Academica Weekly: The Primary Record for the Week Ending 9 August 2026

Academica Weekly: The Primary Record for the Week Ending 9 August 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 3 August 2026 to 9 August 2026: 49 Phase 3 trial registrations; 101 Phase 2 trial registrations; 21 recall events; 127 510(k) clearances; 69 new Health Canada device licences; 3,308 ARTG device entries; 307 open-market insider purchases.

49 Phase 3 trial registrations
101 Phase 2 trial registrations
21 recall events
127 510(k) clearances
71Phase 1 registrations101Phase 2 registrations49Phase 3 registrations24Phase 4 registrations127510(k) clearances264PMA decisions21recall events352,949adverse event reports333,226device event reports27,811device listings3,308ARTG device entries69new device licences536label effective dates58,772new provider enumerations15,384,974industry payments95medtech patent grants85,090literature records307open-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 47 August 2026Current
FDA 510(k)26 July 202614 days behind
FDA PMA26 July 2026Current
FDA recalls5 August 2026Current
FDA guidance31 July 2026Current
FAERS30 June 2026Current
MAUDE30 June 2026Current
GUDID22 April 2026109 days behind
TGA ARTG7 August 2026Current
Health Canada7 August 2026Current
FDA drug labels6 August 20263 days behind
NPPES11 July 2026Current
Open Payments31 December 2024586 days behind
USPTO10 February 2026180 days behind
PubMed8 August 2026Current
SEC Form 47 August 2026Current

Phase 1 Trials

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

NCTStudySponsorEnrollmentPosted
Study of Safety, PK, and Efficacy of Multiple Ascending Doses of HZBio1 in Patients With GoutHangzhou Grand Biologic Pharmaceutical, Inc.90
PSTC100 Study in Healthy Adult SubjectsProspect Therapeutics (Nanjing) Limited70
A Study of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune DiseasesQilu Pharmaceutical Co., Ltd.64
Safety and Tolerability of REGN17235 in Adult Participants With Clonal Cytopenia of Undetermined Significance and Low-Risk Myelodysplastic Syndrome With SF3B1 MutationRegeneron Pharmaceuticals52
Phase I Clinical Study Evaluating the Relative Bioavailability of Different Formulations of HRS-5346 in Healthy ParticipantsShandong Suncadia Medicine Co., Ltd.50
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AMLCharm Therapeutics40
Phase 1 Study in Healthy Adults to See How Sevabertinib Changes Metformin Levels in the BodyBayer40
A Study of SI-B036 in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid TumorsSichuan Baili Pharmaceutical Co., Ltd.39
A Phase I/II Study of Eque-cel in Subjects Withimmune-mediated Necrotizing MyopathyNanjing IASO Biotechnology Co., Ltd.27
A Study to Evaluate the Drug-Drug Interaction Between KL0011034 Injection and Alfentanil Hydrochloride Injection in Participants With Moderate-to-Severe Non-Cancer Chronic PainThe Third Xiangya Hospital of Central South University27

Phase 2 Trials

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

NCTStudySponsorEnrollmentPosted
Study of Safety, PK, and Efficacy of Multiple Ascending Doses of HZBio1 in Patients With GoutHangzhou Grand Biologic Pharmaceutical, Inc.90
A Clinical Study of SHR-9839 as Monotherapy or in Combination With Chemotherapy Plus Adebrelimab Versus Chemotherapy Plus Adebrelimab in Patients With Advanced Esophageal Squamous Suzhou Suncadia Biopharmaceuticals Co., Ltd.84
Effects of Curcumin-Piperine Supplementation in FibromyalgiaAin Shams University80
Neoadjuvant Chemoradiotherapy Combined With CTLA-4 Monoclonal Antibody Plus PD-1 Monoclonal Antibody for Locally Advanced Esophageal CancerSun Yat-sen University51
Golidocitinib Plus Anthracycline-based Therapy for Untreated Nodal T-follicular Helper (TFH) Cell LymphomaSun Yat-sen University47
A Randomized, Open-Label, Multi-Center Study of Vestibular Migraine Prevention: Rimegepant Versus Flunarizine Non-inferiority StudySecond Affiliated Hospital, Zhejiang University, School of Medicine400
Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related ComorbiditiesAbbVie360
A Phase I/II Study of Eque-cel in Subjects Withimmune-mediated Necrotizing MyopathyNanjing IASO Biotechnology Co., Ltd.27
A Study of LG00313112 in Participants With Advanced Solid Malignancies Harboring a TP53 Y220C MutationLG Chem250
Anti-PD-1 Therapy in Recurrent and Metastatic Head and Neck Squamous Cell CarcinomaYanjie Zhang, MD217

