LONDON – Just nine months on from announcing the close of its $6.9 million seed round, Dunad Therapeutics Ltd. has landed a potential $1.3 billion deal with Novartis AG to discover and develop orally available protein degradation drugs. The cash is, of course, backend-loaded, but Dunad is getting a handy $24 million up-front payment and equity investment, and will receive full funding for the research. Read More
In a move that had been expected, the CDC’s Advisory Committee on Immunization Practices unanimously recommended the Pfizer Inc.-Biontech SE COVID-19 vaccine as safe and beneficial for children ages 5 through 11. The recommendation, coming from a 14-0 vote, is the committee’s way of reassuring the American public that the vaccine is safe, according to committee member Beth Bell, clinical professor in the School of Public Health at the University of Washington in Seattle. Read More
Though Wall Street may not have caught on to the value of Clene Inc.’s phase II results with gold nanocrystal suspension CNM-Au8 in amyotrophic lateral sclerosis (ALS), CEO Rob Etherington said his firm is “truly excited” about the data, which bode well for the next stage of development, already underway. Read More
A comparison of the first 10 months of every year going back to 2000 indicates that the volume and value of IPOs and of venture capital financings are at their highest levels in 2021. Private placements and other similar financings are coming in second to last year, while follow-on offerings – the weakest type of financing this year – fall at about fourth place. Read More
With the U.S. biosimilar pathway clearly developed, industry and the FDA are turning their attention to interchangeables in the third iteration of the biosimilar user fee agreement (BsUFA). Read More
Astrazeneca plc has signed an agreement with liquid biopsy testing company Saga Diagnostics AB to develop dPCR assays. Lund, Sweden-based Saga Diagnostics will develop Sagasafe dPCR assays towards undisclosed methylated targets for analysis of tissue samples and liquid biopsies. The assay is part of Saga’s portfolio of “ultrasensitive technologies,” comprising Sagasign for personalized monitoring of cancer burden and minimal residual disease. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 7 Hills, Aldeyra, Astrazeneca, Aurinia, Axon, Clene, Compass, Equillium, Huyabio, Hyloris, Metacrine, Oncoresponse, Primmune, Rhythm, Uniqure, Vicore. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Bicycle, Endo, Eli Lilly, Galecto, Inovio, Medimmune, Roche, Queensland University of Technology, Theoremrx, Quoin, Valirx, Venatorx, Zealand. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Achieve, Akeso, Amylyx, Antengene, Biotheryx, Boehringer, Eli Lilly, GC, Geneventiv, Ikena, Janssen, Landos, Legend, Nova Mentis, Novan, Tryp. Read More
