DUBLIN – A newly published retrospective analysis of the electronic health care records of more than 500,000 COVID-19 patients has found that infection with SARS-CoV-2 carries “a significantly and substantially” greater risk of cerebral venous thrombosis (CVT) than does either one of the two approved mRNA COVID-19 vaccines or infection with influenza virus. Read More
Phase I data on immune responses induced by Inovio Inc.'s COVID-19 DNA vaccine candidate, INO-4800, showed it induced neutralizing antibodies and T-cell responses against all spike protein variants tested in a phase I study, including those first detected in the U.K., South Africa and Brazil. A preliminary report on the analysis, published on bioRxiv, preceded the reporting of phase II data on the candidate expected later this quarter as well as a potential move to phase III testing, pending resolution of a partial clinical hold on the study first announced in September 2020. Read More
HONG KONG – Beijing Stonewise Technology Co. Ltd., a med-tech firm that uses artificial intelligence (AI) to aid in the discovery of small molecule drugs, closed series B and B+ financing rounds that added $100 million to its pocket. The company intends to use the proceeds to upgrade its AI-enabled drug discovery platform. Read More
LONDON – Antibody prospecting specialist Alchemab Therapeutics Ltd. has raised £60 million (US$82.7 million) in a series A round, to take programs in neurodegenerative diseases and cancer into the clinic. Read More
If the FDA follows the advice of its Cellular, Tissue and Gene Therapies Advisory Committee, the U.S. could soon see its first approved islet transplant therapy, but few expect it to be broadly used. The adcom voted 14-9 April 15, with one abstention, that Celltrans Inc.’s donislecel, or cadaveric allogenic pancreatic islet cells, has an overall favorable risk-benefit profile for some patients with type 1 diabetes. Read More
The Biden administration’s fiscal 2022 budget proposal included an allocation for an office described as the Advanced Research Projects Agency – Health, or ARPA-H, which would receive $6.5 billion as part of the National Institutes of Health. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: WHO: Antibiotic pipeline nearly static, Canada creates new drug safety net, CDSCO provides guidance on COVID-19 vaccines. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Diurnal, Elsalys, Exelixis, Fibrogen, GSK, Illuminare, Kintor, Mitochem, Vir. Read More
