The European drug regulator said that the authorization was given based on ‘flawed studies’ conducted by the Indian company. European Medicines Agency said that the recommendation for the
The in-clinic, randomized, placebo-controlled, double-blind Phase IIa trial will evaluate patients with epilepsy using the intermittent photo-stimulation model. The trial’s primary aim is to evaluate the safety and
Lupuzor (also called as Rigerimod, IPP-201101 and P140) received fast track designation from the US Food and Drug Administration (FDA) as well as approval to start Phase III
Currently, the company is conducting a Phase Ib/II trial of APR-246 in combination with carboplatin (AUC 5) and pegylated doxorubicin (30 mg/m2), a second line standard of care
In the first half of 2015, the company intends to start patient enrollment in the Phase I trial, which will be the first-in-human study of its lead Lm-LLO
NovaMedica plans to begin marketing Benegast products in January 2015. Major products in the portfolio include: Benegast Reduflux, Benegast Redugas and Benegast Regulamine. Reduflux contains the proprietary compound
Both aspergillosis and mucormycosis are life-threatening fungal infections predominantly occurring in immunocompromised patients. The committee’s recommendation was based on data from the Cresemba development program, which included analyses
The company said that a small number of adult patients who metabolize Cerdelga more quickly or at an undetermined rate, will not be eligible for Cerdelga treatment. In
Lesinurad is a selective uric acid reabsorption inhibitor (SURI) that works by inhibiting the uric acid transporter URAT1 in the kidney, thereby increasing uric acid excretion resulting in
ShK-186 is being developed for a variety of autoimmune diseases and the results from this trial are scheduled to be reported later in 2015. The trial is designed
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.