More evidence of big pharma’s interest in type 1 diabetes (T1D) arose as Eli Lilly and Co. disclosed its plan to buy encapsulated-cell-therapy collaborator Sigilon Therapeutics Inc., bringing aboard SIG-002, the early-stage drug on which the pair has been working since 2018. The news blasted upward shares of Cambridge, Mass.-based Sigilon (NASDAQ:SGTX), which closed June 29 at $21.15, up $17.24, or 441%. Read More
One of the companies wanting to be part of the upcoming U.S. launch of Humira biosimilars is instead exploring options to raise additional capital so it can continue advancing its biosimilar pipeline in the near term. Alvotech Holdings SA, a pure-play biosimilars company based in Iceland, initially had hoped for FDA approval June 28 for AVT-02, developed as both an interchangeable and biosimilar to the high-concentration formulation (HCF) of Abbvie Inc.’s blockbuster autoimmune drug, Humira (adalimumab). Read More
Although the highest dose of Bioxcel Therapeutics Inc.’s BXCL-501 hit the primary endpoint in the phase III Tranquility II trial for acute agitation in Alzheimer’s disease patients, shares fell dramatically on June 29 by 64% when investors learned the company received an FDA warning letter over infractions at a trial site. Read More
Becoming the first gene therapy approved for hemophilia A, Roctavian (valoctocogene roxaparvovec) finally received the U.S. FDA’s blessing on June 29, after developer Biomarin Pharmaceutical Inc. spent nearly three years working to address issues raised in a 2020 complete response letter. The approval came a day prior to the June 30 PDUFA date. Read More
Lion TCR Pte. Ltd. raised $40 million in series B funding that will see the company advance its clinical trial program for its hepatitis B virus (HBV)-specific T-cell receptor (TCR) cell therapy for HBV-related liver cancer. Read More
Two years after a U.S. FDA advisory committee agreed that Celltrans Inc.’s pancreatic islet cellular therapy had a favorable risk-benefit profile, the agency has finally approved Lantidra (donislecel) for treating adults with type 1 diabetes. Read More
Vesalius Biocapital Partners Sàrl has called a first close on its fourth fund at €95 million (US$103 million) and now is targeting a total of €150 million, with new investors to be accepted on a "rolling closing" basis until the final close in 2024. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Eiger, Immunome, Ironwood, Kineta, Morphimmune, Navidea, Sangamo, Sanofi, Voyager. Read More
