The race to become the first microbiome-based therapy to reach the market continues between two companies. A positive view by the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee on Sept. 22 for RBX-2660 in preventing recurrent Clostridium difficile infection kept Ferring Pharmaceuticals Inc.’s microbiota-based live biotherapeutic moving forward.
Spero Therapeutics Inc. has come out swinging after a U.S. FDA rejection for its oral antibiotic, tebipenem Hbr, picking up a potential $600 million licensing deal with pharma giant GSK plc after agreeing on a plan with the regulator to revive the drug.
An antibody that protects babies against respiratory syncytial virus (RSV) from Astrazeneca Ltd. and Sanofi SA was among a string of recommendations from the EMA’s Committee for Medicinal Products for Human Use, paving the way for approval within the next few months and a potential launch in 2023.
From the beginning of the monkeypox outbreak in the U.S. in May, the federal government has bungled the response, according to both Democratic and Republican members of the Senate Health, Education, Labor and Pensions (HELP) Committee.
While COVID-19 remains a top research priority globally for government and nonprofit entities in partnership with biopharma companies, deal activity also is heavily focused on other infectious diseases, such as smallpox and influenza.
After raising AU$2.2 million in its series A round, University of Western Australia spinout Lixa Pty Ltd. has emerged from stealth mode and is gearing up for clinical trials of its anti-biofilm platform technology that could preserve antibiotics in the fight against antimicrobial resistance.
Ocean Biomedical Inc., a company with preclinical programs in oncology, fibrosis, infectious disease treatments and vaccines, is poised to go public via a merger with Aesther Healthcare Acquisition Corp., a special purpose acquisition company (SPAC).
Astrivax BV has raised €30 million (US$30.1 million) in a seed round to take forward the development of a novel vaccine technology that combines a plasmid vector with a replication-competent virus.
Scientists have discovered a new antibiotic called evybactin that is able to selectively target Mycobacterium tuberculosis, the bacteria that causes tuberculosis (TB) lung infections. As described in NatureChemicalBiology on Aug. 22, 2022. the work is still at an early stage and requires further validation. But, if successful in clinical trials, evybactin could form part of a new group of specific antibiotics designed to target TB.
Interim analysis of a phase III trial testing a single dose of Pfizer Inc.'s bivalent respiratory syncytial virus (RSV) vaccine candidate, RSVpreF, in older adults has revealed efficacy good enough to support a planned BLA submission for the vaccine to the U.S. FDA in fall 2022, the company said. Preparation for further submissions to other regulatory agencies are underway.
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