CLL Market Snapshot: Seismic Changes Rock The Treatment Landscape

The market for chronic lymphocytic leukemia drugs is undergoing big changes, with three new drugs approved: Roche’s antibody Gazyva and two oral therapies from Pharmacyclics/J&J and Gilead. Side effect profiles, administration and progression-free survival rates are helping to guide treatment decisions.

Long quiet and undisrupted, the landscape for treating the typically indolent disease chronic lymphocytic leukemia is now being transformed by the introduction of a trio of new drugs, with more on the way.

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What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up

 
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The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
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DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

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DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
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DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

Aragen’s CEO Says NIH Funding Cut Means Less R&D Money, And Tariffs Would Add To Woes

 
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Aragen’s CEO Manni Kantipudi, who is keenly watching the Trump Administration’s moves on pharma tariffs, discusses funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, and talks with the Indian government to solve intellectual property challenges in an interview.

‘Come Early, Come Often,’ EMA Chief Tells Industry

 

The European Medicines Agency’s chief, Emer Cooke, explained how the agency could help companies with their drug development plans, and said the EU Health Technology Assessment Regulation would help companies design clinical trials that are fit for regulators and HTA bodies.