Press Releases

Remedy Pharmaceuticals, a pioneer in stroke drug development, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Division (OOPD) has granted Orphan Drug Designation for CIRARA for the treatment of “large territory acute ischemic stroke,” which includes large hemispheric infarctions (LHI). LHI is a particularly severe form of ischemic stroke caused by a blockage in the one of two large blood vessels in the brain: internal carotid ar

Adcentrx Therapeutics a clinical-stage biotechnology company advancing innovative protein conjugates for cancer and other life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application of ADRX-0405 for the treatment of select advanced solid tumors. ADRX-0405 is a next-generation antibody-drug conjugate (ADC) composed of a humanized IgG1 antibody targeting six-transmembrane ep

GSK plc announced it is investing £50 million into a major new five-year collaboration with the University of Cambridge and Cambridge University Hospitals, to accelerate research and development into immune-related diseases. The collaboration, which will be called the Cambridge-GSK Translational Immunology Collaboration (CG-TIC), builds on GSK and Cambridge University’s existing scientific relationship and will aim to find ways to more precisely treat immune-related disease with e

The new product launch event hosted by Great Bay Bio (hereinafter referred to as "GBB") was successfully held in Suzhou, where industry players gathered to celebrate the feast of technological innovation. At the event, GBB announced the official launch of the Intelligent Drug Development Ecosystem. The Intelligent Drug Development Ecosystem empowers the entire process of drug discovery and bioprocess development, from drug discovery, molecular sequence generation and optimization, t

Accord Healthcare Limited (Accord) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for Imuldosa® (development code: DMB-3115), a biosimilar of Stelara® (ustekinumab), marketed by Janssen Biotech Inc. A subsidiary of Johnson & Johnson.  In July 2021, Dong-A ST and Meiji Seika Pharma entered into an exclusive global license agreement wit

Roche announced today positive topline one-year results from the open-label, single-arm phase IV ELEVATUM study evaluating Vabysmo® (faricimab) for the treatment of diabetic macular edema (DME) in people from racial and ethnic groups that are often underrepresented in clinical trials.4 Initial data from 124 participants in the United States (US) showed that after one year of treatment with Vabysmo, administered every eight weeks, participants could read an additional 12.3 letter

PharmaLogic Holdings Corp. a premier contract development and manufacturing organization (CDMO) and radiopharmacy solutions provider, announced the official opening of its radiopharmaceutical production and research facility in Salt Lake City, Utah. This state-of-the-art facility represents a major step forward in PharmaLogic's mission to deliver life-saving diagnostic and therapeutic radiopharmaceuticals to patients across North America. "PharmaLogic is pleased to announce

Merck known as MSD outside of the United States and Canada, today announced the presentation of positive results from the Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab, the company’s investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season. The results, along with interim findings from the ongoing Phase 3 trial (MK-1654-007) of clesrovimab, were presented during IDWeek 2024,

Antengene Corporation Limited a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematologic malignancies and solid tumors, today announced that the South Korean Ministry of Food and Drug Safety (MFDS) has approved a supplemental New Drug Application (sNDA) for XPOVIO® (selinexor) in combination with bortezomib and dexamethasone for the treatment of adult pa

Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping vision possibilities, today announced the signing of an exclusive licensing agreement with Optus Pharmaceuticals, a Korean-based pharmaceutical company specializing in total eye care solutions. Under the agreement, Orasis grants Optus Pharmaceuticals the rights to commercialize, import and sell Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%, a novel corrective eye drop for the treatme