Tricida, Inc., a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), announced today that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for veverimer under the Accelerated Approval Program. In its correspondence, FDA also stated that no filing review issues were identified
CURE Pharmaceutical (“CURE”), an innovative drug delivery and development company, today announced that it purchased a $200,000 convertible promissory note issued by Coeptis Pharmaceuticals, Inc., a biopharmaceutical company engaged in the acquisition, development and commercialization of branded 505(b)(2) pharmaceutical products
I-Mab Biopharma ("I-Mab"), a China and U.S.-based clinical-stage biopharmaceutical company exclusively focused on the discovery and development of novel or highly differentiated biologics in immuno-oncology and autoimmune diseases today announced that National Medical Products Administration (NMPA) approved its IND application for TJM2 to conduct clinical trials in patients with rheumatoid arthritis (RA)
LifeMax Laboratories, Inc. (“LifeMax”), a private company focused on treating rare diseases with few or no therapeutic options, today announced that the European Commission granted orphan drug designation to LM-030, an investigational therapy licensed from Novartis and ready to enter into a pivotal clinical trial for the treatment of Netherton Syndrome
Takara Bio USA, Inc. (TBUSA) announced that its parent company, Takara Bio Inc., has launched the world’s first commercially available small intestinal epithelial cells derived from human induced pluripotent stem cells
ILIKOS, an innovative drug development solutions provider based in Cyprus, is formally launching its operations
LEO Pharma A/S and HitGen Inc. are pleased to announce that HitGen and LEO Pharma expands their collaboration with a license to develop a novel class of drugs for a dermatology indication
ATAI Life Sciences AG, a global biotech platform that envisions an end to mental illnesses, and Cyclica Inc., a leading biotechnology company that leverages artificial intelligence and computational biophysics to streamline the drug discovery process, have launched a joint venture aimed at changing the paradigm in which mental health disorders are treated
RMJ Holdings, LLC's (RMJH) a private company developing drug candidates based on its globally patented inverted micellar technology, today announced that its first drug candidate, RMJH-111B for essential hypertension, is being prepared for Phase 3 development
The discovery and development of new drugs is a long, difficult, and expensive process. A potential new medicine may be rejected at any point in the development process due to safety, efficacy, or quality
|
|
|
|
|
|
|
|
|