AllSci News
Oncolytics gains FDA alignment on pivotal path for pelareorep in colorectal cancer
Oncolytics Biotech (Nasdaq: ONCY) has received written feedback from the FDA aligning on a potential pivotal expansion of REO 033, its ongoing randomized...
858 Therapeutics' PARG inhibitor gets second fast-track award for breast cancer
San Diego-based 858 Therapeutics announced receipt of US FDA Fast Track Designation for ETX-19477, an oral poly(ADP-ribose) glycohydrolase (PARG) inhibitor,...
FDA seeks input on regulatory framework for generative AI-enabled medical devices
Category: Regulatory Policy | Regulatory Body: FDA | Geography: United States | Policy Instrument: Guidance document | Topics: AI in drug development ·...
Amylyx moves to raise USD 350m after avexitide's Phase III hypoglycemia win
Cambridge, Massachusetts-based Amylyx Pharmaceuticals (Nasdaq: AMLX) announced a USD 350 million underwritten public offering of common stock, with proceeds...
GSK secures preclinical dengue antibody from Chugai
GSK has secured an exclusive, worldwide license from Japan-based Chugai Pharmaceutical Co., Ltd. (Tokyo: 4519) for AID351, a preclinical pan-serotype...
BioMarin pays USD 275m upfront for early-stage oral HPP bet ALE1
BioMarin Pharmaceutical (Nasdaq: BMRN) has agreed to acquire Alesta Therapeutics for USD 275 million upfront plus up to USD 215 million in development and...
Brigham wins NIA funding to test lamivudine against retrotransposons in Down syndrome Alzheimer's
Brigham and Women's Hospital has received a USD 1.47 million National Institute on Aging UG3/UH3 grant to run a two-phase clinical trial of lamivudine (3TC)...
GenBio AI unveils multiscale virtual cell model spanning DNA to phenotype
A Palo Alto-based AI company has released what it describes as a multiscale, stateful simulation of the human cell, an approach that differs architecturally...
Enveda clears Phase I with exercise-inspired pill targeting post-GLP-1 weight regain
Boulder, Colorado-based Enveda has reported Phase I results for ENV-308, an oral small molecule designed to mimic Lac-Phe, a hormone the body produces...
SciSparc funds NeuroThera Labs spinoff with CAD 5.4m financing round
Vancouver-based NeuroThera Labs Inc. (TSXV: NTLX) has completed a non-brokered private placement in two tranches, raising aggregate gross proceeds of CAD...
Abcuro raises USD 66m to retest ulviprubart after Phase II/III IBM miss
Newton, Massachusetts-based Abcuro, Inc. has closed a USD 66 million Series D financing to fund a new potentially registrational study of ulviprubart, its...
Dana-Farber wins NCI leukemia SPORE to tackle resistance across emerging AML drug classes
Dana-Farber Cancer Institute has received a USD 2.43 million NCI Specialized Program of Research Excellence (SPORE) grant to advance translational research...
Faeth's PIKTOR combo gets FDA fast track for biomarker-selected endometrial cancer
Austin, Texas-based Faeth Therapeutics (Nasdaq: FTH) announced receipt of US FDA Fast Track Designation for sapanisertib and serabelisib (PIKTOR) in...
Novo Nordisk takes mystery obesity drug into FIH trial against semaglutide
Novo Nordisk has registered a first-in-human Phase I study of NNC0721-8060, an investigational subcutaneous agent for overweight and obesity, with...
Nanjing Medical University researchers link bacterial enzyme to improved liver cancer immunotherapy
A specific bacterium found inside liver tumors can actively organize the immune microenvironment in ways that improve responses to checkpoint blockade,...
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