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Big Pharma exits: AstraZeneca pauses multiple programs and scraps an asthma FLAP inhibitor
AstraZeneca said it is cutting several late-stage and mid-stage programs after disappointing efficacy, including discontinuing a Phase 2 asthma trial of atuliflapon, a FLAP inhibitor. The company...
Oncology data and regulatory pressure: FDA proposes withdrawing Tavneos
The FDA has proposed withdrawing Amgen’s Tavneos (avacopan), alleging “untrue statements” were included in the approval application for the C5a receptor antagonist. The notice would unwind the...
Clinical trial momentum in rare neurology: Teva buys Emalex
Teva has struck a $700 million upfront deal to acquire Emalex Biosciences, aiming to move a Tourette syndrome candidate closer to near-approval. The buyout is positioned as Teva’s largest deal in...
Immuno-oncology financing: Coultreon’s $125M Series A for SIK3 oral therapy
Coultreon Biopharma has raised $125 million in a Series A led by Sofinnova Investments to advance COL-5671, an oral salt-inducible kinase 3 (SIK3) inhibitor in Phase 1 for autoimmune diseases. The...
RNA vaccine design principle: hepatocyte detargeting boosts immunity
A Mount Sinai team reported a key design principle for next-generation mRNA therapeutics: detargeting mRNA expression away from hepatocytes can strengthen T-cell immunity in preclinical lymphoma...
AstraZeneca and Amgen real-time trial platform details
As part of the FDA’s real-time trial review effort, the agency says the pilot will rely on a real-time data platform built by Paradigm Health for the AstraZeneca and Amgen studies. The FDA’s...
Biopharma M&A: CareDx to acquire Naveris for HPV liquid biopsy MRD
CareDx agreed to acquire Naveris for up to $260 million, seeking expanded access to liquid biopsy monitoring in HPV-driven cancers. The deal provides $160 million upfront, with as much as $100...
FDA clearance via breakthrough designation: Laguna Diagnostics psychiatric mRNA biomarker test
Laguna Diagnostics received FDA Breakthrough Device designation for its mRNA Gene Biomarker test intended to help differentiate schizophrenia from bipolar I disorder in symptomatic patients. The...
FDA accelerates trial review via real-time data
The FDA launched a pilot effort to collect and review clinical trial data in real time, starting with oncology studies from AstraZeneca and Amgen. The agency said reviewers will access information...
Drug deals and M&A reshape oncology and specialty pipelines
AbbVie struck a right-to-buy option with Kestrel Therapeutics that could reach $1.45 billion to fund and potentially acquire the company’s investigational oral pan-KRAS inhibitor KST-6051. The...
Regulatory approvals and breakthrough designations move precision medicine forward
Health Canada approved the first generic version of Novo Nordisk’s Ozempic (semaglutide) based on Dr. Reddy’s Laboratories’ submission. The regulator said the generic meets safety, efficacy, and...
GLP-1 and obesity program updates intensify competition and scrutiny
Boehringer Ingelheim reported Phase 3 success for survodutide, a dual-acting obesity shot designed to stimulate GLP-1 and glucagon signaling. In the Synchronize-1 trial, Boehringer said treatment...
A new preclinical design principle emerges for mRNA vaccine targeting
Researchers at the Icahn School of Medicine at Mount Sinai reported that detargeting mRNA expression away from hepatocytes can strengthen T-cell immunity in preclinical lymphoma models. In Nature...
Targeted oncology signals and early clinical setbacks reshape R&D priorities
A first-in-human trial generated early evidence for setidegrasib, a KRAS G12D-targeted therapy, in patients with advanced pancreatic ductal adenocarcinoma and non–small-cell lung cancer. The New...
Company guidance and financial updates track momentum and headwinds in diagnostics
NeoGenomics raised full-year 2026 revenue guidance after reporting strong Q1 results, citing momentum in its NGS testing business. The company said NGS testing products contributed about one third...
Biotech funding and investment continues with immunology and precision diagnostics
Coultreon Biopharma, formerly Onco3R Therapeutics, raised a $125 million Series A to advance its oral SIK3 inhibitor COL-5671 through clinical development. The seed for the program traces back to...
New clinical trial rules and oversight models raise execution standards in the UK
The UK implemented the biggest overhaul of clinical trials rules in 20 years, with new regulations taking effect April 28. The changes aim to reduce timelines for approvals and introduce a...
Precision diagnostics and imaging platforms expand in oncology care management
Precision oncology testing continues to expand as CareDx prepares to acquire Naveris for its NavDx HPV liquid biopsy MRD test, which is designed to detect HPV-driven cancer fragments in blood. The...
Regulators move to accelerate clinical trial oversight using real-time data and AI
The FDA announced a pilot approach to review clinical trial data in real time, starting with datasets from AstraZeneca and Amgen. The agency said it will also solicit feedback on a potential...
FDA pulls Tavneos approval, citing manipulated trial data
The FDA moved to withdraw Amgen’s Tavneos (avacopan) after alleging that information used to support approval included untrue statements of material fact and that trial results were manipulated....