news – Page 3356 – pharmaceutical daily

January 7, 2019 Off

F2G combines €24 million loan and investment from Chinese Morningside to speed up its fungal infections treatment candidate olorofim

A UK- and Austria-based Biotech company F2G Ltd, has raised funding from life science investor Morningside Venture Investments Ltd. (Morningside), after borrowing €24 million from the European Investment Bank (EIB) in November 2018 to speed up the phase 2 study for its lead candidate, a treatment for invasive fungal infections, olorofim.

January 4, 2019 Off

Catalyst Pharmaceuticals’ Firdapse tablets meet endpoints in Phase II trial

By Dino Mustafić

Catalyst Pharmaceuticals Phase IIb clinical trial for Firdapse tablets, published in SAGE Open Medicine, for the treatment of MuSK antibody positive Myasthenia Gravis (MuSK-MG), has given evidence that amifampridine phosphate was safe and effective in treating MuSK-MG patients.

January 4, 2019 Off

BerGenBio doses first patient in Phase II monotherapy study of bemcentinib in high-risk MDS & AML

By Dino Mustafić

BerGenBio ASA has been dosed the first patient with bemcentinib, in an investigator-initiated phase II trial, sponsored by GWT-TUD GmbH, a specialist cancer clinical research institution associated with the University of Dresden, Germany.

January 4, 2019 Off

Novavax’ NanoFlu formulkation identified for the Phase 3 clinical trial and sale

By Dino Mustafić

Novavax reported Friday that the Phase 2 clinical trial found all formulations of NanoFlu were well-tolerated and elicited vigorous immune responses to the four strains included in the vaccine.

January 4, 2019 Off

Promedior’s PRM-151 for Idiopathic Pulmonary Fibrosis positioned as a Phase 3-ready candidate

By Dino Mustafić

Maker of fibrosis therapeutics, Promedior, said has agreed with the U.S. Food and Drug Administration (FDA) for registration, on the design of the study of PRM-151, a novel investigational anti-fibrotic immunomodulator, in patients with Idiopathic Pulmonary Fibrosis (IPF).

January 4, 2019 Off

Zealand Pharma adds $5 million equity investment in Beta Bionics

By Dino Mustafić

Copenhagen-based biotechnology company Zealand Pharma focused on peptide-based drugs,has completed a $5 million equity investment in Beta Bionics, a medical technology company developing the iLet bionic pancreas system.

January 4, 2019 Off

Basilea plans investments in R&D, with earnings from Cresemba and Zevtera sale

By Dino Mustafić

Basilea Pharmaceutica’s CEO David Veitch, will present at the 37th Annual J. P. Morgan Healthcare Conference on January 10, 2019, where he’ll describe both the progress made during 2018 and the priorities for 2019 to deliver on the key elements of Basilea’s strategy for continued value creation, the company said Friday.

January 3, 2019 Off

MatriSys asks for meeting with FDA over anti-atopic dermatitis topical drug candidate

By Dino Mustafić

MatriSys Bioscience is waiting to meet with the US FDA to complete preparations for its company-sponsored Phase 2 trial of its anti-atopic dermatitis topical drug candidate, MSB-01, it said Wednesday.

January 3, 2019 Off

Hemostemix looks to enrol more patients as it adds two new medical centers for clinical trials

By Dino Mustafić

Hemostemix has received all approvals from two new medical centers to be clinical trial sites for its Phase II clinical trial for critical limb ischemia (CLI), the company said in an update on the patient enrolment.

January 3, 2019 Off

ProQR’s QR-421a fast tracked, Phase 1/2 clinical trial in 2109

By Dino Mustafić

ProQR Therapeutics N.V. got Fast Track designation from the Food and Drug Administration (FDA) for QR-421a, a first-in-class investigational RNA-based oligonucleotide to tackle the underlying cause of the vision loss related to the Usher syndrome type 2 and non-syndromic retinitis pigmentosa (RP) due to mutations in exon 13 of the USH2A gene.