Alnylam Pharmaceuticals Inc.’s Amvuttra (vutrisiran), a treatment for the rare disease hereditary transthyretin-mediated amyloidosis, was among medicines recommended for approval by regulators from Europe’s Committee for Medicinal Products for Human Use (CHMP) in a busy sitting. Read More
Top-line results from Vistagen Therapeutics Inc.’s Palisade-1 phase III study of PH-94B for treating social anxiety disorder showed the therapy fell shy of the primary endpoint. The South San Francisco-based company’s stock (NASDAQ:VTGN) fell dramatically on the results July 22 as shares closed 86% lower at 15 cents each. Read More
Frontera Therapeutics Inc. raised $160 million in a series B funding round to develop its lead gene therapy product candidate for retinal disease, FT-001, for which INDs have been approved by the U.S. FDA and China NMPA. Read More
With enrollment set to finish any day in Selecta Biosciences Inc.’s Dissolve II study testing SEL-212 in chronic refractory gout (CRG), investor appetite runs high in the space, as contenders line up to take on Horizon Therapeutics plc’s Krystexxa (pegloticase), the only product approved for CRG. Read More
Since the isolation of SARS-CoV-2 and the study of its infection mechanisms, scientists have been trying to understand how this virus accesses the brain and produces neurological symptoms. The receptor necessary for the virus to enter the cell by endocytosis (the receptor for angiotensin-converting enzyme 2, ACE2) is only expressed by some neurons and is hardly detected in the brain. Read More
South Korea’s Medipost Co. Ltd. is gearing up for phase III trials in the U.S. of its stem cell therapy, Cartistem, an allogeneic human umbilical cord blood-derived mesenchymal stem cell therapy for treatment of knee articular damage in patients with osteoarthritis. Read More
In this multipart special report, BioWorld explores the concept of extending lifespan, which is surprisingly well-validated by basic research. The team examined the latest science, the key biological drivers that can be targeted pharmacologically and the companies developing these potential “Fountain of Youth” candidate drugs. Read More
In Extending the human lifespan, a BioWorld special report, the team examined the latest science, the key biological drivers that can be targeted pharmacologically and the companies developing potential “Fountain of Youth” candidate drugs. In this episode of the BioWorld Insider Podcast, the team discussed the report’s highlights and key takeaways.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arbutus, Assembly, Blue Lake, Canbridge, Celldex, Freeline, Hillevax, Immvira, Sonnet, Takeda.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Blue Water, Bridgebio, HDT, Innate, Neurofront, Novaremed, Pharmacyte, Sanofi, Valneva, Zyversa. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Incannex, Junshi, Karyopharm, NLS, Obsidian, Olema, Pliant, Recursion, Sandoz, Sangamo. Read More