The Phase 1 trial will be conducted in normal healthy volunteers. Initiation of this trial is based on encouraging pre-clinical results, including data presented last year at the
On January 25, 2016, Valeant announced that the FDA had accepted for review the Biologics License Application (BLA) submitted by AstraZeneca (LSE/SSE/NYSE: AZN) in partnership with Valeant for
Isavuconazole is an intravenous and oral triazole antifungal indicated for the treatment of adult patients with invasive aspergillosis and adult patients with mucormycosis for whom amphotericin B is
Lion Biotechnologies received gross proceeds of $100m, before paying the placement agents’ fees and estimated offering expenses payable by the Company. t the closing, the Company issued 9,684,000
The P2MC technology allows for the efficient, reproducible and chemically defined differentiation of pluripotent cells into skeletal muscle stem cells, also known as satellite cells. The agreement will
The Fast Track designation, established under the FDA Modernization Act of 1997, is designed to facilitate the development and expedite the review of drugs that are intended to
The MAA filing was based on data from the company’s completed phase 2 study. During the May 2016 Committee for Medicinal Products for Human Use (CHMP) meeting, the
"The preclinical data we presented at ASH in December 2015 supported the evaluation of M281 as a strategy for the rapid and reversible suppression of pathogenic autoantibodies or
The Committees recommended the inclusion of abuse-deterrent labeling for intranasal (11 to 4) and intravenous (9 to 6) routes of abuse. They voted against inclusion of abuse-deterrent labeling
Each unit consists of (i) one share of Pieris’ common stock or non-voting series A convertible preferred stock convertible into one share of common stock, (ii) 0.40 warrants
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.