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.
Seres Therapeutics' corporate presentation cites FDA agreement on study design for SER-155 in allogeneic transplant recipients, alongside Phase 1b data and an earlier-stage checkpoint inhibitor programme.
CBER's pilot under HHS Operation TrialBlazer will test whether outside expert institutions and rolling review can speed first-in-human trials without lowering safety or oversight standards.
FDA's biologics centre says sponsors in the pilot will submit discipline-specific components during pre-IND development, with a QRI vetting each one before the 30-day review begins.
New guidance explains when UK trial applications relying on non-OECD MAD safety data may be considered, including enhanced assessment in limited circumstances and a programme of test facility inspections.
The protein degrader developer reported Q3 2026 results, with ARV-6723 in a Phase 1/2 solid tumour trial and EU and UK filings planned for ARV-102 in PSP.
The gene-editing company reports $108 million in cash, expected to last through 2028, alongside a first dosing in its DMD study and a late-breaking HBV presentation.
The pre-submission advice procedure for sponsors using CTIS, run since 2024 as a pilot, will continue beyond 2026 with updated guidance and templates.
Travere Therapeutics reports 120% growth in U.S. FILSPARI sales for the third quarter, while a $113.1m IPR&D expense drives a $52.3m net loss.
Recursion's Q3 2026 update includes Phase 2 TUPELO results for REC-4881 in familial adenomatous polyposis, a Sanofi option exercise and cash runway extended into 2029.
The NASDAQ-listed laboratory furniture maker plans to buy Nycom, Inc. for an initial base price of $55 million, with PNC Bank expected to provide financing.
The Danish-based oncology company will develop and validate a European biotech's precision oncology predictive device for US use, after its Hørsholm lab gained CLIA certification in July.
Eton Pharmaceuticals has launched ET-900 to test mecasermin, the active ingredient in INCRELEX, in infantile and epileptic spasms, with first dosing targeted for the first quarter of 2027.
Austria's BASG newsticker says CMDh has revised its validation advice, updated RMS request templates and flagged which national requirements actually block the start of a procedure.
A single lot of Marcan Pharmaceuticals' Cyclophosphamide for Injection USP 1000 mg is subject to a Type I recall in Canada after particulate matter was found.
Acumen Pharmaceuticals says ALTITUDE-AD failed on its primary iADRS measure at both doses, and the company will end work on the amyloid antibody and explore strategic options.
Updated Phase 2 data show a markedly higher response rate in KRAS wild-type NSCLC, and the company is discussing a 2027 sBLA with the FDA.
Health Canada lists a Type II recall of several Azurion 7 configurations after surge voltages during start or restart can disable internal power supplies and leave systems unusable.
The US company also signed an option deal with Generian for an oral FcRn antagonist and appointed Sheila Gujrathi as Executive Chair after acquiring Vidya Therapeutics.
The US biotech has amended its Phase 1/2 study of the topical live biotherapeutic beyond EGFR inhibitor rash and shortened antibiotic and steroid washout periods to ease recruitment.
Interim Phase 1b data for the investigational CCR8 antibody, given with toripalimab, show high response rates in a small first-line cohort and no new safety signals.
The US company will pay $3.5 million upfront for rights to mitucapistat and aims to start a multinational Phase 3 trial in central retinal artery occlusion in 2027.
The EU-level advisory scheme for sponsors preparing clinical trial applications will move from pilot to permanent status, with a final report on about 30 applications due by the end of 2026.
The obesity drug developer launched Phase 3 trials of oral VK2735 in obesity and type 2 diabetes, while its subcutaneous VANQUISH studies remain on track to complete in 2027.
The EU regulator has issued a notice on the validation and qualification of computerised systems used in clinical trials; the details are not set out in the information available.
Acumen Pharmaceuticals expects topline results from its 542-patient Phase 2 trial of sabirnetug in early Alzheimer's disease next month, with ARIA rates among the safety measures.
Krascendo 1 data presented at ESMO show divarasib cut the risk of death by 44% in previously treated KRAS G12C-mutated NSCLC versus the two approved inhibitors.
Interim IMAgINATION results presented at ASN Kidney Week show a proteinuria reduction at week 37 and no new safety signals, with eGFR data still to come.
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.