Clinical Trials

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.

Health Canada clears Appili Therapeutics for new phase 3 trial to assess Avigan to prevent Covid-19

Appili Therapeutics, a biopharmaceutical company focused on anti-infective drug development, today announced initiation of its Phase 3 Post Exposure Prophylaxis for COVID-19 (PEPCO) study to evaluate Avigan tablets (favipiravir) in the prevention of Covid-19.

Apnimed doses first patient in phase 2 trial of AD109 in obstructive sleep apnea

Apnimed announced that the first patient has been dosed in a Phase 2 clinical trial evaluating AD109, the company’s first-in-class, oral pharmaceutical under development for the treatment of OSA.