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The Future of AI-Assisted Clinical Operations

Executive Summary Clinical operations sits at the heart of every successful clinical trial. The function is responsible for translating study protocols...
Commercial

BeOne Invests $300 Million to Add Small Molecule Manufacturing at New Jersey Campus

BeOne Medicines has announced a $300 million expansion of its manufacturing and research campus at the Princeton West Innovation...
Manufacturing

Novo Nordisk Sues Eli Lilly Over GLP-1 Drug Advertising Claims

Novo Nordisk has filed a lawsuit against Eli Lilly in U.S. District Court in New Jersey, accusing its rival...
Insights

The End of Siloed Drug Development

Executive Summary Drug development has never been more scientifically advanced—or more operationally complex. Pharmaceutical companies are simultaneously managing increasingly sophisticated therapeutic...
Clinical

Novartis Lets Go of Phase 2 Radioligand Therapy Following Clinic Disappointment

Novartis has ended development of one of its radioligand...
Insights

Top 10 Reasons Commercial AI Requires Stronger Governance in Pharma

Executive Summary Artificial intelligence (AI) is rapidly transforming pharmaceutical commercial...
Research & Development

Summit and Akeso Report Updated HARMONi Survival Data for Ivonescimab in Western NSCLC Patients

Summit Therapeutics and its partner Akeso have released updated overall survival data from the Phase 3 HARMONi trial, providing...
Technology

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 for the world's first table-integrated...
Insights

Top 10 Metrics Pharma Leaders Should Track During Digital Transformation

Executive Summary Digital transformation has become one of the pharmaceutical industry's most significant strategic priorities. Companies are investing billions in...
Uncategorized

Sarclisa Escena Wins FDA Approval for Subcutaneous Use in Multiple Myeloma

Sanofi has received approval from the U.S. Food and...
Clinical

Bausch + Lomb Ends BL1107 Glaucoma Program After Phase 2 Trial Misses Main Goal

Bausch + Lomb has decided to discontinue development of...
Research & Development

ARPA-H Awards Up to $160 Million for Personalized Genetic Medicine Development

The Advanced Research Projects Agency for Health (ARPA-H) has announced a new round of funding through its THRIVE program,...
Commercial

GSK views the Hansoh-partnered ADCs’ phase 3 victory in China as confirming its “priority asset.”

Hansoh Pharmaceutical's two eagerly awaited ADCs have continued to deliver support for partner GSK's promotion of them as a...
Insights

The Return of M&A as a Growth Strategy in Biopharma

Executive Summary Mergers and acquisitions (M&A) have long played a central role in shaping the global biopharmaceutical industry. For decades, pharmaceutical...
Regulatory

Merck Makes History By Getting FDA Green Light For Lipfendra

A decade after PCSK9 inhibitors first entered the market,...
Editorial Team -
Commercial

Novartis to combine its pharma and oncology operations to save $1 Billion

Novartis has opted for a corporate restructure of operations...
Commercial

Regenxbio And Nippon Sinyaku Pen $810M Gene Therapy Agreement

Regenxbio has struck a strategic partnership valued at $810...

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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 -

J&J MedTech presents the first Ottava surgical robot clinical cases

Johnson & Johnson MedTech successfully conducted the initial clinical use of Ottava surgical robot...
Editorial Team -

Regulatory

Regulatory

Merck Makes History By Getting FDA Green Light For Lipfendra

A decade after PCSK9 inhibitors first entered the market,...
Editorial Team -
Commercial

BeOne Invests $300 Million to Add Small Molecule Manufacturing at New Jersey Campus

BeOne Medicines has announced a $300 million expansion of...
Manufacturing

Novo Nordisk Sues Eli Lilly Over GLP-1 Drug Advertising Claims

Novo Nordisk has filed a lawsuit against Eli Lilly...
Insights

The End of Siloed Drug Development

Executive Summary Drug development has never been more scientifically advanced—or...
Clinical

Due to poor phase 2 data, Agios declares goodbye to the sickle cell program

Agios Pharmaceuticals has abandoned an indication for its next-generation...

Research & Development

Market Access

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

The Future of AI-Assisted Clinical Operations

Executive Summary Clinical operations sits at the heart of every...
Editorial Team -
Manufacturing

Novo Nordisk Sues Eli Lilly Over GLP-1 Drug Advertising Claims

Novo Nordisk has filed a lawsuit against Eli Lilly...
Editorial Team -