Special purpose acquisition companies (SPACs) have been making headlines recently in the life sciences, but these entities practice a business model that leaves some observers uneasy. Gary Gensler, chairman of the U.S. Securities and Exchange Commission (SEC), told a Senate committee recently that the risks to investors in SPACs has prompted him to ask his staff to come up with some proposals to increase transparency to investors, potentially leading to additional compliance costs for these entities. Read More
A multicenter study has found that a multiplex diagnostic panel developed by Opgen Inc. can reduce the use of inappropriate antibiotic therapy by 45.1%. Opgen’s Unyvero Hospitalized Pneumonia (HPN) panel uses PCR technology that can detect 21 pathogens and 17 antibiotic resistance markers in less than five hours. During the European Respiratory Society conference, Rockville, Md.-based Opgen presented data showing that combined with antibiotic stewardship, its HPN panel decreased time on inappropriate antibiotic therapy in hospitalized patients with pneumonia at risk for Gram-negative rods. Read More
Rune Labs Inc. is on a mission to make the mysteries of the brain easier to read for both clinicians and biopharma companies. Having a fresh $22.8 million in a series A financing on the books will no doubt make the goal easier to reach. The new round pushed total funding for development of the San Francisco-based company’s brain data software platform to $30.1 million. Read More
PARIS – Sofinnova Partners SAS reported the successful closing of its med-tech accelerator fund, Sofinnova MD Start III, at $75 million. The fund had been oversubscribed and exceeded its original quota, with new investors joining existing ones such as Medtronic plc, Liva Nova plc, Baxter International Inc., French national public investment bank Bpifrance and the European Investment Fund. Read More
Newly launched startup Somne Inc. plans to give CPAP machines a run for their money by replacing CPAP masks and hoses for treating obstructive sleep apnea with a gentler collar encircling the patient’s neck. The new device uses variable negative pressure to ensure users get a good night’s sleep instead of positive airway pressure employed by companies such as Resmed Inc. and Philips Respironics Inc. Read More
DUBLIN – Allarity Therapeutics A/S plans to file an NDA with FDA for dovitinib in renal cell carcinoma (RCC) in the fourth quarter this year, after unveiling a new analysis at the European Society for Molecular Oncology’s virtual congress, which suggest that its companion diagnostic, DRP, can identify patients who obtain a survival benefit from the therapy. Read More
New hires and promotions in the med-tech industry, including: Artio Medical, Davita Kidney Care, Opterion Health, Owlstone Medical, Sera Prognostics. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bayer AG, BEC, Bico Group AB, Biocorp SA, Bwx Technologies, Cardialen, Carmat, Castle Biosciences, Gunze, Hurel, Merck, Oracle, Oxford Nanopore Technologies, Philip Morris, Radialis Medical, Replicel, TAE Life Sciences, Vectura. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Gynesonics, Neovasc, Thermo Fisher. Read More
