Lenvatinib mesylate

MADISON, Wis.--(BUSINESS WIRE)--The U.S. Food and Drug Administration (FDA) has approved the Promega OncoMate® MSI Dx Analysis System as a companion diagnostic designed to identify patients with microsatellite stable (MSS; defined as not MSI-high [not MSI-H]) endometrial carcinoma who may benefit from treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. This is the first Promega companion diagnostic to receive FDA approval. “This approval underscores the critical role diagnostics play in accurately matching the right patients, at the right time with the right therapy,” says Alok Sharma, Global Clinical Market Director at Promega. OncoMate® MSI Dx Analysis System is a PCR-based assay designed to evaluate MSI status in tumor tissue. MSI status can be used to guide treatment decisions and support precision oncology strategies in endometrial carcinoma. “This approval underscores the critical role diagnostics play in accurately matching the right patients, at the right time with the right therapy,” says Alok Sharma, Global Clinical Market Director at Promega. “We are committed to delivering reliable tools that guide clinical decisions and help improve patient outcomes.” The approval was supported through a collaboration with Merck, which markets KEYTRUDA plus LENVIMA in collaboration with Eisai Co., Ltd. Together, the companies are working to advance personalized medicine and expand access to diagnostics that enable informed therapeutic choices. OncoMate® MSI Dx Analysis System was previously cleared by the FDA as the first PCR-based molecular diagnostic for identifying colorectal cancer patients who may benefit from additional testing to diagnose Lynch syndrome. This approval applies to the United States and its territories. Promega MSI technology has received additional regulatory approvals in China and the European Union. Learn more about Promega MSI technology here. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About Promega Corporation Promega Corporation is a leader in providing innovative solutions and technical support to the life sciences industry. The company’s portfolio of over 4,000 products supports a range of life science work across areas such as cell biology; DNA, RNA and protein analysis; drug development; human identification and molecular diagnostics. These tools and technologies have grown in their application over the last 45 years and are used today by scientists and technicians in labs for academic and government research, forensics, pharmaceuticals, clinical diagnostics and veterinary, agricultural and environmental testing. Promega is headquartered in Madison, WI, USA with branches in 16 countries and over 50 global distributors. Learn more at promega.com

Takeda's third-quarter pipeline cull, a head-to-head win against Novo Nordisk's semaglutide and a potential $1 billion-plus licensing deal by Roche made our news this week. Takeda tightened its pipeline in the third quarter. Innovent Biologics reported a head-to-head win against semaglutide in a Chinese phase 3 trial. Roche licensed a respiratory bispecific candidate in a potential $1 billion-plus deal. And more.1. Takeda drops AstraZeneca-partnered neurological program after phase 2 failureTakeda’s AstraZeneca-partnered alpha-synuclein antibody, TAK-341/MEDI1341, has failed in a phase 2 study in multiple system atrophy. The Japanese pharma also stopped developing the orexin-2 receptor agonist danavorexton (TAK-925) for narcolepsy “due to strategic considerations,” while phase 2 development in respiratory conditions remains ongoing.2. Innovent, Lilly's mazdutide trumps Novo's semaglutide in head-to-head diabetes, weight loss studyInnovent Biologics’ China-approved mazdutide has topped Novo Nordisk’s 1-mg semaglutide in a Chinese phase 3 trial conducted in patients with early-stage Type 2 diabetes and obesity. A 6-mg dose of the first-in-class GLP-1/glucagon dual receptor agonist outperformed semaglutide on the proportion of patients who met certain blood sugar and body weight benchmarks. The drug is partnered with Eli Lilly in the country.3. Roche pens $1B biobucks deal for Chinese company's respiratory disease bispecificRoche is paying $75 million upfront and committing up to $995 million in milestones to license a long-acting TSLPxIL-33 bispecific from China’s Qyuns Therapeutics. Coded QX031N, the drug holds promise for chronic obstructive pulmonary disease and asthma, according to Qyuns. The long-acting TSLP mechanism last year attracted GSK to a $1 billion buyout of Aiolos, which got its candidate from China’s Jiangsu Hengrui Pharma.4. Merck, Eisai scrap ambitions for Keytruda-Lenvima pairing in liver cancer subtype after survival missMerck & Co. and Eisai’s Keytruda and Lenvima failed to significantly extend patients’ lives when added to standard transarterial chemoembolization in unresectable, non-metastatic liver cancer. The overall survival miss at an interim analysis has led the pair to close the phase 3 Leap-012 trial. While an FDA expansion appears unlikely, the regimen was recently approved in China based on a positive progression-free survival readout.5. Boehringer returns to Kyowa Kirin with €640M pact for preclinical autoimmune moleculeIn a deal worth up to 640 million euros ($743 million), Boehringer Ingelheim has licensed a preclinical program from Kyowa Kirin that the German pharma hopes could become a “first-in-class … treatment of autoimmune diseases.” No details on the drug’s target or specific indications were given.6. WuXi AppTec sharpens focus by selling off China-based clinical research unitsWuXi AppTec is selling its China-based CRO WuXi Clinical and site management organization WuXi MedKey to Hillhouse. With the divestments, the company aims to emphasize its drug discovery, laboratory testing, process development and manufacturing services, according to a securities filing.7. BIO’s John Crowley urges ‘strategic action’ to strengthen FDA amid China’s biotech rise (Testimony before Congress)In a testimony before the Senate Health, Education, Labor, and Pensions Committee, Biotechnology Innovation Organization chief John Crowley called for “proactive, strategic action” to strengthen the FDA to secure “America’s biotech future” amid China’s rapid rise in biotech. His long list of recommendations includes reducing the time, cost and complexity of early drug development and improving the agency’s first-cycle review success rate.Other News of Note:8. Birds, lizards and cats, oh my: FDA blasts generic drug maker Hetero in scathing Form 4839. Roche's Chugai strikes $200M M&A deal to take over IgAN asset in several Asian countries10. Biogen boosts sales outlook on 'resilient' legacy MS franchise as new launches build momentum11. Astellas taps social media star Babs Costello to promote Izervay for geographic atrophy12. Samsung Bioepis gains full rights to Lucentis, Eylea biosimilars from Biogen in Europe (release)