AgeX Therapeutics, Inc., a biotechnology company focused on developing therapeutics for human aging and regeneration, announced a research collaboration with the University of California, Irvine (UCI) using AgeX’s PureStem® technology to derive neural stem cells, with the goal of developing cellular therapies to treat neurological disorders and diseases for which there are no cures. The collaboration’s initial R&D work, expected to take approximately one year, will be cond

BioCryst Pharmaceuticals, Inc. announced that it has submitted a new drug application (JNDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for approval of oral, once daily berotralstat for the prophylactic treatment of hereditary angioedema (HAE). “The data from APeX-J and the berotralstat clinical program are very exciting for HAE patients in Japan,” said Dr. Isao Ohsawa, president of Saiyu Soka hospital and principal investigator of the APeX-J trial

Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for RUXIENCE™ (rituximab),a potential biosimilar to MabThera® (rituximab). RUXIENCE is a monoclonal antibody (mAb) for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic poly

Aprea Therapeutics, Inc., a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein p53, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for APR-246 in combination with azacitidine for the treatment of myelodysplastic syndromes (MDS) with a susceptible TP53 mutation. MDS represents a spectrum of hematopoietic stem cell malignancies in wh

Decibel Therapeutics, a development-stage biotechnology company developing novel therapeutics for hearing loss and balance disorders, today announced a new strategic research focus on regenerative medicine approaches for the inner ear. The company is also announcing a collaboration and option agreement that gives Decibel exclusive access to novel compounds targeting proteins in a critical regenerative pathway. Decibel’s research focus on regeneration will be powered by the com

Eisai Co., Ltd. announced that it has entered into a joint research and development agreement with Personal Genome Diagnostics Inc. for the cancer genetics panel test, and it has initiated the research. In this joint research and development, Eisai and PGDx will create a kitted cancer gene panel test that enables a comprehensive analysis of mutation in more than 500 cancer gene using liquid biopsy with blood samples. Additionally, the kit will be used in our drug discovery and devel

BioPharmX Corporation and Timber Pharmaceuticals LLC ("Timber"), a privately held biopharmaceutical company focused on the development and commercialization of treatments for orphan dermatologic diseases, today announced that they have entered into a definitive merger agreement. Under the terms of the merger agreement, subject to the approval of BioPharmX's stockholders and Timber's members, a wholly-owned subsidiary of BioPharmX will be merged with and into Timber, with Tim

Pharmapack Europe, organised by Informa Markets, has pinpointed a number of opportunities and threats that drug delivery and pharmaceutical packaging companies must address in 2020. The event, widely seen as Europe’s leading hub for the pharmaceutical packaging and drug delivery industry, will take place next week at the Porte De Versailles in Paris (5-6 February, 2020), with executives meeting to debate key trends, learn new insights and meet new partners. This year’s c

EyePoint Pharmaceuticals, Inc., a biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, and Ocumension Therapeutics, a fast-growing ophthalmology focused pharmaceutical company in China, today announced an exclusive license agreement for the development and commercialization of DEXYCU® (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation following ocular surgery in Mainland China, Hong Kong, Macau and Ta

Ervaxx™, a biotechnology company pioneering the use of Dark Antigens™ to develop T-cell receptor (TCR)-based immunotherapies and off-the-shelf cancer vaccines, has entered a licensing and research collaboration with a leading T-cell immunology group at Cardiff University (Cardiff, UK). The new collaboration will support a multi-year research program with Prof. Andrew Sewell's T-cell modulation group at Cardiff University focusing on the discovery and characterization