DUBLIN – Three different vaccine technologies are being deployed in the desperate global effort to combat the SARS-CoV-2 virus, but Rino Rappuoli, chief scientist at the GSK Vaccines arm of Glaxosmithkline plc, said he sees traditional protein-based adjuvanted subunit vaccines, the trusted workhorse of infectious disease prevention, as offering the best bet for delivering a safe and effective vaccine at scale, within the tight timescales necessitated by the present crisis.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BGI Genomics, Butterfly Network, Motus GI.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agnovos Healthcare, Biostage, Immunexpress, Prisma Health, Quidel, Vero Biotech.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ads Biotec, Atum, Babcock International Group, Cerus, Diazyme Laboratories, Exthera Medical, Grifols, Henry Schein, Ifirst Medical Technologies, Integragen, Ixlayer, Kurabo Industries, Lumos Diagnostics, Microbiosensor, Orthofix, Planet Innovation, Seqster, Suse, Twist Bioscience, Tyto Care, Wittenshein.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ArcherDX, Eurobio Scientific, Extremity Medical, Perkinelmer.
DUBLIN – The Genentech arm of Roche Holding AG plans to move its interleukin-6 inhibitor, Actemra, into a global phase III trial in patients with severe pneumonia associated with COVID-19 infection.
The pressure is rising on the Trump administration to activate the Defense Production Act (DPA) for the COVID-19 outbreak as the Senate yet again reconsiders an economic stimulus package. Sens. Brian Schatz (D-Hawaii) and Chris Murphy (D-Conn.) unveiled the Medical Supply Chain Emergency Act in an effort to force the White House to mandate the production of needed supplies, a bill that is likely to languish until Congress can move on economic relief legislation.
The U.S. FDA has granted an emergency use authorization (EUA) to Cepheid Inc., of Sunnyvale, Calif., for a rapid molecular diagnostic to detect SARS-CoV-2, the virus that causes COVID-19. The Xpert Xpress SARS-CoV-2 test is designed for the qualitative detection of the novel coronavirus and runs on the company’s automated Genexpert systems, with a turnaround time of about 45 minutes.
