The FDA has given a green light to Foundation Medicine Inc.’s Foundationone CDx as a companion diagnostic for Takeda Pharmaceutical Co. Ltd.’s Alunbrig to identify patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small-cell lung cancer (NSCLC). The approval comes as Laboratory Corp. of America Holdings (Labcorp) is launching a companion diagnostic to identify NSCLC patients with the KRAS mutation. NSCLC accounts for about 85% of all lung cancers, with an estimated 1.8 million new cases diagnosed each year worldwide. Of those, 3% to 5% carry the ALK gene mutation, which is often missed with standard testing methods.
Takeda Pharmaceutical Co. Ltd. said findings from its phase III Solstice study testing oral antiviral TAK-620 (maribavir) in treating solid organ transplant recipients with cytomegalovirus infections resistant or refractory to prior therapy (R/R CMV), showed twice the rate of confirmed CMV viremia clearance compared to other conventional therapies.
Takeda Pharmaceutical Co. Ltd. said findings from its phase III Solstice study testing oral antiviral TAK-620 (maribavir) in treating solid organ transplant recipients with cytomegalovirus infections resistant or refractory to prior therapy (R/R CMV), showed twice the rate of confirmed CMV viremia clearance compared to other conventional therapies.
New three-year safety and efficacy data on Takeda Pharmaceutical Co. Ltd.'s dengue vaccine candidate, TAK-003, showed it to be 62% more effective than placebo in preventing virologically confirmed infections with the virus and 83.6% more effective than placebo in preventing hospitalizations caused by the mosquito-borne viral disease and due to any of the four dengue virus serotypes in patients ages 4 to 16.
Vectivbio Holding AG’s IPO last month shone light on short bowel syndrome (SBS), where the company has advanced the glucagon-like peptide-2 analogue apraglutide to the phase III stage. The company aims to show an advantage over same-class Gattex (teduglutide) from Takeda Pharmaceuticals Co. Ltd., cleared by the FDA in December 2012 for adults with SBS and in May 2018 for children at least 1 year of age.
New three-year safety and efficacy data on Takeda Pharmaceutical Co. Ltd.'s dengue vaccine candidate, TAK-003, showed it to be 62% more effective than placebo in preventing virologically confirmed infections with the virus and 83.6% more effective than placebo in preventing hospitalizations caused by the mosquito-borne viral disease and due to any of the four dengue virus serotypes in patients ages 4 to 16.
LONDON – Adaptate Biotherapeutics Ltd. has raised $18 million in the second close of its series A, bringing the total for the round to $34 million and providing the means to accelerate development of a portfolio of antibodies targeting tissue-resident gamma delta T cells.
HONG KONG – Covig-19, an anti-SARS-CoV-2 hyperimmune immunoglobulin therapy that Takeda Pharmaceutical Co. Ltd. developed alongside the Covig-19 Plasma Alliance, has failed to meet its endpoints in a global phase III trial. The multicenter Inpatient Treatment with Anti-Coronavirus Immunoglobulin trial was sponsored and funded by the National Institute of Allergy and Infectious Diseases. It aimed to demonstrate the drug’s safety, tolerability and efficacy in hospitalized adults at the onset of COVID-19 progression, the companies said.
Full rights to TAK-169, a CD38-targeted engineered toxin body that Takeda Pharmaceuticals Co. and Molecular Templates Inc. have been developing, are going to Molecular Templates as is the therapy’s clinical development.
Bridgene Biosciences Inc., a company using an in-house chemoproteomic platform to find and develop small molecules for hard-to-drug targets, has signed its first major pharma partnership with Takeda Pharmaceutical Co. Ltd. for an undisclosed up-front payment.