NEW YORK – Hologic said this week that it is acquiring women's health-focused medical device firm Gynesonics in a $350 million deal. Gynesonics' flagship Sonata System is a US Food and Drug Administration-cleared and CE-marked instrument for diagnostic intrauterine imaging and transcervical treatment of certain symptomatic uterine fibroids, including fibroids that are associated with heavy menstrual bleeding.
Clinical Microbiomics (CMC) of Denmark said last week that it is acquiring the research services business unit of Microba Life Sciences, a developer of microbiome-derived diagnostics and therapeutics based in Australia. The deal will allow CMC, located in Copenhagen, to expand its microbiome research services worldwide and to boost its representation in Asia-Pacific. Under the agreement, Microba will retain revenue from existing contracts it transfers to CMC and commissions for new contracts with existing customers and new customers it refers to CMC. Furthermore, it will receive milestone-based payments over the next four years. Following the transaction, Microba research services staff in Australia, Singapore, and Korea will join CMC.
Australia's Therapeutic Goods Administration this week released a statement on its decision not to register Eisai and Biogen's anti-amyloid Alzheimer's disease drug Leqembi (lecanemab), in which it said the demonstrated efficacy of the drug did not outweigh the safety risks associated with it. Tokyo-based Eisai, which leads development and regulatory submissions for Leqembi, said it will request a reconsideration of the decision.
Leqembi is approved in the US, Japan, China, South Korea, Hong Kong, Israel, UAE, and Great Britain.
The University of Michigan said this week that it has won a five-year, $30 million award from the National Heart, Lung, and Blood Institute to maintain its existing Trans-Omics for Precision Medicine (TOPMed) Informatics Research Center at the University of Michigan School of Public Health. The contract, which commenced in May and is a continuation of the center’s previous award, funds the informatics and biostatistics work behind the genomic data of the TOPMed program. Patient data for TOPMed is provided by research programs such as All of Us, the Million Veterans Program, and the NIH Database of Genotypes and Phenotypes.
Dizal this week said the Center for Drug Evaluation within China's National Medical Products Administration granted breakthrough therapy designation to its EGFR inhibitor sunvozertinib as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 20 insertion mutations who have not had prior systemic therapy. Sunvozertinib is already approved in China as a treatment for relapsed or refractory NSCLC with EGFR exon 20 insertions.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on Precision Medicine Online.