Showing a significant efficacy signal in a phase II trial, Relay Therapeutics Inc.’s zovegalisib (RLY-2608) achieved a 60% volumetric response in patients with PIK3CA-driven vascular anomalies (VAs). The isoform-selective PI3Ka inhibitor is in late-stage clinical trials with various combinations for P13Ka-mutated, HR+/HER2- advanced breast cancer, with VAs representing a second indication for which Leerink Partners analyst Andrew Berens forecasts $2.8 billion in peak revenues. Read More
There are real world demonstrations of how autonomous artificial intelligence agents are poised to disrupt biomedical research, according to two papers published May 19 in Nature. Each describes an AI system that assists across the piece, from generating hypotheses to designing experiments, analyzing the data and refining hypotheses in the light of new data. Read More
Create Medicines Inc. closed a $122 million series B financing round to support its pipeline of therapies that use mRNAs delivered via liquid nanoparticles to express chimeric antigen receptors (CARs) in T cells, NK cells and myeloid cells inside the body of patients. The Cambridge, Mass.-based company estimates the capital will last through 2028, providing the opportunity for multiple clinical readouts of its various products. Read More
Vincentage Pharma Co. Ltd.’s once-daily oral small-molecule GLP-1 receptor agonist, VCT-220, met the primary endpoints in a pivotal phase III trial in overweight or obese patients in China. Based on the top-line data, the Chengdu, China-based company plans to submit an NDA for chronic weight management to China’s National Medical Products Administration. Read More
Boston Scientific Corp. reported positive results from the Fracture investigational device exemption trial which evaluated its Seismiq 4CE coronary intravascular lithotripsy (IVL) catheter in patients with severely calcified coronary artery disease. Late-breaking data presented at the EuroPCR conference in Paris showed that the pivotal study met its primary safety and effectiveness endpoints, with high rates of freedom from major adverse cardiac events at 30 days and strong procedural success. Read More
Elixir Medical Corp. reported four-year data from the Bioadaptor randomized controlled trial presented at the EuroPCR conference in Paris, which showed that patients with coronary artery disease treated with its Dynamx coronary drug-eluting bioadaptor system experienced significantly lower event rates compared to those treated with Medtronic plc’s Resolute Onyx drug-eluting stent, including reduction in cardiovascular death. Read More
It’s back to the drawing board for the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP). After a year of Health and Human Services Secretary Robert Kennedy gutting the panel and restocking it mostly with people who share his views on vaccines, the CDC published a notice in the May 19 Federal Register saying it’s withdrawing the amended ACIP charter renewal issued April 6 and is instead “re-establishing” the committee. Read More
Eli Lilly and Co. lost its bid to have the U.S. Supreme Court strike down the whistleblower provisions in the False Claims Act (FCA) as unconstitutional. Read More
In a move aimed at incentivizing companies to go and stay public, the U.S. SEC proposed two rulemakings May 19 as a foundation to the agency’s Make IPOs Great Again agenda. Read More
New hires and promotions in the biopharma and med-tech industries, including: Byondis, Cytomx, Juniper, Kyverna, Novalgen, Novastra, Orca Bio, Sensorion, Triana, Tulyp, Turn, Vahaticor. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Aerorx, Agenus, Amylyx, Apnimed, Bambusa, Bayer, Biomarin, Biotheryx, Candel, Design, Iecure, Impact, Ipsen, Kelun-Biotech, Lakewood-Amedex, Merck, Microbiotica, Nanobiotix, Novartis, Prokarium, Quince, Regeneron, Sumitomo, United, Vincentage, Zenflow. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Amgen, Artivion, Bioatla, Context, Endospan, Ferring, Immedica, Immunitybio, Takeda. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Accord Biopharma, Acist, Astrazeneca, Boehringer Ingelheim, Daiichi, Genentech, GSK, H. Lundbeck, Krystal, Natera, Vertanical, Viatris. Read More
