Business Wire

Samsung Bioepis' SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the US Food and Drug Administration

Jaa

Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB3, a biosimilar candidate referencing Herceptin® i (trastuzumab). SB3 is Samsung Bioepis’ first oncology biosimilar candidate submitted for regulatory review in the United States (US). If approved, SB3 will be commercialized in the US by Merck, which is known as MSD outside of the US and Canada.

This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171219006354/en/

Christopher Hansung Ko, President & CEO of Samsung Bioepis. (Photo: Business Wire)

Christopher Hansung Ko, President & CEO of Samsung Bioepis. (Photo: Business Wire)

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that includes six first-wave candidates that cover the therapeutic areas of immunology, oncology and diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.

i Herceptin ® is a registered trademark of Genentech Inc.

Contact information

MEDIA CONTACT:
Samsung Bioepis Co., Ltd.
Mingi Hyun
+82-31-8061-1594
mingi.hyun@samsung.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Zscaler Extends Cloud DLP Service with Inline Exact Data Match for Massive Data Sets Covering Users Globally22.10.2018 09:30Tiedote

Zenith Live Europe – Zscaler, Inc. (NASDAQ: ZS), the leader in cloud security, today announced inline Exact Data Match (EDM) with native SSL inspection as part of its advanced Cloud Data Loss Prevention (DLP) service. The inline EDM capability extends the Zscaler™ cloud platform to protect against the loss of sensitive information across all users and branches with more precision while reducing the number of false positives to near zero. This service is provided in the Zscaler cloud, providing the capacity of one billion data points per customer across 100 data centers globally. Traditional DLP appliances that sit in the data center are expensive and resource-intensive, and their protection can be subpar, often failing to alert an organization until after data has been compromised. Zscaler’s inline EDM with native SSL inspection blocks sensitive information before it leaves the network. In the first half of 2018, the Zscaler cloud platform blocked an average of 800,000 SSL-encrypted tr

Vivior Chairman Receives Award for Outstanding Contributions to Refractive Surgery22.10.2018 09:00Tiedote

Michael Mrochen, PhD, Chairman of the Board of Directors at Vivior, receives the Casebeer Award from the International Society of Refractive Surgery. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181021005012/en/ Michael Mrochen, PhD Chairman of the Board of Directors Vivior AG (Photo: Business Wire) The International Society of Refractive Surgery (ISRS), a partner of the American Academy of Ophthalmology, is the leading worldwide organization for refractive surgeons. Each year, ISRS awards members for their special contributions to the ISRS, as well as their dedication to the field. The Casebeer Award recognizes an individual for his or her outstanding contributions to refractive surgery through nontraditional research and development activities (https://www.isrs.org/about-isrs/awards). Michael Mrochen is internationally known for his pioneering work on corneal laser surgery, corneal cross linking, ocular biometry and corn

Investigational Subcutaneous Formulation of Vedolizumab Achieves and Maintains Clinical Remission and Mucosal Healing at Week 52 in Patients with Moderately to Severely Active Ulcerative Colitis22.10.2018 08:00Tiedote

Takeda Pharmaceutical Company Limited [TSE:4502] (“Takeda”) today announced results from the phase 3 VISIBLE 1 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-selective biologic vedolizumab for maintenance therapy in adult patients with moderately to severely active ulcerative colitis (UC) who achieved clinical response* at week 6 following two doses of open-label vedolizumab intravenous (IV) induction therapy. At week 52, a statistically significant proportion of patients receiving vedolizumab SC achieved clinical remission** compared to patients receiving placebo (46.2% vs. 14.3%; p<0.001). A similar rate of clinical remission was observed in the vedolizumab IV reference arm (42.6%). These results were presented at the 2018 United European Gastroenterology (UEG) Week congress in Vienna, Austria. “The VISIBLE 1 results highlight that the investigational subcutaneous formulation of vedolizumab helped patients with moderat

Incyte Announces Positive Interim Data from Phase 2 Trial of Pemigatinib, Its Selective FGFR Inhibitor, in Patients with Cholangiocarcinoma21.10.2018 13:45Tiedote

Incyte Corporation (Nasdaq:INCY) announces updated data from its ongoing Phase 2 FIGHT-202 trial evaluating pemigatinib (INCB54828), its selective fibroblast growth factor receptor (FGFR) inhibitor, in patients with advanced/metastatic or surgically unresectable cholangiocarcinoma (bile duct cancer) who failed at least one previous treatment. In patients with FGFR2 translocations who were followed for at least eight months, interim study results demonstrated an overall response rate (ORR) of 40 percent, the primary endpoint, and a median progression free survival (PFS) of 9.2 months, a key secondary endpoint. These results are being presented at the European Society for Medical Oncology (ESMO) 2018 Congress in Munich, Germany in a poster presentation on Sunday, October 21 from 12:45 p.m. CEST to 1:45 p.m. CEST (6:45 a.m. ET to 7:45 a.m. ET). (Location: Hall A3 – Poster Area Networking Hub; Abstract #756P) “We are pleased to share updated interim results from our ongoing FIGHT-202 trial

Servier and Taiho Oncology Announce Phase III LONSURF® Study Has Met Primary and Secondary Endpoints Demonstrating Prolonged Overall Survival and Progression-Free Survival in Patients with Refractory Metastatic Gastric Cancer21.10.2018 12:10Tiedote

Servier and Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), jointly announced today clinical data from the pivotal Phase III TAS-102 Gastric Study (TAGS) evaluating LONSURF® (trifluridine/tipiracil, TAS-102) versus placebo and best supportive care in patients with heavily pre-treated metastatic gastric cancer who have progressed or are intolerant to previous lines of therapy. The study met its primary endpoint of prolonged overall survival (OS) and secondary endpoint measures of progression-free survival (PFS) consistently supported the OS results, as well as continuing to demonstrate the predictable safety and tolerability profile of trifluridine/tipiracil. Data from TAGS was presented by Dr. Hendrik-Tobias Arkenau, Executive Medical Director of the Sarah Cannon Research Institute UK and an investigator for TAGS, at the ESMO 2018 Congress in Munich, Germany during an oral session (Abstract #LBA25). The study results were simultaneously published in

Phase 3 Data on Filgotinib in Biologic-Experienced Rheumatoid Arthritis to Be Presented at 2018 ACR/ARHP Annual Meeting21.10.2018 01:30Tiedote

Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced detailed results from the Phase 3 FINCH 2 clinical trial of filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response or intolerance to biologic agents. The data, which are being presented as a late-breaking poster at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, suggest filgotinib has a potential role in addressing important unmet needs in the treatment of rheumatoid arthritis. Positive efficacy data from FINCH 2 were previously announced in September 2018. The data show statistically significant improvements in the proportion of patients achieving a range of clinical efficacy endpoints, including the proportion of patients achieving American College of Rheumatology 20 percent (ACR20, primary endpoint), 50 percent

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme