Academica Weekly: The Primary Record for the Week Ending 12 July 2026

Academica Weekly: The Primary Record for the Week Ending 12 July 2026

Trial registrations, clearances, recalls, guidance, safety reports, device listings, and insider filings — assembled from the primary sources with no editor in the loop.

The week of 6 July 2026 to 12 July 2026: 50 Phase 3 trial registrations; 113 Phase 2 trial registrations; 22 recall events; 52 510(k) clearances; 164 new Health Canada device licences; 5,186 ARTG device entries; 872 open-market insider purchases.

50 Phase 3 trial registrations
113 Phase 2 trial registrations
22 recall events
52 510(k) clearances
84Phase 1 registrations113Phase 2 registrations50Phase 3 registrations51Phase 4 registrations52510(k) clearances39PMA decisions22recall events352,949adverse event reports333,226device event reports27,811device listings5,186ARTG device entries164new device licences925label effective dates13,639new provider enumerations15,384,974industry payments95medtech patent grants159,428literature records872open-market insider purchases
One pill per source with new rows this week

Source Ledger

The latest event date each source holds, measured against its expected publication cadence. A stale source keeps its ledger line and loses its section.

SourceLatest eventState
ClinicalTrials.govPhase 1 · Phase 2 · Phase 3 · Phase 431 July 2026Current
FDA 510(k)17 July 2026Current
FDA PMA17 July 2026Current
FDA recalls29 July 2026Current
FDA guidance31 July 2026Current
FAERS30 June 2026Current
MAUDE30 June 2026Current
GUDID22 April 202681 days behind
TGA ARTG1 August 2026Current
Health Canada31 July 2026Current
FDA drug labels12 July 2026Current
NPPES11 July 2026Current
Open Payments31 December 2024558 days behind
USPTO10 February 2026152 days behind
PubMed2 August 2026Current
SEC Form 431 July 2026Current

Phase 1 Trials

84 Phase 1 registrations this week; the 10 below lead the list.

NCTStudySponsorEnrollmentPosted
A Study of LM-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid TumorsLaNova Medicines Limited90
Study on Drug Interactions Affecting the Pharmacokinetics of RSS0343 TabletReistone Biopharma Company Limited40
Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal DiseaseXeno Holdings (US), LLC dba ChoironeX4
QT Interval Effects Study of Oral FXS5626 TabletsShanghai Fosun Pharmaceutical Industrial Development Co. Ltd.28
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of HSK46256 in Patients With Advanced Solid TumorsHaisco Pharmaceutical Group Co., Ltd.275
Rituximab for Treatment of Checkpoint Inhibitor Induced Immune-related Adverse EventsInge Marie Svane25
An Exploratory Study of Obinutuzumab β in the Treatment of Chronic Inflammatory Demyelinating PolyradiculoneuropathyZhongming Qiu24
EWSR1 Immunotherapy in Ewing Sarcoma and DSRCTRabi Hanna24
A Phase I Clinical Trial to Evaluate the Pharmacokinetic and Safety of Ammoxetine Hydrochloride Enteric-Coated Tablets in Participants With Mild Hepatic Impairment, Moderate HepatiCSPC ZhongQi Pharmaceutical Technology Co., Ltd.24
A Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of YKYY025 InjectionBeijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.180

Phase 2 Trials

113 Phase 2 registrations this week; the 10 below lead the list.

NCTStudySponsorEnrollmentPosted
Lemborexant Use for Cognition Improvement in Postoperative Delirium in Elderly Patients: A Randomized Controlled TrialBeijing Tiantan Hospital992
A Study of LM-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid TumorsLaNova Medicines Limited90
Study of YKST02 in Adults With Relapsed or Refractory Multiple MyelomaExcyte Biopharma Ltd64
A Multicenter, Single Arm Study to Evaluate the Preliminary Efficacy and Safety Profile of Inavolisib in Previously Treated Pancreatic Ductal Adenocarcinoma PatientsFudan University62
Lumacaftor Yields Reversal of Impaired Cerebral Blood Flow in Heart Failure PatientsQanatpharma AG60
A Study of MZE782 in Adults With PKUMaze Therapeutics38
Trial of Therapies With IT cDC1s Combined w/ IT Trastuzamab for Her+ or IT Nivolumab for Her- BC LMDH. Lee Moffitt Cancer Center and Research Institute30
Bepirovirsen Liver Biopsy StudyNational University Health System, Singapore30
A Study of SYH2070 Injection in Participants With Mixed HyperlipidemiaCSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.240
An Exploratory Study of Obinutuzumab β in the Treatment of Chronic Inflammatory Demyelinating PolyradiculoneuropathyZhongming Qiu24

