BioAlliance Pharma, an innovative Company dedicated to the development of orphan oncology, announced today that Validive (clonidine Lauriad) received a Fast Track designation from the US Food and Drug Administration (FDA) for the prevention ...
Tags: FDA, BioAlliance Pharma, disease, Validive
Duke University’s Duke Clinical Research Institute (DCRI) has been selected by Oxygen Biotherapeutics, a pharmaceutical company, to conduct the Phase III clinical trial of the company’s newly acquired compound, levosimendan. ...
BioDelivery Sciences International (BSDI) announced that it engaged in a positive meeting with the US Food and Drug Administration (FDA) regarding the clinical development program for Clonidine topical gel that will allow the program to ...
Alnylam Pharmaceuticals, a RNAi therapeutics company, announced that the US Food and Drug Administration (FDA) has granted fast track designation to patisiran (ALN-TTR02) for the treatment of transthyretin (TTR)-familial amyloid ...
Tags: Alnylam, Fast Track Designation
The US Food and Drug Administration (FDA) has approved breakthrough therapy designation for Danish biotechnology company Genmab and British pharmaceutical company GlaxoSmithKline’s (GSK) Arzerra (ofatumumab) in combination with ...
Tags: therapy designation, Medicine
Drug research and development company Curemark has won a new patent for its proprietary technology CM-1212 to treat drug and alcohol addiction. The new patent is entitled 'Pharmaceutical Preparation for the Treatment of the Symptoms of ...
Tags: Alcohol Addiction, Drug research
Biopharmaceutical development company Chelsea Therapeutics has announced the US FDA acceptance of Northera (droxidopa) new drug application (NDA) resubmission to treat symptomatic neurogenic orthostatic hypotension (NOH). The company is ...
Clinical-stage pharmaceutical company Adynxx has obtained the US Food and Drug Administration (FDA) fast track designation for its AYX1 injection, which is used for prevention of chronic pain. In a five-cohort, dose-escalating study ...
The US Food and Drug Administration (FDA) has cleared Omeros' investigational new drug application (IND) for OMS824 in Huntington's disease. OMS824 is developed to selectively inhibit phosphodiesterase 10 enzyme that is expressed in areas ...
Tags: Omeros'IND, Medicine
Sanofi Pasteur and KaloBios Pharmaceuticals have announced the issuance of FDA fast track designation for novel biologic candidate KB001A targetting Pseudomonas Aeruginosa (Pa). An antibody fragment KB001A is developed against Pa that ...
Tags: Sanofi Pasteur, KB001A
Biotechnology company Genmab has obtained FDA fast track designation in double refractory multiple myeloma for daratumumab. As per the designation, the human CD38 monoclonal antibody Daratumumab is suitable for multiple myeloma patients ...
TransTech Pharma has received FDA fast track designation for new small-molecule chemical compound TTP488, for the treatment of Alzheimer's disease. TTP488 prevents interaction of a material found in the Alzheimer's patients cells, ...
Tags: Transtech Alzheimer, FDA, Medicine
Chimerix, a US-based company which discovers, develops and commercializes oral antiviral therapeutics, has won the US Food and Drug Administration (FDA) fast track designation for CMX001 for the prevention of cytomegalovirus (CMV) ...
Tags: Chimerix, oral antiviral therapeutics, FDA, CMX001
The US FDA has granted Soligenix fast track designation for OrbeShield for the reduction of mortality associated with gastrointestinal acute radiation syndrome (GI ARS). The oral beclomethasone 17,21-dipropionate (oral BDP) earlier ...
Tags: US FDA, Soligenix, fast track designation, OrbeShield
Isis Pharmaceuticals has obtained the US FDA fast track designation for ISIS-TTR to treat familial amyloid polyneuropathy (FAP). The antisense drug ISIS-TTR, a part of the Isis-GSK strategic RNA therapeutic alliance, is being developed ...
Tags: amyloid polyneuropathy candidate, Pharmaceuticals, genetic disease, drug