Phase 3 Trials

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

NCTStudySponsorEnrollmentPosted
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal RPhathom Pharmaceuticals, Inc.500
A Study of Outcomes in Chinese Patients Treated With Anifrolumab Who Have Active Mod-severe Systemic Lupus ErythematosusAstraZeneca417
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar PsoriasisTakeda40
Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate CancerUniversity College, London1,500
Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)Sling Therapeutics, Inc.130
A Clinical Trial to Evaluate the Efficacy and Safety of TQB3909 Tablets Versus Investigator's Choice in the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small LympChia Tai Tianqing Pharmaceutical Group Co., Ltd.128
Evaluate the Concordance Between PET Imaging of [18F]-APN-1607 Injection and Postmortem Brain Tissue Tau Pathology in Individuals With HV and MCI or AD.JYAMS PET Research & Development Limited12
APEX-STROKE CALM-ICH DomainFudan University1,100
Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual DiseaseExelixis600
Hyaluronic Acid vs I-PRF With Microneedling in Enhancing Peri-implant Soft TissueAin Shams University42

Phase 4 Trials

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

NCTStudySponsorEnrollmentPosted
Net Clinical Benefit of Edoxaban Versus Apixaban in Patients With Atrial Fibrillation and Coronary Artery DiseaseSamsung Medical Center3,000
Daily Tadalafil as Adjunctive Therapy Versus Monotherapy for PDE5 Inhibitor-Resistant Erectile DysfunctionAl-Azhar University260
Calorie Restricted Dietary Intervention in Type 2 Diabetes Patients With Obesity for RemissionYeouido St. Mary's Hospital25
South Asian Patients With Diabetic Macular Oedema Treated With Faricimab Assessing the Efficacy, Durability, and Safety (SEAFAR Study)Birmingham and Midland Eye Centre Sandwell and west Birmingham NHS trust120
Ezetimibe for Arrhythmia Recurrence After AF AblationSecond Affiliated Hospital, Zhejiang University, School of Medicine120
Outcomes After Planned Discontinuation of AntiSeizure MedicationUniversity of Michigan40
Airway Dysfunction, Occlusions and Remodeling: COPD Patients and MepolizumabWestern University, Canada36
Optimizing H. Pylori Eradication Regimen Under Intensified Acid SuppressionQilu Hospital of Shandong University316
Reducing Opioid Use After Upper Extremity Surgery: Testing Lower Prescriptions and Pill QuantityAdventHealth260
Comparing Esketamine and Remazolam With Propofol for Breathing Safety in Pediatric GastroscopySecond Affiliated Hospital of Wenzhou Medical University120

510(k) Clearances

127 510(k) clearances this week; the 10 below lead the list.

K numberDeviceApplicantClassDecision
Corsano CardioWatch 287-2 SystemCorsano Health B.V.2
CorVista System® with PCWP Add-OnAnalytics For Life, Inc.2
METICULY Patient-specific CMF solutionMeticuly Co., Ltd.2
MONARCH™ Platform (MON-000008)Auris Health, Inc.2
NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10,Hycor Biomedical2
Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.2
Accuro 3SRivanna Medical, Inc.2
EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical Impact2
RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp2
Tiger 2 SystemZavation Medical Products, LLC2

