Daiichi Sankyo and AstraZeneca’s HER2-directed antibody-drug conjugate (ADC) ENHERTU has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of unresectable or metastatic hormone receptor-positive HER2 low or HER2 ultralow breast cancer. This latest designation marks the eighth BTD for ENHERTU and highlights the significant potential for the therapy in addressing unmet medical needs…
Medtech company Hologic has finalized its previously announced acquisition of Endomag, a UK-based developer of breast cancer surgery technologies, for approximately $310 million. Erik Anderson, President of Breast and Skeletal Health Solutions at Hologic noted: “We are thrilled to complete the acquisition of Endomag and are looking forward to working with our new colleagues to increase access to their innovative technologies, which…
Digital health company Sidekick Health has announced its acquisition of PINK!, a digital therapeutics company specializing in cancer support and women’s health. This strategic move is set to enhance Sidekick Health’s portfolio and strengthen its position in the DTx market. PINK! Coach, a prescription digital therapeutic (PDT) for breast cancer within Germany’s regulated nationwide DiGA (Digitale Gesundheitsanwendungen) formulary, will now be part…
Digital therapeutics company Mika Health has announced a new collaboration with AstraZeneca and Daiichi Sankyo. The initiative, named “UNITE,” aims to enhance the treatment experience for women undergoing breast cancer therapy in Switzerland through the use of Mika Health’s AI-enabled mobile platform. The UNITE initiative was unveiled at the HLTH Europe conference and signifies a significant step towards integrating digital solutions in…
GC Aesthetics, a company specializing in the design, manufacture, and distribution of breast implants and medical devices, has launched a new product aimed at improving breast reconstruction for women. The FixNip Nipple and Areola Reconstruction Implant (NRI) addresses a significant clinical need by providing a long-term aesthetic solution. FixNip NRI features a biocompatible smooth silicone structure with a floral-shaped nitinol frame. This…
Bayer and Hologic have announced a collaboration to introduce a solution for contrast-enhanced mammography (CEM), a technique enhancing breast tissue visualization for improved breast cancer detection and treatment guidance. Contrast-enhanced mammography is a breast imaging modality aiding in breast cancer diagnosis. By integrating Hologic’s mammography technologies with Bayer’s contrast delivery system, the MEDRAD Stellant FLEX Computed Tomography (CT) Injection System, the collaboration…
Roche has achieved CE Mark approval for the VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx, a companion diagnostic designed to identify metastatic breast cancer patients expressing low levels of HER2. This approval enables the consideration of ENHERTU (trastuzumab deruxtecan) as a targeted treatment for these patients. Metastatic breast cancer (mBC) affects a significant portion of patients, with approximately half expressing low…
MOLLI Surgical, a company active in surgical innovation, has unveiled its latest breakthrough: OncoPen, a novel surgical tool designed to enhance precision and confidence in breast cancer surgery. The launch of OncoPen represents a significant advancement in minimally invasive surgery and promises improved outcomes for patients battling breast cancer. The OncoPen is seamlessly integrated with the MOLLI 2 System, providing surgeons with…