Japan’s Central Social Insurance Medical Council said it would issue similar drug price revisions in 2023 as it did in 2022 for drugs listed on the National Health Insurance, confirming the move to annual price cuts on drugs.
Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, failed to meet the primary endpoint of noninferiority compared to Roche Holding AG’s valganciclovir in the phase III Aurora study for cytomegalovirus (CMV) infection in hematopoietic stem cell transplant recipients. The multicenter, randomized, double-blind, double-dummy, active-controlled study was to form the basis for a future label expansion for the therapy.
Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, failed to meet the primary endpoint of noninferiority compared to Roche Holding AG’s valganciclovir in the phase III Aurora study for cytomegalovirus (CMV) infection in hematopoietic stem cell transplant recipients. The multicenter, randomized, double-blind, double-dummy, active-controlled study was to form the basis for a future label expansion for the therapy.
Sosei Heptares and Eli Lilly and Co. have signed a potential $731 million deal to discover, develop and commercialize small molecules that modulate G protein-coupled receptor (GPCR) targets associated with diabetes and metabolic diseases.
Shionogi & Co. Ltd.’s orally administered COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622), scored emergency regulatory approval from Japan’s Ministry of Health, Labor and Welfare for SARS-CoV-2 infection, and the Japanese government has agreed to purchase 1 million courses of Xocova for domestic supply of the antiviral.
Sotyktu (deucravacitinib), the tyrosine kinase 2 (TYK2) inhibitor for psoriasis from Bristol Myers Squibb Co., is “a good first-in-class” drug, said Nimbus Therapeutics LLC CEO Jeb Keiper, but his firm may have the best in class, ready for phase III trials. Takeda Pharmaceutical Co. Ltd. apparently believes so. The company has agreed to pay $4 billion up front and pledge as much as $2 billion more in potential milestone payments to acquire Nimbus’s wholly owned subsidiary, Nimbus Lakshmi Inc., thereby bringing aboard the TYK2 prospect called NDI-034858.
MEI Pharma Inc. has discontinued the global development of its phosphoinositide 3-kinase (PI3K) delta inhibitor, zandelisib, outside Japan. “In light of FDA’s guidance, we no longer believe clinical development can be completed within a time period that would support further investment, or with sufficient certainty of the regulatory requirements to justify continued global development efforts,” said Daniel Gold, MEI’s president and CEO.
Astellas Pharma Inc.’s zolbetuximab, a monoclonal antibody targeting Claudin 18.2, met the primary endpoint of progression-free survival in the phase III Spotlight trial in CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, according to top-line data.
Astellas Pharma Inc.’s zolbetuximab, a monoclonal antibody targeting Claudin 18.2, met the primary endpoint of progression-free survival in the phase III Spotlight trial in CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, according to top-line data.
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