The G protein-coupled receptor (GPCR) is a foundational building block of modern medicine. While nearly everyone has taken one sometime in the past few decades, development has greatly slowed. With a fundraiser in hand, Septerna Inc. is looking at new ways of working around and through old problems. Read More
Cue Biopharma Inc.’s Kenneth Pienta, acting chief medical officer, called “very strong” the latest phase Ib data with IL-2-based candidate CUE-101 in HPV-positive, recurrent head and neck squamous cell carcinoma (HNSCC), and “by midyear, we're going to have enough data to go forward to talk to the FDA to develop a strategy with them” for a registrational study, likely in third-line patients. Meanwhile, Wall Street sifted through the latest findings from Cambridge, Mass.-based Cue, which closed (NASDAQ:CUE) at $7.99, down $2.61, or 24%. The stock had been posting a gradual run-up for several days. Read More
Two studies published this January by separate research teams have conclusively identified Epstein-Barr virus infection as the cause of multiple sclerosis, and the mechanism by which the immune response to EBV infection triggers an attack on the myelin sheath, the insulation that enables high-speed neuronal transmission. Read More
Pfizer Inc.’s oral antiviral Paxlovid (nirmatrelvir) COVID-19 antiviral looks set for approval in the European Union after it was given the green light by its top regulatory committee. The EMA’s Committee for Medicinal Products for Human Use recommended conditional marketing authorization for treatment of COVID-19 in adults who don’t require supplemental oxygen but are at increased risk for progressing to severe disease. Read More
With phase Ib data published in The Lancet Microbe showing Suzhou Abogen Biosciences Co. Ltd.’s mRNA COVID-19 vaccine candidate ARCoV had acceptable safety and induced a strong immune response in the 120 people who received it, company partner Walvax Biotechnology Co. Ltd. is continuing to enroll participants in a large phase III test of the vaccine. If successful, the program could become the first of several Chinese-developed mRNA vaccines poised to take on the pandemic.
PERTH, Australia – As COVID-19 infections in Australia continue to mount, a dozen or so Australian compounds are winding their way through the pipeline that could offer additional protection to the vaccines and antivirals that are already provisionally approved by Australia’s Therapeutic Goods Administration. Read More
While BioWorld’s Infectious Disease Index showed a huge 144% climb in 2020, an enthusiastic response toward defeating the SARS-CoV-2 virus, the index dropped significantly in early 2021 and spent most of the year spiking up and down, reacting abruptly to the promises of herd immunity and the threats of vaccine-resistant variants. Read More
Shares of TG Therapeutics Inc. fell 40% Jan. 27 after the firm disclosed in a U.S. SEC filing that the FDA had put a partial clinical hold on certain studies testing Ukoniq (umbralisib) and ublituximab, or the combination, for chronic lymphocytic leukemia and non-Hodgkin lymphoma. Read More
PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) plans to increase all fees and charges to industry by 2.6% for the 2022 to 2023 financial year, and it is seeking feedback on proposed options. Read More
The U.S. International Trade Commission (USITC) reported Jan. 26 that it will investigate whether Alvotech Hf and Teva Pharmaceutical Industries Ltd. misappropriated trade secrets when developing a potential interchangeable biosimilar to Abbvie Inc.’s mega-blockbuster, Humira (adalimumab). Read More
In keeping with its Drug Competition Action Plan released in 2017, the U.S. FDA finalized two guidances this week focused on the submission and review of generic drugs. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aligos, Biotheryx, Cyclerion, Evaxion, Lipidor, Panbela, Tyme, Vaccinex, Valneva, Xbiotech. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aridis, Atai, Cocrystal, Dalriada, Johnson & Johnson, Meiragtx, Nanobiotix, Nurosene. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allergy, Ascletis, Cortexyme, Gilead, Hope, Ibio, Immunocore, Incyte, Molecular Targeting.