Phase 3 Trials

50 Phase 3 registrations this week; the 10 below lead the list.

NCTStudySponsorEnrollmentPosted
Mo-Rez in First- Line (1L) Maintenance Treatment of Non- Homologous Recombination Deficient Ovarian Cancer (HRd OC) [BEHOLD-Ovarian03]GlaxoSmithKline720
Micronutrient Enhancement for Development and Health in Adolescents - The MEDHA StudyJohns Hopkins Bloomberg School of Public Health3,000
Safety and Efficacy Evaluation of SMZ1 With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration Without Polypoidal Choroidal VasculopathySANGMYUNG innovation266
Effects, Metabolic Mechanisms and Predictors of Response to Acupuncture in Treating Psychoneurological Symptoms Among Breast Cancer SurvivorsUniversity of Illinois at Chicago252
Efficacy and Safety Study of Tunodafil Hydrochloride Tablets in Erectile DysfunctionYangtze River Pharmaceutical Group Co., Ltd.780
A Study of TACE in Combination With SHR-8068, Adebrelimab, and Bevacizumab Versus TACE in Participants With Incurable Hepatocellular CarcinomaSuzhou Suncadia Biopharmaceuticals Co., Ltd.690
Intrauterine G-CSF Infusion for Thin EndometriumNanjing University620
Single-Dose vs. Divided-Dose G-CSF for Stem Cell Mobilization in Healthy Allogeneic DonorsFirst Affiliated Hospital of Zhejiang University560
A Phase III Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe HypertriglyceridemiaZhejiang Doer Biologics Co., Ltd.480
Sintilimab Versus Mitomycin in Combination With Capecitabine and IMRT for Limited-stage Anal Squamous Cell CarcinomaCancer Institute and Hospital, Chinese Academy of Medical Sciences350

Phase 4 Trials

51 Phase 4 registrations this week; the 10 below lead the list.

NCTStudySponsorEnrollmentPosted
Efficacy of Nonsteroidal Anti-Inflammatory Drugs for the Prevention of Cystoid Macular Edema Following Cataract PhacoemulsificationPomeranian Medical University Szczecin88
Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening ColonoscopyFundacion Clinic per a la Recerca Biomédica818
Microneedling-Assisted Metformin, Tranexamic Acid, and Modified Kligman's Formula for MelasmaSameh Sarsik80
Olaparib+Trastuzumab+Pertuzumab Neoadjuvant for Elderly HER2+ Breast CancerWen-Ming Cao45
Effect of Different Resin Composite Packing Techniques on Pulp Condition (Randomized Clinical Trial)October 6 University30
A Prospective Longitudinal Analysis of Faricimab (Vabysmo 6mg) For Choroidal Neovascularization in Presumed Ocular Histoplasmosis SyndromeCincinnati Eye Institute, Southwest Ohio25
A Multicenter, Prospective, Randomized Controlled Clinical Trial Assessing the Efficacy of a Novel Cellular, Acellular, Matrix-like Product (CAMP) Plus Standard of Care Versus StanBioLab Holdings160
Cardiac Magnetic Resonance and Echocardiography Study With AcoramidisEidos Therapeutics, a BridgeBio company150
Ciprofol vs Propofol for Hemodynamic Stability in Patients Having General Anesthesia for Endovascular Thrombectomy After Ischemic StrokeRenJi Hospital124
Ultra-Long GnRH-a Pretreatment for FET Outcomes in Patients With Deep Infiltrating EndometriosisLi-jun Ding120

510(k) Clearances

52 510(k) clearances this week; the 10 below lead the list.

