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Clinical

BioMarin’s BMN 401 Meets One Primary Goal but Misses Clinical Endpoint in Late-Stage ENPP1 Deficiency Trial

BioMarin Pharmaceutical said its experimental enzyme replacement therapy BMN 401 met one of two primary goals in a late-stage...
Regulatory

AstraZeneca receives approval for blood pressure medication

AstraZeneca's baxdrostat is approved by the FDA to treat blood pressure in patients with uncontrolled hypertension. The drug, to...
Clinical

Regeneron’s Melanoma Drug Underperforms in Phase 3 Trial

A phase 3 study of Regeneron Pharmaceuticals’ LAG-3 inhibitor failed to achieve its primary endpoint, marking the company’s second...
Insights

Will AI Replace Traditional CRO Models in Clinical Research?

Executive Summary Artificial intelligence is reshaping clinical research, but it is not simply replacing existing operational models—it is redistributing how...
Regulatory

Following FDA hold, Aardvark will examine phase 3 data early

Aardvark Therapeutics is set to disclose results from its...
Manufacturing

Takeda Plans 4,500 Job Cuts as CEO Transition and Three Drug Launches Approach

Takeda has outlined plans to reduce around 4,500 roles...
Clinical

Alkermes Reports Positive Phase 3 Results for Lumryz in Idiopathic Hypersomnia

Alkermes reported that its phase 3 Revitalyz study of sodium oxybate treatment Lumryz met all primary and key secondary...
Clinical

Good News For Enterprise As It Announces Phase 2 Cystic Fibrosis Victory

A phase 2 study of Enterprise Therapeutics’ cystic fibrosis (CF) therapy candidate achieved its primary goal, advancing the biotech’s...
Insights

What Happens When AI Becomes a Scientific Co-Pilot?

Executive Summary Artificial intelligence is rapidly evolving from a background automation tool into an active scientific co-pilot capable of supporting...
Insights

Digital Twins in Healthcare: Hype, Reality, and Future Applications

Executive Summary Digital twins are emerging as one of the...
Insights

How Pharmaceutical Companies Are Using AI for Faster Regulatory Submissions

Executive Summary Pharmaceutical companies are increasingly using artificial intelligence to...
Commercial

Novo Pens Deal With Cellular Intelligence to Advance Parkinson’s Cell Therapy

Over six months after Novo Nordisk withdrew from the cell therapy sector, its Parkinson’s disease program appears to have...
Uncategorized

Partner Therapeutics’ Bizengri Grabs FDA Green Light

The FDA’s seventh approval under its pilot program highlights the agency’s ability to accelerate drug reviews through the U.S....
Manufacturing

Daiichi Revises ADC Supply Plans After Changes in Cancer Drug Demand Forecasts

Daiichi Sankyo said changes in projected demand for several antibody-drug conjugate (ADC) cancer medicines in its pipeline and commercial...
Regulatory

AstraZeneca receives approval for blood pressure medication

AstraZeneca's baxdrostat is approved by the FDA to treat...
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Chugai and Gero Partner to Develop Antibodies for Age-Related Diseases Using AI

Chugai Pharmaceutical has entered into a research collaboration with Singapore-based Gero to develop antibody-based...
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J&J MedTech presents the first Ottava surgical robot clinical cases

Johnson & Johnson MedTech successfully conducted the initial clinical use of Ottava surgical robot...
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Wisp Launches Weight Care Vertical for Women with Hormonal Imbalances

Common conditions in women such as PCOS, menopause, and endometriosis often lead to hormonal...
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PicnicHealth Launches New Service Bringing Observational Clinical Trials to the Virtual Realm

Health technology company PicnicHealth has launched a new product, Virtual Site, which allows researchers...
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Regulatory

Regulatory

AstraZeneca receives approval for blood pressure medication

AstraZeneca's baxdrostat is approved by the FDA to treat...
Editorial Team -
Regulatory

AstraZeneca receives approval for blood pressure medication

AstraZeneca's baxdrostat is approved by the FDA to treat...
Clinical

Regeneron’s Melanoma Drug Underperforms in Phase 3 Trial

A phase 3 study of Regeneron Pharmaceuticals’ LAG-3 inhibitor...
Insights

Will AI Replace Traditional CRO Models in Clinical Research?

Executive Summary Artificial intelligence is reshaping clinical research, but it...
Insights

The New Competitive Advantage in Life Sciences: Real-Time Data Intelligence

Executive Summary Life sciences organizations are entering a new era...

Research & Development

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Manufacturing

Cellares Raises $257 Million Series D to Expand Global Cell Therapy Manufacturing

Cellares has raised $257 million in a Series D...
Manufacturing

Recipharm Commissions Bengaluru Facility for Nonbacterial Beta-Lactam Tablet Manufacturing

Swedish contract development and manufacturing organization (CDMO) Recipharm has...

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Clinical

Regeneron’s Melanoma Drug Underperforms in Phase 3 Trial

A phase 3 study of Regeneron Pharmaceuticals’ LAG-3 inhibitor...
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