Human Trials

26 Nov 2020
- Clinical Trials
- Human Trials
Celltrion completes enrolment for global phase II clinical trial with Covid-19 treatment candidate

By PBR Staff Writer

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.
25 Nov 2020
Clinical Trials
Human Trials
US FDA approves Roche’s Xofluza to prevent influenza following contact with infected person

By PBR Staff Writer

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.
25 Nov 2020
Clinical Trials
Human Trials
Health Canada clears Appili Therapeutics for new phase 3 trial to assess Avigan to prevent Covid-19

By PBR Staff Writer

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.
25 Nov 2020
Clinical Trials
Human Trials
Apnimed doses first patient in phase 2 trial of AD109 in obstructive sleep apnea

By vbandhakavi

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.
25 Nov 2020
Clinical Trials
Human Trials
City of Hope begins phase 1 clinical trial of Covid-19 vaccine candidate

By PBR Staff Writer

City of Hope, the US-based independent biomedical research and treatment centre, has commenced phase 1 clinical trial to evaluate its first SARS-CoV-2 investigational vaccine.
24 Nov 2020
Clinical Trials
Human Trials
GSK begins patient dosing in phase 3 trial of RSV maternal candidate vaccine

By PBR Staff Writer

British drugmaker GlaxoSmithKline (GSK) has started patient dosing in a phase 3 clinical trial to assess the safety and efficacy of the respiratory syncytial viirus (RSV) vaccine candidate for maternal immunisation.
24 Nov 2020
Clinical Trials
Human Trials
Pfizer doses first participant in phase 3 study evaluating anti-TFPI investigational therapy

By PBR Staff Writer

Pfizer announced that the first participant has been dosed in the Phase 3 BASIS study of marstacimab (PF-06741086), an anti-tissue factor pathway inhibitor (anti-TFPI) being evaluated for the treatment of people with severe hemophilia A or B, with or without inhibitors.
23 Nov 2020
Clinical Trials
Human Trials
AstraZeneca’s AZD1222 vaccine demonstrates promising efficacy

By PBR Staff Writer

AstraZeneca announced that its AZD1222 vaccine has demonstrated a significant effect in preventing Covid-19 in an interim analysis of clinical trials in the UK and Brazil.
23 Nov 2020
Clinical Trials
Human Trials
Clear Creek Bio doses first patient in phase 2 outpatient study of Brequinar to treat Covid-19

By PBR Staff Writer

Clear Creek Bio, Inc. announced today that the company has dosed the first patient in the CRISIS2 study, a Phase 2 clinical study evaluating brequinar for the treatment of Covid-19.
19 Nov 2020
Clinical Trials
Human Trials
Pfizer, BioNTech’s Covid-19 vaccine candidate meets all primary efficacy endpoints in phase 3 study

By PBR Staff Writer

Pfizer and BioNTech have announced that their BNT162b2 Covid-19 vaccine candidate has achieved all primary efficacy endpoints in the phase 3 study.

Drug Discovery

Research & Development

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Astellas and AI Proteins sign miniprotein therapeutics deal

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Patient Enrollment

US FDA approves Avacta Group’s IND application for AVA6000

AM-Pharma enrols first patients in Covid-19 phase III trial

Regulation

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Viatris files applications in Japan for approval of Effexor to treat GAD

Scholar Rock submits application of SMA therapy to FDA

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Manufacturing

Formation Bio launches $600m drug development fund

ENCell and Lucy Biotech forge alliance for mesenchymal stem cell therapy

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Packaging

Uwe Röhrhoff Steps Down as Interim CEO of Gerresheimer AG

Gerresheimer at CPHI Frankfurt 2025

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Human Trials

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

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

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

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

City of Hope begins phase 1 clinical trial of Covid-19 vaccine candidate

GSK begins patient dosing in phase 3 trial of RSV maternal candidate vaccine

Pfizer doses first participant in phase 3 study evaluating anti-TFPI investigational therapy

AstraZeneca’s AZD1222 vaccine demonstrates promising efficacy

Clear Creek Bio doses first patient in phase 2 outpatient study of Brequinar to treat Covid-19

Pfizer, BioNTech’s Covid-19 vaccine candidate meets all primary efficacy endpoints in phase 3 study

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Research & Development

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