GSK plc has announced it has stopped early two pivotal phase III trials of its urinary tract infection drug, gepotidacin, for efficacy and is preparing regulatory filings for what could be the first new oral antibiotic for the disease in more than 20 years.
CSL Ltd. subsidiary CSL Seqirus signed a licensing and development deal with Arcturus Therapeutics Inc. to in-license Arcturus’ late-stage self-amplifying mRNA vaccine platform technology. Arcturus will receive $200 million up front and is eligible to receive more than $1.3 billion in development milestones and over $3 billion in commercial milestones. In addition, it could capture a 40% net profit share for COVID-19 vaccines and up to double-digit royalties for vaccines against flu, pandemic preparedness and three other respiratory pathogens.
Pfizer Inc.’s bivalent prefusion vaccine for protecting newborns from severe respiratory syncytial virus (RSV) hit one of its two primary endpoints in its phase III study, which was good enough for the company to stop enrollment and plan to submit a BLA to the U.S. FDA by year-end. PF-06928316 is one of six RSV vaccines in active phase III development globally, which includes an Astrazeneca plc-Sanofi SA collaboration plus one from GSK plc. Pfizer’s is the only one developed for infants by way of maternal immunization and for older adults.
The U.K. is launching a coordinated national program of research into the unprecedented outbreak of monkeypox that has spread across Europe and North America – regions where the disease is not endemic – over the past six months. Taking a lead from the SARS-CoV-2 playbook, there will be work to sequence the viral genome and to study how it is evolving, linking this to changes in the transmission and pathology of the virus.
GSK plc has announced results from its respiratory syncytial virus (RSV) vaccine in older people that look stronger than those from its rival, Pfizer Inc., as the race to develop a first ever vaccine against the common respiratory disease heats up.
A phase IIb trial of nangibotide in septic shock has demonstrated preliminary signs of efficacy in a subset of biomarker-defined patients and provided its developer, Inotrem SA, with a dataset that will inform the design of a registration program for the drug. Subject to agreement from regulatory agencies, the company aims to move the triggering receptor on myeloid cells 1 inhibitor into a first phase III trial in early 2024. “We should have a clearer picture by the beginning of the second next year,” CEO Sven Zimmermann told BioWorld.
CSL Ltd. subsidiary Seqirus inked a $30.1 million deal with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop and evaluate two influenza A subtype H2Nx (avian flu) vaccines in a phase I trial.
The Nobel Prize in Physiology or Medicine 2022 was awarded to Svante Pääbo today "for his discoveries concerning the genomes of extinct hominins and human evolution." Pääbo, who is currently the director of the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany, and his colleagues overcame extreme technical challenges to sequence the DNA of ancient hominids – because after tens of thousands of years, there is no such thing as aging well for DNA.
To jumpstart the development of much-needed antibiotics, the European Federation of Pharmaceutical Industries and Associations (EFPIA) released a new report Sept. 28 demonstrating the economic benefit of granting additional exclusivity for another drug as a way of incentivizing antibiotic R&D.
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