Clinical News-CliniExpert

Chi-Med Announces Surufatinib Granted FDA Orphan Drug Designation for Pancreatic Neuroendocrine Tumors

LONDON, Nov. 25, 2019 (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug desi

FDA Grants Priority Review to Genentech’s Risdiplam for Spinal Muscular Atrophy

South San Francisco, CA -- November 24, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the N

Pivotal Data from Phase 3 Study of Sutimlimab in Cold Agglutinin Disease to be Presented at ASH 2019 Late-Breaking Session

CAMBRIDGE, Mass., Nov. 21, 2019 /PRNewswire/ -- Sanofi, Full data from the pivotal Phase 3 CARDINAL trial evaluating the safety and efficacy of sutimlimab in people with primary cold agglutinin diseas

Newron Receives FDA Rare Pediatric Disease Designation for Sarizotan for the Treatment of Rett Syndrome

MILAN & MORRISTOWN, N.J. -- November 19, 2019 -- Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for pat

Myovant Sciences Announces 97% Response Rate in Positive Phase 3 HERO Study of Once-Daily, Oral Relugolix in Men with Advanced Prostate Cancer

BASEL, Switzerland, Nov. 19, 2019 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women's health and prostate cancer, today

Allergan Announces Positive Phase 3 ACHIEVE II Trial Results for Ubrogepant Published in The Journal of the American Medical Association

DUBLIN, Nov. 19, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that positive results from ACHIEVE II (UBR-MD-02), a pivotal Phase 3 clinical trial evaluating the efficacy, safety and t

New Results From COSMIC-HF Presented At AHA 2019 Show Treatment Of Heart Failure Patients With Omecamtiv Mecarbil Was Associated With Neutral Or Improved Measures Of Diastolic Function

THOUSAND OAKS, Calif., SOUTH SAN FRANCISCO, Calif., and SURESNES, France, Nov. 18, 2019 /PRNewswire/ -- Amgen (NASDAQ: AMGN), Cytokinetics, Incorporated (NASDAQ: CYTK) and Servier announced that new r

Merck and Bayer’s Investigational Drug Vericiguat Meets Primary Endpoint in Phase 3 Study of Patients with Worsening Chronic Heart Failure

KENILWORTH, N.J.--(BUSINESS WIRE)--November 18, 2019 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 VICTORIA study evaluating the efficacy an

Zosano Pharma Announces Completion of Pre-NDA Meetings with FDA for Qtrypta™

FREMONT, Calif., Nov. 13, 2019 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that it has received minutes from pre- New Drug

Results of a Randomized Study of the Safety and Efficacy of Cenobamate in Adults with Uncontrolled Focal Seizures Published in The Lancet Neurology

PARAMUS, N.J., Nov. 13, 2019 /PRNewswire/ -- SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., an innovative global pharmaceutical company focused on developing treatments for ce

Anifrolumab Demonstrated Superiority Across Multiple Efficacy Endpoints in Patients with Systemic Lupus Erythematosus in Phase III TULIP 2 Trial

November 11, 2019 -- AstraZeneca will tomorrow present detailed results from the positive Phase III TULIP 2 trial for anifrolumab, a potential new medicine for the treatment of moderate to severe syst

AVEO Oncology and Biodesix Announce Initiation of the CyFi-2 Study, a Phase 2 Randomized Study of Ficlatuzumab in Combination with High-Dose Cytarabine vs. High-Dose Cytarabine Alone in Patients with Relapsed and Refractory AML

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- November 8, 2019 -- AVEO Oncology (AVEO) and Biodesix, Inc. today announced the initiation of the CyFi-2 study, a randomized Phase 2 clinical study evaluating ficla