Shenzhen Chipscreen Biosciences Co. Ltd.’s Bilessglu (chiglitazar), a peroxisome proliferator-activated receptor (PPAR) pan-agonist globally for the treatment of type 2 diabetes mellitus, has received marketing approval from the NMPA in China.
Once upon a time, Intarcia Therapeutics Inc. was a biotech unicorn valued at $3.5 billion. Its allure was its implantable Medici drug delivery system that consisted of a mini pump about the size of a matchstick. But a unicorn’s life is never completely charmed. Intarcia faced obstacles along the way – two complete response letters from the U.S. FDA and the denials of three formal dispute resolution requests. Now it looks like this story won’t have a happy ending.
The Tokyo University of Science (TUS) has developed a self-powered diaper biosensor that can monitor urine sugar levels, which could be a boon for both diabetic patients and their caregivers. Caregivers at nursing homes currently open patients’ diapers every few hours to check for urination, thus increasing the caregivers’ workload. The psychological impact on the patient is also increased, for example when their sleep is disturbed.
Facing inevitable challenges ahead beyond peak performance for its wildly successful cystic fibrosis franchise, Vertex Pharmaceuticals Inc. is continuing to look to the future, announcing Aug. 24 it licensed rights to CRISPR gene-editing technology from Arbor Biotechnologies Inc. Co-founded by Feng Zhang and David Walt, Arbor's tech could figure into new Vertex cell therapies for diabetes, hemoglobinopathies and other diseases.
Gentibio Inc. has raised $157 million to develop its engineered regulatory T cells (Tregs), setting itself a target to cure type 1 diabetes and treat other diseases caused by the immune system. Boston-based Gentibio launched in August last year with $20 million seed funding from Orbimed, Novartis Venture Fund and RA Capital. Those investors stayed on into the next round, which was led by Matrix Capital Management with participation by Avidity Partners and JDRF T1D Fund.
Ushering in a new era for the U.S. biosimilar marketplace, the FDA, on July 28, approved its first interchangeable biosimilar, which also will be the first to bring biosimilar competition to the U.S. insulin space. The honor went to Viatris Inc.’s Semglee, which the FDA recognized as both biosimilar to and interchangeable with Sanofi SA’s blockbuster drug Lantus (insulin glargine), a long-acting insulin analogue.
Following November’s equity investment that brought it a 14% ownership in Protomer Technologies Inc., Eli Lilly and Co. has acquired the privately held company engineering protein and peptide therapeutics that sense molecular activators. If development and commercial milestones are met, the deal could be worth more than $1 billion.
Despite an FDA advisory committee’s narrow ruling that Provention Bio Inc.’s teplizumab has benefits that outweigh the risks in treating diabetes, the agency sent the company a complete response letter (CRL) regarding the diabetes therapy’s priority BLA. The CRL came the evening of July 2, Provention said, the PDUFA date that had been set months before.
New and updated preclinical and clinical data presented by biopharma firms at the 81st Scientific Sessions of the American Diabetes Association, including: Astrazeneca, Boehringer, Diabetology, Eiger, Eli Lilly, Novo, Remd, Scohia.
Poxel SA and Sumitomo Dainippon Pharma Co. Ltd. said their first-in-class drug, Twymeeg (imeglimin hydrochloride), won its first approval in Japan, where it could change the treatment regimen for type 2 diabetes.
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