https://vigi-eye.com/analysis/2026-11-15-view-paid-is-not-covered-build-the-access-case-around-the-policy-not-the-claimsVigiEyeen2026-11-15Paid is not covered: build the access case around the policy, not the claimshttps://vigi-eye.com/analysis/2026-11-15-ema-consults-on-medically-important-veddra-terms-to-anchor-veterinary-signal-manVigiEyeen2026-11-15EMA consults on medically important VeDDRA terms to anchor veterinary signal managementhttps://vigi-eye.com/analysis/2026-11-15-tuhura-s-aml-ind-clearance-tests-how-small-biotechs-fund-early-phase-oncology-trVigiEyeen2026-11-15TuHURA's AML IND clearance tests how small biotechs fund early-phase oncology trialshttps://vigi-eye.com/analysis/2026-11-15-mhra-s-monthly-licence-list-is-a-cheap-supply-chain-check-as-danish-shortages-moVigiEyeen2026-11-15MHRA's monthly licence list is a cheap supply-chain check as Danish shortages mounthttps://vigi-eye.com/analysis/2026-11-15-medicare-fraud-plea-shows-how-kickbacks-and-weak-oversight-corrupt-lab-and-devicVigiEyeen2026-11-15Medicare fraud plea shows how kickbacks and weak oversight corrupt lab and device supply chainshttps://vigi-eye.com/analysis/2026-11-15-chmp-backs-fortvita-s-pd-1-antibody-zybrivo-in-first-line-non-squamous-nsclcVigiEyeen2026-11-15CHMP backs Fortvita's PD-1 antibody Zybrivo in first-line non-squamous NSCLChttps://vigi-eye.com/analysis/2026-11-15-ema-drafts-new-list-of-medically-important-veddra-terms-for-veterinary-pharmacovVigiEyeen2026-11-15EMA drafts new list of medically important VeDDRA terms for veterinary pharmacovigilancehttps://vigi-eye.com/analysis/2026-11-14-ema-s-veterinary-signal-page-phenobarbital-dog-labelling-new-mah-templates-veddrVigiEyeen2026-11-14EMA's veterinary signal page: phenobarbital dog labelling, new MAH templates, VeDDRA 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approachhttps://vigi-eye.com/news/item/c/752198cf933dd31cbe30VigiEyeen2026-11-13Imricor starts US launch of NorthStar iMR system after paediatric FDA clearanceshttps://vigi-eye.com/news/item/c/0db254b4ba607ba4a8ceVigiEyeen2026-11-13Helus Pharma, formerly Cybin, reports $150.9M six-month net loss as share compensation riseshttps://vigi-eye.com/news/item/c/240bad34c7d3adf3d7f0VigiEyeen2026-11-13Beyond Air reports record $2.3M quarterly revenue as FDA reviews second-generation LungFit PHhttps://vigi-eye.com/news/item/c/811777c899b2328f0396VigiEyeen2026-11-13IM Cannabis sells German arm to CEO-controlled Slil, refocusing on Israelhttps://vigi-eye.com/news/item/c/74d9e16e8d3418c8964dVigiEyeen2026-11-13MacroGenics reports $288M cash and 2028 runway, putting B7-H3 ADC MGC026 in head and neck cancer firsthttps://vigi-eye.com/news/item/c/53f4dc62f13b5a8c210bVigiEyeen2026-11-13Cerenome reports first CNSide revenue and completes enrolment in Phase 2 glioblastoma 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stagehttps://vigi-eye.com/news/item/c/fdcc3e2ac6af59875057VigiEyeen2026-11-13GH Research moves GH001 to single-dose inhaler regimen as FDA feedback on depression plan is positivehttps://vigi-eye.com/news/item/c/2a3377d79610c37dae39VigiEyeen2026-11-13Medicare begins paying for Lucid's EsoGuard as PAVmed's Veris nears FDA 510(k) filinghttps://vigi-eye.com/news/item/c/3125da9dfa5315e8ebfeVigiEyeen2026-11-13FDA lifts ARD-101 clinical hold in Prader-Willi; Aardvark to run open-label trialhttps://vigi-eye.com/news/item/c/225c80f18fc349ac959eVigiEyeen2026-11-13MetaVia details DA-1726 interim data and vanoglipel MASH plans in investor deckhttps://vigi-eye.com/news/item/c/27113b583630e4846173VigiEyeen2026-11-13Fortress Biotech Q3 revenue rises 9% to $19.2M as Oaktree facility is repaidhttps://vigi-eye.com/news/item/c/c438ff045d1b6a2f48a1VigiEyeen2026-11-13Benitec: all treated OPMD patients responded to BB-301; pivotal trial planned for mid-2027https://vigi-eye.com/news/item/c/1b10546a3d2fe5bddd6aVigiEyeen2026-11-13TuHURA