Having a COVID-19 therapy approved through an emergency use authorization (EUA) is not the same as having access to it, even if it’s free. Accounting for one-third of the nearly 4 million COVID-19 cases confirmed globally as of Monday and 28.5% of the 278,957 deaths, the U.S. is getting 40% of the 1.5 million vials of remdesivir Gilead Sciences Inc. is donating worldwide.

The U.S. FDA’s enforcement regarding products related to the COVID-19 pandemic has picked up steam recently, but the U.S. Federal trade commission (FTC) is also involved in this enforcement arena. Leonard Gordon, a partner at Venable LLP’s New York office, told BioWorld that while the FTC and FDA missions seem to overlap, the FTC primarily targets unsupportable advertising claims rather than product labeling, a particularly relevant area in the COVID-19 pandemic.

Boston Scientific Corp. reported positive results for its Emblem subcutaneous implantable defibrillator (S-ICD) system and next-generation Watchman Flx left atrial appendage closure (LAAC) device at the Heart Rhythm Society scientific sessions, which were online only this year due to the COVID-19 pandemic.

In the rush to develop a COVID-19 vaccine, integral parts of the equation are being overlooked in the U.S., according to a whistleblower complaint filed this week by Rick Bright over his removal as director of the Biomedical Advanced Research and Development Authority (BARDA). Even if millions of doses of vaccine are ready to go by January, as the NIH’s Anthony Fauci a few weeks ago said could happen, there may not be enough needles and syringes to deliver those doses.

Several companies have reported quarterly results over the past couple of days, and those offering testing for COVID-19 have seen impressive numbers. Standing out was San Diego-based Quidel Corp., whose numbers caught the attention of William Blair’s Brian Weinstein. Indeed, its $174.7 million in revenue far exceeded his organization’s estimate of $160 million, driven by influenza.

As states in the U.S. move past the initial push for tests to identify active COVID-19 infections, antibody tests are ramping up quickly to aid in disease surveillance and return-to-work screenings. The rush has spurred an explosion in serology tests, many hastily developed and of questionable value. However, as the pandemic enters its third month, some companies are offering high-accuracy tests with validated results.

The COVID-19 pandemic has shaken the world – and the face of diagnostics. In a matter of weeks, a host of companies has worked to develop tests to find those patients who currently have the disease, as well as those who have developed antibodies.

Brisbane, Calif.-based Caredx Inc. has reported a strategic alliance with Weill Cornell Medicine that makes the company the exclusive development and commercialization partner for Uromap, a urine-based gene-expression test for acute cellular rejection in kidney transplant recipients.

Palo Alto, Calif.-based Varian Medical Systems Inc. has joined the ranks of other companies in withdrawing its guidance even as at least one analyst saw positive news for the second quarter. For her part, BTIG’s Marie Thibault noted that the company missed on Americas oncology gross order metric, while falling short on consensus non-GAAP earnings per share (EPS) by five cents.