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 US biotech reports first dosing in its AURORA trial, with topline data due in the second half of 2027, after a $115M October financing.
The company acquired Advanced Vision Science from Santen to secure IOL supply for its Phase 3 glaucoma programme, and has begun implanting patients with its second candidate, BIM-DRS.
Vivani Medical says top-line Phase 1 data for its NPM-139 semaglutide implant are due this week, while the Cortigent merger still awaits final regulatory approvals.
The company says Phase 2 DMD topline data are expected in Q1 2027, with FSHD enrolment in the TRAVERSE study also due to begin that quarter.
Published preclinical data show the oral A3 adenosine receptor agonist reduced a urinary proteinuria marker by 48–80%, and an Italian Phase II study in five adults is under regulatory review.
Final results from the 92-patient study show comparable recovery times and no viral rebound to Day 28, while the company readies a tivoxavir marboxil resubmission for Q4 2026.
The US biotech reported Q3 2026 results, with enrolment continuing in the DIRECTION-GD trial of YB-101 and Phase 2a topline data due in the second half of 2027.
The US biotech says PERFORMA is progressing, with 52-week topline data due in 2029, and an FDA End-of-Phase 2 meeting on alcohol use disorder is set for December.
EyePoint will wind down wet AMD development of DURAVYU after LUGANO and LUCIA missed their primary endpoint, redirecting resources to its diabetic macular edema trials.
Methodological guideline MP 155/2026 sets requirements and procedure for pharmacy permit holders in Slovakia that plan to offer vaccination as part of pharmacy care.
The agency's draft guidance sets out recommendations for first-in-human and limited-experience oncology protocols, and excludes haematologic malignancies; comments are open until 11 January 2027.
MHRA issued a Class 4 (advisory) defect notification after Star Pharmaceuticals reported a typographical error on the front face of the carton for Enalapril maleate/Hydrochlorothiazide 20 mg/12.5 mg Tablets, where the hydrochlorothiazide strength is printed as "12. mg" instead of "12.5 mg". The risk is low, but the incorrect strength on the outer packaging could cause confusion and may require a correction of the labelling.
HappyScale Wellness Corp., trading as Join Luma, says a seven-provider comparison ranked it cheapest for compounded tirzepatide, while noting the product is not FDA-approved.
German regulator lists a notice from BD Switzerland Sarl on BD Connecta, but defect, affected lots and required actions appear only in the manufacturer's attached advisory.
Roche will bring 16 abstracts to the CTAD Congress in Boston, spanning its brain-shuttle antibody, an oral NLRP3 inhibitor and its Elecsys blood-based Alzheimer's tests.
The company reached its 120-patient target in the placebo-controlled RESOLVE study and reported Q3 2026 results, with cash it says lasts into the second half of 2028.
The cell therapy developer reported Q3 2026 results, with Phase 3 melanoma data due in H1 2027 and cash of $536.3 million funding operations into Q4 2028.
The company's Q3 update puts Phase 2b PACE-1 topline data in the second half of 2027, with two Phase 3 trials planned pending FDA alignment.
The US biotech reported $503.5m in cash after its August IPO, and said FDA feedback supports a fixed-dose Phase 2b trial and a Phase 3 study in non-obstructive HCM.
Metagenomi plans to open the Phase 1/2 INTEGR8 trial in the first half of 2027, with first clinical data expected in the second half of that year.
The company says its Phase 3 IMPROVE-PAH study has approvals in 28 countries, 79 active sites and FDA orphan designation, with interim safety data due in the first half of 2027.
Updated Phase 1 data for the Claudin 6 x CD3 T cell engager show a 5.6-month median PFS, with liver enzyme elevations emerging as a dose-related safety issue.
The US biotech also reported 5% mean weight loss at 12 weeks for oral obesity candidate CRB-913 and said cash should last into 2028.
Topline Phase 2 data for PGN-EDODM1 in myotonic dystrophy type 1 show improved myotonia and a generally well-tolerated profile, with higher-dose results due in H1 2027.
Phase 2 FREEDOM2-DM1 data for PGN-EDODM1 show no serious adverse events at 10 mg/kg, but the March 2026 FDA partial clinical hold is still unresolved.
Initial Phase 2 SURF302 data support a planned Phase 3 adjuvant study in 2027, while a roughly $400 million offering extends Tyra's cash runway to 2030.
Coya Therapeutics says 137 patients are enrolled in the ALSTARS study of COYA 302, above the 120 planned, as it reports a $10.6 million third-quarter net loss.
The US biotech reported a 46% overall response rate in 76 patients with platinum-resistant or refractory ovarian cancer and said a $50 million offering extends its cash runway into Q1 2028.
The US company says two male pattern hair loss studies of its extended-release oral minoxidil were positive, with no treatment-related serious or cardiac adverse events of special interest.
The US biotech says its cash of $161.4 million should fund operations into 2029 as it progresses two epilepsy-focused programmes.
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.