Business Wire

GALDERMA

19.6.2024 07:01:29 CEST | Business Wire | Press release

Share
Galderma Granted Key Manufacturing License Updates for New Biologics Capabilities at Its Center of Excellence

Galderma today announced that the Swedish Medical Products Agency (Läkemedelsverket) issued key manufacturing license updates that will allow the company to pursue its ambitious growth and innovation roadmap.

The license updates, issued following the agency’s good manufacturing practices (GMP) inspection of Galderma’s center of excellence in Uppsala, Sweden, enable Galderma to manufacture and perform bioanalytical testing on RelabotulinumtoxinA (QM1114). One of Galderma’s key innovation pipeline assets in Injectable Aesthetics, RelabotulinumtoxinA is a next-generation liquid neuromodulator in Injectable Aesthetics developed using Galderma’s proprietary PEARL™ technology. This technology preserves the molecule’s integrity, resulting in a highly active, complex-free botulinum toxin A.

 

“Our commitment to leading innovation in dermatology is reflected in our high-performance operations. These new license updates granted by the Swedish authorities reflect Galderma’s skills and the capacities we are building to support our rapid growth trajectory. As we work to extend our category leadership globally, these new capabilities will increase Galderma’s autonomy to manufacture and commercialize the next generation of scientifically differentiated innovations in dermatology.”

 

ADRIAN MURPHY

HEAD OF GLOBAL OPERATIONS

GALDERMA

 

Galderma’s center of excellence in Uppsala is one of the company’s four state-of-the-art manufacturing and R&D facilities around the world. Galderma is currently expanding this site in response to growing global demand for science-based premium dermatology solutions. The new facility—scheduled for completion by the end of 2025—will be strategically positioned to cater to the higher demand for injectable aesthetics treatments worldwide and the development of upcoming products. With a modular design that allows for seamless further expansion in the future, this forward-looking approach aligns with both Galderma’s growth strategy and its environment, social and governance (ESG) roadmap.

About RelabotulinumtoxinA (QM1114)
Developed by Galderma, RelabotulinumtoxinA is a highly active, innovative, complex-free and ready-to-use liquid botulinum toxin A with a proprietary strain. Manufactured using a unique state-of-the-art process, it is designed as a liquid. This avoids the need to reconstitute from powder and thus eliminates the variability, errors and risks associated with reconstitution, which would be expected to improve the consistency of results. RelabotulinumtoxinA is currently being investigated globally, with a view to expanding its neuromodulator portfolio – part of the broadest injectable aesthetics portfolio on the market.

About Galderma
Galderma (SIX: GALD) is the emerging 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

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240618347979/en/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Incyte Announces New Positive 54-Week Late-Breaking Data for Povorcitinib in Hidradenitis Suppurativa at the 2026 American Academy of Dermatology (AAD) Annual Meeting28.3.2026 20:00:00 CET | Press release

Phase 3 data from the STOP-HS program demonstrate povorcitinib’s substantial and durable clinical efficacy through Week 54 in patients with moderate to severe hidradenitis suppurativa (HS). Through Week 54, clinically meaningful and durable responses were observed across all groups in both STOP-HS1 and STOP-HS2, with up to 71.4% of patients achieving HiSCR50. Improvements in clinical responses across high stringent thresholds were observed, with up to 57% of participants achieving HiSCR75 and up to 29% of participants achieving HiSCR100. Povorcitinib treatment led to consistent reductions across key inflammatory lesion types, with full resolution (ANdT=0) achieved in up to 20% of patients. Additionally, clinically meaningful improvements in quality-of-life measures, including skin pain and fatigue, were observed at Week 54. The overall safety profile of povorcitinib through 54 weeks is consistent with previously reported data, and both doses were well tolerated. Incyte (Nasdaq:INCY) to

Takeda’s Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care28.3.2026 20:00:00 CET | Press release

About 70% of patients treated with zasocitinib achieved clear or almost clear skin (sPGA 0/1) at week 16 in Phase 3 plaque psoriasis studies A significantly greater PASI 75 response rate versus placebo was observed as early as week 4 Safety profile consistent with Phase 2b studies with no new safety signals identified Takeda(TSE:4502/NYSE:TAK)today announced new data from the two pivotal Phase 3studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented as a late-breaking abstract at the 2026 American Academy of Dermatology (AAD) Annual Meeting, these data show that convenient once-daily oral zasocitinib demonstrated rapid and durable skin clearance with a safety profile consistent with Phase 2b studies.1,2 “Our goal in psoriasis treatment is clear or almost clear skin, and previously this has been achieved primarily with injectable therapies,” said Melinda Gooderham,

AAD 2026: Late-Breaking Nemolizumab Data Demonstrate Clinically Meaningful Benefits for Children Aged 2 to 11 With Moderate-to-Severe Atopic Dermatitis28.3.2026 16:00:00 CET | Press release

Pharmacokinetics, safety and efficacy clinical study data show that nemolizumab achieved clinically meaningful reductions in skin lesions and itch through Week 16, which were sustained up to a year in children aged 2 to 11 with moderate-to-severe atopic dermatitis1 These findings reinforce the previously established safety and efficacy of nemolizumab in adults and adolescents with moderate-to-severe atopic dermatitis, for which it is approved by multiple global regulatory authorities2,3 Up to 25% of children are affected by atopic dermatitis, and currently there are limited approved treatment options for children living with moderate-to-severe atopic dermatitis4,5 Galderma (SIX: GALD) today announced new phase II data showing that nemolizumab was well tolerated and effective in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis, with a clinically meaningful and sustained reduction in skin lesions and itch for up to a year.1 Results will be presented in a late-break

Angelalign Technology (6699.HK)Releases 2025 Results: Passion for Clinical Excellence Drives Worldwide Growth27.3.2026 20:56:00 CET | Press release

Angelalign Technology Inc. (6699.HK) (“Angel” or the “Company”) released its financial results for fiscal year 2025. During the reporting period, the Company continued to do well in both the global and China markets. Total case volume was 532,400, which increased 48.1%, revenue was USD 370.3 million, which increased 37.8%, and adjusted net profit was USD 43.8 million, which increased 63.0%. The results were driven by Angel’s passion for clinical excellence and its open and inclusive culture that empowers talented people to work together to meet customer needs, the Company said. Fox Hu, CEO of Angel, stated: “The clear aligner industry is complex and multidisciplinary. It requires top-tier technical and operational talent along with seamless collaboration among professionals from diverse geographies. Angel’s open and inclusive culture attracts professionals who share a passion for clinical excellence and a dedication to bringing outstanding products and services to customers. This melti

Axway Positioned as a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment27.3.2026 18:46:00 CET | Press release

Axway, a 74Software company (Euronext: 74SW) and global leader in federated API management and enterprise integration, has been named a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment.1 Axway Amplify securely connects, orchestrates, and automates data integration. Organizations in financial services, manufacturing, healthcare, and other industries rely on Amplify to modernize integrations and confidently unlock data to deliver superior digital services faster. The report notes: “The platform benefits from Axway’s long-standing experience in B2B integration, secure file transfer, and legacy connectivity, providing differentiated capabilities for organizations that need to expose and control APIs around core systems that are not cloud-native.”1 This multi-pattern expertise in security, integration, and federated governance — built during the early phases of the API-driven digital transformation — becomes especially critical as enterprises seek to govern dat

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye