Noah AI Industry News

Delivers real-time biopharma news and signals — powered by AI, curated for professionals.

Lexicon Pharmaceuticals Faces Setback in Type 1 Diabetes Drug Development

Lexicon Pharmaceuticals Faces Setback in Type 1 Diabetes Drug Development

Lexicon Pharmaceuticals has encountered another regulatory hurdle in its quest to bring Zynquista (sotagliflozin) to market for type 1 diabetes patients. The U.S. Food and Drug Administration (FDA) has requested additional time to review the company's latest submissions, further delaying the drug's potential approval.

NoahAI News9/24/2025
Ionis' Zilganersen Shows Promise in Pivotal Study for Rare Neurological Disease

Ionis' Zilganersen Shows Promise in Pivotal Study for Rare Neurological Disease

Ionis Pharmaceuticals has announced positive results from a pivotal Phase I-III study of zilganersen, an investigational antisense oligonucleotide therapy for Alexander disease (AxD), a rare and often fatal neurological condition. The study's success paves the way for a potential FDA submission, marking a significant milestone in the treatment of this devastating disorder.

NoahAI News9/24/2025
Bristol Myers Squibb's Iberdomide Shows Promise in Key Multiple Myeloma Study

Bristol Myers Squibb's Iberdomide Shows Promise in Key Multiple Myeloma Study

Bristol Myers Squibb (BMS) has announced positive interim results from a pivotal Phase 3 clinical trial of iberdomide, its experimental protein-degrading drug for multiple myeloma. The study, known as Excaliber-RRMM, evaluated iberdomide in combination with Darzalex and dexamethasone against a standard regimen in patients with relapsed or refractory multiple myeloma.

NoahAI News9/24/2025
FDA Takes Unusual Step to Repurpose Old GSK Drug for Autism Treatment

FDA Takes Unusual Step to Repurpose Old GSK Drug for Autism Treatment

The U.S. Food and Drug Administration (FDA) has initiated an unconventional process to repurpose an old GlaxoSmithKline (GSK) drug as a potential treatment for autism-related symptoms. This move, part of the Trump administration's efforts to combat autism, involves the revival of leucovorin, a medication GSK hasn't marketed in over two decades.

NoahAI News9/24/2025
Qventus Unveils 'AI Solution Factory' to Accelerate Healthcare AI Deployment

Qventus Unveils 'AI Solution Factory' to Accelerate Healthcare AI Deployment

Qventus, a leader in healthcare artificial intelligence (AI) solutions, has announced the launch of its innovative "AI Solution Factory," a groundbreaking approach designed to accelerate the development and deployment of AI-driven tools for healthcare organizations. This new initiative promises to revolutionize the way hospitals and health systems integrate AI into their operations, potentially transforming patient care and operational efficiency.

NoahAI News9/24/2025
FDA Rejects Scholar Rock's SMA Drug, Citing Manufacturing Issues at Novo-Owned Facility

FDA Rejects Scholar Rock's SMA Drug, Citing Manufacturing Issues at Novo-Owned Facility

Scholar Rock's bid to introduce the first muscle-targeted treatment for spinal muscular atrophy (SMA) has hit a roadblock as the U.S. Food and Drug Administration (FDA) rejected its application for apitegromab. The decision, communicated through a complete response letter (CRL), cited manufacturing concerns at a third-party facility in Indiana, now owned by Novo Nordisk.

NoahAI News9/24/2025
Sanofi Injects $625M into Venture Arm, Bolstering Biotech Investment Strategy

Sanofi Injects $625M into Venture Arm, Bolstering Biotech Investment Strategy

Sanofi, the French pharmaceutical giant, has announced a significant $625 million cash infusion into its investment arm, Sanofi Ventures. This strategic move aims to capitalize on the current biotech landscape, which is characterized by limited capital but abundant scientific innovation.

NoahAI News9/24/2025
Rome Therapeutics Faces Layoffs and Strategic Review Amid Challenging Market Conditions

Rome Therapeutics Faces Layoffs and Strategic Review Amid Challenging Market Conditions

Boston-based preclinical biotech Rome Therapeutics is undergoing significant changes as it grapples with challenging market conditions. The company, which garnered attention for its innovative approach to drugging the "dark genome," is now implementing cost-cutting measures and exploring strategic options to ensure the continued advancement of its novel science and programs.

NoahAI News9/24/2025
Moderna's Next-Gen COVID-19 Vaccine Shows Promise Against Latest Variant

Moderna's Next-Gen COVID-19 Vaccine Shows Promise Against Latest Variant

Moderna has reported encouraging early results from human trials of its updated COVID-19 vaccine, mNEXSPIKE, demonstrating strong immune responses against the rapidly spreading LP.8.1 sublineage of SARS-CoV-2. The pharmaceutical company's latest data underscores the potential of its next-generation vaccine to offer enhanced protection against emerging virus variants.

NoahAI News9/23/2025
Seres Therapeutics Implements Strategic Restructuring Amid Financial Challenges

Seres Therapeutics Implements Strategic Restructuring Amid Financial Challenges

Seres Therapeutics, a prominent microbiome biopharma company, has announced a significant workforce reduction as part of its efforts to conserve resources and advance its pipeline. The Cambridge, Massachusetts-based firm is taking decisive action to extend its cash runway and focus on key development programs.

NoahAI News9/23/2025
Celltrion Acquires Eli Lilly's New Jersey Plant in $330M Deal, Citing Tariff Mitigation

Celltrion Acquires Eli Lilly's New Jersey Plant in $330M Deal, Citing Tariff Mitigation

South Korean pharmaceutical company Celltrion has announced the acquisition of Eli Lilly's drug substance plant in Branchburg, New Jersey, for 460 billion Korean won ($330 million). The deal, expected to close by the end of 2025, marks a significant move in Celltrion's strategy to mitigate potential pharmaceutical import tariffs and expand its U.S. operations.

NoahAI News9/23/2025
FDA Rejects Scholar Rock's SMA Drug Due to Manufacturing Issues at Novo-Owned Facility

FDA Rejects Scholar Rock's SMA Drug Due to Manufacturing Issues at Novo-Owned Facility

Scholar Rock's bid to introduce the first muscle-targeted treatment for spinal muscular atrophy (SMA) has encountered a significant setback. The U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) rejecting the company's application for apitegromab, citing manufacturing concerns at a third-party facility in Indiana.

NoahAI News9/23/2025
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