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The Future of Global Drug Regulation

Executive Summary Drug regulation is entering a period of significant transformation. For decades, pharmaceutical regulation has relied on established scientific standards,...
Insights

Why Pharmaceutical Companies Need AI Factories

Executive Summary Artificial intelligence is moving from experimentation to infrastructure. Pharmaceutical companies have spent the past several years testing AI across...
Regulatory

Phase 3 of Merck and Moderna’s customized cancer vaccine lowers recurrence, paving the way for approval

Key Trial Breakthrough in Skin Cancer The personalized mRNA cancer vaccine developed by Merck & Co. and Moderna has proven...
Regulatory

FDA Issues Warning Letters to Aurobindo’s Eugia Unit and Tianjin Kilo Pharmaceutical

The U.S. Food and Drug Administration (FDA) has issued warning letters to Aurobindo Pharma’s sterile injectables and oncology subsidiary...
Insights

Quantum Computing and Drug Discovery

Executive Summary Pharmaceutical drug discovery is fundamentally a problem of...
Regulatory

After a GLP-1 inhibitor lowers blood sugar crashes in a Ph. 3 victory, Amylyx prepares to push for approval

A $35 Million GLP-1 Bet Pays Off It looks like...
Clinical

Biokin’s Iza-Bren Meets Primary Endpoint in Phase 3 Panku-Lung01 Lung Cancer Trial

Biokin Pharma reported positive results from the phase 3 Panku-Lung01 study of iza-bren, its EGFRxHER3 bispecific antibody-drug conjugate (ADC)...
Commercial

Leo Pharma Pens Mega Deal to Buy Tanabe’s Skin Disease Drug

Leo Pharma is continuing its push to expand its pipeline this year, agreeing to pay up to $435 million...
Clinical

Definium Bags Major Phase 3 Victory With LSD Formula

Definium Therapeutics has scored another phase 3 success with its LSD-based therapy, this time demonstrating positive results in generalized...
Research & Development

Oregon Study Finds Triple-Drug Regimen Kept Infant Macaques HIV-Free for One Year

New research involving infant macaques has produced findings that...
Insights

Why Data Is Becoming Pharma’s Most Valuable Asset

Pharma's:Executive Summary For decades, pharmaceutical companies have built competitive advantage...
Commercial

PTC Therapeutics Acquires ST-920 Fabry Disease Gene Therapy Program From Sangamo

PTC Therapeutics has agreed to acquire Sangamo Therapeutics’ ST-920 Fabry disease gene therapy program, gaining control of a treatment...
Commercial

Zealand Bags Huge Money By Selling Rights to Takeda’s Blood Cancer Drug

While the FDA considers whether to approve Takeda and Protagonist Therapeutics' rusfertide, Zealand Pharma has monetized its remaining economic...
Clinical

Taiho and Cullinan Report Phase 3 Progression-Free Survival Win for Zipalertinib

Taiho Pharmaceutical and Cullinan Therapeutics announced that their investigational EGFR inhibitor zipalertinib, combined with platinum-based chemotherapy, met the primary...
Commercial

Leo Pharma Pens Mega Deal to Buy Tanabe’s Skin Disease Drug

Leo Pharma is continuing its push to expand its...
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Commercial

Lilly Continues Good M&A Run With $2.3B Deal For JAK Inhibitor Biotech Ajax

Eli Lilly continues its rapid pace of dealmaking, announcing...
Commercial

Celltrion Healthcare introduces a biosimilar version of Humira called Yuflyma, in the US

Celltrion Healthcare, a biopharmaceutical company based in South Korea,...

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Information Technology

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...
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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 -

Regulatory

Insights

Why Pharmaceutical Companies Need AI Factories

Executive Summary Artificial intelligence is moving from experimentation to infrastructure. Pharmaceutical...
Regulatory

Phase 3 of Merck and Moderna’s customized cancer vaccine lowers recurrence, paving the way for approval

Key Trial Breakthrough in Skin Cancer The personalized mRNA cancer...
Regulatory

FDA Issues Warning Letters to Aurobindo’s Eugia Unit and Tianjin Kilo Pharmaceutical

The U.S. Food and Drug Administration (FDA) has issued...
Research & Development

Novo Launches Late-Stage Trial of Lower-Dose Wegovy Pill for Weight Management

Novo Nordisk has started a new late-stage clinical study...

Research & Development

Market Access

Manufacturing

Lilly Adds $4.5 Billion to Indiana Manufacturing Expansion, Total U.S. Commitments Exceed $50 Billion

Eli Lilly has announced an additional $4.5 billion investment...
Manufacturing

Lilly and Profluent Sign Up to $2.25 Billion Collaboration to Develop AI-Designed Genetic Medicines

Eli Lilly has entered into a multi-program research collaboration...

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Insights

The Future of Global Drug Regulation

Executive Summary Drug regulation is entering a period of significant...
Editorial Team -
Manufacturing

Ensoma Restructures Operations to Focus on EN-374 for X-Linked Chronic Granulomatous Disease

Boston-based biotechnology company Ensoma has carried out another organizational...
Editorial Team -