Researchers at the University of California San Diego believe they have found an early pinch point in the biology of Alzheimer’s disease, one that can be blocked without disturbing the brain’s normal chemistry. The scientists credit AI for guiding them there. The study, published April 23 in Cell, focused on phosphoglycerate dehydrogenase, or PHGDH, an…
Label update broadens Camzyos reach in obstructive HCM, trims echo burden for stable patients
The FDA has approved a sweeping label update for Bristol Myers Squibb’s Camzyos (mavacamten), the first‑and‑only FDA‑approved cardiac myosin inhibitor for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Until Camzyos reached the market in 2022, physicians mainly relied on beta‑blockers, calcium‑channel blockers, disopyramide or invasive septal‑reduction surgery to relieve outflow obstruction. The latest update lets…
University of Miami achieves 10x speedup in HIV drug research with new compute alliance
The ALAFIA AIVAS desktop supercomputer accelerates complex molecular dynamics and AI applications, delivering performance speedups as high as 80-100X for some research applications. Researchers at the University of Miami have achieved a roughly 10x acceleration in complex HIV drug simulations, thanks to a new compute alliance with Miami-based ALAFIA. This dramatic speedup, powered by ALAFIA’s…
JAMA: Potential rare vision complications linked to blockbuster GLP-1s
A new case series published in JAMA Ophthalmology has spotlighted rare but potentially serious vision issues in patients taking semaglutide or tirzepatide, two popular glucagon-like peptide-1 (GLP-1) receptor agonists commonly used to treat diabetes and aid weight loss. In the investigation, nine individuals reported sudden vision changes while on semaglutide or tirzepatide; seven of these…
Oracle exec maps data integration strategy for modern clinical trials in 2025 and beyond
From FHIR-based APIs to “hybrid data models” and blockchain-enabled audit trails, biopharma companies are exploring a range of strategies in their quest to incorporate Real World Data (RWD) into clinical trials. But technology alone won’t resolve the deeper issues at play. From bridging disparate data sources to safeguarding patient privacy under evolving regulations, sponsors face…
Beckman Coulter debuts automated clone screening system claiming 90% reduction in manual steps
Beckman Coulter Life Sciences has announced a new automated clone screening platform for biologic drug development. The Cydem VT system integrates several established technologies — microbioreactor arrays, liquid handling, and analytical measurements — into a single platform capable of monitoring up to 96 parallel bioreactors. The system provides continuous monitoring of pH, dissolved oxygen, and…
Drug Discovery & Development’s Brian Buntz clinches 2023 Azbee national gold award
Our own pharma editor, Brian Buntz, has won national gold in the 2023 Azbee Awards of Excellence. The accolade from the American Society of Business Publication Editors (ASBPE) recognized Buntz’s coverage for Drug Discovery & Development, which was highlighted in the sister print publication of Medical Design & Outsourcing. ASBPE is a widely recognized professional…
Science unbound: AI and open data accelerate the pace of discovery
Scientists have long been perceived and portrayed in film as old people in white lab coats perched at a bench full of bubbling fluorescent liquids. The present-day reality of scientific research is quite different from old stereotypes, with AI-driven scientific breakthroughs emerging as a major driving force behind new discoveries. Scientists are increasingly data jockeys…
Development challenges and regulatory changes for cell and gene therapies
Cell and gene therapies are the fastest growing area for drug development. The groundwork for this category was laid with the mapping of the human genome in 2003, and the field has developed rapidly in the intervening decades. These powerful therapies have significant potential for the treatment of cancer and other previously “undruggable” diseases. But…
FAQ: What are pharmacokinetics and pharmacodynamics?
Drug formulation involves balancing the body’s ability to use and then eliminate the drug candidate. The field of pharmacology is dedicated to this balancing act, studying how a drug candidate influences biological systems and the body’s reaction to that compound. This task involves the study of pharmacokinetics (PK) and pharmacodynamics (PD). Pharmacokinetics is the study…
OcuMedic, Gelest ink drug-delivering contact lens deal
OcuMedic said today that it entered into an exclusive supply agreement and picked up a strategic investment from Gelest for its proprietary drug-eluting soft contact lens of an undisclosed amount. Under the terms of the agreement, Morrisville, Pa.-based Gelest is set to manufacture and supply OcuMedic’s key chemistry components used in the controlled release of…
Intersect ENT’s Ascend study misses endpoint
Intersect ENT (NSDQ:XENT) shares plunged today after the company said it failed to meet the primary endpoint in a study of its Ascend investigational drug-coated sinus balloon. The 70-person, randomized, double-blind trial was designed to compared treatment with Intersect ENT’s DCB when randomized against an uncoated balloon control. The study missed the primary endpoint, frontal sinus…
FDA clears Insulet’s OmniPod Dash as insulin pump alternative
Insulet (NSDQ:PODD) said today that it won FDA clearance to market its Omnipod Dash alternate controller-enabled (ACE) infusion pump as an integrated insulin pump. The Acton, Mass.-based company received FDA 510(k) clearance for the Omnipod Dash in June 2018 and launched the device earlier this year. The latest indication states that the pump can reliably and…