With the U.S. FDA go-ahead Feb. 2 for GSK plc’s oral daprodustat for anemia in patients with chronic kidney disease (CKD), the picture brightened for would-be competitors in the hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor space, including high-profile Akebia Therapeutics Inc., which has appealed last spring’s the complete response letter from gatekeepers with regard to vadadustat.
Adhering to the recommendation of a mixed advisory committee vote, the U.S. FDA cleared use of GSK plc’s daprodustat as the first oral hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor for treating anemia in patients with chronic kidney disease (CKD) who are on dialysis. For CKD patients not on dialysis, the agency determined the drug’s safety has not been established.
Now there are three. Moderna Inc. has posted strong phase III study data on its mRNA respiratory syncytial virus (RSV) vaccine, keeping pace with Pfizer Inc. and GSK plc’s candidates, which have May PDUFA dates. Moderna’s top-line results of the ConquerRSV pivotal efficacy study of mRNA-1345 show the vaccine hit its primary efficacy endpoints of 83.7% against RSV-associated lower respiratory tract disease in older adults.
Citing federal preemption, the U.S. Court of Appeals for the First Circuit tossed multidistrict litigation (MDL) involving GSK plc’s labeling of Zofran, an antiemetic approved for postoperative use and in conjunction with chemo or radiation, but that is commonly used off-label in pregnancy.
Wuxi Biologics (Cayman) Inc. is providing an exclusive license to GSK plc for a preclinical bispecific T-cell engaging antibody along with the option of three additional bi- and multispecific TCE antibodies developed by Wuxi. In exchange, Wuxi will receive an up-front payment of $40 million and up to $1.46 billion in additional payments for research, development, regulatory and commercial milestones across the four TCE antibodies. Wuxi Biologics, of Shanghai, is also eligible to receive tiered royalties on net sales.
Wuxi Biologics (Cayman) Inc. is providing an exclusive license to GSK plc for a preclinical bispecific T-cell engaging antibody along with the option of three additional bi- and multispecific TCE antibodies developed by Wuxi. In exchange, Wuxi will receive an up-front payment of $40 million and up to $1.46 billion in additional payments for research, development, regulatory and commercial milestones across the four TCE antibodies. Wuxi Biologics, of Shanghai, is also eligible to receive tiered royalties on net sales.
It was a year of turmoil in Europe as Russia’s invasion of Ukraine and the fall-out from the COVID-19 pandemic shaped the fortunes of the life sciences industry in 2022. After years of tension, Russia’s attempt to annex Ukraine on Feb. 24 caused outrage and disruption and was unanimously opposed on humanitarian grounds by the life sciences and pharma industry.
Wave Life Sciences Ltd. and GSK plc have entered into a strategic collaboration to advance oligonucleotide therapeutics, including Wave's preclinical RNA editing program targeting α1-antitrypsin deficiency (AATD), WVE-006. The discovery collaboration has an initial 4-year research term. The first part of the arrangement is a discovery collaboration that enables GSK to advance up to eight programs and Wave to advance up to three programs, leveraging Wave's PRISM oligonucleotide platform and GSK's expertise in genetics and genomics.
Wave Life Sciences Ltd. is partnering again. The company is getting $170 million up front – $120 million in cash and a $50 million equity investment – in a new partnership with GSK plc to advance oligonucleotides in unnamed targets. The agreement, which has a four-year research term, allows for GSK to advance up to eight programs using Wave Life’s platform and for Wave Life to advance three, or more if GSK approves, of its own collaboration programs.
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.
