Sen. Amy Klobuchar (D-Minn.) has posted new legislation that would bolster antitrust enforcement and deter anticompetitive behavior in the private sector, but the bill faces considerable opposition. Glenn Lammi of the Washington Legal Foundation told BioWorld that the legislation would blunt investment in the life sciences due to provisions that would make the possession of a patent an indication of legally actionable anticompetitive behavior.
“We look forward to the day where we can get back to normal,” U.S. President Donald Trump said Monday at a COVID-19 news conference in which reporters sat every-other-seat apart. In an unusually somber tone, the president said it now looks like it will be at least July or August before the outbreak “washes through.”
The past week has seen a lot of movement in terms of tests to detect SARS-CoV-2, the virus that causes COVID-19. “It is notable that the diagnostics community is coming together in a way we have not seen in our 20 years covering this industry,” wrote William Blair analyst Brian Weinstein in a March 14 note. “Regulators, lab professionals, and manufacturers are all in a frenetic fury to try and get testing up and running, and we generally see a sense of ‘in it together’ playing out.”
The U.S. effort to deploy diagnostics for the novel coronavirus has been plagued by missteps by the CDC and the FDA from the outset, leading to delays and missed opportunities. The Trump administration declared a national emergency March 13, but concerns remain about how quickly the array of available tests can be conducted and whether there are enough testing supplies to handle the anticipated demand.
Sientra Inc., of Santa Barbara, Calif., reported gains in both its breast products and Miradry segments during its fourth-quarter earnings call after the close of the market March 11. For his part, CEO Jeff Nugent noted that the company had experienced record total net sales in the fourth quarter of $23.2 million, representing growth of 22% year-on-year. However, the company provided full-year 2020 guidance for 12% to 17% growth, which William Blair’s Margaret Kaczor said was below her organization’s 22% estimate, “though the shortfall is largely a result of negative impacts from COVID-19.”
The U.S. Securities and Exchange Commission (SEC) Thursday extended the public on-ramp for small companies that take longer than five years to generate $100 million in annual revenue, as well as some of the business development companies that invest in them.
Taking a breather from the political rhetoric that’s permeated the U.S response to COVID-19 and pushed legislation aimed at lowering drug prices to the back burner, a House subcommittee Wednesday advanced several bipartisan bills intended to improve the safety and ensure the supply of drugs and medical devices.
U.S. FDA commissioner Stephen Hahn appeared before a congressional panel to discuss the administration’s budget proposal for the agency, but the outbreak of COVID-19 predictably dominated the proceedings.
As the COVID-19 outbreak continues to dominate the news, an increasing number of companies have come forward to help. For its part, CHF Solutions Inc., of Eden Prairie, Minn., is looking to bring its device-based intervention for fluid management to the fight.
Avellino Lab USA Inc. has developed a diagnostic test for the novel coronavirus SARS-CoV-2, which has been validated in keeping with the U.S. Food and Drug Administration (FDA)'s Policy for Diagnostics Testing in Laboratories Certified to Perform High-Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency. Physicians can order the assay now, while the company continues testing.
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