Human Trials

Johnson & Johnson seeks EU approval for its COVID-19 vaccine

Janssen-Cilag International, a subsidiary of Johnson & Johnson has submitted a conditional marketing authorisation application (cMAA) to the European Medicines Agency (EMA) for its investigational single-dose Janssen COVID-19 vaccine candidate.

USFDA approves EUA for bamlanivimab-etesevimab combo to treat Covid-19 patients

The U.S. Food and Drug Administration (FDA) has approved Emergency Use Authorization (EUA) for investigational bamlanivimab and etesevimab as a combination therapy for the treatment of mild to moderate Covid-19 patients.

Johnson & Johnson submits EUA application for single-dose Covid-19 vaccine

Johnson & Johnson’s subsidiary Janssen Biotech has submitted an Emergency Use Authorization (EUA) application to the US Food and Drug Administration (FDA) for its investigational single-dose Janssen Covid-19 vaccine candidate.

AstraZeneca secures conditional marketing authorisation for Covid-19 vaccine in Europe

AstraZeneca has secured a conditional marketing authorisation for its Covid-19 vaccine in the European Union (EU) for active immunisation in individuals aged 18 years and above.

US DOD to fund Humanetics’ new drug test against Covid-19

The US Department of Defense (DOD) has approved the funding of US-based private pharmaceutical firm Humanetics to test its drug candidate BIO 300 in treating pulmonary inflammation triggered by COVID-19.

Merck discontinues Covid-19 vaccine candidates on grounds of poor performance

American pharma giant Merck has announced that it has discontinued the development of its SARS-CoV-2/Covid-19 vaccine candidates V590 and V591, after they performed poorly in phase 1 clinical trials.

Gritstone advancing Covid-19 vaccine, plans to begin trials with NIAID support

Gritstone Oncology, a biotech firm developing vaccines, has announced that it is advancing the development of a second generation vaccine against Covid-19.

Dr. Reddy’s receives approval to conduct Phase 3 clinical trial for Sputnik V vaccine in India

Dr. Reddy’s Laboratories has announced that it has received approval from the Drugs Control General of India (DCGI) to conduct phase 3 clinical trial for the Sputnik V vaccine in India.

NewAmsterdam Pharma completes $196m Series A funding for phase 3 development programme

NewAmsterdam Pharma (NAP), a clinical stage company focused on the research and development of transformative therapies for cardio-metabolic diseases, announced completion of a $196M (€160M) Series A funding round.