Noah AI Industry News

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

UniQure's Huntington's Gene Therapy Shows Promising Results, Poised for FDA Submission

UniQure's Huntington's Gene Therapy Shows Promising Results, Poised for FDA Submission

UniQure has reported groundbreaking results from a pivotal Phase I/II trial of its gene therapy AMT-130 for Huntington's disease, demonstrating a 75% slowing of disease progression after three years. The company is now gearing up for a potential first-in-class approval and launch, with plans to submit a Biologics License Application (BLA) to the FDA in early 2026.

NoahAI News9/24/2025
FDA Rejects Two Spinal Muscular Atrophy Therapies Citing Manufacturing Concerns

FDA Rejects Two Spinal Muscular Atrophy Therapies Citing Manufacturing Concerns

In a surprising turn of events, the U.S. Food and Drug Administration (FDA) has denied approval for two separate spinal muscular atrophy (SMA) therapies within the same week, both due to manufacturing-related issues. These regulatory actions have sent ripples through the pharmaceutical industry, highlighting the critical importance of manufacturing processes in drug development and approval.

NoahAI News9/24/2025
Pharmaceutical Industry Update: FDA Repurposing, Major Acquisitions, and Psychedelics Revival

Pharmaceutical Industry Update: FDA Repurposing, Major Acquisitions, and Psychedelics Revival

In a flurry of activity, the pharmaceutical industry has seen significant developments across multiple fronts, from regulatory shifts to high-profile acquisitions and emerging therapeutic areas.The U.S. Food and Drug Administration (FDA) has announced plans to repurpose GSK's Wellcovorin (leucovorin) for cerebral folate deficiency, a condition linked to "developmental delays with autistic features." This move follows a recent press conference where President Donald Trump, alongside Health Secretary Robert F. Kennedy Jr., suggested a potential connection between Tylenol use during pregnancy and rising autism rates.

NoahAI News9/24/2025
Cardiosense Appoints New CEO to Lead Growth of Wearable Heart Monitor

Cardiosense Appoints New CEO to Lead Growth of Wearable Heart Monitor

Cardiosense, a rising player in the wearable medical device industry, has announced the appointment of Eric Meizlish as its new CEO. This strategic move comes as the company seeks to capitalize on the recent 510(k) clearance of its CardioTag heart monitor and accelerate its growth in the competitive healthtech market.

NoahAI News9/24/2025
Hengrui Pharma Expands Global Reach with $1.1B ADC Deal

Hengrui Pharma Expands Global Reach with $1.1B ADC Deal

Jiangsu Hengrui Pharmaceuticals has announced a potential $1.1 billion licensing agreement with Glenmark Pharmaceuticals, marking another significant step in the Chinese company's global expansion strategy. The deal centers around trastuzumab rezetecan, Hengrui's antibody-drug conjugate (ADC) designed to rival AstraZeneca and Daiichi Sankyo's blockbuster drug Enhertu.

NoahAI News9/24/2025
Harmony Biosciences' Fragile X Trial Fails to Meet Primary Endpoint

Harmony Biosciences' Fragile X Trial Fails to Meet Primary Endpoint

Harmony Biosciences faced a significant setback as its pivotal trial for a Fragile X syndrome treatment failed to meet its primary endpoint. The company's $60 million investment in ZYN002, a synthetic cannabidiol, has encountered a major obstacle, casting doubt on the future of the drug candidate.

NoahAI News9/24/2025
Privia Health Acquires Evolent's ACO Business for $100M, Expanding Value-Based Care Footprint

Privia Health Acquires Evolent's ACO Business for $100M, Expanding Value-Based Care Footprint

Privia Health, a leading physician enablement company, has announced the acquisition of Evolent Health's accountable care organization (ACO) business, Evolent Care Partners, for $100 million in cash. The deal, which is expected to close in the fourth quarter, marks a significant expansion of Privia's value-based care network and reinforces its position in the rapidly evolving healthcare landscape.

NoahAI News9/24/2025
FDA Requests Additional Manufacturing Information for High-Dose Spinraza, Biogen Plans Prompt Resubmission

FDA Requests Additional Manufacturing Information for High-Dose Spinraza, Biogen Plans Prompt Resubmission

The U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Biogen regarding its application for a high-dose regimen of Spinraza (nusinersen) in the treatment of spinal muscular atrophy (SMA). The agency has requested updated technical information related to the chemistry, manufacturing, and controls (CMC) portion of the filing.

NoahAI News9/24/2025
Cyclerion Therapeutics Pivots to Neuropsychiatry with MIT-Licensed Technology

Cyclerion Therapeutics Pivots to Neuropsychiatry with MIT-Licensed Technology

Cyclerion Therapeutics, a Cambridge, Massachusetts-based biotech company, has announced a significant strategic shift, repositioning itself as a neuropsychiatric-focused entity. This move marks the latest in a series of pivots for the company, which has previously explored heart failure, sickle cell disease, and mitochondria-related disorders.

NoahAI News9/24/2025
CDC Advisory Committee Recommends Changes to MMRV Vaccine Schedule, Sparking Industry Debate

CDC Advisory Committee Recommends Changes to MMRV Vaccine Schedule, Sparking Industry Debate

The pharmaceutical industry is grappling with the implications of recent recommendations by the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) regarding the measles, mumps, rubella, and varicella (MMRV) vaccine schedule. The committee's decision has ignited discussions about vaccine safety, efficacy, and the role of healthcare providers in immunization choices.

NoahAI News9/24/2025
Biopharma Layoffs Surge as Companies Prioritize Cost-Cutting and Key Programs

Biopharma Layoffs Surge as Companies Prioritize Cost-Cutting and Key Programs

Pharmaceutical Industry Workforce Reshaping Amid Strategic Shifts and Market PressuresThe pharmaceutical and biotech sectors are experiencing significant workforce restructuring as companies navigate challenging market conditions, reprioritize pipelines, and realign resources. Recent months have seen a wave of layoffs affecting thousands of employees across numerous organizations, from industry giants to emerging biotechs.

NoahAI News9/24/2025
Manufacturing Issues Derail Scholar Rock's Spinal Muscular Atrophy Drug Approval

Manufacturing Issues Derail Scholar Rock's Spinal Muscular Atrophy Drug Approval

Scholar Rock's investigational myostatin blocker apitegromab for spinal muscular atrophy (SMA) has hit a roadblock in its path to approval. The U.S. Food and Drug Administration (FDA) declined to approve the drug, citing manufacturing issues at a third-party facility. This setback highlights the critical importance of manufacturing processes in drug development and approval.

NoahAI News9/24/2025
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