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. Read More
Annovis Bio Inc. presented new clinical efficacy and biomarker data from two phase II studies of its lead candidate, ANVS-401 (posiphen), at the 2021 Alzheimer's Association International Conference (AAIC) that saw the stock sink soon afterward. The Berwyn, Pa.-based company’s shares (NYSE:ANVS) took a powerful hit as shares had plunged a dramatic 60% to close at $43.50 each on July 29. Read More
Eli Lilly and Co. has established a multiyear collaboration with Kumquat Biosciences Inc. for the discovery, development and commercialization of new small molecules for stimulating tumor-specific immune responses. Kumquat will receive $70 million up front, including an equity investment, and is eligible for more than $2 billion in potential milestone payments plus royalties on any marketed products. Read More
Zydus Cadila Group could make history after applying for approval for the first ever human DNA vaccine in India. But that could be just the start for a technology that could treat a vast array of diseases, including cancer, infectious diseases and chronic diseases. Read More
LONDON – Topas Therapeutics GmbH announced the close of a series B round at €40 million (US$47.5 million), to take forward its two lead immune tolerizing programs. The first, TPM-203, is in clinical development for the treatment of the rare, severe autoimmune skin disorder pemphigus vulgaris, while the second, TPM-502, is due to enter the clinic in celiac disease before the end of the year. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alx, Arca, Ascletis, Astrazeneca, Clarity, Disc, Eccogene, Enyo, Hutchmed, Karyopharm, Kintor, Mersana, Mind Medicine, Zucara, Zymeworks. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Addex, Aeterna, Anavex, Ascentage, Astrazeneca, Augmenta, Catalent, Cocrystal, Editas, Emergent, IDT, Indivior, Inveniai, Prism, Peptidream, Takeda, TFF, Unity. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Apic, Arcturus, I-Mab, Lexeo, Mycovia, Nrx, Pharmamar, Takeda, Xoma. Read More
