Human Trials

Novartis announces NEJM publication of three pivotal trials showing durable and potent efficacy of inclisiran

Novartis announced today the publication of three pivotal Phase III clinical trials for inclisiran, a potential first-in-class small interfering RNA (siRNA) investigational agent for hyperlipidemia in adults.

Imfinzi delivers sustained OS benefit in final analysis of CASPIAN trial

AstraZeneca said that Imfinzi (durvalumab) has been demonstrated to have delivered a sustained overall survival (OS) benefit in the final analysis of the phase 3 CASPIAN trial in extensive-stage small cell lung cancer.

Merck announces top-line results from phase 3 trials evaluating Gefapixant

Merck announced top-line efficacy results from two ongoing pivotal Phase 3 trials (COUGH-1 and COUGH-2) evaluating the efficacy and safety of gefapixant (MK-7264), an investigational, orally administered, selective P2X3 receptor antagonist, for the treatment of refractory or unexplained chronic cough.

Moderna doses first patient with mRNA-1273 in coronavirus vaccine trial

Moderna has announced the dosing of the first participant in a phase1 study of mRNA-1273, the company’s mRNA vaccine candidate against the novel coronavirus (SARS-CoV-2).

Pfizer, EMD Serono to scrap phase 3 study of avelumab in LA SCCHN

Pfizer and EMD Serono are set to scrap the phase 3 JAVELIN Head and Neck 100 study as it was found that avelumab in addition to chemoradiotherapy (CRT) is unlikely to deliver the desired result.

FDA clears first clinical study for a polymicrobial phage library-based treatment for antibiotic-resistant infections

Adaptive Phage Therapeutics (APT) said that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of PhageBank, a personalized bacteriophage therapeutic for the treatment of MDR and complicated bacterial infections.

TOURMALINE-MM2 study on NINLARO fails to deliver desired results

Takeda Pharmaceutical said that the phase 3 TOURMALINE-MM2 study evaluating the addition of NINLARO (ixazomib) to lenalidomide and dexamethasone in certain multiple myeloma population could not deliver the desired results.

InMed Pharmaceuticals announces completed enrollment in phase 1 clinical trial of INM-755 CBN Cream in healthy subjects

InMed Pharmaceuticals has completed enrollment in its first Phase 1 clinical trial with INM-755 in healthy subjects (Study 755-101-HV).

Kala’s dry eye disease candidate KPI-121 meets objective in STRIDE 3 trial

Kala Pharmaceuticals said that its dry eye disease candidate KPI-121 0.25% has delivered positive results in a phase 3 trial called STRIDE 3.