Despite seeing good growth in 2019, with net sales jumping to almost $2.4 million vs. $993,000 over the previous year, Electrocore Inc. has suspended its guidance due to uncertainty over COVID-19. The company previously said full-year revenue should be in the range of $7 million to $9 million.
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.
It took less than a week from the publication of Science 37’s whitepaper on March 12 encouraging virtual clinical trials to the FDA’s decision to endorse the idea, tailored to address the COVID-19 pandemic.
PERTH, Australia – As Australia closes its borders to all non-citizens and non-residents, it looks within the country for solutions to manage the worsening COVID-19 pandemic.
It took less than a week from the publication of Science 37’s whitepaper on March 12 encouraging virtual clinical trials to the FDA’s decision to endorse the idea, tailored to address the COVID-19 pandemic.
Hoth Therapeutics Inc., of New York, and Voltron Therapeutics Inc. have formed a joint venture, Halovax, to develop a vaccine for COVID-19 that can be advanced to clinical testing.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alivecor, Arch Therapeutics, Canon Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Behold.ai, Biome Analytics, COVID-19 Healthcare Coalition, Harvard Bioscience, Masimo, Medical Alley Association, Mitre, Nxgen MDx, Novocyt, Parallax Health Sciences, Senseonics, Smiths Group, Thornhill Medical, Xphyto Therapeutics.
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.
Humanigen Inc., the Burlingame, Calif.-based developer of an anti-human-GM-CSF monoclonal antibody for preventing and treating cytokine storms, is urgently working to spin up a phase III trial of the candidate, lenzilumab, for COVID-19 patients whose immune systems have gone into overdrive.
