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 approval comes 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. Ferring isn’t alone in pioneering this type of treatment. Seres Therapeutics Inc. was granted priority review designation by the FDA in October and given a PDUFA date of April 26, 2023, for its oral microbiome therapeutic consisting of a consortium of highly purified Firmicutes spores also for treating recurring CDI.

Takeout prospects for Horizon benefit Viridian in TED

Viridian Therapeutics Inc. gained ground thanks to news that big pharma firms are showing an interest in Horizon Therapeutics plc, with its drug Tepezza (teprotumumab-trbw), cleared by the U.S. FDA in January 2020 for thyroid eye disease (TED). With a drug bearing the same mechanism of action as Tepezza in TED, Viridian recently unveiled positive data from its phase I/II study.

Researchers establish proof of concept for germline-targeting HIV vaccine

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. The work, described in an accompanying perspective as a "seminal proof of concept in humans," by South African virologist Penny Moore, proved the possibility of eliciting broadly neutralizing antibodies able to recognize globally diverse HIV strains and prevent HIV infection – something that before had proved impossible, Moore said. Both articles were published in Science.

Bebtelovimab out, Kineret in, as US and globe fight to end the pandemic

The world appears to be 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. Failed trials and regulatory disappointments stall or end some programs, while others forge ahead, armed with solid data and strong financial support. The World Health Organization has tallied a cumulative 639.1 million confirmed cases of the SARS-CoV-2 virus worldwide, including 6.61 million deaths, as of Nov. 30. Confirmed cases in the U.S. have reached 97.3 million, including 1.07 million deaths.

Full-Life acquires Focus-X in $245M deal to expand radiopharmaceuticals pipeline

Full-Life Technologies Ltd. agreed to acquire Focus-X Therapeutics Inc. to expand its radiopharmaceutical oncology therapy pipeline in a deal worth up to $245 million. Full-Life will pay Focus-X an up-front payment, potential development, regulatory and sales-based milestones, as well as royalties based on product sales. The deal is expected to be completed in the first quarter of 2023.

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