Clinical News-CliniExpert

Iterum Therapeutics Announces Completion of Enrollment in Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infection

DUBLIN, Ireland and CHICAGO, Dec. 26, 2019 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibio

FDA Complete Response Letter for Investigational Cabotegravir and Rilpivirine Long-Acting HIV Treatment

TITUSVILLE, N.J., December 21, 2019 -– The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (C

Phathom Pharmaceuticals Announces Initiation of Pivotal Phase 3 Clinical Trial for Vonoprazan in Helicobacter Pylori (H. pylori) Infection

BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Dec. 23, 2019 -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel tre

Acasti Pharma Provides Update on Timing of Topline Results for TRILOGY 1 Phase 3 Trial of CaPre

LAVAL, Québec, Dec. 23, 2019 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and comm

Mycovia Pharmaceuticals Completes Enrollment in its Third Phase 3 Clinical Trial for VT-1161 (ultraVIOLET) in Patients with Recurrent Vulvovaginal Candidiasis

DURHAM, N.C.--(BUSINESS WIRE) December 18, 2019 -- Mycovia Pharmaceuticals, Inc. (“Mycovia”) today announced it has completed enrollment for its ongoing Phase 3 ultraVIOLET clinical trial for VT-1161.

Boehringer Ingelheim Discontinues Development of BI 1467335 for NASH

Ingelheim, Germany and Sydney, Australia, 18 December 2019 – Boehringer Ingelheim and Pharmaxis Ltd today announced the discontinuation of the development of BI 1467335 for the treatment of NASH (non-

Epizyme Announces FDA Advisory Committee Votes Unanimously in Favor of Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 18, 2019 -- Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today announced that the Oncologic Drugs

Biohaven Achieves Positive Topline Results in Pivotal Phase 2/3 Study of Vazegepant, the First and Only Intranasal CGRP Receptor Antagonist in Clinical Development for the Acute Treatment of Migraine

NEW HAVEN, Conn., Dec. 17, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced positive topline results from its randomized, dose ranging, placebo controlled

BioMarin Announces Positive Final Results from Placebo-Controlled Phase 3 Data in Children with Achondroplasia Treated with Vosoritide

SAN RAFAEL, Calif., Dec. 16, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today reported positive final results from its randomized, double-blind, placebo-controlled Phase 3 study

Pivotal DREAMM-2 Study Demonstrated a Clinically Meaningful Overall Response Rate with Belantamab Mafodotin (GSK2857916) for Patients with Relapsed/Refractory Multiple Myeloma

London, UK - December 16, 2019 -- GlaxoSmithKline today announced treatment with the investigational single-agent belantamab mafodotin resulted in a clinically meaningful 31% overall response rate (OR

Alnylam Reports Positive Topline Results from ILLUMINATE-A Phase 3 Study of Lumasiran for the Treatment of Primary Hyperoxaluria Type 1

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 17, 2019 -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the ILLUMINATE-A Phase 3 study of lumasira

Mirum Pharmaceuticals Completes Successful Pre-NDA Meeting with FDA for Maralixibat

FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 16, 2019 -- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for d