Page 38 - Human Use News Today

This clinical trial assesses whether landiolol for patients with tachycardia and established septic shock requiring prolonged vasopressor support reduces the ri

NOTICE: For the convenience of capital market participants, Chugai makes efforts to provide English translations of the information disclosed in Japanese, provided that the Japanese...

Positive opinion from Committee for Medicinal Products for Human Use recommending approval of Bylvay® (odevixibat) based on Phase III ASSERT clinical-trial data in Alagille syndrome (ALGS) already received in July 2023Committee for Orphan Medicinal Products confirms a negative opinion of its review recommending not to maintain the orphan designation for Bylvay in ALGSIpsen plans to submit a new Marketing Authorisation Application for the treatment of ALGS by the end of 2023 under a new bran...

Investegate announcements from Ipsen updates on E.U. Marketing Authorisation Application for odevixibat in Alagille syndrome

The expanded Indication now includes children of all ages with achondroplasia, the most common form of skeletal dysplasia leading to disproportionate short stature.

The CONSORT (CONsolidated Standards Of Reporting Trials) 2010 statement is the standard guideline for reporting completed randomised trials. The CONSORT Dose-finding Extension (DEFINE) extends the guidance (with 21 new items and 19 modified items) to early phase dose-finding trials with interim dose escalation or de-escalation strategies. Such trials generally focus on safety, tolerability, activity, and recommending dosing and scheduling regimens for further clinical development. These trials a...

SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 provides guidance for clinical trial protocol writing. However, neither the original guidance nor its extensions adequately cover the features of early phase dose-finding trials. The SPIRIT Dose-finding Extension (DEFINE) statement is a new guideline that provides recommendations for essential items that should be provided in the protocols of these trials. It details extensions to the SPIRIT 2013 guidance, incorpora...

FOSTER CITY - Geron Corporation , a late-stage clinical biopharmaceutical company, today reported that it has granted non-statutory stock options to purchase an aggregate of 401,220 shares of Geron...

/PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today...

Revenue at 30 September 2023 Activity 9-month revenue: €573.9 million, up 2.7% at...