All articles by Staff Writer
Staff Writer
Fujirebio and Sysmex sign agreement for the supply of reagent raw materials in the field of Immunoassay
Fujirebio Holdings, Inc. (President & CEO: Goki Ishikawa) and Sysmex Corporation (President: Kaoru Asano) today announced that they have signed an agreement for the mutual supply of reagent raw materials owned by both companies (“the Agreement”). The Agreement is based on a basic agreement on business collaboration in the field of immunoassay*1 which the two companies signed in October 2023.
RevBio Receives FDA Approval to Conduct a First-in-Human Clinical Trial for its Regenerative Bone Adhesive for Cranial Flap Fixation
This Clinical Trial will Show the Safety and Probable Benefit of TETRANITE® for Replacing the Use of Metal Plates and Screws
SolasCure demonstrates proof-of-concept in Phase lla safety trial of Aurase Wound Gel
SOLASCURE Ltd (SolasCure), a biotechnology company developing a hydrogel containing tarumase (provisional INN), a recombinant enzyme derived from maggots, and which aims to accelerate wound debridement and contribute to wound bed preparation & healing, today announced the results of its proof-of-concept, first-in-human, Phase IIa safety study. The CLEANVLU trial evaluated the Company’s first investigational product, Aurase Wound Gel, for use in chronic venous leg ulcer patients over 12 applications of the product (dosed every 3 days).
Thermo Fisher Scientific signs long-term, exclusive U.S. distributor agreement with Aesku.Group for IFA testing kits & instruments.
Thermo Fisher Scientific, the world leader in serving science, today announced an exclusive distribution agreement with Aesku.Group (Aesku), a leading provider of innovative diagnostic solutions, to market, sell, and support their portfolio of FDA-Cleared IFA products, automated instruments, and software in the United States. With this agreement, Thermo Fisher positions itself to offer laboratories a comprehensive suite of automated diagnostic systems and methodologies available in the U.S. market.
Contract for NHS Scotland diagnostic imaging technology awarded to Sectra
International medical imaging IT and cybersecurity company Sectra (STO: SECT B) has signed a contract to provide radiology teams and other healthcare professionals throughout the NHS in Scotland with the cloud-based enterprise imaging service Sectra One Cloud. The agreement with NHS National Services Scotland (NSS) will span across 15 NHS boards and provide tools that will support healthcare teams as they review and report on around 5 million radiology examinations a year working across NHS Scotland organizations.
Microbix & BioGX Collaborate on real-time PCR Assays & Controls
Quality Controls for Respiratory Viral, Pharyngitis, and Genital Ulcer Disease Panels
New data for Roche’s Columvi and Lunsumio presented at ASH 2023 support continued benefit for people with lymphoma
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data from its CD20xCD3 T-cell engaging bispecific antibody programme, including eight oral presentations, were presented at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition, 9-12 December 2023. Based on 32-month and 3-year follow-ups of two pivotal studies for fixed-duration treatments of Columvi® (glofitamab) and Lunsumio® (mosunetuzumab), respectively, data show that remissions were maintained in the majority of patients with heavily pre-treated lymphomas.1,2 Additionally, new early-phase data of novel Columvi or Lunsumio combination regimens support ongoing investigation in Phase III studies in earlier lines of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).3,4,5,6
Thermo Fisher Scientific and Project HOPE Partner to Advance Health Equity Among HIV Positive Youth in Sub-Saharan Africa
Collaboration designed to improve health outcomes by enabling expanded access to HIV testing and support services in Nigeria
Thermo Fisher Scientific Extends the Expiration of Tender Offer for All Outstanding Common Shares and ADSs of Olink
Offer Now Scheduled to Expire at 5:00 p.m., New York Time, on December 14, 2023
Medical Device First to Enter the European Market with Sustainable, Innovative Sterilization Approach with Chlorine Dioxide Gas
The first ever CE mark was awarded to a medical device sterilized using chlorine dioxide gas following new MDR regulations. Sterilization services are performed by ClorDiSys Solutions, Inc in their New Jersey, FDA registered contract sterilization facility. The device is a Class II medical device that is a surgical lighting device to provide illumination of an electrocautery pencil during surgery. The device contains an embedded battery, forcing restrictions on the sterilization modality. Ethylene oxide is becoming a growing concern for the medical device industry due to its environmental and health concerns and limited sterilization capacity. However, it is also explosive, meaning the embedded battery was not compatible. Material compatibility and overall efficacy eliminated contending methods such as Gamma irradiation, dry heat, vaporized hydrogen peroxide, E-Beam, and other methodologies. This left chlorine dioxide as the clear sterilization approach due to the materials and inclusion of an embedded battery within the device.