Academica Weekly: The Primary Record for the Week Ending 26 July 2026

Academica Weekly: The Primary Record for the Week Ending 26 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 20 July 2026 to 26 July 2026: 51 Phase 3 trial registrations; 101 Phase 2 trial registrations; 26 recall events; 100 510(k) clearances; 1 FDA guidance documents; 224 new Health Canada device licences; 3,677 ARTG device entries; 747 open-market insider purchases.

51 Phase 3 trial registrations
101 Phase 2 trial registrations
26 recall events
100 510(k) clearances
72Phase 1 registrations101Phase 2 registrations51Phase 3 registrations34Phase 4 registrations100510(k) clearances284PMA decisions26recall events1guidance documents352,949adverse event reports333,226device event reports27,811device listings3,677ARTG device entries224new device licences777label effective dates58,772new provider enumerations15,384,974industry payments95medtech patent grants197,768literature records747open-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 202695 days behind
TGA ARTG1 August 2026Current
Health Canada31 July 2026Current
FDA drug labels26 July 2026Current
NPPES11 July 2026Current
Open Payments31 December 2024572 days behind
USPTO10 February 2026166 days behind
PubMed2 August 2026Current
SEC Form 431 July 2026Current

Phase 1 Trials

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

NCTStudySponsorEnrollmentPosted
Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and OsteosarcomaH. Lee Moffitt Cancer Center and Research Institute74
A Phase 1, Double-blind, Randomized Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Single Dose and Multiple Doses of CG-0416 in Healthy PartiHongKong Curegene Innovation Co., Limited64
Study to Compare the Plasma Concentration of Belumosudil Given as an Oral Suspension and as a Tablet to Healthy Adult Male ParticipantsSanofi58
The Anesthetic and Analgesic Effect of Adjunct Liposomal Bupivacaine in Periodontal Surgical ProceduresThe University of Texas Health Science Center at San Antonio58
A Study to Learn How the Study Medicine Called PF-08653945 is Taken up Into the Blood in Adults With Overweight or ObesityPfizer57
Study to Evaluate the Safety and Effectiveness of Withaferin A as a Treatment to Prevent GvHD in Transplant PatientsTata Memorial Centre54
Phase 1, First in Human (FIH), Open-Label, Single-Arm, Ascending Dose Study to Assess the Safety, Tolerability and Preliminary Immunogenicity of ITI-9001 in Japanese Patients With Immunomic Therapeutics, Inc.45
SHR2554 Plus Liposomal Mitoxantrone as First-line Treatment for Peripheral T-cell Lymphoma (PTCL)Institute of Hematology & Blood Diseases Hospital, China44
Venetoclax in Association With 3+7 and Midostaurin in FLT3-mutated Acute Myeloid LeukemiaUniversity Hospital, Bordeaux41
Study of ECC4703 With Sulfasalazine and PitavastatinEccogene40

Phase 2 Trials

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

NCTStudySponsorEnrollmentPosted
Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and OsteosarcomaH. Lee Moffitt Cancer Center and Research Institute74
A Randomized Clinical Trial Evaluating the Efficacy of Clinical Pharmacist Assistance Along With Pharmaceutical and Non-pharmaceutical Therapy in the Early Rheumatoid ArthritisDeraya University70
SMP-656 for HER2-Positive Advanced Breast CancerChengdu SciMount Pharmatech Co., Ltd.60
The Anesthetic and Analgesic Effect of Adjunct Liposomal Bupivacaine in Periodontal Surgical ProceduresThe University of Texas Health Science Center at San Antonio58
Fosrolapitant Combined With Palonosetron to Prevent Trastuzumab Rezetecan Related CINVTianjin Medical University Cancer Institute and Hospital56
Study to Evaluate the Safety and Effectiveness of Withaferin A as a Treatment to Prevent GvHD in Transplant PatientsTata Memorial Centre54
Fruquintinib Plus Anti-EGFR Antibody for Third-Line Treatment of RAS Wild-Type mCRCCancer Institute and Hospital, Chinese Academy of Medical Sciences46
SHR2554 Plus Liposomal Mitoxantrone as First-line Treatment for Peripheral T-cell Lymphoma (PTCL)Institute of Hematology & Blood Diseases Hospital, China44
Venetoclax in Association With 3+7 and Midostaurin in FLT3-mutated Acute Myeloid LeukemiaUniversity Hospital, Bordeaux41
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) WitUCB Biopharma SRL402

