Pharmaceuticals, Biotechnology and Life Sciences
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.
InDex Pharmaceuticals Holding AB has appointed Johan Giléus as new Chief Financial Officer (CFO) who will take over his new duties from May 1, 2017.
Celyad is about to kick the THINK trial in the USA, after the U.S. FDA authorized its initiation. THINK evaluates NKR-2 CAR-T cells in seven indications, five solid cancers and two hematological malignancies.
OptiBiotix health has signed a manufacturing, supply, and profit sharing deal with Sacco, one of Europe’s leading suppliers of probiotics ingredients.
Valisek, a joint venture between ValiRx, a clinical stage biotechnology company and Tangent Reprofiling Limited, plans to add a third clinical site, in Tbilisi, Georgia.
Notable news in the pharmaceutical and biotech markets includes a slew of mergers and acquisitions, new drug trails and product launches as industry leaders search for competitive advantage and increased revenue streams.
Innate Pharma has reported its consolidated financial results for the year ended December 31, 2016.