PMA Approvals

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

PMADeviceApplicantDecision
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)Abbott Medical
Dorsal Root Ganglion (DRG) IPGAbbott Medical
Deep Brain Stimulation (DBS) IPGAbbott Medical
NEXUS Aortic Arch Stent Graft SystemEndospan , Ltd.
Axonics Sacral Neuromodulation SystemBoston Scientific Corporation
Axonics Sacral Neuromodulation SystemBoston Scientific Corporation
Gelsyn-3Ibsa Institut Biochimique SA
CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc.
SimpleScreen™ CRCFreenome, LLC
Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-Defibtech, LLC

Recalls

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

FirmProductReasonCatalog rowsPosted
Beckman Coulter Inc.REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus InsAnalyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."2
Aniara Diagnostica LLC5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.3
Hardy DiagnosticsHardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceDue to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in1
United Orthopedic Corp.Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic SurDue to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.4
Siemens Healthcare Diagnostics, Inc.Atellica CH Urine Albumin REF: 11537225processing Atellica CH Urine Albumin (UAlb) tests on Atellica CH and Atellica CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1
Boston Scientific Neuromodulation CorporationINFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord StimulatorSpinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explan1
Philips Medical Systems Nederland B.V.Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280.Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.3
Biofire DefenseFilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intendedFirm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.1
Siemens Healthcare Diagnostics, Inc.Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319ULOut-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is l1
Siemens Healthcare Diagnostics, Inc.Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219ULout-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as e1

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
TrellOss®-MCPNexxt Spine, LLCGeneral internal orthopaedic fixation system implantation kit
NARNorth American Rescue, LLCFirst aid kit, non-medicated, single-use
Facial cleansing brushShenzhen Mebao Intelligent Technology Co.,LtdHand-held electric massager
TrellOss®-MCPNexxt Spine, LLCGeneral internal orthopaedic fixation system implantation kit
MelpexMelpex Beauty InstrumentsGeneral-purpose surgical scissors, reusable
HomlandHongKong Pishon Medical Equipment Co., LimitedBath back rest/seat
ProCureTwin Med, LLCBlood lancet, single-use
QUASAR Standalone ACIF SystemGS Medical Co., Ltd.Metallic spinal interbody fusion cage
MelpexMelpex Beauty InstrumentsGeneral-purpose surgical scissors, reusable
QUASAR Standalone ACIF SystemGS Medical Co., Ltd.Metallic spinal interbody fusion cage

Australia (TGA ARTG)

3,308 ARTG device entries this week; the 10 below lead the list.

BrandManufacturerSponsorClassEffective
InterOss CollagenSigmaGraft IncCompliance Management SolutionsClass III
M12A Office System SoftwareGlobal Instrumentation LLCCompliance Management SolutionsClass IIb
Intercollagen GuideSigmaGraft IncCompliance Management SolutionsClass III
M12R Recorder, 10-Lead Cable AHA, System KitGlobal Instrumentation LLCCompliance Management SolutionsClass IIb
InterOss CollagenSigmaGraft IncCompliance Management SolutionsClass III
2D Panoramic Dental Imaging SystemHefei Meyer Optoelectronic Technology IncMDSS AU Pty LtdClass IIb
Dental Cone-beam Computed TomographyHefei Meyer Optoelectronic Technology IncMDSS AU Pty LtdClass IIb
M12R Battery CoverGlobal Instrumentation LLCCompliance Management SolutionsClass IIb
M12R, 10 Lead Patient Cable (DIN)Global Instrumentation LLCCompliance Management SolutionsClass IIb
InterOss CollagenSigmaGraft IncCompliance Management SolutionsClass III

Canada (Health Canada MDALL)

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

DeviceCompanyClassLicensed
VS8 BurVersah, LLC2
Tapered Densah Pilot Drill G4Versah, LLC2
Single Use Irrigation Syringe (SOFJEC)HLB Life Science Co., Ltd.2
NIBP Cuff, ThighNihon Kohden Corporation2
NIBP Cuff, AdultNihon Kohden Corporation2
Ascend Single-Use Flexible Cysto-NephroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.2
Endoscopic Video Image Processor HDGuangzhou Red Pine Medical Instrument Co., Ltd.2
Minecel Pen Pro M HandpieceGNI Co., Ltd.2
Microneedling CartridgeGNI Co., Ltd.2
Level One, Twist Drill, Angulus IIKLS Martin L.P.2

