Platform

• Enhancing patient treatment experience and care with a new self-administered solution for vaginal therapeutics
• Versatile platform technology developed from a safe, award-winning, FDA-cleared medical device
• Strategic collaboration supporting the continued development of a novel intravaginal drug delivery approach to address unmet needs in women’s health

LONDON–(BUSINESS WIRE)–Calla Lily Clinical Care, a women’s health-focused medical technology company, and Merck, a leading science and technology company, have entered a strategic collaboration to support the continued development of Callavid^®, a novel platform for intravaginal drug delivery. The collaboration represents the first industry partnership for the Callavid technology.

Callavid is a transformational leak-resistant medical device designed to address challenges associated with the self-administration of vaginal therapeutics. Administration via the vaginal route can be associated with increased patient anxiety related to positioning, dosing accuracy, and concerns around leakage, particularly for certain therapeutics used in fertility treatments, oncology, and hormone therapies.

Developed by the team at Calla Lily Clinical Care, Callavid’s patented leak-free design delivers vaginal therapeutics using a small, tampon-shaped device combined with an integrated absorbent liner. Callavid is designed for hygienic insertion, remains in place during drug absorption, and can be easily and cleanly removed. By supporting more consistent drug delivery and reducing concerns around leakage and positioning, Callavid is uniquely designed to improve the overall patient experience when administering vaginal medications.

Thang Vo-Ta, Co-founder and CEO of Calla Lily Clinical Care, commented: “This collaboration with Merck marks an important milestone in the development of Callavid, our novel vaginal drug delivery platform. Merck’s scientific heritage and forward-looking approach to innovation make them an ideal partner as we work to address long-standing unmet needs in women’s health. By improving how vaginal therapeutics are delivered and experienced, Callavid has the potential to enhance both patient outcomes and quality of life. We see this collaboration as a meaningful step toward translating our technology into real-world clinical and patient impact.”

Dr Lara Zibners, Co-founder and Chairman of Calla Lily Clinical Care, said: “Our initial engagement with Merck through the Merck Innovation Challenge in October 2024 was an important moment of alignment around the need for more patient-centric innovation in women’s health. As both a clinician and a patient, I have seen how profoundly drug delivery can shape treatment experience. This collaboration builds on that early dialogue and reflects a shared interest in rigorously exploring new approaches that may improve how therapies are delivered and experienced by patients.”

About Calla Lily Clinical Care www.callali.ly/

Calla Lily Clinical Care is an ambitious women’s health focused company that has developed the proprietary Callavid^® platform for intravaginal drug delivery. Callavid is adaptable to a wide range of therapeutics, with initial target indications in fertility and pregnancy, where the Company seeks to offer the world’s first drug-device combination product to prevent threatened miscarriage and for IVF luteal phase support. The device is also capable of delivering therapeutics for oncology, menopause, infectious diseases, and live biotherapeutics to reduce repeated antibiotic use and antimicrobial resistance (AMR). For pharmaceutical partners, Callavid offers a differentiated drug delivery modality for pipeline drugs, and a means of extending the lifecycle of established assets, including off-patent therapeutics. The Company is a certified B-Corp.

Follow us on LinkedIn (@Calla Lily Clinical Care).

Contacts

Media
Lily Jeffery

lily.jeffery@zymecommunications.com

IEO and Laife Reply Join Forces to Digitalise the Biobank Through Artificial Intelligence




IEO and Laife Reply Join Forces to Digitalise the Biobank Through Artificial Intelligence

The two partners launch “Bianca”, the first large-scale digitalisation initiative in Italy focused on histopathological samples, aimed at training AI algorithms to support pathologists’ diagnostic activities.

