Clinical trials legislation and practice: EU CTR and CTIS, ICH E6(R3) GCP, FDA clinical guidance, ACT EU, inspections, and newly registered industry Phase 3 trials.
The oncolytic virus developer reports $3.9M in cash, a headcount-led restructuring expected to save about $3M a year, and a first-patient dose for CLD-401 targeted for H2 2027.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Early-Phase IND Protocol Recommendations for Solid Tumors." The purpose of this draft guidance is to provide recommendations to sponsors and clinical investigators developing early-phase trials, which include first-in- human (FIH) protocols or protocols for drugs and biologic products with limited human experience, submitted under an Investigational New Drug Application (IND) to the appropriate disease-specific division located within the Office of Oncologic Diseases (OOD) in the Center for Drug Evaluation and Research (CDER) and the Office of Clinical Evaluation (OCE) in the Center for Biologics Evaluation and Research (CBER.) This draft guidance is specific to solid tumors and does not address protocols for investigational drugs intended to treat hematologic malignancies.
The company formerly known as Quince Therapeutics says its inhaled rapamycin programme will read out first in post-lung-transplant BOS in Q1 2027, with cash expected to last through 2028.
The US biotech says non-dilutive deals, including a manufacturing sale and a ZYNYZ royalty sale, extend its funding as it focuses on investigational ADC MGC026.
The company formerly known as Plus Therapeutics posted $0.7M in diagnostic revenue for Q3 2026, added Aetna coverage and reported clean early safety data for REYOBIQ.
The oncology developer says emavusertib is enrolling in CLL and PCNSL, with first CLL combination data due in December 2026, while financing extends runway just into the first quarter of 2027.
The US diagnostics firm says pivotal enrolment is finished and a backup cartridge site is secured, but its $7.38M cash runway extends only to the second quarter of 2027.
Health Canada lists a Type II recall in which Boston Scientific is correcting the instructions for use for Vercise Clinician Programmers, covering IPG recharge intervals and battery longevity estimates.
Five-year follow-up from trial VLA1553-303 shows most vaccinated adults retain neutralising antibodies above the seroresponse threshold, with older adults matching younger ones.
Valneva reports positive Phase 2 data for its tetravalent Shigella candidate, with a significant efficacy signal against S. sonnei in adults and immunogenicity in Kenyan infants.
The company says final Phase 1 device data support one fixed dose per visit, with an End-of-Phase 2 meeting for treatment-resistant depression expected in Q1 2027.
The US biotech reports early DA-1726 liver-fat and weight data from a very small cohort, and sets out FDA, Phase 2a and Phase 2 steps, with $8.8M in cash.
Interim Phase 1b/2a data in oculopharyngeal muscular dystrophy dysphagia showed responses in every Cohort 1 and 2 patient, with no serious adverse events, alongside Benitec's fiscal first-quarter results.
The US regulator has allowed a Phase 1b study of TBS-2025 in relapsed or refractory mutant NPM1 acute myeloid leukaemia, as TuHURA reports third-quarter results with $1.9 million in cash.
The company signed a start-up agreement with Thermo Fisher Scientific's clinical research business for a Phase 2 progressive MS trial, after FDA cleared its IND in August.
The US biotech says median progression-free survival has not been reached with 30 mg onvansertib plus FOLFIRI/bev in first-line RAS-mutated metastatic colorectal cancer, and it is preparing a registrational trial.
Obsidian Therapeutics reported Q3 2026 results alongside updated SITC data on its engineered TIL therapy, and said enrolment in the Agni-01 registration-enabling cohort should complete by end of Q1 2027.
The US company says enrolment in its Phase 3 rilparencel trial will exceed 500 patients, while cash of $141.9 million funds operations into mid-2027.
Nektar reported Q3 2026 revenue of $9.4M, a $55.7M net loss and $952.9M in cash as its late-stage rezpegaldesleukin programme moved into full recruitment mode.
A safety review committee has recommended moving Azitra's ATR-04 Phase 1/2 trial to Cohort 2, as the company reports a $3.0 million third-quarter net loss.
The cell therapy developer reported that laromestrocel missed its primary endpoint in infants with hypoplastic left heart syndrome, and is now weighing a sale or merger.
Ensysce's Q3 report shows the psilocybin-based CY200 Phase 2a protocol is under UK review, with the MHRA and an ethics committee requesting further information.
Interim NEXICART-2 data in relapsed/refractory AL amyloidosis will go to ASH in December, as Immix confirms a mid-2027 FDA filing plan and cash into mid-2028.
The gene-editing company's unaudited interim accounts show a sharp fall in revenue, higher research spending, lower cash and negative shareholders' equity at 30 September 2026.
The US neurology company named four late-stage assets and said it is building commercial readiness across epilepsy, movement disorders, neurodevelopment and pain.
The renamed Nasdaq-listed company says its oral colon-targeted AhR agonist for ulcerative colitis remains on course for an IND filing and Phase 1a start in the first half of 2027.
Novartis says remibrutinib 25 mg twice daily showed early, sustained efficacy to Week 52 in three chronic inducible urticaria subtypes, with results due at ACAAI 2026.
DBV Technologies presented additional results from its 654-child VITESSE trial of the VIASKIN Peanut Patch at ACAAI in Phoenix, including severity of reactions and compliance.
The US device maker says its pivotal acute kidney injury trial is about 75% enrolled, while it advances a PMA submission and reports higher third-quarter Quelimmune sales.
The clinical-stage biotech says PRECISE-AD results are due in the first quarter of 2027, with cash expected to last through 2027.
Coherus Oncology will supply LOQTORZI for a planned US study pairing it with Oncolytics' investigational oncolytic virus pelareorep in squamous cell anal carcinoma.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.