Phase 3 Trials

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

NCTStudySponsorEnrollmentPosted
A Randomized Clinical Trial Evaluating the Efficacy of Clinical Pharmacist Assistance Along With Pharmaceutical and Non-pharmaceutical Therapy in the Early Rheumatoid ArthritisDeraya University70
A Clinical Trial of TQH3906 Capsules in Adult Patients With Moderate to Severe Plaque PsoriasisChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.400
Safety and Efficacy of OTL78 (Zopocianine)Clinton Bahler36
Clinical Efficacy and Safety of MB LuxuryⓇ Product Containing Epigallocathecin Gallate (EGCG) on Erythema, Melanin, and Skin HydrationNaniek Widyaningrum300
Testing the Addition of a New Anti-Cancer Drug, Glofitamab to Usual Chemotherapy for Burkitt and Double Hit LymphomaNational Cancer Institute (NCI)271
Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure PatientsShanghai Zhongshan Hospital1,526
Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of VG081821AC Tablets in Patients With Early to Mid-stage Parkinson's DiseaseZhejiang Vimgreen Pharmaceuticals, Ltd.152
Apixaban to Prevent Decompensation of Early Liver Cirrhosis TrialUniversity College, London1,142
Y-6 Sublingual Tablets for Acute Penetrating Artery InfarctionNeurodawn Pharmaceutical Co., Ltd.944
A Study to Investigate Pharmacokinetics, Safety, and Tolerability of B2227 Extended-Release Injectable Suspension and Vraylar® in Participants With SchizophreniaBostal Drug Delivery Co., Ltd84

Phase 4 Trials

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

NCTStudySponsorEnrollmentPosted
Efficacy of Intrathecal Administration of Budesonide to Prevent Bronchopulmonary DysplasiaIndonesia University86
Split Face Study of the Duration of Local Anesthetics - Fifth ArmWeill Medical College of Cornell University50
How Healthy Adults Respond to the Nasal Flu VaccineUniversity of Alabama at Birmingham20
An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail PsoriasisModern Research Associates, PLLC15
SMILE Surgery in One Eye Compared to Ray Tracing-guided LASIK Surgery in the Fellow EyeStanford University62
Omega-3-Based Nutraceutical Supplementation as Adjunctive Therapy in Adults With Otitis Media With Effusion: A Multicenter, Double-Blind, Randomized Placebo-Controlled TrialIsola Tiberina - Gemelli Isola Hospital, Rome, Italy501
The Association Between Bilateral Intermediate Cervical Plexus Block and Salivary Biomarkers of Surgical Stress Response Following Total ThyroidectomyUniversity Hospital Dubrava48
Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency University of Tennessee Graduate School of Medicine280
A Single Center, Open-Label Study to Evaluate the Ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratograph® 5M to Detect Tear Film Stability The Eye Care Institute20
Iodine Drapes Used in TSATnicholson128

510(k) Clearances

100 510(k) clearances this week; the 10 below lead the list.

K numberDeviceApplicantClassDecision
Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2
Zeiss Clinic 360Carl Zeiss Meditec, AG2
Drivewire 35 GuidewireRapid Medical Ltd.2
Cubresa BrainPETCubresa, Inc.2
SportSuite Vision SoftwareStryker Endoscopy
Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.2
Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C CervicalStryker Spine2
Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.2
Natural CyclesNatural Cycles Nordic AB2
BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitBiofire Defense, LLC2

PMA Approvals

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

PMADeviceApplicantDecision
Edwards Crimper: 9600CREdwards Lifesciences, LLC
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)Abbott Medical
Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29Edwards Lifesciences, LLC
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)Abbott Medical
HeartMate 3™ Left Ventricular Assist System (LVAS)Abbott Medical
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-PMedtronic, Inc.
AED 3; CPR Uni-PadzZOLL Medical Corporation
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, CobaltMedtronic Cardiac Rhythm Disease Management
Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICD, Primo MRI VR ICD,Medtronic Cardiac Rhythm Disease Management
Vercise Deep Brain Stimulation (DBS) SystemsBoston Scientific Corp

Recalls

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

FirmProductReasonCatalog rowsPosted
Windstone Medical Packaging, Inc.AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2) ACDF/Fusion Pack, Pack Number AMS14710B; 3) Spine Pack, Pack Number AMS14991A; 4)The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin le4
Permobil IncM5 Corpus Power Wheelchair REF,120032This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, and may create an unstable condition in certain circumstances1
Argon Medical Devices, IncL-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, in2
Permobil IncPermobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the user to fall from the wheelchair or the wheelchair to tip over,1
Alphatec Spine, Inc.SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix SystemIntraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interf1
Karl Storz EndoscopyFlexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.1
Medline Industries, LPMedline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397PMedline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.4
Medline Industries, LPMEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556NThe procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.2
Medtronic MiniMed, Inc.MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in mi1
Medline Industries, LPMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779UAffected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhi9

FDA Guidance

1 guidance documents this week.

TitleTopicIssued
Hemodialysis Blood Tubing Sets - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration StaffPremarket, 510(k), Gastroenterology-Urology; Medical Devices; Center for Devices and Radiological Health; Final

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)

3,677 ARTG device entries this week; the 10 below lead the list.

