EC

Samsung Bioepis Announces New Data on Adalimumab Biosimilar, SB5 at the Annual European Congress of Rheumatology (EULAR 2022)

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Tuesday, May 31, 2022
Royal commission, Psoriatic arthritis, Social media, Medicine, Global Medical Device Nomenclature, Ulcerative colitis, European Commission, News, Patient, Poster, Samsung, SB5, EULAR, Ankylosing spondylitis, European, EC, Gastroenterology, Infliximab, Biogen, Hematology, Axial spondyloarthritis, RA, Congress, Safety, Rheumatoid arthritis, Endocrinology, SB2, LinkedIn, Inflammation, Twitter, Ophthalmology, Biosimilar, Male, Diagnosis, Adalimumab, GLOBE, Generic drug, Pharmaceutical industry, Rheumatology

The addition of new data to our adalimumab biosimilar, SB5 is great news for patients with rheumatic and other inflammatory diseases, said Donghoon Shin, Vice President and Medical & Lifecycle Safety Team Leader at Samsung Bioepis.

Key Points: 
  • The addition of new data to our adalimumab biosimilar, SB5 is great news for patients with rheumatic and other inflammatory diseases, said Donghoon Shin, Vice President and Medical & Lifecycle Safety Team Leader at Samsung Bioepis.
  • This real-world study, sponsored by Biogen GmbH, is designed to provide insights into outcomes of the transition from reference adalimumab to adalimumab biosimilar (SB5).
  • SB5 was approved by the European Commission (EC) in August 2017, under the brand name IMRALDI as a biosimilar to HUMIRA3.
  • Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company.

New Data Show Statistically Greater Improvements in Clinical Outcomes with Subcutaneous Infliximab, Compared to Intravenous Infliximab, in Patients With Rheumatoid Arthritis

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Tuesday, May 31, 2022
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Joint, Royal commission, Product, Toulouse III - Paul Sabatier University, Disease, NRI, Immune system, The American Journal of Managed Care, Randomized controlled trial, Pain, Swelling, European Commission, Degenerative disease, EULAR, CGMP, EC, Celltrion, III, Observation, Poster, Biosimilar, US Foods, Medication package insert, IV, Adult, Rheumatoid arthritis, FDA, IBD, Infliximab, Inflammatory bowel disease, Rheumatology, Congress, American Journal, Senior, Disease-modifying antirheumatic drug, Risk, Population, European Medicines Agency, Patient, Human, RA, Marketing, Diagnosis, Medical device, Pharmaceutical industry, EU

The post-hoc study investigated whether the numerical advantage of SC infliximab compared to IV, shown in most efficacy parameters at weeks 30 and 54, was statistically significant.

Key Points: 
  • The post-hoc study investigated whether the numerical advantage of SC infliximab compared to IV, shown in most efficacy parameters at weeks 30 and 54, was statistically significant.
  • Results showed a statistically significant difference in favour of SC compared to IV-treated patients at week 30 in almost all clinical variables, including low disease activity rates and remission rate.
  • Efficacy of Subcutaneous Infliximab (CT-P13 SC) Compared with Intravenous Infliximab in Rheumatoid Arthritis: A Post-hoc Analysis of a Phase 3 Randomized Controlled Trial.
  • A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 30-week results from part two of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis.

DGAP-News: SHARE BUY-BACK PROGRAMME OF THE COMPANY

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Monday, May 30, 2022
Company, General Standard, Regulation (European Union), CPI, ISIN, Share repurchase, DGAP, Regulated market, Investment, Contract, EU, Association, Prejudice, EC, LUXEMBOURG, Frankfurt Stock Exchange, Compliance, Margin of appreciation, European Regulators' Group for Electricity and Gas, Sale, News, Program, LCA, Security (finance), Car rental, Bank

The Company ranks among the most significant real estate groups focusing on long-term investments and property leases, especially in Central and Eastern Europe and Germany.

Key Points: 
  • The Company ranks among the most significant real estate groups focusing on long-term investments and property leases, especially in Central and Eastern Europe and Germany.
  • - Modalities of the repurchase of the shares: the shares can be repurchased by the Company itself, or through a company in which the Company holds directly the majority of the voting rights, or through a person acting in its own name but for the account of the Company.
  • It is proposed to the general meeting of the shareholders of the Company to be held on 30 May 2022 to approve the Programme and to authorise the board of directors of the Company (with option to delegate) to implement the Programme.
  • Those aspects related to the share redemption Programme are set forth in the provisions of "Transparency" Directive and of the "Market Abuse" Regulation.

