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 finished enrolling 169 evaluable patients in NANOPULSE-AF about three months early and reported Q3 2026 cash of $189.2 million.
The company's third-quarter update reports continued enrolment in both studies, cash of $202.9 million into Q2 2028, and plans to discuss expanding its ALPS programme with the FDA.
The San Diego company projects FY26 China revenue of $100.5M-$111M, a possible 2027 China launch for F351 and a mid-2027 Phase 1 start for CG923308.
vTv Therapeutics says 166 participants are randomised in its Phase 3 CATT1 trial, with topline data expected mid-2027, as the FDA grants orphan designation to HPPD for sickle cell disease.
The US biotech's November 2026 corporate presentation reports interim DA-1726 liver-fat data and lays out a timeline running into 2027.
Aptevo reports that successive changes to mipletamig's priming-dose regimen have substantially lowered infusion-related reactions in the RAINIER study, with Phase 2 planned for 2027.
The company plans to start the global Headliner study of micvotabart pelidotin in mid-2027, with FDA feedback on dose selection due in the first quarter of 2027.
Dogwood Therapeutics has enrolled 239 patients in its Phase 2b CINP trial of Halneuron, expects top-line results in November, and raised $5 million from its largest shareholder.
An investor presentation proposes pairing the investigational TLR3 agonist with Revolution Medicines' daraxonrasib, though no trial of the combination has been established.
The US biotech reported Q3 2026 results, with Novartis milestones of $87.5 million and cash of $582.6 million expected to fund operations into 2029.
The US drugmaker now expects LINZESS net sales of $1.20-$1.25bn, while its confirmatory Phase 3 STARS-2 trial of apraglutide in short bowel syndrome continues.
Entrada Therapeutics says ELEVATE-45-201 Cohort 1 met its safety and tolerability objective, with Cohort 2 data for both Duchenne programmes expected in the first half of 2027.
The US antibody developer says its 2026 data guidance was met, with an ITP update due at ASH in December and further data planned for 2027.
Climb Bio's Q3 2026 update reports sustained APRIL suppression at 12 weeks for CLYM116, a Phase 2 IgA nephropathy start, and cash expected to last into H2 2028.
An independent safety board found no serious adverse events in the first PBGENE-DMD patient through week eight and endorsed treating more patients in Part 1 of FUNCTION-DMD.
ANI Pharmaceuticals announced a proposed offer for Egetis Therapeutics alongside its third-quarter results, aiming to add EMCITATE to its rare disease portfolio; the deal has not closed.
New ELIMINATE-B results for PBGENE-HBV show undetectable pgRNA and cccDNA reductions at the 0.4 mg/kg dose, with no dose-limiting toxicities or serious adverse events reported.
The German regulator has posted a manufacturer notice on the spinal surgery instrument, but its own entry gives no detail on the defect, affected lots or required actions.
The US obesity drug developer reported Q3 results, saying it has $1.04bn in cash expected to fund operations into mid-2028.
Topline OPUS-1 data show noninferiority to PCV20 and PCV21 with comparable safety; serotypes 3 and 12F missed a stricter threshold against PCV21.
The company plans to meet the FDA in the first half of 2027 on a possible accelerated approval route for its ENPP3 x CD3 bispecific antibody.
Dianthus Therapeutics' third-quarter update shows claseprubart beating its CIDP response target at interim, with MMN top-line results expected next month and cash guided into 2030.
Lyell Immunopharma reported updated PiNACLE data in third-line-plus large B-cell lymphoma, with pivotal readout due mid-2027 and a BLA planned for the second half of that year.
The company has released abstracts covering LOTIS-7, a marginal zone lymphoma trial and full Phase 3 LOTIS-5 results, including a progression-free survival gain and higher Grade 5 event rates.
Patient-reported results from pivotal Study 302 suggest responders had sustained quality-of-life gains, though the analyses were descriptive and fall outside the FDA-approved prescribing information.
Patient-reported results in relapsed or refractory cutaneous T-cell lymphoma point to sustained improvements among responders, though the analyses were descriptive and sit outside the US label.
Translational data at SITC 2026 show immune-activation rises in most evaluable patients, with HPV-16-specific T-cell expansion in six of 14 and tumour shrinkage in four of those six.
Kayserbetten has assessed that IDA beds sold in Canada carry an injury risk comparable to a serious incident abroad, tied to hand control locking instructions.
The company held its 2026 revenue guidance at $1.0–1.04 billion, said its pitolisant GR application is under FDA review, and released multiple-dose data for orexin agonist BP-205.
The company said it expects to submit the design of its next SER-155 study to the FDA in the first quarter of 2027, with progress dependent on funding.
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.