wins FDA IND clearance for VISTA antibody TBS-2025 in relapsed AMLhttps://vigi-eye.com/news/item/c/71aedd335b6551140dacVigiEyeen2026-11-13Milestone cuts costs by about 30% as CARDAMYST posts $1.0M third-quarter saleshttps://vigi-eye.com/news/item/c/ed0b021ed68bb9670d47VigiEyeen2026-11-13Biofrontera wins FDA nod for Ameluz in superficial BCC as Q3 revenue rises 30%https://vigi-eye.com/news/item/n/ca84bf9e574c6c7f133eVigiEyeen2026-11-13EMA publishes draft veterinary PV guideline listing medically important VeDDRA termshttps://vigi-eye.com/news/item/n/4994af80ad0f77d16f4aVigiEyeen2026-11-13EMA opens consultation on medically important VeDDRA terms list for veterinary pharmacovigilancehttps://vigi-eye.com/news/item/c/cf21e4b34b6b724104a6VigiEyeen2026-11-13CHMP backs Roche's Gazyvaro as add-on therapy for autoantibody-positive 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phone lines remain openhttps://vigi-eye.com/news/item/u/22d3a87842d6dc86VigiEyeen2026-11-13EMA publishes Revision 2 of VICH GL49 on residue depletion study method validationhttps://vigi-eye.com/news/item/u/a4ef34eb72890222VigiEyeen2026-11-13CHMP backs seven new medicines and 11 indication extensions at November meetinghttps://vigi-eye.com/news/item/u/9225bd1e8d213b30VigiEyeen2026-11-13BASG: Danish sperm bank blocks donor 8306/Bernt over alpha-1 antitrypsin deficiency carrier statushttps://vigi-eye.com/news/item/u/82614c3dfe39160eVigiEyeen2026-11-13Denmark flags supply problems for Biocon's Ogivri 150 mg trastuzumab biosimilar until end-Novemberhttps://vigi-eye.com/news/item/u/9a126ceeef1d2fc6VigiEyeen2026-11-13Spain's AEMPS flags mupirocin- and fusidic acid-resistant Staphylococcus aureus in childhood impetigo caseshttps://vigi-eye.com/news/item/u/c6a695c0ae7ffc82VigiEyeen2026-11-13Spain's veterinary committee backs seven decentralised applications, including pimobendan chews and deltamethrin collarshttps://vigi-eye.com/news/item/u/352ca74efbca64b4VigiEyeen2026-11-13EMA publishes revised reflection paper on heat treatment against endogenous retroviruses in live veterinary vaccineshttps://vigi-eye.com/news/item/u/f5de3c87c8171637VigiEyeen2026-11-13Denmark flags supply problems with Sandoz's Vivelle Dot 75 microgram estradiol patches until Decemberhttps://vigi-eye.com/news/item/u/4a6ac0c74a4d476aVigiEyeen2026-11-13Denmark flags Vivelle Dot 25 microgram patch shortage linked to Sandoz production problemshttps://vigi-eye.com/news/item/u/dae1d9d22acf0149VigiEyeen2026-11-13DKMA updates Vivelle Dot 37.5 supply notice: shortage expected to last until end of Decemberhttps://vigi-eye.com/news/item/u/42f157f6953df9daVigiEyeen2026-11-13DKMA updates foreign-supply window for estradiol 75 microgram patches in Danish supply failurehttps://vigi-eye.com/news/item/u/e567abd252bfc337VigiEyeen2026-11-13Denmark flags supply problems with Perrigo's NorLevo emergency contraceptive tabletshttps://vigi-eye.com/news/item/u/24793a41262ad66aVigiEyeen2026-11-13Denmark flags supply problems with Paranova's NorLevo emergency contraceptive tabletshttps://vigi-eye.com/news/item/u/e4d148657de52905VigiEyeen2026-11-13Delaware US Attorney's Office launches Program Fraud Task Force with DOJ and state partnershttps://vigi-eye.com/news/item/u/01afa9ab8d4fb0ecVigiEyeen2026-11-13Wisconsin DOJ charges Milwaukee woman over alleged $1m Medicaid fraudhttps://vigi-eye.com/news/item/u/9f56adda26a20efcVigiEyeen2026-11-13Quest Diagnostics pays $13m to resolve Medicare and Medicaid kickback allegations over Giants suite ticketshttps://vigi-eye.com/news/item/u/4a4848d50adead77VigiEyeen2026-11-13California lab and owner pay $1.25m to settle False Claims Act kickback allegationshttps://vigi-eye.com/news/item/u/6eeae3b919fe5fb9VigiEyeen2026-11-13New York doctor indicted over alleged $6.8M Medicare fraud involving phantom consultations and orthotic braces