K numberDeviceApplicantClassDecision
Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-NasC.R. Bard, Inc.2
LungFlow Airway CatheterFree Flow Medical, Inc.2
ClearSafe Closed SystemMedSource Labs, LLC2
Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; TridenHowmedica Osteonics Corp., Dba Stryker Orthopaedics2
NYES Tuff Cuff L3 Disposable GownsNew York Embroidery Studio2
SedLine Sedation MonitorMasimo Corporation2
Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting SoftwCochlear Americas2
AI Contouring (VA10A)Varian Medical Systems2
WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation2
Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.2

PMA Approvals

39 PMA decisions this week; the 10 below lead the list.

PMADeviceApplicantDecision
Precision Spinal Cord Stimulator (SCS) SystemsBoston Scientific Corp
EverFlex™ Self-expanding Peripheral Stent SystemMedtronic Vascular, Inc.
Vercise Deep Brain Stimulation (DBS) SystemsBoston Scientific Corp
FARAPULSE™ Pulsed Field Ablation System (FARAPULSE)Farapulse, Inc.
Model 3150 Implantable Pulse Generator (IPG)Inspire Medical Systems
HexaGen RF Generator Software and RemoteMedtronic, Inc.
Volt™ PFA SystemAbbott Medical
Protege™ GPS™ Self-expanding Peripheral Stent SystemMedtronic Vascular, Inc.
Trilogy Transcatheter Heart Valve SystemJenaValve Technology, Inc.
Belotero® Intense (+) LidocaineMerz North America, Inc.

Recalls

22 recall events this week; the 10 below lead the list.

FirmProductReasonCatalog rowsPosted
ICU Medical, Inc.ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pumpIn a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.2
Intuitive Surgical, Inc.da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or1
Argon Medical Devices, IncGeneral Biospy Tray, REF: GUTS1000Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.6
Oscor Inc.Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.3
Abiomed, Inc.ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessoriesA potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are13
Olympus Corporation of the AmericasOlympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.4
Boston Scientific CorporationRapid Refill Continuous Injection System, UPN M00566001Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficu1
Elekta, Inc.Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cDue to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.3
Wallac OyGSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.1
Think Surgical, Inc.TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentaDue to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.1

Drug Safety Reports (FAERS)

352,949 adverse event reports this week; the 10 below lead the list.

ReactionReports
Off label use19,437
Drug ineffective17,826
Nausea13,583
Product dose omission issue12,230
Diarrhoea12,101
Death11,969
Fatigue11,899
Pruritus10,348
Headache9,032
Meningioma8,392

Device Safety Reports (MAUDE)

333,226 device event reports this week; the 10 below lead the list.

BrandManufacturerEvents
FreeStyle Libre 326,773
Dexcom G7 Continuous Glucose Monitoring System16,748
FreeStyle Libre 3 Plus13,218
t:slim X2 Insulin Pump with Control-IQ Technology10,423
DreamStation Auto CPAP8,072
CareLink SmartSync Common App iOS7,354
Inset Guard7,073
t:slim X2 Insulin Pump with Control-IQ+ Technology5,375
Quick Set4,518
MiniMed 780G US System BLE Connect 3.0 mg/dL4,366

Device Listings (GUDID)

27,811 device listings this week; the 10 below lead the list.

BrandCompanyGMDNPublished
MelpexMelpex Beauty InstrumentsGeneral-purpose surgical scissors, reusable
Anyplus Peek Cage SystemGS Medical Co., Ltd.Polymeric spinal interbody fusion cage
Wrap Around Quick ReleaseShielding International Inc.Radiation shielding apron
Anyplus Peek Cage SystemGS Medical Co., Ltd.Polymeric spinal interbody fusion cage
ProCureTwin Med, LLCWound hydrogel dressing, non-antimicrobial
TrellOss®-MCPNexxt Spine, LLCGeneral internal orthopaedic fixation system implantation kit
Golden Isles Pedicle Screw SystemIntelivation, LLCOrthopaedic implantation sleeve, reusable
TrellOss®-MCPNexxt Spine, LLCSpinal fixation plate, non-bioabsorbable
K2-HF SHOULDER, SH-6 T powder, 20g.Yeti Dentalprodukte GmbHDental appliance fabrication material, ceramic
Wrap Around Quick ReleaseShielding International Inc.Radiation shielding apron

Australia (TGA ARTG)

5,186 ARTG device entries this week; the 10 below lead the list.

