Clinical Trials

XTANDI^® treatment granted priority review by FDA

23 August 2019 | By Rachael Harper (European Pharmaceutical Review)

XTANDI® sNDA seeks to add an indication for men with prostate cancer that's spread but is sensitive to hormone therapy.

Imfinzi combination fails advanced lung cancer study

22 August 2019 | By Rachael Harper (European Pharmaceutical Review)

A late-stage clinical trial for Imfinzi and an experimental treatment has not extended the lives of patients with advanced non-small cell lung cancer.

Investigational Zika vaccine receives Fast Track designation

21 August 2019 | By Rachael Harper (European Pharmaceutical Review)

An investigational Zika vaccine currently being evaluated in a Phase I study has been given a Fast Track designation by the FDA.

FDA approves IND application for coeliac treatment

20 August 2019 | By Victoria Rees (European Pharmaceutical Review)

The FDA has accepted an IND application for AG017, a new drug designed to treat the causes of coeliac disease which will soon enter new trials.

Complete response letter handed to Sarepta Therapeutics

20 August 2019 | By Victoria Rees (European Pharmaceutical Review)

The pharmaceutical company has received a complete response letter for its golodirsen injection, which had been submitted for accelerated approval.

New drug for treatment-resistant forms of tuberculosis approved

15 August 2019 | By Rachael Harper (European Pharmaceutical Review)

Pretomanid in combination with bedaquiline and linezolid has been approved by the FDA for treatment-resistant tuberculosis of the lungs.

Cannabinoids in pharma series: cannabinoids on the market today

15 August 2019 | By Victoria Rees (European Pharmaceutical Review)

This series investigates the growing interest from the pharmaceutical industry in cannabinoids. In this first piece, we hear from industry experts about the current situation of the ingredient on the pharmaceutical market.

Chlamydia vaccine passes safety trial

14 August 2019 | By Rachael Harper (European Pharmaceutical Review)

A first-of-its-kind experimental chlamydia vaccine trial has been found to be safe and able to provoke an immune response.

Ebola clinical trial stopped early due to positive results

13 August 2019 | By Rachael Harper (European Pharmaceutical Review)

An Ebola clinical trial has been stopped early as Regeneron's REGN-EB3 therapy shows superiority to ZMapp in preventing Ebola deaths.

FDA grants Orphan Drug Designation to DYN101 treatment

12 August 2019 | By Victoria Rees (European Pharmaceutical Review)

A treatment for Centronuclear Myopathies has received Orphan Drug Designation from the FDA and will begin Phase I/II trials.

Clinical trial reporting is improved by professional medical writers

12 August 2019 | By Rachael Harper (European Pharmaceutical Review)

A new systematic review has shown that the speed and quality of clinical trial reports are improved by professional medical writers.

SGS Life Sciences

Metastatic melanoma treatment gets Breakthrough Therapy Designation

5 August 2019 | By Rachael Harper (European Pharmaceutical Review)

Breakthrough Therapy Designation has been granted for investigational agent bempegaldesleukin in combination with nivolumab.

First UK national pilot study for medical cannabis launched

31 July 2019 | By Victoria Rees (European Pharmaceutical Review)

Project TWENTY21, a nationwide study to investigate medicinal cannabis, has launched in the UK in order to collect data on the therapeutics.

Cannabidiol-based treatment receives marketing approval from EMA

30 July 2019 | By European Pharmaceutical Review

EMA’s human medicines committee had cleared the cannabidiol oral solution, Epidiolex, for use to treat seizures.