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What an Autonomous Clinical Trial Might Look Like by 2030

Executive Summary Clinical trials are undergoing one of the most significant transformations in pharmaceutical history. Advances in artificial intelligence (AI), digital...
Regulatory

Takeda’s Orzeyful Approved as First Orexin Agonist for Narcolepsy Type 1

The U.S. Food and Drug Administration (FDA) has approved Takeda’s oveporexton, which will be marketed under the brand name...
Commercial

The biggest pharmaceutical deal ever would be the “unlikely” AstraZeneca-BMS mega-merger

Word spread that two big pharma players, Bristol Myers Squibb and AstraZeneca, each valued at more than $130 billion,...
Commercial

Supernus and Indivior Agree to Create CNS-Focused Company in All-Stock Merger

Supernus Pharmaceuticals and Indivior Pharmaceuticals have agreed to combine in an all-stock merger that will create a central nervous...
Commercial

Hinge Health to Buy Out Cylinder Health in a Deal Worth Over $100M

Hinge Health has agreed to acquire digital gastrointestinal care...
Technology

Claryx Appears From Stealth to Deal with the $45B Hospital-Acquired Infections Issue

Healthcare-related infections remain a persistent challenge for hospitals, affecting...
Clinical

Merck’s Tulisokibart Misses Phase 2 Endpoint in SSc-ILD but Meets Goals in HS Trial

Merck & Co. has reported mixed clinical results for tulisokibart, its investigational anti-TL1A monoclonal antibody, with a Phase 2...
Insights

The New Competitive Advantage in Biopharma Isn’t Science Alone

Executive Summary For decades, scientific innovation has been the defining competitive advantage in biopharmaceuticals. Companies that discovered breakthrough molecules, developed novel...
Insights

Why Protocol Complexity Continues to Threaten Trial Success

Executive Summary Clinical trials remain the foundation of pharmaceutical innovation, but their increasing complexity has become one of the industry's...
Regulatory

FDA Grants Full Approval to Fabhalta for IgA Nephropathy

Novartis has received full approval from the U.S. Food...
Clinical

After phase 3 data ended blockbuster hopes, GSK eliminated a major cough medication candidate

Analysis of the phase 3 results on camlipixant, which...
Commercial

Dimerix Acquires Phase 2-Ready AKI Drug DMX-652 From Mission Therapeutics

Dimerix has acquired DMX-652, a phase 2-ready drug candidate for acute kidney injury (AKI), from Mission Therapeutics in a...
Insights

Top 10 Strategic Priorities for Pharmaceutical Leaders in 2026

Executive Summary The pharmaceutical industry is entering a period of profound transformation. While scientific innovation remains the foundation of long-term...
Insights

Why Data Quality Is Becoming Pharma’s Biggest AI Challenge

Executive Summary Artificial intelligence (AI) has become one of the pharmaceutical industry's most important strategic priorities. Companies are investing heavily in...
Regulatory

Takeda’s Orzeyful Approved as First Orexin Agonist for Narcolepsy Type 1

The U.S. Food and Drug Administration (FDA) has approved...
Editorial Team -
Commercial

AstraZeneca’s Phase III Lung Cancer Data Fails to Hit the Mark With Investors

AstraZeneca announced the main findings of a Phase III...
Commercial

Sanofi Acquires Vigil Neuroscience for $470M to Boost Alzheimer’s Drug Pipeline

Sanofi is acquiring Vigil Neuroscience for $470 million to...

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Claryx Appears From Stealth to Deal with the $45B Hospital-Acquired Infections Issue

Healthcare-related infections remain a persistent challenge for hospitals, affecting roughly one in every 40...
Editorial Team -

J&J’s OTTAV Robotic Surgical System has received FDA market authorization in the U.S.

The U.S. Food and Drug Administration (FDA) granted Johnson & Johnson De Novo clearance...
Editorial Team -

Alnylam Inks $2B Agreement With Inceptive to Change sIRNA Design With AI Leader

Alnylam has entered into a partnership with the scientist instrumental in developing the technology...
Editorial Team -

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...
Editorial Team -

Regulatory

Regulatory

Takeda’s Orzeyful Approved as First Orexin Agonist for Narcolepsy Type 1

The U.S. Food and Drug Administration (FDA) has approved...
Editorial Team -
Regulatory

Takeda’s Orzeyful Approved as First Orexin Agonist for Narcolepsy Type 1

The U.S. Food and Drug Administration (FDA) has approved...
Commercial

The biggest pharmaceutical deal ever would be the “unlikely” AstraZeneca-BMS mega-merger

Word spread that two big pharma players, Bristol Myers...
Commercial

Supernus and Indivior Agree to Create CNS-Focused Company in All-Stock Merger

Supernus Pharmaceuticals and Indivior Pharmaceuticals have agreed to combine...
Insights

From Data-Rich to Insight-Rich: Pharma’s Next Transformation

Executive Summary The pharmaceutical industry has become one of the...

Research & Development

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Manufacturing

Avalyn Files for IPO Targeting Up to $209.7 Million to Advance Inhaled Lung Therapies

Avalyn Pharma, a Boston-based company focused on inhaled therapies...
Manufacturing

Replimune Cuts 224 Jobs in Massachusetts After Second FDA Rejection of RP1

Replimune is reducing its workforce by 224 employees across...

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Insights

What an Autonomous Clinical Trial Might Look Like by 2030

Executive Summary Clinical trials are undergoing one of the most...
Editorial Team -