TURIN, Italy–(BUSINESS WIRE)–The Pathology Division of the European Institute of Oncology (IEO) and Laife Reply, the Reply Group company specialised in AI and Big Data solutions for the healthcare sector, have entered into a collaboration to develop Bianca, the first project in Italy aimed at creating an AI-based digital biobank designed as an integral part of clinical diagnostic practice. The initiative is part of a broader technological innovation journey that structurally integrates research and development into routine diagnostic processes in pathology, transforming the traditional histopathological sample workflow into an end-to-end digital ecosystem. The complete digitalisation of histopathological and molecular diagnostic workflows aims to make analysis more efficient, scalable and reproducible, laying the foundations for the evolution of AI-supported oncological diagnostics.

Selected under the “Agreements for Innovation” programme promoted by the Italian Ministry of Enterprises and Made in Italy (MIMIT), and building on a well-established collaboration between IEO and Reply, the BIANCA project initially involves the digitalisation of histopathological slides using state-of-the-art scanners capable of generating ultra-high-resolution digital images of tissue samples. On this platform, Artificial Intelligence algorithms are developed and trained to analyse images and support pathologists in histological and molecular analysis, as well as in the formulation of clinical and diagnostic hypotheses.

Launched at the end of 2024 with a planned overall duration of 30 months, the project has now reached its midway point. The extensive archive of histopathological samples collected over the years by the IEO Biobank is currently at an advanced stage of digitalisation. At the same time, Laife Reply is working closely with the joint IEO Pathology and Information Systems team to train AI algorithms on different types of cancer. This includes the introduction of advanced algorithmic solutions based on self-annotation mechanisms, capable of automatically labelling pathological findings on images, reducing the manual workload for clinicians, accelerating model training, improving accuracy and enabling large-scale replicability.

The project is also exploring the use of multimodal algorithms capable of combining histopathological images with structured clinical data to identify and analyse new biomarkers. In particular, research activities are already underway on specific diseases, with the aim of predicting information that is currently obtainable only through complex tests, thereby reducing time, costs and the overall impact on patients.

“Bianca represents a turning point for oncological pathology,” said Professor Nicola Fusco, Director of the Pathology Division at IEO. “The integration of digitalisation and AI enables a significant improvement in the quality, standardisation and reproducibility of diagnosis—both histopathological and molecular—by optimising the entire workflow, reducing reporting times, rationalising costs and improving the overall efficiency of diagnostic services for our patients. At the same time, the project contributes to the training of a new generation of pathologists with highly specialised skills, capable of combining morphological and molecular expertise with advanced digital tools and AI algorithms, paving the way for a sustainable evolution of oncological diagnostics.”

“With Bianca, we are collaborating with IEO to support the evolution of pathology in the oncological field,” said Carlo Malgieri, Partner at Laife Reply. “This is not just about applying artificial intelligence to individual cases, but about building a scalable and industrialisable framework designed to be offered to hospitals and smaller healthcare organisations. The framework integrates sample digitalisation, advanced algorithms and high-performance analytics infrastructures. This approach makes it possible to support clinicians, enable new services for healthcare systems and oncological research, and ensure transparency and explainability—key elements to guarantee that every algorithm-supported decision is trustworthy.”

Laife Reply

Laife Reply is a Reply Group company operating in the Health, Welfare and Pharma sectors. It develops Artificial Intelligence solutions ranging from Medical Imaging, Drug Discovery and Digital Therapeutics to Natural Language Processing for the analysis of unstructured data. https://www.reply.com/laife-reply/en

IEO – Istituto Europeo di Oncologia

The European Institute of Oncology (IEO) is a Scientific Institute for Research, Hospitalisation and Healthcare (IRCCS) and an international reference centre in the field of oncology. The Institute has developed an innovative care model based on key principles such as patient centrality, full integration between research and clinical activity, early diagnosis and prevention. This is complemented by a data-driven strategy, enabling the rapid development of Artificial Intelligence algorithms to accelerate diagnosis and improve the efficiency of therapeutic pathways. https://www.ieo.it/en/

