Human Trials

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.

GSK, Vir Biotechnology to evaluate neutralising Covid-19 antibody in AGILE study

GlaxoSmithKline, along with Vir Biotechnology, has agreed with the UK-based AGILE initiative to assess VIR-7832 in patients with mild to moderate Covid-19 in a phase 1b/2a clinical study.

Russian Covid-19 vaccine Sputnik V succeeds in phase 2 trial in India

Dr. Reddy’s Laboratories said that the Russian Covid-19 vaccine Sputnik V has met the primary endpoint of safety in a phase 2 clinical trial in India.

Teva, MedinCell announce positive results for registration trial of TV-46000/mdc-IRM for patients with Schizophrenia

Teva Pharmaceuticals Industries and MedinCell announced positive results for study TV46000-CNS-30072 (the RISE study – The Risperidone Subcutaneous Extended-Release Study), a Phase 3 clinical trial designed to evaluate the efficacy of TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) as a treatment for patients with schizophrenia.

MODAG initiates first-in-patient phase 1b trial for Anle138b in Parkinson´s Disease

MODAG, a German biotechnology company focused on the development of disease-modifying small molecule therapeutics for neurodegenerative diseases, announced the clinical trial initiation of a first-in-patient Phase 1b study for anle138b in patients with mild to moderate Parkinson´s Disease (PD).

Lilly to begin pragmatic study of bamlanivimab for COVID-19 in New Mexico

Eli Lilly and Company announced plans to begin a new pragmatic study of bamlanivimab (LY-CoV555) in high-risk patients with COVID-19, in collaboration with major local institutions in the state of New Mexico.

Merck reports positive results for Keytruda, Lenvima combo in phase 3 KEYNOTE-775/Study 309 trial

Merck and Eisai announced that the pivotal Phase 3 KEYNOTE-775/Study 309 trial evaluating the investigational use of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) and its secondary efficacy endpoint of objective response rate (ORR) in patients with advanced endometrial cancer following at least one prior platinum-based regimen.

Novartis’ Kisqali demonstrates nearly five years median OS in metastatic breast cancer

Novartis announced updated median overall survival (OS) results for Kisqali (ribociclib) in combination with endocrine therapy, marking the longest survival data ever reported in premenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+HER2-) metastatic breast cancer.