BrandManufacturerSponsorClassEffective
Impress®Merit Medical Systems IncMerit Medical Australia Pty LtdClass IIa
ReSolve®, StayFIX®Merit Medical Systems IncMerit Medical Australia Pty LtdClass IIb
XiVE®Dentsply Implants Manufacturing GmbHDentsply Sirona Pty LtdClass IIb
Friadent®Dentsply Implants Manufacturing GmbHDentsply Sirona Pty LtdClass IIb
DS Implants™Dentsply Implants Manufacturing GmbHDentsply Sirona Pty LtdClass IIb
Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDentsply Sirona Pty LtdClass IIb
Friadent®Dentsply Implants Manufacturing GmbHDentsply Sirona Pty LtdClass IIb
DS OmniTaper™Dentsply Implants Manufacturing GmbHDentsply Sirona Pty LtdClass IIb
PALACOS® fast R+GHeraeus Medical GmbHHeraeus Medical Australia Pty LtdClass III
Ankylos®Dentsply Implants Manufacturing GmbHDentsply Sirona Pty LtdClass IIb

Canada (Health Canada MDALL)

164 new device licences this week; the 10 below lead the list.

DeviceCompanyClassLicensed
Firstfit Surgical Kit with Voice Prosthesis Ready for Insertion Contains Classic Indwelling Voice ProsthesisFreudenberg Medical, LLC3
National Opthalmic Pack AMedline Industries, LP2
Zolid LunarisAmann Girrbach AG3
Transpac IV Monitoring Kit W/Safeset Reservoir and Blood Sampling PortICU Medical Inc.2
Transpac IV Monitoring Kit W/ Safeset Reservoir, Needleless ValveICU Medical Inc.2
Bm Contour Pro LSiemens Healthcare GmbH2
Bm Contour Pro L SetSiemens Healthcare GmbH2
Bm Contour Pro MSiemens Healthcare GmbH2
Bm Contour Pro M SetSiemens Healthcare GmbH2
Bm Contour Pro SSiemens Healthcare GmbH2

Drug Labels

925 label effective dates this week; the 10 below lead the list.

BrandGenericManufacturerEffective
Orraya WART REMOVER PatchesSalicylic Acid 40% Wart Remover PatchesWenzhou Yuyuan Pharmaceutical Co., Ltd.
Cold Sore Fever Blister TreatmentDocosanolSportpharm LLC
ciprofloxacinCiprofloxacinHawaii Repack, Inc.
Xeljanz Xr XeljanzTofacitinibPfizer Laboratories Div Pfizer Inc
Diclofenac SodiumDiclofenac SodiumHawaii Repack, Inc.
DoveCinnamon Pumpkin Antiperspirant DeodorantConopco d/b/a Unilever
DoveSugar Cookie Antiperspirant DeodorantConopco d/b/a Unilever
ENOKON PAIN RELIEF Spray.Pain Relief Spray.Henan Enokon Medical Instrument Co., Ltd.
7 Day Spot and Tag Remover PenSalicylic AcidGuangxi Keyun E-commerce Co., Ltd.
ENOKON PAIN RELIEF CreamPain Relief CreamHenan Enokon Medical Instrument Co., Ltd.

Workforce (NPPES)

13,639 new provider enumerations this week; the 10 below lead the list.

StateNew providersOrganizations
CA1,984290
TX964322
FL863240
NY733115
MI58495
OH56177
PA44377
MA43241
IL40496
NC404104

Industry Payments (Open Payments)

15,384,974 industry payments this week; the 10 below lead the list.

