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Regulatory

Takeda’s Qdenga Makes History as First Vaccine to Get the Nod in India

Takeda has secured approval from the Drug Controller General of India (DCGI) for Qdenga, making it the first vaccine...
Commercial

Tempus purchases a specialist in cancer genomics in a $1.5 billion deal: Personalis

Since the two first joined forces in oncology three years ago, Tempus is expanding its cancer programs with plans...
Insights

How RNA Therapeutics Are Expanding Beyond Rare Diseases

Executive Summary RNA therapeutics have emerged as one of the most significant innovations in modern medicine. Initially developed to address rare...
Commercial

Samsung Biologics Plans $1.8 Billion Acquisition of PolyPeptide

Samsung Biologics has announced plans to acquire Swiss contract development and manufacturing organization (CDMO) PolyPeptide in a transaction valued...
Regulatory

Amgen Submits FDA Hearing Request to Defend Tavneos for ANCA-Associated Vasculitis

Amgen has submitted a package of data and analyses...
Clinical

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

Johnson & Johnson has reported striking Phase 3 results...
Uncategorized

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...
Insights

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...
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 activator of pyruvate kinase (PK) in sickle cell disease (SCD)...
Clinical

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...
Insights

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,...
Regulatory

Takeda’s Qdenga Makes History as First Vaccine to Get the Nod in India

Takeda has secured approval from the Drug Controller General...
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Commercial

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

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

Regulatory

Takeda’s Qdenga Makes History as First Vaccine to Get the Nod in India

Takeda has secured approval from the Drug Controller General...
Editorial Team -
Commercial

Tempus purchases a specialist in cancer genomics in a $1.5 billion deal: Personalis

Since the two first joined forces in oncology three...
Insights

How RNA Therapeutics Are Expanding Beyond Rare Diseases

Executive Summary RNA therapeutics have emerged as one of the...
Commercial

Samsung Biologics Plans $1.8 Billion Acquisition of PolyPeptide

Samsung Biologics has announced plans to acquire Swiss contract...
Clinical

Sanofi Ends Amlitelimab Development in Atopic Dermatitis After Phase 3 Program Review

Sanofi has decided to stop pursuing amlitelimab for atopic...

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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Regulatory

Takeda’s Qdenga Makes History as First Vaccine to Get the Nod in India

Takeda has secured approval from the Drug Controller General...
Editorial Team -
Insights

How RNA Therapeutics Are Expanding Beyond Rare Diseases

Executive Summary RNA therapeutics have emerged as one of the...
Editorial Team -