European Building Renovation Market Analysis and Forecast 2022-2026: Leading Players include Sika AG, RockWool International & Saint-Gobain

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Friday, May 27, 2022
Urbanization, Climate change, ROI, Investment, Government, Building material, COVID-19, Energy, GHG, EC, Workforce, Industry, EPC, Growth, Pressure, State government, Segment, CAGR, Construction, Real estate, Renewable energy, EU

An in-depth analysis of Europe Building Renovation market by value, by building type, by segment, etc.

Key Points: 
  • An in-depth analysis of Europe Building Renovation market by value, by building type, by segment, etc.
  • A detailed analysis of Europe building renovation market by regional renovation plans building floor area, and deep renovation spending.
  • This report analyses the market as per energy renovation rate in building stock (both residential & non-residential)
    Provides an analysis of the COVID-19 impact on Europe building renovation market.
  • Europe building renovation market is moderately fragmented, with many players operating in the market.

Eisai Contributes to the Science of Cancer Medicine at ASCO 2022

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Friday, May 27, 2022
MSD, Physician, Annual general meeting, Patient, Merck & Co., ADC, Society, Merck, Bristol Myers Squibb, EC, American Society of Clinical Oncology, Trial of the century, Research, FDA, Pembrolizumab, Eisai, LEAP, RCC, Cleavage, Safety, ASCO, Lung, Cancer, MD, FR, Pharmaceutical industry

"Safety and efficacy analyses in platinum-resistant ovarian cancer for farletuzumab ecteribulin suggest antibody drug conjugates may represent a promising therapeutic strategy for these patients with limited treatment options," said Dr. Takashi Owa, President, Oncology Business Group at Eisai.

Key Points: 
  • "Safety and efficacy analyses in platinum-resistant ovarian cancer for farletuzumab ecteribulin suggest antibody drug conjugates may represent a promising therapeutic strategy for these patients with limited treatment options," said Dr. Takashi Owa, President, Oncology Business Group at Eisai.
  • "Eisai's first antibody drug conjugate combines our in-house developed anti-folate receptor alpha antibody and our anticancer agent eribulin using an enzyme cleavable linker, illustrating our dedication to building on our medicines to improve cancer care for more patients."
  • In June 2021, Eisai and Bristol Myers Squibb entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of farletuzumab ecteribulin, a folate receptor alpha (FRα)-targeting ADC.
  • There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

Global Vision Care Devices and Equipment Market Report 2022: Market is Expected to Grow to $37.79 Billion in 2026 at a CAGR of 8.8% - Long-term Forecast to 2031 - ResearchAndMarkets.com

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Thursday, May 26, 2022
Health, Optical, Internet, Luxottica, Lens (anatomy), European Commission, Johnson & Johnson Vision, The Cooper Companies, State, Asia-Pacific, Eye, Marketing, EC, Novartis, Deloitte, Johnson & Johnson, Bausch Health, FDA, Personal computer, ZEISS, Awareness, Macular degeneration, Hospital, Safety, MDR, Glaucoma, Bausch & Lomb, Growth, Escalon, California, Diagnosis, Medical device, EU

The main types of vision care devices and equipment are intraocular lenses, ophthalmic lasers, glaucoma drainage devices, contact lenses, and others.

Key Points: 
  • The main types of vision care devices and equipment are intraocular lenses, ophthalmic lasers, glaucoma drainage devices, contact lenses, and others.
  • Asia Pacific was the second-largest region in the vision care devices and equipment market.
  • The rising use of electronic devices is a continuous driver for the growth of the vision care devices and equipment market.
  • Global Vision Care Devices And Equipment Market, Segmentation By Type, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

Cairn Homes Plc: Holding(s) in Company

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Thursday, May 26, 2022
Central Bank of the Republic of Turkey, Ix, Exercise, Disclosure, Person, LEI, Vii, Council Implementing Regulation (EU) No. 282/2011, EC, Intention, Life, Central bank, Acquisition, Letter, Security (finance), Auction, Medical device, Transparency, EU, Regulation

In case of proxy voting: [name of the proxy holder] will cease to hold [% and number] voting rights as of [date]

Key Points: 
  • In case of proxy voting: [name of the proxy holder] will cease to hold [% and number] voting rights as of [date]
    Done at London on 25/05/2022.
  • iii Other reason for the notification could be voluntary notifications, changes of attribution of the nature of the holding (e.g.
  • As the disclosure of cases of acting in concert may vary due to the specific circumstances (e.g.
  • v Applicable in the cases provided for in Regulation 15(b) to (h) of the Regulations (Article 10 (b) to (h) of Directive 2004/109/EC).

