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Regulatory

FDA Clears Jazz’s Ziihera for First-Line Treatment of HER2-Positive Gastroesophageal Cancer

Jazz’s ;The U.S. Food and Drug Administration has approved Jazz Pharmaceuticals’ Ziihera (zanidatamab-hrii) for previously untreated adults with unresectable,...
Insights

Why AI Agents Will Become Every Pharmaceutical Employee’s Copilot

Executive Summary Artificial intelligence is moving from a technology employees use to a capability that works alongside them. Pharmaceutical companies have...
Insights

How Digital Twins Are Transforming Drug Development

Executive Summary Drug development is becoming increasingly data-driven, computational, and personalized. Yet pharmaceutical companies still rely heavily on physical experiments...
Regulatory

FDA Extends Review of Capricor’s Deramiocel for Duchenne Muscular Dystrophy to November

The U.S. Food and Drug Administration (FDA) has extended its review of Capricor Therapeutics’ investigational cell therapy deramiocel for...
Insights

Top 10 Digital Commercial Excellence Strategies

Executive Summary Pharmaceutical commercial organizations are undergoing a fundamental shift...
Insights

AI-Powered Protocol Design

Executive Summary Clinical trial protocols determine how studies are designed,...
Regulatory

J&J Gets First-Ever FDA Label Expansion For Imaavy

Just 16 months after securing its first FDA green light for Imaavy, Johnson & Johnson has expanded the monoclonal...
Commercial

Roche Licenses Hanmi’s HM17321 Obesity Candidate in Deal Worth Up to $2.3 Billion

Roche, through its subsidiary Genentech, has entered into a licensing agreement with South Korea-based Hanmi Pharm for HM17321, an...
Technology

Suki Launches AI Dictation Tool Integrated With Epic and Meditech EHRs

Suki announced Tuesday the release of Suki Dictation, an artificial intelligence-powered dictation solution designed for healthcare organizations. The tool...
Regulatory

Teva Faces New Competition Investigation in Turkey Over Generic Drug Access

Teva Pharmaceutical Industries is facing a new competition investigation...
Insights

How Digital Twins Are Transforming Drug Development

Executive Summary Drug development is becoming increasingly data-driven, computational, and...
Insights

Why Every Pharma Company Needs a Unified Data Platform

Pharma Company:Executive Summary Pharmaceutical companies have never had more data. Research organizations generate molecular and genomic information. Clinical teams produce trial...
Insights

AI-Powered Pharma Customer Engagement

Executive Summary Pharmaceutical customer engagement is undergoing a fundamental shift. Healthcare professionals (HCPs) are exposed to growing volumes of scientific information,...
Regulatory

Osivax Gets Flu Vaccine License to Go For Combo Shot Vision

Osivax has obtained a license from GC Biopharma for its influenza vaccine, giving the French biotech an opportunity to...
Commercial

Kroger Health Joins Hands With Performance Kitchen to Provide Medically Tailored Food

Kroger Health, a division of the Kroger Company, has...
Commercial

Glenmark Strikes Biotech Deal with AbbVie

Under the terms of the agreement, AbbVie has secured...

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Commercial

Information Technology

Suki Launches AI Dictation Tool Integrated With Epic and Meditech EHRs

Suki announced Tuesday the release of Suki Dictation, an artificial intelligence-powered dictation solution designed...
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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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Regulatory

Insights

Why AI Agents Will Become Every Pharmaceutical Employee’s Copilot

Executive Summary Artificial intelligence is moving from a technology employees...
Insights

How Digital Twins Are Transforming Drug Development

Executive Summary Drug development is becoming increasingly data-driven, computational, and...
Regulatory

FDA Extends Review of Capricor’s Deramiocel for Duchenne Muscular Dystrophy to November

The U.S. Food and Drug Administration (FDA) has extended...
Clinical

Ambros and Werewolf Merge as Neridronate Advances in Phase 3 Trial for CRPS-1

Ambros Therapeutics and Werewolf Therapeutics have entered into an...

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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Insights

How Digital Twins Are Transforming Drug Development

Executive Summary Drug development is becoming increasingly data-driven, computational, and...
Editorial Team -