Drug Labels

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

BrandGenericManufacturerEffective
sapropterin dihydrochlorideSapropterin DihydrochlorideHikma Pharmaceuticals USA Inc.
MiraFAST KIDS soft chewsMagnesium HydroxideBayer HealthCare LLC.
Uline Hand SanitizerAlcoholUline
Family Beauty Antibacterial Hand WipesBenzalkonium ChlorideZhejiang Bright Care Co., Ltd.
Petroleum Jelly, Lil Drug StorePetrolatum JellyLil' Drug Store Products, Inc.
Hydrating Hand Sanitizer WATERMELON POPAlcohol 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.
Cold Sore Fever Blister TreatmentDocosanolWalgreens
Trazodone HydrochlorideTrazodone HydrochlorideNuCare Pharmceuticals,Inc.
Atorvastatin calciumAtorvastatin CalciumRemedyRepack Inc.
Isopropyl alcohol 70 percent ReadyInCaseIsopropyl AlcoholP & L Development, LLC

Workforce (NPPES)

58,772 new provider enumerations this week; the 10 below lead the list.

StateNew providersOrganizations
CA7,9521,185
TX4,1741,146
FL3,9561,137
NY2,967489
MI2,564387
OH2,470418
IL1,973385
PA1,815295
MD1,805393
NC1,788433

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)

85,090 literature records this week; the 10 below lead the list.

PMIDTitleJournalRevised
Clinical competence and the Ombudsman.British medical journal
The impact of outdoor living space access on the dairy cow metabolome profile.RSC advances
A proposal of an echocardiography-based pathway for the diagnosis and management of angina with no obstructive coronary arteries: a state-of-the-art review: Advancing Targeted Therapy and Prognosis ThEuropean heart journal. Imaging methods and practice
Creating a service system architecture for people living with multiple long-term conditions.Future healthcare journal
Empowering biomedical evidence exploration and synthesis with deep knowledge graph research.Nature machine intelligence
Iron deficiency without anemia: An underrecognized and undertreated clinical condition with special focus on colorectal cancer.Clinical hematology international
Sonication fluid cultures enhance pathogen identification in fracture-related-infection (FRI).Journal of bone and joint infection
Correction to "N-Heterocyclic Carbene-Ag(I)-Phosphine Complexes: Comprehensive Synthesis, Characterization, and Bonding Analysis via Density Functional Theory".ACS omega
Lathyrol Targets G6PD to Disrupt Redox Homeostasis in Non-Small Cell Lung Cancer.ACS omega
Comparing Chemoenzymatic and Conventional Synthetic Strategies to Wall Teichoic Acid Peptidoglycan Fragments.Israel journal of chemistry

Literature by Subject (MeSH)

151,759 annotated literature records this week; the 10 below lead the list.

MeSH headingArticles
Humans 75,538
Female 41,598
Male 38,650
Middle Aged 22,088
Animals 22,043
Adult 21,873
Aged 15,807
Mice 8,301
Young Adult 8,121
Retrospective Studies 7,730

Insider Buying (Form 4)

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

TickerOwnerTradedSharesValue (USD)
Lim Jung Jae131,38723,649,660,000
Forbion Growth Opportunities Fund III Cooperatief U.A.3,600,00064,800,000
Lord Albert L20,00058,000,000
Lord Albert L20,00057,900,000
Space Summit Capital LLC1,087,00010,870,000
Redmile Group, LLC600,00010,200,000
MA Eagle II Holdings Fund404,69410,000,000
Harrison Street Real Assets Fund LLC372,8569,999,998
Frazier Life Sciences XI, L.P.588,2359,999,995
Mahoney Michael F186,2409,001,408

Academica Weekly is assembled and published automatically each week. This issue covers 3 August 2026 to 9 August 2026 and was built on 9 August 2026.

Index

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