BrandManufacturerSponsorClassEffective
myrayCefla SCWilliam Green Pty LtdClass IIb
myrayCefla SCWilliam Green Pty LtdClass IIa
myrayCefla SCWilliam Green Pty LtdClass IIa
myrayCefla SCWilliam Green Pty LtdClass IIb
myrayCefla SCWilliam Green Pty LtdClass IIa
myrayCefla SCWilliam Green Pty LtdClass IIb
myrayCefla SCWilliam Green Pty LtdClass IIb
myrayCefla SCWilliam Green Pty LtdClass IIb
myrayCefla SCWilliam Green Pty LtdClass IIa
myrayCefla SCWilliam Green Pty LtdClass IIa

Canada (Health Canada MDALL)

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

DeviceCompanyClassLicensed
Bd Nexiva Closed IV Catheter System - Dual Port with Bd Maxzero Needle-Free ConnectorBecton Dickinson Infusion Therapy Systems Inc.2
Bd Nexiva Closed IV Catheter System - Dual Port - Bd Q-Syte Needle-Free ConnectorBecton Dickinson Infusion Therapy Systems Inc.2
Charge BaseZolar Technology & Mfg Co. Inc.2
Rotary FilesZolar Technology & Mfg Co. Inc.2
Deep Ensemble for Recognition of Malignancy (Derm)Skin Analytics Limited3
Acl Top 970 ClInstrumentation Laboratory Co.3
Idk Extract Stool Preparation SystemImmundiagnostik AG2
Endoscopic Image ProcessorHunan Endoso Life Technology Co., Ltd.2
Single-Use BronchoscopeHunan Endoso Life Technology Co., Ltd.2
Headgear Frame AssemblyShenzhen Sany Pioneer Technology Co., Ltd.2

Drug Labels

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

BrandGenericManufacturerEffective
Elevate Beard Regrowth TreatmentBeard Regrowth TreatmentGuangzhou Jianyuan Biological Technology Co.,Ltd
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLidocaineGuangdong Aimu Biological Technology Co., Ltd
NumbingLidocaineYiyangyuan Life Sciences (Hong Kong) Co., Limited
hydrocortisoneHydrocortisoneEywa Pharma Inc
Luxe Color FoundationOctinoxate 7% Zinc Oxide 5%Guangzhou Huixue Biotechnology Co., Ltd.
CVS Topical Anesthetic HemorrhoidalDibucaineCVS Pharmacy, Inc.
HydrOXYzine HydrochlorideHydroxyzine HydrochlorideA-S Medication Solutions
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25 KitAvobenzone, Homosalate, Octinoxate, Octisalate, OctocryleneXact Packing Limited
AeroaidBenzalkonium ChlorideAero Healthcare US LLC
escitalopramEscitalopramPreferred Pharmaceuticals Inc.

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)

197,768 literature records this week; the 10 below lead the list.

PMIDTitleJournalRevised
Antagonism of CD95 signaling blocks butyrate induction of apoptosis in young adult mouse colonic cells.The American journal of physiology
The extra- and intracellular barriers to lipid and adenovirus-mediated pulmonary gene transfer in native sheep airway epithelium.Gene therapy
Unique lipoproteins secreted by primary astrocytes from wild type, apoE (-/-), and human apoE transgenic mice.The Journal of biological chemistry
Deregulation of p53/p21Cip1/Waf1 pathway contributes to polyploidy and apoptosis of E1A+cHa-ras transformed cells after gamma-irradiation.Oncogene
Development of an enzyme-labeled oligonucleotide probe for detecting the Escherichia coli attaching and effacing A gene.Microbiology and immunology
Dynamin is required for recombinant adeno-associated virus type 2 infection.Journal of virology
Dominance hierarchy formation in juvenile crayfish procambarus clarkiiThe Journal of experimental biology
EMAN: semiautomated software for high-resolution single-particle reconstructions.Journal of structural biology
Diverse behavioural defects caused by mutations in Caenorhabditis elegans unc-43 CaM kinase II.Nature
Syntaxin 1A is expressed in airway epithelial cells, where it modulates CFTR Cl(-) currents.The Journal of clinical investigation

Literature by Subject (MeSH)

404,657 annotated literature records this week; the 10 below lead the list.

MeSH headingArticles
Humans 198,188
Female 118,043
Male 108,431
Animals 62,439
Middle Aged 62,133
Adult 59,952
Aged 46,526
Mice 24,724
Young Adult 22,860
Retrospective Studies 21,381

Insider Buying (Form 4)

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

TickerOwnerTradedSharesValue (USD)
NONEBlackstone Private Multi-Asset Credit & Income Fund5,162,524135,000,000
Lincoln Financial Investments Corp7,381,89075,000,000
Fairmount Funds Management LLC5,120,70074,250,150
NONEUAW Chrysler Retirees Medical Benefits Plan56,43649,499,614
NONEAssured Guaranty Ltd.1,465,71536,400,000
B&R Technology Sponsor LLC (Cayman)2,750,00027,500,000
RA Capital Management, L.P.919,94025,094,209
RA Capital Management, L.P.461,46113,496,223
Allbaugh Larry Eugene289,77312,750,012
Huang Jack Jiajia640,44011,041,186

Academica Weekly is assembled and published automatically each week. This issue covers 20 July 2026 to 26 July 2026 and was built on 3 August 2026.

Index

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