PERTH, Australia – Regenerative medicine company Mesoblast Ltd. saw its stock drop 37% on the news that it received an FDA complete response letter to its BLA for Ryoncil (remestemcel-L) for the treatment of pediatric steroid-refractory acute graft-vs.-host disease. Read More
Pharmacyte Biotech Inc. is now in a series of 30-day cycles with the FDA as a planned phase IIb study of its lead candidate has been placed on hold. On Sept. 2, Pharmacyte submitted its IND for a phase IIb trial of its product, known as Cypcap, in locally advanced, inoperable pancreatic cancer and, on Oct. 2, the company said the FDA placed the application on hold. Read More
DUBLIN – In what continues to be a year like no other, European biotechnology firms engaged in drug development raised $4.783 billion in equity financing during the third quarter. It is an unprecedented level of funding for the sector. Read More
The American Federation for Aging Research (AFAR) is involved in supporting research designed to unravel the biology of aging and expanding the field, and this week it held a webinar on the “Business of Longevity: Moving Biomedical Advances into Biotech Opportunities.” The panelists reviewed the latest research and looked at what it will take to attract more investment and biotech companies into what remains a nascent area but one that offers tremendous commercial opportunities. Read More
Synthetic Biologics Inc. said a phase IIb trial of one of its two lead candidates, SYN-010, in people with constipation-predominant irritable bowel syndrome (IBS-C) will be discontinued after an interim futility analysis suggested it was unlikely to meet the study's primary endpoint. Read More
Humanigen Inc. reported progress in COVID-19 treatment by deploying a drug candidate, lenzilumab, that was created to fight cytokine storms in CAR T patients. The drug is partnered for the latter with Gilead Sciences Inc., which rolled out pandemic news of its own related to the investigational broad-spectrum antiviral Veklury (remdesivir). Read More
The COVID-19 pandemic has done little to encourage bipartisan comity in Washington, and the Oct. 2 hearing of the House Select Subcommittee on the Coronavirus Crisis reflected that partisan tension. Secretary of Health and Human Services Alex Azar noted, however, that the department is doing its best to cooperate with oversight of the vaccine program by the Government Accountability Office (GAO), but that the nearly three dozen GAO requests for oversight have come at a difficult time. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aiviva, Algernon, Astrazeneca, Cytokinetics, Epygenix, Kyowa, Mei, Otonomy, RVL, Synthetic Biologics, Xencor. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aduro, Akorn, Allele, Chiesi Global Rare Diseases, Chinook, Cognate, Fibrogenesis, Innate Immune, Jaguar, Lakes, Novus, PDL, Protalix, R4D Biotech, Scancell, Teva. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biomarin, Bluebird, Innovation, Kyowa Kirin, Mesoblast, Optibiotix Health, Ovoca, Pharmacyte, Sanofi, Seed Health. Read More
