Based on a preliminary data analysis of its second and newest COVID-19 booster candidate, Moderna Inc. said it plans to ask the U.S. FDA to approve mRNA-1273.214 ahead of potential shipping in late summer 2022. The vaccine contains mRNA-1273 (Spikevax) and a vaccine candidate targeting omicron. New phase II/III results show the candidate hitting all the study’s primary endpoints when compared to Moderna’s original vaccine, mRNA-1273. Read More
Pointing to an anomalously high placebo response rate at eastern European trial sites in its Forward phase III trial testing fostamatinib in warm autoimmune hemolytic anemia (wAIHA), Rigel Pharmaceuticals Inc. executives remained confident there could be a path forward for the SYK inhibitor in treating the rare blood disorder. The disappointing top-line data, however, sent company shares (NASDAQ:RIGL) falling more than 60% June 8 to close at 70 cents, a penny above its same day 52-week low. Read More
News that the U.S. FTC is finally going to reexamine the role of pharmaceutical benefit managers (PBMs) and their impact on prescription drug prices and availability is playing to applause from several sectors that have been complaining for years about PBM practices. Read More
Hua Medicine Ltd. presented findings from two phase III trials of its first-in-class dual-acting glucokinase activator dorzagliatin that show the drug significantly improved early phase insulin secretion and glucose sensitivity in patients with type 2 diabetes, thereby restoring glucose homeostasis to treat the underlying cause of diabetes. Read More
Philadelphia’s Mineralys Therapeutics Inc. has secured a further $118 million to develop MLS-101, a potential hypertension drug in-licensed from Mitsubishi Tanabe Pharma Corp. Read More
Ariceum Therapeutics GmbH is picking up where Ipsen SA left off and taking forward the targeted radiopharmaceutical drug satoreotide, developed by the French pharma to phase II but subsequently divested when it ditched its radiation therapy portfolio. Read More
Synklino A/S has raised €29.8 million (US$31.8 million) in a series A round to take forward SYN-002, a treatment for cytomegalovirus (CMV) infections in both donated organs and patients undergoing hematopoietic stem cell and solid organ transplants. Read More
AI-enabled drug discovery company Insilico Medicine Ltd. has raised $60 million in a series D round to support expansion of its pipeline. The Hong Kong and New York-based company will use the proceeds to support clinical testing of its lead asset, a potential treatment for idiopathic pulmonary fibrosis (IPF), as well as the advancement of its Pharma.AI platform. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Diabetes Association's 82nd Scientific Sessions, including: Lilly, Sernova, Vertex, Zealand. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology annual meeting, including: Neoimmunetech, Nouscom, Novartis, Noxxon, Oricell, Ose, Pfizer, Phio, Puma, Seagen, Taiho, Transgene, VBI, Verastem, Veru. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allovir, Annexon, Apellis, Concert, Eli Lilly, Engrail, GSK, Kazia, Merck, Moderna, Nascent, Newron, Ridgeback, Seres, Sobi. Read More