PayerTotal (USD)Payments
BioNTech SE180,558,679164
AbbVie Inc.156,382,6831,720,745
Stryker Corporation132,155,940162,439
Medtronic, Inc.117,649,217342,148
Arthrex, Inc.104,199,46449,443
Edge Endo LLC91,139,12711
Zimmer Biomet Holdings, Inc.83,904,35132,760
Intuitive Surgical, Inc.72,225,869116,855
Takeda Pharmaceuticals U.S.A., Inc.71,616,187171,595
Advanced Accelerator Applications63,931,988167

Patents (USPTO, A61)

95 medtech patent grants this week; the 10 below lead the list.

AssigneeGrants
Globus Medical, Inc.8
Hytto Pte. Ltd.2
Medicrea International2
Koninklijke Philips N.V.2
Warsaw Orthopedic, Inc.2
Neodyne Biosciences, Inc.1
GlaxoSmithKline Intellectual Property Development Limited1
University of Florida Research Foundation, Incorporated1
Intuitive Surgical Operations, Inc.1
Universitätsspital Basel1

Literature (PubMed)

159,428 literature records this week; the 10 below lead the list.

PMIDTitleJournalRevised
Angiopoietin-1 gene transfer improves impaired wound healing in genetically diabetic mice without increasing VEGF expression.Clinical science (London, England : 1979)
A New Lysosome-Targetable Turn-On Fluorogenic Probe for Carbon Monoxide Imaging in Living Cells.Analytical chemistry
From fragments to drugs: How AI and in silico methods accelerate fragment-to-lead optimization.European journal of medicinal chemistry
Discovery of a potent and selective small-molecule inhibitor of ubiquitin-specific peptidase 15 (USP15) for the treatment of breast cancer.European journal of medicinal chemistry
Development of highly selective, low-toxicity and orally available Mcl-1 inhibitors based on 3,5-dimethyl-4-sulfonimide-1H-pyrrole scaffold via P2/P3 dual pocket binding optimization.European journal of medicinal chemistry
Dengue virus nonstructural proteins as small-molecule targets: Advances, challenges, and future directions.European journal of medicinal chemistry
Discovery of pyrazole-based selective covalent ITK inhibitors with In vivo activity.European journal of medicinal chemistry
Structure based identification of novel 4,5,6,7-tetrahydro-7H-pyrazolo[3,4-c]pyridin-7-one derivatives as nonacidic ATX inhibitors with promising antifibrotic effects.European journal of medicinal chemistry
Developing a chronic test for field-collected mayflies: The influence of laboratory conditions on development and survival of Cloeon dipterum.Environmental toxicology and chemistry
Detection of hard electrophilic reactive metabolites formed from alicyclic amines using glutathione trapping.Xenobiotica; the fate of foreign compounds in biological systems

Literature by Subject (MeSH)

225,152 annotated literature records this week; the 10 below lead the list.

MeSH headingArticles
Humans 144,466
Female 81,693
Male 77,975
Animals 53,268
Middle Aged 41,549
Adult 41,247
Aged 30,754
Mice 17,640
Retrospective Studies 17,442
Young Adult 15,129

Insider Buying (Form 4)

872 open-market insider purchases this week; the 10 below lead the list.

TickerOwnerTradedSharesValue (USD)
MetLife Investment Management, LLC120,000,0004,800,000,000,000,000
VisionWave Holdings, Inc.979,257,6003,407,816,448
ICONIQ Strategic Partners VIII Holdings, L.P.3,661,74643,296,294
Thrivent Financial for Lutherans1,350,00031,563,000
Huang Jack Jiajia1,668,06027,990,047
Globalharvest Holdings Venture Ltd2,061,66627,667,558
Globalharvest Holdings Venture Ltd1,951,24524,839,349
Globalharvest Holdings Venture Ltd1,778,87123,623,407
Griffith William J.G.1,830,87321,648,242
Globalharvest Holdings Venture Ltd1,475,59519,772,973

Academica Weekly is assembled and published automatically each week. This issue covers 6 July 2026 to 12 July 2026 and was built on 3 August 2026.

Index

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