South Africa’s Competition Commission sent a warning this week to the biopharma industry when it announced that it is prosecuting Roche Holding AG for what it called excessive pricing of the company’s breast cancer drug, Herceptin, which is also marketed as Herclon in South Africa.
PARIS – Healshape SAS is preparing a $6.8 million series A round to develop a 3D bioprinted breast implant obtained from the patients' own cells. Supported by Pulsalys SAS, Lyon Saint-Etienne’s technology transfer acceleration company, this startup from Villeurbanne, France, has already benefited from more than a million dollars of French public funding and subsidies.
Illumina Inc. and Agendia NV are joining forces for a multiyear partnership to develop diagnostic tests for breast cancer. The collaboration will unite lllumina’s Miseq Dx sequencing platform, with Agendia's flagship genomic test, Mammaprint, which identifies a patient’s breast cancer recurrence risk. Illumina has been steadily signing partnerships over the past few years and currently has more than 30 IVD partners and 40 sequencing-based solutions for cancer under development.
Legochem Biosciences Inc. has licensed out its antibody-drug conjugate (ADC) LCB-14 to Iksuda Therapeutics Ltd. in the duo’s latest deal that is worth $1 billion. Daejeon, South Korea-based Legochem will receive $50 million in an up-front payment and near-term milestones, and up to $950 million in developments, regulatory and commercial milestones.
Prelude Corp. (dba Preludedx) reported positive results from the SweDCIS randomized trial showing its DCISionrt test predicts radiation benefit for lowering 10-year local invasive breast cancer risk. The prognostic, artificial intelligence (AI)-based tool assesses and predicts the benefit of radiotherapy for women with ductal carcinoma in situ (DCIS) following breast-conserving surgery (BCS).
TORONTO – Koios Medical Inc. has received Health Canada approval for its DS Smart Ultrasound decision support software, which the company said accurately interprets breast ultrasound examinations. Company CEO Chad McClennan told BioWorld greater accuracy will provide early cancer detection rates, while reducing costly false positives and unnecessary biopsies.
Lunit Inc. has won FDA approvals for the company’s breast cancer detection product Lunit Insight MMG and the triage and notification software Lunit Insight CXR Triage, only days apart. Lunit Insight MMG is an artificial intelligence (AI) product for breast cancer detection from mammography images. Lunit’s second approval is for Lunit Insight CXR Triage, its AI-powered chest X-ray triaging product.
PARIS – The French National Authority for Health (HAS) is expanding the available range of novel autologous technologies reimbursed in the context of breast reconstruction following ablative surgery. In doing so, the HAS is paving the way towards reimbursement for novel autologous techniques in general.
The Menarini Group and Radius Health Inc.’s phase III Emerald study of oral elacestrant as a monotherapy vs. standard of care in treating estrogen receptor-positive/HER2-negative advanced or metastatic breast cancer hit its two primary endpoints. The study’s top-line data, according to the companies, showed statistically significant progression-free survival in both the overall population and in patients with tumors harboring estrogen receptor 1 mutations.
A genetic biomarker-based diagnostic test developed by Inbiomotion SL to identify treatment for early-stage
breast cancer could significantly improve patient survival, a study has found. Data from the phase III NSABP-B34 study published in the Journal of the National Cancer Institute Cancer Spectrum, showed that in patients with MAF-negative (mutation biomarker) tumors – determined with Inbiomotion’s MAF Test – adjuvant treatment with clodronate was associated as having the greatest benefit compared to placebo-treated control patients receiving the same standard of care.
