Between Cases Daily · Oct 23: Ultomiris IgAN nod, EQT to take QIAGEN private, point-of-care vaginitis PCR

FDA granted accelerated approval to Alexion's Ultomiris (ravulizumab) for IgA nephropathy (announced Oct. 21). It's for reducing proteinuria in adults with primary IgA nephropathy (IgAN) at risk for disease progression. AstraZeneca calls it the first and only C5 complement inhibitor approved for this use. The approval rests on an interim look at the Phase III I CAN trial, where Ultomiris cut proteinuria 43.4% vs. placebo at 34 weeks. It hasn't been shown to slow kidney function decline, and continued approval may depend on the trial's week-106 eGFR results. It's given by IV every eight weeks after a loading dose. It's the drug's fifth indication. Late-breaking I CAN results are set for ASN Kidney Week on Oct. 23. (AstraZeneca)

bioMérieux got FDA 510(k) clearance and a CLIA waiver for its BIOFIRE SPOTFIRE Vaginitis Panel (Oct. 22). The multiplex PCR test reports 8 results from one swab, covering bacterial vaginosis, yeast and Trichomonas, in about 20 minutes at the point of care. It works with self-collected or clinician-collected swabs. bioMérieux calls it the first rapid molecular vaginitis test. The CLIA waiver lets non-lab staff run it, and the company is pitching it for family practice, urgent care and OB/GYN offices. U.S. commercial availability starts at the beginning of 2027. (bioMérieux)

Eko Health launched CORE 300, an FDA-cleared AI-enabled stethoscope (Oct. 22). The 510(k) clearance covers pediatric and adult patients. Eko says it's the first stethoscope with traditional and digital listening in a single chestpiece. It offers up to 35x amplification, active noise cancellation and a real-time heart rate display. Paired with the Eko app, it can run Eko's FDA-cleared AI for structural murmur detection. Eko says it's priced in line with premium traditional stethoscopes. It went on sale Oct. 22 at ekohealth.com, with Canada, the U.K. and select European markets to follow. (Eko Health)

EQT agreed to take QIAGEN private (Oct. 21). The all-cash offer is €46.50 per share, a 40.3% premium to the share price before takeover reports surfaced in July. It values QIAGEN at about €10.8 billion in enterprise value (about $12.1 billion). QIAGEN's boards unanimously back the deal. Closing is expected in mid-2027 and needs at least 50% of shares plus one tendered, plus regulatory clearances. QIAGEN keeps its name and runs independently under current management until then. After closing, its NYSE and Frankfurt listings would end. QIAGEN had about 5,400 employees as of Sept. 30. (QIAGEN)

Fractyl Health is cutting about 45% of its workforce (Oct. 22). The goal is to focus on Revita, an endoscopic procedure on the duodenal lining that's in pivotal testing for keeping weight off after people stop GLP-1 drugs. The cuts should be mostly done by November. Fractyl plans to file a De Novo request with FDA in late Q4 2026 and is targeting a possible U.S. launch in early 2028. It's dropping internal work on its Rejuva gene therapy program. Separately, Ferring told BioSpace on Oct. 22 that "a limited number of employees will leave the company" as it refocuses U.S. resources. It didn't say how many people, where or when. (Fractyl · BioSpace)

Medtronic, Senior Coronary CathWorks Territory Manager — Albany, NY/Hartford, CT. Posted Oct. 22. Base $85,000 plus a Sales Incentive Plan. You'd sell Medtronic's coronary portfolio (stents, balloons, guidewires, imaging) plus CathWorks, its angio-based FFR technology, and support cases in the cath lab. Asks for a bachelor's and 4+ years of relevant sales, clinical or related experience (or an associate's with 6+ years, or a high school diploma with 8+ years). Cath lab experience preferred. Up to 50% travel, with regular overnights. The application window is expected to close Oct. 31. Posting

Johnson & Johnson Innovative Medicine, Immunology Sales Specialist, Gastroenterology — San Jose, CA. Posted Oct. 22. Anticipated base $99,000–$185,500. Calls on office- and hospital-based GI providers. Asks for a bachelor's and at least 4 years of direct selling to healthcare professionals in pharma, biotech, device or healthcare, "or large account management, or business to business experience." Experience with injectable or infused products and complex reimbursement preferred. Posting

Abbott, Strategic Account Manager, Cancer Diagnostics — Kansas City. Posted Oct. 22. Base $99,300–$198,700. A health system role: you'd work with IDNs, health systems and academic centers to drive adoption of Abbott's cancer diagnostics. Accounts are in parts of Missouri and Kansas, including Kansas City, Topeka and Wichita. Asks for a bachelor's, 6+ years of healthcare sales and/or marketing (diagnostic, surgical or pharma) and 2+ years selling into IDNs, health systems or academic institutions. 25% travel. Posting

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