Clinical News-CliniExpert

Moderna Announces First Patient Dosed in Phase 1/2 Study of mRNA-3705 for Methylmalonic Acidemia

mRNA-3705 is Moderna’s second rare disease program to enter clinical studies mRNA-3705 granted Orphan Drug and Rare Pediatric Disease designation by the U.S. FDA MMA associated with significant mortal

Second-Generation mRNA COVID-19 Vaccine Candidate, CV2CoV, Demonstrates Improved Immune Response and Protection in Preclinical Study

London UK and Tübingen, Germany / Boston, USA -16 August 2021 Preclinical study provides evidence for strongly improved immune responses with second-generation mRNA backbone jointly developed by CureV

Pfizer and BioNTech Announce Submission of Initial Data to U.S. FDA to Support Booster Dose of COVID-19 Vaccine

Phase 1 safety and immunogenicity data in individuals who received a third dose of the Pfizer-BioNTech vaccine (BNT162b2) show a favorable safety profile and robust immune responses The booster dose e

VTX-801 Receives U.S. FDA Fast Track Designation for the Treatment of Wilson Disease

Paris, France and New York, NY, August 12, 2021 -- Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administrati

Exicure Provides Interim Results from Ongoing Phase 1b/2 Clinical Trial of Cavrotolimod (AST-008)

CHICAGO & CAMBRIDGE, Mass.--(BUSINESS WIRE) August 5, 2021 -- Exicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA™) technol

Pfizer Announces Positive Top-Line Results from Phase 2b/3 Trial of Ritlecitinib in Alopecia Areata

NEW YORK--(BUSINESS WIRE) August 04, 2021 -- Pfizer Inc. (NYSE: PFE) today announced positive top-line results from the Phase 2b/3 ALLEGRO trial evaluating oral once-daily ritlecitinib in patients wit

New England Journal of Medicine Publishes Positive Phase 3 Trial Results for REGEN-COV (casirivimab and imdevimab) to Prevent SARS-CoV-2 Infection

TARRYTOWN, N.Y., Aug. 4, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the New England Journal of Medicine (NEJM) published positive detailed results from a

Complete Response Letter Received from FDA for Treosulfan

TORONTO and CHICAGO and WEDEL, Germany, Aug. 03, 2021 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (“Medexus” or the “Company”) (TSX: MDP) (OTCQX: MEDXF) and medac GmbH (“medac”) announced today t

SpringWorks Therapeutics Announces Phase 1b/2a Clinical Trial of Mirdametinib in Patients with Advanced Solid Cancers Harboring MAPK-Activating Mutations

STAMFORD, Conn., Aug. 03, 2021 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients

FDA Expands Authorized Use of REGEN-COV (casirivimab and imdevimab)

TARRYTOWN, N.Y., July 30, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization (

Lilly Releases Donanemab Data That Demonstrated Relationship Between Reduction of Amyloid Plaque and Slowing of Cognitive Decline

FDA Broadens Existing Emergency Use of Lilly and Incyte's Baricitinib in Patients Hospitalized with COVID-19 Requiring Oxygen

INDIANAPOLIS, July 29, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today the U.S. Food and Drug Administration (FDA) has broadened the Emergency Use Autho