Areteia Therapeutics Inc. has launched to put its lead candidate, dexpramipexole, an oral treatment for eosinophilic asthma, through a phase III trial. Areteia was created by Knopp Biosciences LLC, which has put the small-molecule eosinophil maturation inhibitor through a phase II study, and also by Population Health Partners. Areteia has both the development and commercial rights to dexpramipexole. Read More
Amounts raised through biopharma financings in the second quarter are down by 61% since last year and are at the lowest point since 2017. The same holds true when looking at the first half of the year. Each of the prior four years raised more than this year by the end of June, signifying that investors are backing up after an intensely robust financing environment following the emergence of the COVID-19 pandemic and the feverish biopharma therapeutic and vaccine development that began in 2020. Read More
Aldeyra Therapeutics Inc. CEO Todd Brady said that, with new data from a crossover trial with reproxalap in dry eye disease (DED), the question of “approvability has been put to bed,” and the company plans a pre-NDA meeting with U.S. FDA in the third quarter of this year. Read More
Several genetic studies in a range of model organisms have pointed to an important role for the B-cell lymphoma 2 (BCL2)-associated athanogene 3 (BAG3) gene in the maintenance of cardiac function. Read More
Legislation that would renew the U.S. FDA’s user fee programs is stuck in process on Capitol Hill, a predicament that seems to resist resolution to date. FDA commissioner Robert Califf said on a July 12 webinar that the FDA “is a decision-making machine” that is reliant on both user fees and congressional appropriations, and that a failure on the part of Congress to act on user fee legislation may force the agency to halt new hires and possibly lay off some FDA staff. Read More
The revised Build Back Better bill Democrats in the U.S. Senate are looking to pass in the next few weeks could deliver savings of $18 billion to $24 billion per year from 2028 through 2031 through drug pricing reforms that include direct Medicare price negotiations, according to a Congressional Budget Office estimate. Read More
Providing faster and better access to new medicines is the driving force behind a two-year proof-of-concept pilot program the EMA plans to launch in September. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ADC, Aquestive, Biomica, Exelixis, Freeline, Genentech, Hansa, Immunocore, Ionis, Macrogenics, Mediwound, Moderna, Novo Nordisk, Pliant, Sanofi, Swedish Orphan, Telix, Tonix. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Athenex, Athos, Cannabotech, Catalyst, Cybin, Cytodyn, Destiny, GSK, Jacobus, Kala, Pantherx, Tscan. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anthos, Arcutis, Can-Fite, Iterum, Lipocine, Perrigo, Pfizer, SCG. Read More
