Clinical Trials

Dr. Reddy’s, RDIF secure DCGI’s approval for Sputnik V vaccine trial in India

Russian Direct Investment Fund (RDIF), along with Dr. Reddy’s Laboratories, has secured approval from the Drug Control General of India (DCGI) to carry out clinical trials of Sputnik V vaccine in India.

ImmunityBio gets FDA authorisation to begin trial of novel Covid-19 vaccine candidate

ImmunityBio has secured authorisation from the US Food and Drug Administration (FDA) to commence a phase I clinical study of its novel Covid-19 vaccine candidate, called hAd5-Covid-19.

Seagen, Astellas report positive results from PADCEV phase 2 trial in advanced urothelial cancer

Seagen and Astellas Pharma announced positive topline results from the second cohort of patients in the pivotal phase 2 single-arm clinical trial known as EV-201.

J&J halts Covid-19 vaccine trials after unexplained illness in participant

Johnson & Johnson (J&J) has halted further dosing in all Janssen’s Covid-19 vaccine candidate clinical trials, as a result of unexplained illness in a study participant.

BMS presents positive data from phase 3 True North Trial of Zeposia in UC

Bristol Myers Squibb announced detailed results from True North, a pivotal, placebo-controlled Phase 3 trial evaluating oral Zeposia (ozanimod) as an induction and maintenance therapy in adult patients with moderate to severe ulcerative colitis (UC).

Pfizer’s Ibrance fails to meet primary endpoint in early breast cancer trial

The German Breast Group (GBG) and Pfizer announced that the Ibrance (palbociclib) has failed to meet the primary endpoint in phase 3 early breast cancer trial.

Rigel enrols first patients in phase 2 Covid-19 trial of fostamatinib

Rigel Pharmaceuticals has recruited the first patients in a phase 2 study designed to assess the safety of fostamatinib for the treatment of hospitalised Covid-19 patients.

Noxopharm announces first Covid-19 patient treated in Veyonda study

As the number of COVID-19 cases and deaths continues to rise in most countries, Australian clinical-stage drug development company Noxopharm is pleased to announce treatment of the first patient with its lead pipeline candidate, Veyonda, in the company’s Phase 1 NOXCOVID-1 study.

Pfizer, Sangamo dose first participant in phase 3 study of Hemophilia A gene therapy treatment

Pfizer and Sangamo Therapeutics, a genomic medicines company, today announced that the first participant has been dosed in the Phase 3 AFFINE study of giroctocogene fitelparvovec (SB-525), an investigational gene therapy for hemophilia A patients.