Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for diroximel fumarate (BIIB098), a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis (MS)
Morphic Therapeutic (Morphic), a biotechnology company developing oral integrin therapies, announced recently that it has entered into a research and development collaboration with Janssen Biotech, Inc. (Janssen) to discover and develop novel integrin therapeutics for patients with conditions not adequately addressed by current therapies
The Virginia Commonwealth University (VCU) College of Engineering and Fuzionaire Diagnostics (Fuzionaire Dx) have executed a research agreement establishing a collaborative program to work toward applications of Fuzionaire Dx’s proprietary radiochemistry platform
MolecularMD Corporation, a molecular diagnostic specialty laboratory that enables the development and commercialisation of precision medicines in oncology, announced today that it has been acquired by ICON plc (NASDAQ: ICLR)
Pharmaceutical Product Development, LLC (PPD) and Happy Life Tech (HLT) of China have signed an exclusive agreement to develop a distinctive service offering for the China drug-development market delivering data science-driven clinical trials and real-world evidence of drug products’ effectiveness, safety and value
ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), today announced that the first patient has been dosed in a Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-402 (loncastuximab tesirine) in combination with Pharmacyclics LLC’s ibrutinib in patients with advanced diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL)
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a pivotal Phase 3 clinical trial, PRECISION-AF, to assess the safety and efficacy of GencaroTM(bucindolol hydrochloride) as a genetically-targeted treatment for atrial fibrillation (AF) in patients with a specific type of heart failure (HF
Evotec AG and the Helmholtz Centre for Infection Research (“HZI”) announced today a collaboration with the goal to address a major global health threat by developing novel antibiotics that overcome drug-resistant bacterial pathogens
BGN Technologies, the technology transfer company of Ben-Gurion University (BGU), disclosed today a novel artificial intelligence (AI) platform for monitoring and predicting the progression of neurodegenerative diseases for the purpose of identifying markers for personalized patient care and improved drug development
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven") announced today that it received orphan drug designation from the U.S. Food and Drug Administration (FDA) for its product candidate verdiperstat (previously BHV-3241), a novel myeloperoxidase (MPO) inhibitor, for the treatment of multiple system atrophy (MSA)
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