Eli Lilly and Co.’s definitive agreement to acquire privately held Disarm Therapeutics Inc. brings Cambridge, Mass.-based Disarm $135 million up front and as much as $1.225 billion in additional future payments for potential development, regulatory and commercial milestones if Lilly successfully develops and commercializes therapies tied to the agreement. Read More
DUBLIN – The Lancet Infectious Diseases has published the first clinical data on BBIBP-CorV, an inactivated whole virus vaccine directed against SARS-CoV-2. The early stage phase I/II study tested the Chinese-developed vaccine in 540 healthy volunteers, including 96 older participants. All vaccine recipients seroconverted and the adverse event profile was mild. Read More
“It’s coming. We know it’s coming.” That was Nevan Krogan’s blunt reminder that SARS-CoV-2 is not the first virus to wreak temporary havoc on humanity, nor will it be the last. Read More
One of 19 children dosed with an experimental gene therapy for Sanfilippo syndrome has died following the treatment, given as part of a phase II/III trial of the medicine run by its developer, Paris-based Lysogene SA. The trial has been on clinical hold since June, but the immediate cause of the death is unknown, the company said. Read More
CEO Christopher Missling said New York-based Anavex Life Sciences Corp. is still deciding on the dose for the pivotal study with Anavex2-73 (blarcamesine) in Parkinson’s disease dementia (PDD), and called the phase II findings “just the first data run,” about which the firm “wanted to immediately inform shareholders.” Read More
PERTH, Australia – During the COVID-19 pandemic, 90% of Australia’s clinical trials were put on hold, and the market cap of biotech and medical device companies on the Australian Securities Exchange dropped 5% to AU$11 billion (US$7.78 billion), according to a recent report by Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre. Read More
LONDON – COVID-19 research is generating a wealth of data every day, but it is coming from many and disparate sources, making it difficult to assess its quality, dovetail datasets together and decide how to apply it. Read More
In Regeneron Pharmaceuticals Inc.’s Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn), the FDA has approved its first ever treatment for the Ebola virus in pediatric and adult patients. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Apellis, Astex, Castle Creek, Eiger, GNT, Ionis, J&J, Janssen, Kalvista, Lysogene, Oryzon, Otsuka, Regenrx, Regulus, Sage, Vertex. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apexigen, Armata, Eton, Merck, Immunitybio, OS, Regeneron, Zhittya. Read More
