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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...
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 to evaluate lower maintenance doses of its oral obesity treatment...
Insights

Quantum Computing and Drug Discovery

Executive Summary Pharmaceutical drug discovery is fundamentally a problem of understanding molecules. Researchers need to determine how compounds interact with biological...
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...
Commercial

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

Leo Pharma is continuing its push to expand its...
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 may support further investigation of CytoDyn’s CCR5-targeting antibody leronlimab in...
Insights

Why Data Is Becoming Pharma’s Most Valuable Asset

Pharma's:Executive Summary For decades, pharmaceutical companies have built competitive advantage around scientific expertise, intellectual property, manufacturing capabilities, commercial reach, and...
Commercial

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

PTC Therapeutics has agreed to acquire Sangamo Therapeutics’ ST-920...
Commercial

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

While the FDA considers whether to approve Takeda and...
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...
Insights

Reinventing the Pharmaceutical Commercial Model

Executive Summary The pharmaceutical commercial model is entering a period of structural change. For decades, commercial organizations have relied on relatively...
Commercial

Eli Lilly Files Six Lawsuits Over Sales of Unapproved Retatrutide

Eli Lilly has filed six new lawsuits in the United States as part of its effort to combat the...
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

Madrigal Signs Licensing Deal with CSPC for Preclinical GLP-1 Candidate in $2 Billion Agreement

Madrigal Pharmaceuticals has entered into a licensing agreement with...
Commercial

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

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

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Commercial

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...
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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...
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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...
Editorial Team -

Regulatory

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...
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...

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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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...
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