Pharma Giant Expands Into Emerging Psychedelic Therapies With AbbVie’s $1.2 billion acquisition of Gilgamesh Pharmaceuticals’ lead depression drug, the psychedelic therapeutics space has soundly rebounded from Lykos’ rejection last year. There are now seven programs in Phase III trials across…
Critics Warn Plan May Hinder Innovation and Patient Access The FDA’s proposed Rare Disease Evidence Principles review process is a starting point for getting rare disease therapies across the finish line, but industry leaders say there are more concrete steps…
The fight against misinformation goes to the heart of trust in public health We are at a critical juncture. While best estimates conclude that vaccines have saved more than 150 million lives in the past 50 years, the potential for…
Nuvation Bio’s IBTROZI™ Wins Regulatory Approval in Japan for Advanced ROS1-Positive Non-Small Cell Lung Cancer Nuvation Bio Inc. (NYSE: NUVB), a global oncology company dedicated to developing novel therapies for some of the most challenging cancers, announced that Japan’s Ministry…
Layoffs From Just 6 Pharmas Could Wipe Out Over 39,000 Jobs This year, Novo Nordisk and Merck announced significant layoffs, with Novo planning to axe about 9,000 employees and Merck projecting it could let go of roughly 6,000. Meanwhile, Bayer,…
Lexicon Backs Phase III Go Decision for Non-Opioid Pain Med With Post-Hoc AnalysisSupporting Lexicon Pharmaceuticals’ decision to advance the non-opioid analgesic pilavapadin into late-stage development—despite a topline miss in March—is an “improving” regulatory environment for non-addictive options for chronic pain,…
Key challenges in AAD sourcing: GMP compliance, supply reliability & quality control Amino acid derivatives (AADs) are essential starting materials for solid-phase peptide synthesis, crucial for the development of peptide-based therapeutics in areas like oncology, metabolic disorders, and infectious diseases. As…
Intellia Therapeutics Completes Enrollment in the Global Phase 3 HAELO Study of Lonvoguran Ziclumeran (lonvo-z) for Hereditary Angioedema Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced it has completed enrollment…
Saphnelo self-administration TULIP-SC Phase III trial meets primary endpoint in patients with systemic lupus erythematosus based on an interim analysis Positive high-level results from a pre-specified interim analysis of the Phase III TULIP-SC trial in patients with systemic lupus erythematosus…
Roche enters into a definitive merger agreement to acquire 89bio, and its phase 3 FGF21 analog for the therapy of moderate to severe MASH 89bio’s pegozafermin allows for a potentially best-in-disease treatment for moderate to severe Metabolic Dysfunction-Associated Steatohepatitis (MASH),…
Republicans Ratchet Up Pressure as Monarez Levels Damning Allegations Against Kennedy During a hearing in front of the Senate’s HELP committee, Susan Monarez addressed her controversial firing and recalled a conversation where Health Secretary Robert F. Kennedy Jr. allegedly said…
FDA Takes Long Overdue Baby Step Toward Regulating Compounder Drug Ads A complex state vs. federal regulatory scheme allows drug compounders to advertise drugs without disclosing risks like a pharma company must do. Experts say it’s time for the FDA…