Avenda Health Inc. has taken a page out of the breast cancer book with a new technology that offers very localized treatment of prostate tumors in a procedure the company refers to as a prostate cancer lumpectomy. The FDA granted breakthrough device designation to the product based on its potential to transform care for one of the most common cancers. Read More
The controversy over the use of ethylene oxide (EtO) is back in play, thanks to a May 5 letter from the Office of Inspector General at the Environmental Protection Agency to the EPA. The letter recommends that the agency revisit its work on determining the status of EtO based on new data, data that may lead to more restricted use of EtO to sterilize medical devices. Read More
About 13 years after four MIT graduate students and a computer science professor launched Ginkgo Bioworks Inc., the Boston-based synthetic biology platform business is merging with a special purpose acquisition company (SPAC) in the largest life sciences deal of its kind to date. Read More
PARIS – Microsure BV reported closing a $3.25 million funding round to develop its supermicrosurgery robot, Musa. This series B round was led by Dutch investment agency Invest-NL NV. The other 50% of the funding came from existing Dutch shareholders Brabant Development Agency NV and venture capital partners Innovation Industries Fund, as well as from Ten Cate Investreingsmaatschappij BV. Read More
A cautious optimism pervaded the March 11 Senate Health, Education, Labor and Pensions (HELP) Committee update on COVID-19, with witnesses and lawmakers alike welcoming the continuing decline of infections, hospitalizations and deaths in the U.S. Read More
Building on existing guidance and nearly eight years’ experience with biosimilar monoclonal antibodies and fusion proteins, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a final guidance detailing a streamlined approach to licensing biosimilars. Read More
The discovery of synthetic lethality between BRCA mutations and PARP inhibitors ranks has led to major advances in the treatment of BRCA-mutated cancers. Mutations in BRCA1 and BRCA2 can leave cells with a deficiency in homologous repair (HR). And that deficiency can make them vulnerable to PARP inhibitors, which block alternate DNA repair pathways, as well as platinum-based treatment, which induces DNA mutations that BRCA-deficient cells are unable to cope with. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Belkin Laser, Bio-Techne, Boston Scientific, Heartflow, Lucence, Molecular Targeting Technologies. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: American Bionostica, Applied DNA Sciences, Biointellisense, Castle Biosciences, Cytosorbents, Doctor On Demand, Grand Rounds Health, Ott Scientific, Protech Home Medical, Quipt Home Medical, Speedx, Veemed. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avenda Health, Whiterabbit. Read More
