Featured Articles
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An Updated View Of The Federal Segment: Veterans Affairs Formulary Management
7/24/2024
As the largest integrated healthcare provider in the U.S., the VA presents tremendous opportunity for life sciences companies. This article provides actionable information about the VA's drug benefit design, drug pricing, clinical guidance, and formulary placement and management.
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COVID-19 Is Back: Are We "FLiRT"-ing With Another Disaster?
7/22/2024
A combination of vaccine hesitancy and the emergence of new COVID-19 virus strains is prolonging health risks, particularly for older individuals and patients with underlying medical conditions. Vaccine developers must remain committed to updating vaccines and producing better treatments.
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The Keys To Biotech Success: People And Relationships
7/19/2024
Sofinnova managing partner Henrijette Richter discusses the ingredients and recipe needed for biotech startup success.
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When Consumer Protection, Unfair Trade Practices, And AI Collide
7/18/2024
The EU, and a growing number of U.S. state governments, are extending consumer protection laws to AI technologies. Life sciences companies should monitor new policy developments and understand how and where specific uses of AI will be regulated.
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Companies To Watch: Athira Pharma
7/16/2024
Athira Pharma is developing small molecule therapeutics for neurodegenerative diseases, including its lead candidate, fosgonimeton, for Alzheimer's disease.
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USPTO Proposed 'Terminal Disclaimer' Rule Could Impact Life Science Patent Protections
7/15/2024
A proposed rule change by the USPTO to tie patent validity together based on the filing of terminal disclaimers would have a significant impact on how life sciences patents are prosecuted.
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Reading The Room In Oncology Drug Development
7/11/2024
Oral conversations with the FDA about trial design and protocol can lead to questions, and answers, that help drug developers avoid costly surprises and misunderstandings.
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Correct But Misleading: AI Hallucinations In Complex Decision-Making
7/11/2024
Managing risks associated with AI hallucinations requires "explainability," a process that identifies patterns or behaviors in AI models that are inconsistent with training data or logical expectations. Regulators are mandating transparency in AI models used for drug testing and development.
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Patient Access Challenges Are Changing Pharma Investment Strategies
7/9/2024
Downward pressure on drug prices is causing biopharmaceutical companies to focus more time and energy on market access strategies — such as coverage and reimbursement scenario mapping, evidence generation, and resource development planning — much earlier in product development.
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Could GenAI Dramatically Reduce The Cost Of Regulatory Medical Writing?
7/3/2024
Time-poor regulatory professionals stand to benefit substantially from generative AI, which can speed up the creation of marketing authorization applications or life cycle maintenance activities, for example. However, success will depend on how the technology is applied and controlled.