CENTOGENE’s CentoCloud® Is Now CE-Marked as One of the Only Decentralized SaaS Platforms Compliant With European IVD Regulatory Framework

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Wednesday, May 25, 2022
NGS, Company, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Lists of diseases, U.S. Securities and Exchange Commission, Nasdaq, Patient, Genetic testing, IVD, Nature, EC, Legislation, Research, Neurodegeneration, Industry, Software, IVDR, Risk, Instability, Security (finance), Software as a service, DNA sequencing, SEC, Growth, Diagnosis, Laboratory, Classification, CEO, European Economic Area, GLOBE, Medical device, Pharmaceutical industry, EEA, Service

CentoCloud enables laboratories around the world to establish and run state-of-the-art genomic testing and deliver the best diagnostic insights to local patients.

Key Points: 
  • CentoCloud enables laboratories around the world to establish and run state-of-the-art genomic testing and deliver the best diagnostic insights to local patients.
  • As a cloud-based SaaS platform, CentoCloud is specifically designed to support laboratories with the execution of superior Next Generation Sequencing (NGS)-based diagnostics.
  • The Companys fully automated bioinformatics pipeline analyzes NGS data based on CENTOGENEs validated testing products, annotated with data from the CENTOGENE Biodatabank.
  • As a CE-marked IVD, CentoCloud can be applied to the clinical diagnosis of patients with genetic diseases.

EC Healthcare Acquires Health Screening Services Chain, Further Expand Customer Base and Consolidate the Health Screening Market

Retrieved on: 
Monday, May 23, 2022
NEW, Hang Seng Composite Index Series, Audience, Leadership, Cardiology, HEALTH, Professional, SPINE, COVID-19, EC, SEHK, Obstetrics, UMH, Group, Precision medicine, Intelligence, Acquisition, Growth, KONG, HAIR, Health insurance, Hospital

The Target Group has a long-standing history in providing comprehensive health screening services in Hong Kong since 2002.

Key Points: 
  • The Target Group has a long-standing history in providing comprehensive health screening services in Hong Kong since 2002.
  • Upon completion of the acquisition, the Group shall operate a total of 6 health screening services centers, covering New Territories, Kowloon and Hong Kong Island, thereby further consolidating the health screening market in Hong Kong.
  • Leveraging on Target Group's wide loyal customers and its long-established reputation for premium services, the Group will effectively expand its customer base.
  • We believe that this acquisition will enable the Group to further consolidate the healthcare market and fortify our leadership in discretionary medical market.

Cytek® Biosciences Receives CE Marking for Series of cFluor® Reagents, TBNK Kit

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Tuesday, May 24, 2022
CLC, Regulation Fair Disclosure, Flow cytometry, Software, CE marking, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, Certification, Disclosure, IVDD, Solution, FSP, CE, COVID-19, EC, Regulation, Research, Securities Act of 1933, Securities Exchange Act of 1934, Industry, Intellectual property, Forward-looking statement, Compliance, Terminology, Hospital, Union, Full Spectrum, LinkedIn, Twitter, SEC, Growth, Laboratory, Security (finance), CEO, Achievement, GLOBE, Medical device

Cytek Biosciences, Inc. (Nasdaq: CTKB), a leading cell analysis solutions company, today announced that a series of single-color cFluor reagents and a 6-color TBNK kit have received CE Marking under the European Union In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC.

Key Points: 
  • Cytek Biosciences, Inc. (Nasdaq: CTKB), a leading cell analysis solutions company, today announced that a series of single-color cFluor reagents and a 6-color TBNK kit have received CE Marking under the European Union In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC.
  • CE-IVD certification allows Cytek to enter into new markets for clinical in vitro diagnostics, noted Dr. Wenbin Jiang, CEO of Cytek Biosciences.
  • Cytek cFluor reagents represent our years of experience understanding full spectrum cytometry and how fluorophores react together in multicolor panels.
  • Cytek, cFluor, Full Spectrum Profiling, FSP and Northern Lights are trademarks or registered trademarks of Cytek Biosciences, Inc.