Fluidigm files for emergency use of saliva-based test for COVID-19

Fluidigm (NASDAQ:FLDM) is up 27% premarket in reaction to its filing for Emergency Use Authorization (EUA) for an extraction-free saliva-based test, Advanta Dx SARS-CoV-2 RT-PCR test, to detect the SARS‑CoV‑2 virus.

The test, developed in collaboration with McDonnell Genome Institute and Washington University School of Medicine, provides an easy-to-administer protocol that does not require collection via invasive nasopharyngeal swab and is processed on the Biomark HD microfluidics platform.

https://seekingalpha.com/news/3582883-fluidigm-files-for-emergency-use-of-saliva-based-test-for-covidminus-19

Iveric Bio’s Zimura shows sustained benefit in eye disorder study

IVERIC bio (NASDAQ:ISEE) announces positive 18-month data from a Phase 3 (listed as a Phase 2 in ClinicalTrials.gov) clinical trial evaluating C5 inhibitor Zimura (avacincaptad pegol) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

At month 18, the relative reduction in the mean rate of GA was 28.1% in the Zimura 2 mg arm and 30.0% in the 4 mg arm.

In October 2019, the company announced positive 12-month data from the trial.

A second pivotal study, ISEE2008, testing Zimura 2 mg, will launch this month.

Management will host a conference call today at 8:00 am ET to discuss the results.

https://seekingalpha.com/news/3582896-iveric-bios-zimura-shows-sustained-benefit-in-eye-disorder-study

FDA clears Abbott next-gen glucose monitor for young children

The FDA has issued 510(k) clearance for Abbott’s (NYSE:ABT) FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system for patients as young as four years old with diabetes.

The company says the device is the only iCGM system with optional real-time alarms that measure glucose levels every minute over a period of 14 days (wear time).

https://seekingalpha.com/news/3582909-fda-clears-abbott-next-gen-glucose-monitor-for-young-children

Myriad nabs new coverage policies for Prolaris

Myriad Genetics (NASDAQ:MYGN) has received favorable coverage decisions for Prolaris from three new commercial health plans including one of the top five national providers of health insurance.

The first new coverage policy became effective on June 8, 2020, the second becomes effective today and the third one on July 31.

In combination, these health plans cover ~26M commercial lives bringing total commercial coverage for Prolaris up to 55M lives.

Prolaris is a genetic test that directly measures tumor cell growth. The Prolaris test paired with both prostate-specific antigen and Gleason provides the level of aggressiveness of a patient’s individual prostate cancer.

https://seekingalpha.com/news/3582911-myriad-nabs-new-coverage-policies-for-prolaris

Lilly launches late-stage study of baricitinib in COVID-19

Enrollment is underway in a Phase 3 clinical trial, COV-BARRIER, evaluating Eli Lilly’s (NYSE:LLY) Olumiant (baricitinib), an oral JAK1/JAK2 inhibitor licensed from Incyte (NASDAQ:INCY), in hospitalized COVID-19 patients including those with at least one elevated marker of inflammation but not on mechanical ventilation.

The primary endpoint is the proportion of patients receiving 4 mg of baricitinib each day (with background therapy) who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by day 28 compared to placebo (with background therapy).

The trial will enroll ~400 participants across sites in the U.S., Europe and Latin America.

The FDA approved Olumiant in June 2018 for rheumatoid arthritis.

https://seekingalpha.com/news/3582916-lilly-launches-late-stage-study-of-baricitinib-in-covidminus-19

Thermo Fisher nabs accelerated review in U.S. for glioma test

The FDA has granted Breakthrough Device Designation to Thermo Fisher Scientific’s (NYSE:TMO) Oncomine Precision Assay to identify low-grade glioma patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be suitable for Agios Pharmaceuticals’ (NASDAQ:AGIO) vorasidenib.

The designation, akin to Breakthrough Therapy status for a drug, provides for more intensive guidance on development by the FDA, the involvement of more senior agency personnel, the assignment of a case manager and priority review of the marketing application.

The companies have been collaborating on companion diagnostics since 2017.

https://seekingalpha.com/news/3582922-thermo-fisher-nabs-accelerated-review-in-u-s-for-glioma-test

Baudax Bio launches Anjeso in U.S.

Baudax Bio (NASDAQ:BXRX) announces the commercial launch of ANJESO (meloxicam) injection, indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.

The company has hired, trained, and now deployed 50 acute care sales representatives and that the Centers for Medicare and Medicaid Services has approved transitional pass-through status and established a new reimbursement code for ANJESO.

The code, C9059, is scheduled to become effective July 1.

https://seekingalpha.com/news/3582924-baudax-bio-launches-anjeso-in-u-s