China's National Healthcare Security Administration will not be adding Pfizer Inc.'s COVID-19 treatment Paxlovid to its list of medicines covered by basic medical insurance schemes in the country, due to its high prices.
Little more than a month after the U.S. FDA approved the first gene therapy for adults with hemophilia B, Uniqure NV’s Hemgenix, strong phase III data have come from Pfizer Inc. The Pfizer results show fidanacogene elaparvovec, a vector containing an AAV capsid and a high-activity human coagulation factor IX (FIX) gene for treating adult men with moderately severe to severe hemophilia B, hit the primary endpoint in the phase III Benegene-2 study. The one-time therapy is designed to allow those living with hemophilia B to be able to produce FIX instead of receiving regular, ongoing doses of exogenous FIX.
Pfizer Inc. has acquired rights to respiratory syncytial virus (RSV) drug candidate sisunatovir from Lianbio Co. Ltd. in a deal worth up to $155 million covering development and commercialization rights in mainland China, Hong Kong, Macau and Singapore. With this agreement, Pfizer now holds global development and commercialization rights to the candidate, an orally administered fusion inhibitor is designed to block RSV replication by inhibiting F-mediated fusion with the host cell.
Both neutralizing antibodies and antibody effector functions are needed for protection against re-infection with respiratory syncytial virus (RSV), which may explain why it has been challenging to design an effective vaccine against the virus. As reported in the Dec. 12, 2022, issue of Cell, researchers carried out a human challenge study where volunteers were given a candidate vaccine for RSV, Ad26, or placebo.
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.