Reply

Reply [EXM, STAR: REY, ISIN: IT0005282865] specialises in the design and implementation of solutions based on new communication channels and digital media. Reply is a network of highly specialized companies supporting key industrial groups operating in the telecom and media, industry and services, banking, insurance and public administration sectors in the definition and development of business models enabled for the new paradigms of AI, cloud computing, digital media and the Internet of Things. Reply services include: Consulting, System Integration and Digital Services. www.reply.com

Contacts

Media contact:
Reply
Fabio Zappelli

f.zappelli@reply.com
Tel. +390117711594

Irene Caia

i.caia@reply.com
Tel. +39 02 535761

IEO – Istituto Europeo di Oncologia
Donata Francese

Donata.francese@dfpress.it
Tel + 39 02 535761

U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1




U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1

• This FDA Acceptance is a Milestone for People Living with Narcolepsy Type 1 Who Need New and Different Treatment Options
• Oveporexton is an Orexin Agonist Designed to Restore Orexin Signaling and Address the Underlying Orexin Deficiency that Causes Narcolepsy Type 1
• The Prescription Drug User Fee Act (PDUFA) Target Action Date is the Third Quarter of this Calendar Year

OSAKA, Japan & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) and granted Priority Review for oveporexton (TAK-861) for the treatment of narcolepsy type 1 (NT1). Oveporexton is an investigational oral orexin receptor 2 (OX2R)-selective agonist designed to address the underlying orexin deficiency that causes NT1 by restoring orexin signaling. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year. Takeda remains on track to potentially bring the first approved orexin agonist treatment to people living with NT1.

NT1 is a chronic, rare neurological disease caused by a loss of orexin and characterized by excessive daytime sleepiness and cataplexy (sudden loss of muscle tone). This results in a spectrum of physical, cognitive and psychosocial effects that can have a debilitating impact on many aspects of a person’s life, including work, education and social interactions. Despite existing therapies, the majority of patients continue to experience symptoms and are forced to cope with the continued impact of NT1.

“The FDA’s acceptance of our NDA is a milestone for people living with narcolepsy type 1,” said Andy Plump, M.D., Ph.D., president of R&D at Takeda. “Considering the high unmet need, this community deserves a new and different treatment approach that aims to address the underlying orexin deficiency that causes NT1 by restoring orexin signaling. We are one step closer to potentially transforming the current treatment paradigm and intend to deliver through our leading work in orexin science.”

The NDA filing is supported by a comprehensive data package including the FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) global Phase 3 studies. Key oveporexton data measuring objective and patient-reported improvements in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life and daily life functions demonstrate statistically significant and clinically meaningful improvements achieving near normal ranges across the broad range of symptoms investigated. Oveporexton was generally well-tolerated with a safety profile consistent across clinical studies to date. The most common adverse events were insomnia, urinary urgency and urinary frequency. Learn more about the Phase 3 data results here.

Oveporexton previously received Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in NT1 from the U.S. FDA and the Center for Drug Evaluation of China’s National Medical Products Administration. Oveporexton has also received Sakigake designation from the Japanese Ministry of Health, Labour and Welfare.

The NDA filing has no significant impact on the full year consolidated forecast for the fiscal year ending March 31, 2026.

About Takeda’s Orexin Franchise

Takeda is spearheading orexin science with the most advanced development program. The tailored portfolio of investigational orexin agonists could benefit a broad range of conditions where orexin biology plays a role. Oveporexton is the lead investigational orexin receptor 2 (OX2R)-selective agonist asset in Takeda’s orexin franchise, currently in late-stage development for the treatment of NT1. TAK-360 is the next oral OX2R agonist in Takeda’s orexin franchise, initially being developed for individuals with narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). Additional orexin agonists are also in development, including TAK-495.

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

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Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

Contacts

Japanese Media:

Tsuyoshi Tada

tsuyoshi.tada@takeda.com

U.S. and International Media:

Cassie Ercanbrack

cassie.ercanbrack@takeda.com