Pharmaceuticals, Biotechnology and Life Sciences
Galapagos NV has started two new Phase 2 studies of filgotinib in small bowel Crohn`s disease and in fistulizing Crohn`s disease, both led by filgotinib collaboration partner Gilead Sciences.
DBV Technologies has finished the patient enrollment in the Phase III study testing the use of Viaskin Peanut, for the treatment of peanut allergic children four to 11 years of age, including patients with a history of severe anaphylaxis.
Bristol-Myers Squibb has appointed Dr. Thomas J. Lynch, Jr. executive vice president and chief scientific officer, effective March 16, 2017.
TiGenix’s study of Cx601 showed that results after two years are consistent with the results communicated at week 24 and week 52, said Dr Marie Paule Richard, Chief Medical Officer of TiGenix.
Oxford BioDynamics has appointed a new Senior Vice President of Commercial Development to be based in the US. The new VP is Martin Reeves, who will take up this role in March 2017.
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.
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.
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.
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”).
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.