Press Releases

Fortress Biotech, Inc., an innovative biopharmaceutical company focused on acquiring, developing and commercializing high-potential marketed pharmaceutical products and development-stage pharmaceutical product candidates, announced that the European Medicines Agency (“EMA”) Committee for Orphan Medicinal Products issued a positive opinion on Cyprium Therapeutics’ (“Cyprium”) application for Orphan Drug Designation for Copper Histidinate, also referred to as CUTX-

Axovant Gene Therapies Ltd, a clinical-stage company developing innovative gene therapies for neurological diseases, announced that its subsidiary has signed a three-year Clinical Supply Agreement (“CSA”) with Oxford Biomedica plc (LSE:OXB), a leading gene and cell therapy group. The CSA builds on the worldwide license agreement signed between the two companies in June 2018 for the Parkinson’s disease gene therapy program OXB-102, now called AXO-Lenti-PD. Under the

Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its investigational drug pevonedistat for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS). Pevonedistat, a first in class NEDD8-activating enzyme (NAE) inhibitor, could be the first novel treatment for HR-MDS patients in more than a decade, expanding treatment options that have so far been limited to hypomethylating agent (

Sangamo Therapeutics, Inc., a genomic medicine company, announced that it has executed a global licensing collaboration agreement with Novartis to develop and commercialize gene regulation therapies to address three neurodevelopmental targets, including autism spectrum disorder (ASD) and other neurodevelopmental disorders. The collaboration will leverage Sangamo’s propriety genome regulation technology, zinc finger protein transcription factors (ZFP-TFs), to aim to upregulate the expres

Constant Therapeutics announced that its peptide drug TXA127, a pharmaceutical formulation of the natural human peptide angiotensin-(1-7), will be tested in a Phase 2 clinical trial at Columbia University Irving Medical Center in New York, New York. The double-blind, placebo-controlled trial will recruit 100 patients with COVID-19 who require oxygen but are not in the ICU. The endpoints include incidence of renal failure and incidence of respiratory failure. Further details of the study are p

Intravacc, a global leader in translational research and development of viral and bacterial vaccines, and Celonic Group, a premium biopharmaceutical contract development and manufacturing organization (CDMO), specialized in development and production of Advanced Therapy Medicinal Products (ATMP) and mammalian cell lines expressed bio-therapeutics, announced that they have signed a research agreement to further design, develop and produce a Covid-19 vaccine based on an immunogenic Spike (S) pr

Schrödinger, Inc.and Viva Biotech Holdings announced a strategic collaboration to expand the reach of structure-based drug discovery by generating de novo crystal structures of high-value targets. Under the terms of the collaboration, Schrödinger will identify drug discovery targets for which there are currently no crystal structures in the public domain, including those that could lead to first-in-class therapeutic candidates for its internal pipeline. Viva Biotech w

HemoShear Therapeutics, a clinical stage company developing treatments for rare metabolic disorders, has received Fast Track and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA) for HST5040, a once-daily oral small molecule drug being developed to treat methylmalonic acidemia (MMA) and propionic acidemia (PA).   In June, HemoShear received clearance from the FDA for its Investigational New Drug application to conduct a phase 2 clinical study

MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market and the JASDAQ Market of the Tokyo Stock Exchange, announced an agreement with BioComo (President: Masayuki Fukumura, Mie prefecture, Japan;  http://www.biocomo.jp/) and Mie University (Mie prefecture, Japan) for joint development of a SARS-CoV-2 vaccine using BC-PIV, a human parainfluenza virus type 2 vector developed by BioComo and Tetsuya Nosaka, M.D., Ph.D., professor of the Department of Microbiology an

CARISMA Therapeutics Inc., a biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for the Company's lead product candidate, CT-0508, an anti-human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M). Under this IND, CARISMA intends to initiate its Phase 1, first-in-human, multi-center study i