Between Cases Weekly · Issue #2 · Oct 21: Hibsago nod, Aetna 2027 precert list, Penumbra DVT clearance

Oct. 31: Drugmakers in the third round of Medicare drug price negotiation must accept or reject CMS's final offers. The negotiation period ends Nov. 1. CMS must publish any negotiated prices by Nov. 30. (CMS fact sheet, PDF)

CY2027 physician fee schedule final rule: not out yet. As of Oct. 21, CMS's fee schedule rules page still lists only the July proposed rule. (CMS) The AMA expects the final rule by about Nov. 1. (AMA)

Hibsago (bepirovirsen, GSK), 10/20: the first FDA-approved antisense oligonucleotide for chronic hepatitis B. It's for certain adults without cirrhosis who have taken HBV antivirals for at least six months, have suppressed virus levels and have HBsAg of 3,000 IU/mL or less on an FDA-authorized test. FDA also authorized Roche's Elecsys HBsAg II quant II RxDx assay as the companion diagnostic. Across two trials, 24% of Hibsago patients met the requirements to stop their existing HBV medicine, compared with none on placebo. It carries a boxed warning for serious liver reactions and low platelet counts. (FDA · FDA novel approvals list)

Evoxac oral solution (cevimeline, Cosette), 10/20: a liquid form of the same drug in Evoxac capsules, for dry mouth symptoms in adults with Sjögren's disease. It's meant in part for patients who have trouble swallowing capsules. Cosette expects it to be available in the U.S. by the end of 2026. (Cosette)

First generic of Climara Pro (Zydus), approved 10/19: a once-weekly estradiol and levonorgestrel patch for women with an intact uterus. (FDA)

Brytly (apraclonidine 0.125%, Alcon), 10/16: the first nonprescription apraclonidine eye drop, for eye redness from minor irritations, in adults and children 12 and older. (FDA)

Final guidance on prescription drug apps, 10/20. Apps connected to a device, like an inhaler app, generally should be described on the drug's label. Standalone apps, like dose reminders or symptom trackers, belong on the label only if they're essential for safe and effective use or show a meaningful clinical benefit. In most cases, FDA will treat what a companion app displays as promotional material. (FDA)

Centinel Spine prodisc C Nova, announced 10/19: now approved for two-level cervical disc replacement. That gives Centinel three prodisc C devices (Vivo, SK and Nova) approved for one- and two-level use. Nova is in limited U.S. release. (ODT)

Gore VIABAHN VBX, 10/8: a panel-track supplement adds use as a bridging stent to keep visceral arteries perfused in fenestrated and branched aortic aneurysm repair (FEVAR and BEVAR). (P160021/S051)

Vascular: Penumbra says its Lightning computer assisted vacuum thrombectomy (CAVT) technology is now cleared to treat deep vein thrombosis. In the BOLT-DVT trial, Penumbra reports 98% of patients had complete or near-complete clot removal, with a median device time of 18 minutes and a 3.1% 48-hour major adverse event rate. (Penumbra, Oct. 20) Also cleared: Okami LOBO vascular occlusion system (K262798) and Stryker Excelsior Reach microcatheter (K261649).

Diabetes: The twiist automated insulin delivery system is now cleared for adults with insulin-treated type 2 diabetes. Sequel sells it, and the clearance went to its partner DEKA. In the trial, time in target range rose from 57% to 73%. (MedTech Dive)

Imaging: Fujifilm ECHELON Synergy MRI (K262902), Samsung V10/H10 ultrasound (K263150), Mindray Resona I10 ultrasound (K261617) and Bayer MEDRAD MRXperion MR injection system (K262043).

Imaging AI: RapidAI's Rapid ICH v4.0 (K262301) and NeuroDR (K262134). 3DR Labs says NeuroDR builds 3D neurovascular models from head and neck CT angiography with no manual technologist clicks. (3DR Labs)

Diagnostics: CDC's B. anthracis real-time PCR assay (K262368).

Ortho: Paragon 28 APEX 3D S Diamond Tibia (K261120), Nexus CMF TruVision single-use 1.9mm arthroscopy system (K260156) and CarboFix CarboClear cervical navigated instruments (K263154).

