Clinical News-CliniExpert

Nirsevimab MEDLEY Phase II/III Trial Demonstrated Favourable Safety and Tolerability Profile in Infants at High Risk of RSV

28 June 2021 -- The MEDLEY Phase II/III trial evaluated the safety and tolerability of nirsevimab compared to Synagis (palivizumab) when given to infants at high risk of respiratory syncytial virus (R

Merck Presents Results from Phase 1 Trial Evaluating Investigational Islatravir Subdermal Implant for the Prevention of HIV-1 Infection at CROI 2021

KENILWORTH, N.J.--(BUSINESS WIRE) March 8, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from a Phase 1 study evaluating the safety, tolerabilit

BioMarin Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to Valoctocogene Roxaparvovec, Investigational Gene Therapy for Hemophilia A

SAN RAFAEL, Calif., March 8, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Th

Valneva and Pfizer Announce Initiation of Phase 2 Study for Lyme Disease Vaccine Candidate

March 08, 2021 -- Saint-Herblain (France) and New York, NY, March 8, 2021 – Valneva SE (“Valneva”), a specialty vaccine company focused on prevention of diseases with major unmet needs, and Pfizer Inc

Genentech Provides Update on Tecentriq U.S. Indication in Prior-Platinum Treated Metastatic Bladder Cancer

South San Francisco, CA -- March 7, 2021 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company is voluntarily withdrawing the U.S. indication for Tec

Ridgeback Biotherapeutics and Merck Announce Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

MIAMI & KENILWORTH, N.J.--(BUSINESS WIRE) March 6, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics, LP today announced preliminary resul

CytoDyn’s Phase 3 Trial Demonstrates Safety, a 24% Reduction in Mortality and Faster Hospital Discharge for Mechanically Ventilated Critically Ill COVID-19 Patients Treated with Leronlimab

VANCOUVER, Washington, March 05, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140),

Loxo Oncology at Lilly Announces Publication of Pirtobrutinib (LOXO-305) Phase 1/2 Data in The Lancet

INDIANAPOLIS, March 5, 2021 /PRNewswire/ -- Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), today announced that The Lancet has published data from the p

Tirzepatide Achieved Superior A1C and Body Weight Reductions Across All Three Doses Compared to Injectable Semaglutide in Adults with Type 2 Diabetes

INDIANAPOLIS, March 4, 2021 /PRNewswire/ -- Tirzepatide led to superior A1C and body weight reductions from baseline across all three doses compared to injectable semaglutide 1 mg in adults with type

Provention Bio Announces Publication of Extended Follow-up Data from the Pivotal "At-Risk" TN-10 Study of Teplizumab in Science Translational Medicine

RED BANK, N.J., March 3, 2021 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that ex

Vir Biotechnology and GSK Provide Update on NIH-Sponsored ACTIV-3 Trial Evaluating VIR-7831 in Hospitalised Adults with COVID-19

London UK 03 March 2021 -- Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today provided an update on the VIR-7831 (GSK4182136) arm of the National Institutes of Health’

On Target Laboratories Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Pafolacianine Sodium Injection for Identification of Ovarian Cancer During Surgery

WEST LAFAYETTE, Ind., March 3, 2021 /PRNewswire/ -- On Target Laboratories, Inc., a privately-held biotechnology company developing fluorescent markers to target and illuminate cancer during surgery,