Clinical Trials

Pfizer, Sangamo announce updated results of phase 1/2 Alta study of giroctocogene fitelparvovec

Pfizer and Sangamo Therapeutics, a genomic medicines company, announced updated follow-up data from the Phase 1/2 Alta study of giroctocogene fitelparvovec (SB-525 or PF-07055480), an investigational gene therapy for patients with severe hemophilia A.

Sinovac receives up to $500m for Covid-19 vaccine development

Sinovac Life Sciences (Sinovac LS), a subsidiary of Sinovac, has received up to $500m in funding for the development of its Covid-19 vaccine candidate.

Appili announces dosing of first patient in phase 3 Covid-19 trial

Appili Therapeutics announced that first patient has been dosed in the phase 3 PRESECO (preventing severe Covid disease) clinical trial to assess oral Avigan tablets (favipiravir) to treat Covid-19.

Dr. Reddy’s and RDIF commence clinical trials for Sputnik V vaccine in India

Dr. Reddy’s Laboratories and Russian Direct Investment Fund (RDIF) announced that they have commenced adaptive phase 2/3 clinical trials for Sputnik V vaccine in India after receiving the necessary clearance from the Central Drugs Laboratory, Kasauli, India.

Amgen, Takeda, UCB enrol first patient in Covid-19 global platform study

Biopharmaceutical company Amgen, along with two other drugmakers Takeda and UCB, has enrolled the first patient in a global platform trial of hospitalised patients with Covid-19.

NeoImmuneTech doses first patient in Covid-19 trial

NeoImmuneTech has dosed the first patient in its phase 1 study designed to assess NT-I7 (efineptakin alfa) in adult patients with mild Covid-19.

Haoma Medica completes first-in-human trial for NaQuinate

Haoma Medica announced the completion of a first-in-human trial for NaQuinate, a naphthoquinone carboxylic acid, which is being developed as a novel orally administered therapeutic for osteoporosis.

Celltrion completes enrolment for global phase II clinical trial with Covid-19 treatment candidate

Celltrion Group announced enrolment completion of 327 patients with mild-to-moderate symptoms of SARS-CoV-2 infection in the global Phase II clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. Celltrion anticipates submission for emergency use authorisation (EUA) to the Korean Ministry of Food and Drug Safety (MFDS), conditional on results from the global Phase II pivotal trial.

US FDA approves Roche’s Xofluza to prevent influenza following contact with infected person

Roche has secured US FDA approval for its supplemental new drug application (sNDA) for Xofluza (baloxavir marboxil), an oral medicine, to prevent influenza in people 12 years and older following their contact with someone suffering with influenza or post-exposure prophylaxis.