Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adlon, Alzamend Neuro, Hutchmed, Ildong, Immunic, Jazz, Lupin, Mesoblast, Puma, Prometic, Scpharmaceuticals.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Access Bio, Almac Sciences, Areum Bio, Bellaseno, Bio-Rad, Ensysce Biosciences, ERS Genomics, Exothera, Hart Medical Equipment, Icon, Leisure Acquisition Corp., Nippon Gene, Nonacus, Northwest Ohio Medical Equipment, Novigenix, Ossis, Pall, Pamgene, PRA Health Sciences, Qiagen, Seegene, Spinelife.com, Sysmex, Vivera, Zimmer Biomet.
As confirmed cases and deaths from COVID-19 continue their downward slide, biopharma research efforts remain front and center, providing a new therapeutic for emergency use in the U.S. and high-efficacy phase III data for what could become the country’s fourth vaccine and its first protein subunit option.
The COVID-19 vaccine from Curevac AG looks far less protective than mRNA-based rivals, according to phase IIb/III data, but the company suggested it could still be approved in younger age groups or supplied to poorer countries at lower cost.
Shares in Altimmune Inc. and Angion Biomedica Corp. were sharply down after the companies announced trial disappointments from a nasal COVID-19 vaccine and two investigational therapies. Altimmune was worst hit, with shares (NASDAQ:ALT) dropping 38% to $9.80 June 30 after announcing its nasal COVID-19 vaccine did not produce enough immune response and axing an immunotherapy trial after encountering problems finding enough subjects.