Clinical Trials
The triple therapy improves lung function in the Phase III KALOS and LOGOS studies
DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.
On its Q1 earnings call, Moderna avoided criticizing policy changes affecting vaccines but de-emphasized its flu/COVID-19 vaccine for under-50 and prioritized cancer programs.
As the PDUFA date for the UK major’s IL-5 inhibitor draws close.
Two potentially first-in-class molecules signify Zai Lab’s renewed drive for the in-house discovery of drugs that it requires “to be innovative, differentiated and to have the potential to make a big difference for patients,” its global R&D head tells Scrip.
CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.
The AKT inhibitor proves ineffective for metastatic castration-resistant disease in a Phase III trial.
With positive data versus radiation therapy in KEYNOTE-689, Merck & Co. files for approval in perioperative head and neck cancer, adding to additional claim in that cancer type.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Akeso explains the circumstances behind the release of preliminary overall survival data from a head-to-head Phase III trial with ivonescimab in lung cancer, which some investors viewed as disappointing.
Novotech's CEO talks about rising interest for trials in regions with “regulatory agility” and “strategic insulation” from geopolitical complexity, especially among emerging and mid-sized biotech sponsors. Operational "reassessment” among some sponsors on exposure to China-based CROs/CRDMOs is another area he discussed.
Akeso’s penpulimab will be the second to hit the US market for nasopharyngeal carcinoma, but the first to win FDA approval for the indication based on clinical findings in US patients.
The Belgium-based firm will take the first-in-class drug, based on tick saliva, targets inflammation without increasing bleeding, into a Phase IIb trial is in preparation, supported by a new series B funding round.
CFO François Roger tells Scrip the French drugmaker is flexible geographically on making investments but its spend in the US has risen regardless of the threat of tariffs.
Cobenfy is approved as a monotherapy, but failed in the adjunctive setting when combined with generic atypical antipsychotics, giving BMS a second Phase III failure in two weeks.
Two Phase III trials testing tegoprazan read out positively, but the potassium-competitive acid blocker will compete with Phathom’s Voquezna (vonoprazan).
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The biotech reported Phase I multiple-ascending dose data for its obesity drug for the second time in a week, but its safety and tolerability do not offset concerns about relatively unimpressive weight reduction.
Arbele has emerged as a global leader in the Cadherin 17 area, not only in clinical progress but also for its “secret recipe” for application in T-cell engagers, its CEO tells Scrip.
AstraZeneca and Daiichi’s DESTINY-Breast09 trial testing Enhertu with pertuzumab versus standard of care showed a statistically significant and meaningful PFS improvement.