Human Trials

Bayer’s Adempas meets primary endpoint in phase 4 trial in PAH patients

Bayer said that the phase 4 REPLACE trial evaluating Adempas (riociguat) in intermediate-risk adult patients with pulmonary arterial hypertension (PAH) has met its primary endpoint.

Novartis says high-dose Enerzair Breezhaler reduces asthma exacerbations versus medium-dose

Novartis announced that high-dose, once-daily Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) significantly reduces both moderate-or-severe and severe asthma exacerbation rates in patients whose asthma is uncontrolled on medium- or high-dose long-acting beta2-agonist (LABA)/inhaled corticosteroids (ICS), when compared with a once-daily medium-dose of the same treatment.

Octapharma launches phase 3 superiority study for PANS

Octapharma has launched a phase 3, multicenter superiority study to compare the effectiveness of PANZYGA (immune globulin intravenous, human - ifas) 10% Liquid Preparation versus placebo in patients with pediatric acute-onset neuropsychiatric syndrome (PANS).

PharmaCyte Biotech submits IND to FDA for clinical trial in inoperable pancreatic cancer

PharmaCyte Biotech has submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for a planned Phase 2b clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

Twist Bioscience announces potent SARS-CoV-2 neutralising data from Covid-19 therapeutic antibody programme

Twist Bioscience announced data demonstrating the potent neutralizing effects of multiple potential therapeutic antibodies, both Immunoglobulin G (IgG) antibodies and substantially smaller single domain VHH “nanobodies,” against SARS-CoV-2, the virus that causes Covid-19.

Sanofi, GSK begin phase 1/2 clinical trial of Covid-19 vaccine candidate

French pharmaceutical firm Sanofi and British drugmaker GlaxoSmithKline (GSK) have commenced the phase 1/2 clinical of the Covid-19 adjuvanted recombinant protein-based vaccine candidate.

Vir, GSK begin phase 2/3 trial of VIR-7831 as Covid-19 antibody treatment

Vir Biotechnology and GlaxoSmithKline (GSK) have started a phase 2/3 study of VIR-7831 (also known as GSK4182136) as a Covid-19 antibody treatment by dosing the first patient.

Celltrion receives Korean MFDS approval to initiate trial of Covid-19 antiviral antibody treatment candidate

Celltrion Group announced that the Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s Investigational New Drug (IND) application for a Phase I clinical trial of CT-P59, a COVID-19 antiviral antibody treatment candidate.

FARXIGA significantly reduces kidney failure and CV or renal death risks in CKD patients in DAPA-CKD trial

Detailed results from the ground-breaking Phase III DAPA-CKD trial showed that AstraZeneca’s FARXIGA (dapagliflozin) on top of standard of care reduced the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo (p<0.0001) in patients with chronic kidney disease (CKD) Stages 2-4 and elevated urinary albumin excretion.