While the FDA’s Oncologic Drugs Advisory Committee (ODAC) shared some of the agency’s concerns about uncertainties surrounding Mesoblast Ltd.’s Ryoncil (remestemcel-L), it voted 9-1 Aug. 13 that the mesenchymal stromal cell (MSC) product showed evidence of efficacy as a treatment for steroid-refractory acute graft-vs.-host disease (GVHD) in children. Read More
Cansino Biologics Inc. launched its second pre-revenue share offering on Aug. 13, reaping ¥5.2 billion ($749 million) from Shanghai’s STAR market. Read More
Triggering receptor expressed on myeloid cells 2 (TREM2) was first discovered because variants affect the risk of developing late-onset Alzheimer’s disease (AD). Read More
Immunoscape Ltd. closed an $11 million global equity financing round led by U.S.-based venture firm Anzu Partners along with University of Tokyo Edge Capital in Japan, and Indonesia's NPR Holdings. The company plans to use the funds to ramp up its immune profiling technology platform, which performs deep T-cell analysis, and expand partnerships to develop vaccines for COVID-19 and other viruses as well as targeted oncology therapies. Read More
Two decades after the federal government jumpstarted U.S. R&D investment in its understanding and control of nanoscale matter, funding for the efforts across the government reached about $1.4 billion in fiscal 2020, part of a total cumulative investment of about $29 billion. Though FDA-budgeted nanotech research has accounted for just a fraction of that, at a modest $133 million since 2009, substantial advances have still been made, according to a presentation on the state of nanotech progress and innovation issued this summer. Read More
HONG KONG – China’s Arctic Vision Biotechnology Co. Ltd. has entered into an exclusive deal with New York-based Eyenovia Inc. to develop and commercialize ophthalmic formulations that are delivered using the latter’s first-in-class microdosing spray technology. Read More
HONG KONG – Following FDA approval of its IND, Israel-based Kahr Medical Ltd. is set to start a phase I/II trial of lead product DSP-107, a second-generation CD47- and 41BB-targeting compound. The move puts Kahr among a number of companies working on drugs against checkpoint molecule CD47. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Algernon, Azurrx, Bio-Path, Cerecor, Debiopharm, Gyroscope, Novo Nordisk, Treadwell, Viela. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Molecular, Akeso, Antengene, Biomarin, Enzychem, Genentech, Hoth, Micurx, NS, Passage, Scholar Rock, TG. Read More
