Clinical News-CliniExpert

Novartis Announces MET Inhibitor Capmatinib (INC280), the First Potential Treatment for METex14 Mutated Advanced Non-Small Cell Lung Cancer, Granted Priority FDA Review

EAST HANOVER, N.J., Feb. 11, 2020 /PRNewswire/ -- Novartis announced today that the US Food and Drug Administration (FDA) accepted and granted Priority Review to capmatinib's (INC280) New Drug App

Johnson & Johnson Announces Collaboration with U.S. Department of Health & Human Services to Accelerate Development of a Potential Novel Coronavirus Vaccine

NEW BRUNSWICK, N.J., February 11, 2020 – Johnson & Johnson today announced that its Janssen Pharmaceutical Companies will further expedite its investigational coronavirus vaccine program through a

Lilly Announces Topline Results for Solanezumab from the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Study

INDIANAPOLIS, Feb. 10, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the analysis performed by Washington University School of Medicine in the Dominantly Inherited Alzhei

U.S. FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma

SANTA MONICA, Calif.--(BUSINESS WIRE)--Feb. 10, 2020 -- Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Appli

Genentech Provides Topline Results From Investigator-Led Phase II/III Trial With Gantenerumab in Rare Inherited Form of Alzheimer’s Disease

South San Francisco, CA -- February 9, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the gantenerumab arm of the Phase II/III DIAN-TU-001 study did

Zogenix Announces Positive Top-line Results from Global Pivotal Phase 3 Trial of Fintepla for the Treatment of Lennox-Gastaut Syndrome

EMERYVILLE, Calif., Feb. 06, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today reported positive top-line results from its

Genentech’s Risdiplam Showed Significant Improvement in Motor Function in People Aged 2-25 With Type 2 or 3 Spinal Muscular Atrophy

South San Francisco, CA -- February 6, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today presented 1-year data from the pivotal Part 2 of SUNFISH, a global placebo-con

Regeneron Announces Expanded Collaboration with HHS to Develop Antibody Treatments for New Coronavirus

TARRYTOWN, N.Y., Feb. 4, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced an expanded agreement with the U.S. Department of Health and Human Services (HHS) to develo

CTI BioPharma Establishes Accelerated Approval Pathway for Pacritinib in Treating Myelofibrosis Patients With Severe Thrombocytopenia

SEATTLE, Feb. 3, 2020 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced that following a meeting with the U.S. Food and Drug Administration ("FDA" or "the Agency")

CEPI and GSK Announce Collaboration to Strengthen the Global Effort to Develop a Vaccine for the 2019-nCoV Virus

Oslo, Norway; London, UK -- 03 February 2020 CEPI, the Coalition for Epidemic Preparedness Innovations, and GSK today announced a new collaboration aimed at helping the global effort to develop a vacc

CytoDyn Announces Stunning Results from Clinical Trials Evaluating mTNBC and MBC with Leronlimab and will Request an Emergency Type C Meeting with FDA to Enroll 50 Awaiting Patients with a Serious Solid Tumor Cancer Condition

VANCOUVER, Washington, Jan. 31, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 anta

Gilead Sciences Statement on the Company’s Ongoing Response to the 2019 Novel Coronavirus (2019-nCoV)

Foster City, Calif., January 31, 2020 — Gilead Sciences today issued the following statement from Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences: "Gilead is working closely with g