Category: news

March 9, 2017 Off

Servier cleared for UCART development in the USA

By Dino Mustafić

Servier has been cleared with Investiga New Drug (IND) by the U.S. Food and Drug Administration (FDA) for the clinical development of UCART19, an allogeneic, gene-edited cellular therapy candidate to treat relapsed/refractory acute lymphoblastic leukemia.

March 8, 2017 Off

FDA accepts Allergan’s sNDA for schizophrenia treatment

By Dino Mustafić

U.S. Food and Drug Administration (FDA) has accepted Allergan’s supplemental New Drug Application (sNDA) for VRAYLAR (cariprazine), seeking the addition of new clinical data evaluating VRAYLAR for the maintenance of efficacy in adults with schizophrenia to the current product label.

March 8, 2017 Off

IntegraGen and Laboratoire CERBA join forces to fight colorectal cancer

By Dino Mustafić

IntegraGen SA, a company specializing in the decoding of the human genome and performing interpretable genomic tests for academic and private laboratories and a developer of diagnostic tools in oncology, and Laboratoire CERBA, has signed a licensing agreement allowing Laboratoire CERBA to develop and provide to prescribing clinicians a test based on IntegraGen’s proprietary miR-31-3p biomarker.

March 8, 2017 Off

Esperite in €1million private placement

By Dino Mustafić

Esperite N.V. has announced a €1 million private placement of 100 convertible notes with a principal amount of €10,000 each, with share subscription warrants attached (the “First Tranche Notes and Warrants”).

March 8, 2017 Off

Alexion waits for FDA’s OK for generalized myasthenia gravis drug

By Dino Mustafić

U.S. Food and Drug Administration(FDA) has accepted for review the Alexion Pharmaceuticals’s supplemental Biologics License Application (sBLA) to extend the indication for Soliris (eculizumab) as a potential treatment for patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.