Merck KGaA, Darmstadt, Germany, is buying Silence Therapeutics for about $1.3B in equity value ($1.1B enterprise value). That's $20 per ADS in cash, a 130% premium to the Oct. 16 close. Silence says the deal puts its lead drug, divesiran for polycythemia vera, with a company that can speed its Phase 3 development. (Silence, Oct. 19)

Alcon has acquired Neurotech Pharmaceuticals. That brings in ENCELTO, an encapsulated cell therapy implanted in the eye and the only FDA-approved treatment for MacTel type 2. Alcon's release cites an estimated 25,000 diagnosed MacTel patients in the U.S. The release gives no price. (Alcon, Oct. 20)

Azra AI completed its purchase of Blackford Analysis, which makes enterprise software for running imaging AI. Its parent, Sopris Capital, bought Blackford from Bayer on Oct. 2. (Azra AI, Oct. 20)

Medtronic got a CE mark for its Vitalis pacemaker portfolio. That covers Europe, not the U.S. The five devices include three with conduction system pacing. (MedTech Dive)

Sequel says twiist can be prescribed now for type 2 diabetes. It works with Abbott's FreeStyle Libre 3 Plus and Senseonics' Eversense 365 sensors. (MedTech Dive)

EyePoint is cutting about 53% of its workforce after its second Phase 3 miss for Duravyu in wet AMD. It's ending both wet AMD trials early and shifting to diabetic macular edema. The company expects about $30M in savings and about $9M in severance and separation costs. (Fierce Pharma)

Spine Innovation completed the first surgery with its LOGIC Ti expandable titanium lumbar interbody on Oct. 14. The company says it is looking for U.S. sales and distribution partners. (Spine Innovation, Oct. 20)

Enlivex is cutting about 60% of its staff to focus on Allocetra, a cell therapy in development for knee osteoarthritis. It plans a placebo-controlled Phase 2b. (BioSpace)

Centinel's two-level prodisc C Nova approval and Paragon 28's APEX 3D tibia clearance are in the FDA watch above.

Stryker, Joint Replacement Associate Sales Rep, Salt Lake City. Posted 10/19. An entry-level role. $75,000–$90,000, "and may be eligible to earn commission and/or bonuses." Asks for a bachelor's, an associate's or a medical certification (CST, PT and similar) plus at least 2 years of related experience. A high school diploma with 4+ years, or 4+ years of active-duty military, also qualifies. 50% travel. Posting

Medtronic, Sales Rep II, Spine, Nashville. Posted 10/20. "100% commission based." Asks for a bachelor's plus 2+ years of relevant sales, clinical or related experience. An associate's with 4+ years or a high school diploma with 6+ years also qualifies. Medtronic expects applications to close Oct. 24. Posting

BD, Territory Manager, Manhattan. Posted 10/20. $125,992–$207,888 base plus incentive. You'd in-service surgeons and OR staff and support cases. Asks for a bachelor's and at least 3 years of general sales. Medical sales preferred. Posting

Pfizer, Senior Oncology Account Specialist (Breast Cancer), Sacramento. Posted 10/19. Base $108,600–$250,700. Asks for a BA/BS (or an associate's with 8+ years, or a high school diploma with 10+ years) and at least 4 years of pharma sales or 4 years of oncology HCP experience. Last day to apply: Oct. 29. Posting

Merck, Vaccine Customer Representative, Spokane, WA. Posted 10/20. The posted salary range is $79,200–$124,700, and it applies to the posting's primary location (North Wales, PA). The territory covers Spokane and nearby Washington plus parts of Idaho. Asks for a bachelor's with 0–3 years of sales, or a high school diploma with 4+ years of relevant work. A possible entry point for people breaking in. Posting

Abbott, Enterprise Account Manager, Molecular Diagnostics, Florida. Posted 10/19. Base $113,300–$226,700. Asks for a bachelor's and 3–5+ years of enterprise account sales in diagnostics or medical devices. Posting

Abbott, Health Systems Executive, Infectious Disease Diagnostics, Great Lakes. Posted 10/20. Base $78,000–$156,000. Asks for a bachelor's and at least 6 years of proven success calling on large health systems. About 4 days a week of travel, with up to ~50% overnight. Posting

Johnson & Johnson MedTech (Vision), Capital Equipment Specialist, Chicago. Posted 10/20. Base $81,000–$131,100. The equipment includes phaco, femto and excimer systems. Asks for a bachelor's, at least 3 years of medical device sales and at least 2 years of capital equipment sales. Ophthalmic surgery selling preferred. Posting

GE HealthCare, Clinical Solutions Leader, Ambulatory Surgery Centers, Remote. Posted 10/19. $108,000–$162,000. You'd lead a team serving electrophysiology-focused ASCs and carry your own territory. A cath lab or EP lab clinical background (RN, RCIS, RCES or lead technologist) is strongly preferred. Posting

Spine Innovation: looking for U.S. sales and distribution partners for its LOGIC lumbar interbody system. Release

RIM Medical Technologies: independent spine and ortho distributors in selected U.S. territories for its Bone Dust Trap, which captures autologous bone during surgery. Looking for spine, ortho, neurosurgery, orthobiologics and ASC experience. Page

HealKEE Medical (AeroKEE): independent reps and rep agencies for a single-use GI/endoscopy product, targeting Atlanta and the Southeast. Commission-based 1099 or rep agency arrangement, starting with a non-exclusive 90-day pilot. The listing references a May 2026 meeting, so confirm it's still open. Listing