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Clinical

Novartis Reports Positive Phase 3 Results for Rhapsido in Relapsing Multiple Sclerosis

Novartis has reported positive results from two phase 3 clinical trials evaluating Rhapsido (remibrutinib) in relapsing multiple sclerosis (MS),...
Manufacturing

ArsenalBio Lays Off 99 Employees and Shifts Focus to In Vivo CAR-T Programs

Arsenal Biosciences (ArsenalBio) is reducing its workforce by 99 employees as part of a strategic transition toward the development...
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...
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...
Insights

Top 10 Digital Commercial Excellence Strategies

Executive Summary Pharmaceutical commercial organizations are undergoing a fundamental shift from traditional sales models toward digitally enabled, data-driven operating models....
Insights

AI-Powered Protocol Design

Executive Summary Clinical trial protocols determine how studies are designed, which patients are eligible, what data is collected, and how...
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...
Technology

Suki Launches AI Dictation Tool Integrated With Epic and Meditech EHRs

Suki announced Tuesday the release of Suki Dictation, an...
Regulatory

Teva Faces New Competition Investigation in Turkey Over Generic Drug Access

Teva Pharmaceutical Industries is facing a new competition investigation in Turkey over allegations that certain patent and regulatory practices...
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...
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...
Commercial

Clinical-stage Pieris Pharma signs agreement with Genentech for respiratory and ophthalmology therapies

As if the partnerships with Boston Pharmaceuticals, AstraZeneca, and Servier were not enough for the biotech firm,
Commercial

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

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

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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

Manufacturing

ArsenalBio Lays Off 99 Employees and Shifts Focus to In Vivo CAR-T Programs

Arsenal Biosciences (ArsenalBio) is reducing its workforce by 99...
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...
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...

Research & Development

Market Access

Manufacturing

Daiichi Revises ADC Supply Plans After Changes in Cancer Drug Demand Forecasts

Daiichi Sankyo said changes in projected demand for several...
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...

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Manufacturing

Aura Biosciences Refocuses on Ocular Oncology Programs and Cuts Workforce by 20%

Aura Biosciences is restructuring its operations under recently appointed...
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