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 company reported Q3 2026 results, saying it opted for a single-arm pivotal design despite the FDA recommending it consider randomisation, citing feasibility in a rare disease.
Lipocine has begun the BLOOM study of LPCN 1154, a 48-hour at-home oral brexanolone regimen, after an earlier Phase 3 trial missed its primary endpoint.
The Oncology Center of Excellence draft covers first-in-human trials and products with limited human experience; comments are open until 11 January 2027.
Week 24 data from the head-to-head psoriatic arthritis study show 54.9% of bimekizumab-bkzx patients reaching ACR50 versus 43.8% on risankizumab, with no new safety signals.
Post-hoc analyses of the Phase 3 PHOENYCS GO study, shown at ACR Convergence 2026, favour the investigational drug over placebo, but the measure is unvalidated and the analyses fall outside any regulatory filing.
Can-Fite says a patient with advanced hepatocellular carcinoma who had a complete response in its Phase II Namodenoson study has reached ten-year survival, though the company stresses the case is anecdotal.
The randomised trial in late-line MSS colorectal cancer without liver metastases is intended to select the dose for a Phase 3 programme, with first results due in the first half of 2027.
Efgartigimod met its primary endpoint in a combined myositis population, but statistical significance was seen in IMNM and not in dermatomyositis alone, shaping argenx's filing plans.
The once-monthly antibody cut moderate-to-severe vasomotor symptom frequency by 83% versus 33% with placebo, and the company reported no serious or Grade 3+ adverse events in treated patients.
ArriVent BioPharma says firmonertinib did not meet progression-free survival goals in NSCLC, while reporting a cash position of $393.2 million that it expects to last to mid-2028.
The US biotech reported Q3 2026 results, said Part 2c enrolment completes in November, and put its cash runway into the first half of 2028.
Trevi Therapeutics reported Q3 2026 results, citing a Phase 3 start in IPF chronic cough, a positive FDA meeting on non-IPF ILD cough and $299.4 million in cash.
Translational analysis from a Phase 1b/2 combination trial points to antigen-presenting activity and CD8 effector memory T-cell expansion, with a poster due at ASH on 12 December.
Initial Phase 1/2 results for the allogeneic CD19-targeted CAR NK therapy support a compressed Day 0/2/4 dosing schedule, and the company plans FDA talks on a registrational path.
Laboratory data for APVO451, APVO452 and APVO711 were shown at SITC on 7 November; the company expects two molecules to enter IND-enabling studies in 2027.
Whitehawk Therapeutics said its biparatopic antibody drug conjugate for small-cell lung cancer has entered a US Phase 1 trial, as it reported Q3 2026 results with $169.7 million in cash.
Topline Part B results for VDPHL01 show hair-count gains in over 500 men, with no treatment-related serious adverse events or cardiac events of special interest.
The 600 mg dose beat placebo on ACR20 at Week 28, but 300 mg did not separate; Immunovant also says further Sjögren's development beyond Phase 2 looks unlikely.
The company reports a statistically significant efficacy gain over BCG alone in Cohort A of QUILT-2.005 and plans a supplemental BLA filing by the end of 2026.
After FDA discussions and ESMO data showing an 82% response rate in later-line disease, Tango plans a front-line trial in MTAP-deleted pancreatic cancer in the first half of 2027.
The US cell therapy developer expects eGFR-slope topline data from the PROACT 1 trial in mid-2027 and plans an accelerated approval submission the following year.
Phase 1/2 data at ACR Convergence 2026 show durable responses across myositis, lupus nephritis and systemic sclerosis, with a low rate of severe cytokine release syndrome.
The manufacturer is revising the instructions for use of its OptiCross intravascular ultrasound imaging catheters, according to a field safety notice published by the Dutch inspectorate IGJ.
Interim results from six patients met the primary and key secondary endpoints, while the FDA and EMA granted regulatory designations for QRX003 in Peeling Skin Syndrome.
Ravimiamet says Sanofi Winthrop Industrie is ending production and sale of the furosemide prolonged-release capsules globally, with no new deliveries to Estonia and pharmacy stocks running low.
The UK regulator's page, last updated 6 November 2026, sets out risk-based and triggered inspections, dossier requests and the inspection process, with ICH E6(R3) as the reference standard.
The MHRA and several EU regulators and ethics committees have authorised sites in the Phase 1/2 ASCEND study, with first dosing still expected by the end of 2026.
Elicio Therapeutics says pre-specified subgroup analyses from AMPLIFY-7P will shape Phase 3 design, despite the trial missing its primary disease-free survival endpoint in the overall population.
The US cell therapy developer says its cash runway extends into mid-2027 and that SC451, a hypoimmune islet therapy for type 1 diabetes, could enter the clinic as early as this year.
Two Phase 3 EMBARQ studies in chronic spontaneous urticaria met all primary and key secondary endpoints, while the company drops its Phase 2 prurigo nodularis study.
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.