Pfizer Inc. and Clear Creek Bio Inc. have entered into a research collaboration and exclusive license agreement to advance the discovery and development of potential inhibitors of the SARS-CoV-2 papain-like protease (PLpro) for the oral treatment of COVID-19.
Twelve months after a single shot of Valneva SE’s chikungunya vaccine, positive antibody persistence was found, threatening a deadly disease that has long resisted treatment. The new data are derived from a study of 363 healthy adult participants that followed them from month 6 after vaccination to month 12. Nearly all, 99%, kept their neutralizing antibody titers for 12 months beyond the seroresponse threshold of 150, which hit the primary endpoint and the antibody level agreed with regulators as endpoint under the accelerated approval pathway.
Pfizer Inc. and Biontech SE have initiated a phase I study to evaluate the safety, tolerability and immunogenicity of BNT-162b4, a next-generation COVID-19 vaccine candidate that aims to enhance SARS-CoV-2 T-cell responses and potentially broaden protection against COVID-19.
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.
Pfizer Inc. has divulged 3C-like proteinase (3CLpro) (SARS-CoV-2) inhibitors reported to be useful for the treatment of SARS-CoV-2 infection (COVID-19).
Differences in individual responses to COVID-19 vaccines have been linked directly to different human leukocyte antigen (HLA) alleles and it has been shown that people carrying one specific variant, HLA-DQB1*06, generate higher antibody responses and are better protected from SARS-CoV-2 infection.
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.
Even though the EU had approved more than a dozen biosimilars by 2012, the follow-on biologics were still in their embryonic stage around the world when BioWorld published The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies in early 2013. Now, nearly a decade later, the global biosimilar landscape has matured with many more biosimilars approved across the globe, but the uptake, and thus the savings, is not what some policy makers and people in industry had hoped for or expected.
Long considered a make-or-break market for novel drugs and biologics and a success story for generics, the U.S. has been more challenging for biosimilars than many experts initially expected. U.S. biosimilar “uptake has been good, but not great,” Steven Lucio, senior principal for pharmacy solutions at Vizient Inc., told BioWorld. That could change next year when at least seven biosimilars referencing Abbvie Inc.’s immunosuppressive drug, Humira (adalimumab), are expected to launch in the U.S.
Researchers from Anacor Pharmaceuticals Inc. and Pfizer Inc. have published preclinical data for the novel benzoxaborole prodrug AN-15368, being developed for the treatment of Chagas disease.
