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J&J’s Bispecific Combination Works Wonders on Myeloma Progression in Phase 3 Study

Johnson & Johnson has reported striking Phase 3 results for its dual bispecific antibody regimen in earlier-line multiple myeloma,...

Top 10 Reasons Drug Development Timelines Remain Difficult to Compress

Executive Summary The pharmaceutical industry has made remarkable advances in accelerating drug development. Artificial intelligence (AI), decentralized clinical trials, real-world...

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...

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...

The End of Siloed Drug Development

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

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

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

Novartis Lets Go of Phase 2 Radioligand Therapy Following Clinic Disappointment

Novartis has ended development of one of its radioligand therapy (RLT) candidates after less-than-stellar clinical results halted its progress. The...

Top 10 Reasons Commercial AI Requires Stronger Governance in Pharma

Executive Summary Artificial intelligence (AI) is rapidly transforming pharmaceutical commercial operations. From customer segmentation and omnichannel engagement to content generation,...

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...

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...

Top 10 Metrics Pharma Leaders Should Track During Digital Transformation

Executive Summary Digital transformation has become one of the pharmaceutical...

Sarclisa Escena Wins FDA Approval for Subcutaneous Use in Multiple Myeloma

Sanofi has received approval from the U.S. Food and Drug Administration for Sarclisa Escena, a subcutaneous formulation of its...

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

Bausch + Lomb has decided to discontinue development of its investigational glaucoma eye drop BL1107 after the treatment failed...

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,...

Merck Makes History By Getting FDA Green Light For Lipfendra

A decade after PCSK9 inhibitors first entered the market,...

Eli Lilly Invests $250 Million to Strengthen Ties with Purdue University

Eli Lilly is deepening its investment in Indiana by...

Novo Nordisk Set to Slash Victoza Production to Boost Ozempic Supply

In response to the escalating demand for its GLP-1...

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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...

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...

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...

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

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

Regulatory

Merck Makes History By Getting FDA Green Light For Lipfendra

A decade after PCSK9 inhibitors first entered the market,...

Top 10 Reasons Drug Development Timelines Remain Difficult to Compress

Executive Summary The pharmaceutical industry has made remarkable advances in...

The Future of AI-Assisted Clinical Operations

Executive Summary Clinical operations sits at the heart of every...

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

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

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

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

Research & Development

Market Access

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...

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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The Future of AI-Assisted Clinical Operations

Executive Summary Clinical operations sits at the heart of every...