The U.S. FDA has approved its first fecal microbiota treatment. Rebyota (fecal microbiota, live-jslm), from privately held Ferring Pharmaceuticals Inc., is now approved to prevent recurring Clostridioides difficile infection (CDI) in adults. The Nov. 30 approval came about two months after the FDA’s Vaccines and Related Biological Products Advisory Committee voted 13-4 to support the microbiome therapy’s effectiveness in reducing recurrent CDI in adults after antibiotic treatment for recurrent CDI. Read More
Word that big pharma firms are sniffing around Horizon Therapeutics plc as a takeover candidate caused not only that firm’s shares to jump but also provided a boost for Viridian Therapeutics Inc., which has a thyroid eye disease (TED) candidate set to challenge Horizon’s Tepezza (teprotumumab-trbw), cleared by the U.S. FDA in January 2020. Read More
A diverse group of government and academic researchers, marking World AIDS Day 2022, have published details of an investigational vaccine they said safely induced broadly neutralizing antibody-precursors against HIV in nearly all participants in a small phase I trial. Read More
The world is emerging from the COVID-19 pandemic, as both cases and deaths have remained consistently low in recent months, despite continuous mutation of the SARS-CoV-2 virus. Nevertheless, there is a shuffling of candidates in the arsenal as new variants bump once-effective therapies and the next generation of options enter the arena. Read More
Full-Life Technologies Ltd. reported that it will acquire Focus-X Therapeutics Inc. to expand its radiopharmaceutical oncology therapy pipeline in a deal worth up to $245 million. Read More
When the COVID-19 pandemic effectively shut down travel and conferences starting in the first part of 2020, the general lament was that the lack of face-to-face interaction would hamper biopharma companies’ ability to secure deals and investments. Instead, the opposite happened. Now, coming off two years of record-breaking financing, the biopharma sector is facing an inevitable correction, though a handful of venture capital panelists suggested there’s room for optimism. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 9 Meters, AC Immune, Alector, Alzecure, Aridis, Ascletis, Athira, Bioxcel, Clarametyx, Clover, Dianthus, Eisai, Henlius, Intravacc, ISA, Kira, Lysogene, Menarini, Nectin, Nimbus, Sanofi, Sorrento, X4. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcellera, Asana, Astellas, Cosmo, ERS, Hillstream, Immunoprecise, Iris, Ligand, Liminatus, Minotaur, Oncorus, Pharmajet, Rallybio, Sana, Scynexis, Trialspark. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ananda, Aum, First Wave, Lobe, Nova Mentis, Regeneron, Sensorion, Transcode, Vistagen. Read More
