Industry Insights

51. How T3P Is Helping To Advance API Development 5/16/2024

    Uncover how innovative reagent selection accelerates the development of promising drug-like molecules in challenging research environments.

52. Sorriso's Path To Oral Biologics Dosing Is Through The Gut 6/30/2025

    Following positive results from a Phase 1b trial, company leaders describe scaling their yeast expression and spray-drying processes as they prepare for Phase 2.

53. Your Drug Or Mine? Managing Drug Delivery Device Differentiation Hazards 5/13/2020

    To ensure that patients receive the correct product and medication dosage and to minimize the potential for medication error, drug delivery devices must be designed both to be differentiable from similar products and also to facilitate distinguishability between varying doses of the same medication.

54. Are There Business Benefits To Serialization Beyond Compliance? 6/18/2015

    This may seem a complex question to answer as you begin your serialization journey. It is difficult to look beyond the significant challenges that lie ahead in this undoubtedly complex project — initial funding and stakeholder engagement, vendor selection and delivery adherence, 

55. Measuring The Impact Of Reforms On India's Clinical Trial Environment 10/12/2017

    The clinical trial environment in India has seen a downward trend since 2013, when the government approached the Supreme Court regarding the death of 2,644 volunteers during clinical trials over seven years.

56. Genentech v. Amgen Federal Circuit Judgment: What Did We Learn? 8/18/2020

    The Federal Circuit recently issued Rule 36 judgments in two separate BPCIA cases: Genentech v. Amgen and Janssen v. Celltrion. Because the Federal Circuit decided both appeals without opinion, several open questions remain unresolved regarding BPCIA litigation. This two-part article explores those questions, starting with Genentech v. Amgen.

57. Advanced Process Risk Assessment And Control Strategy Development In Solid Oral Dosage Forms 6/5/2025

    Using four solid oral dosage drugs representing distinct manufacturing strategies, this article showcases that risk-based thinking and robust control strategies mitigates process variability.

58. New US Legislation Creates Momentum For Biosimilars 6/25/2021

    Most biosimilars (follow-on biologic products) still only have shares below 50% in the U.S., which is far different than market shares in Europe. One major reason is a mistrust around biosimilars’ safety and efficacy. Congress has stepped in to address that issue through the Advancing Education on Biosimilars Act of 2021, with the goal of encouraging rapid uptake soon after biosimilars become commercially available.

59. Patenting Functionally Claimed Biological Compounds After Amgen V. Sanofi 7/10/2023

    Snell & Wilmer attorneys discuss the recent SCOTUS decision to uphold the Federal Circuit's holding that Amgen’s patent claims for functionally claimed antibodies were invalid for failing to meet the enablement requirement. The attorneys share what this means for the industry going forward.

60. Meet The Scientist — Dr. Peng Zhang

    While pursuing a career as a medical doctor, Peng Zhang realized there were limited treatments for patients suffering from a variety of diseases. She made the decision to fill that void by focusing on discovering and developing therapeutics.