Camargo

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PDUFA VII: More Changes Coming in the Latest Reauthorization

Camargo

As we noted in a separate blog post , the forthcoming reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA VII) includes several provisions that are expected to help advance cell and gene therapy products, as well as therapies designed to treat rare diseases. However, the anticipated impact of PDUFA VII will extend well beyond those industry segments.

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The Composition and Value of a Portfolio Analysis

Camargo

One of Camargo’s differentiating offerings is the portfolio analysis, a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio. Informed by today’s competitive drug development landscape, as well as by the sponsor’s strategic goals and capabilities, a portfolio analysis involves assessing product concept and differentiation, strategic planning, factoring in unmet patient needs, and estimating timelines and e

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PDUFA VII: Implications for Developers of Cell and Gene Therapies

Camargo

One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA VII , as the reauthorization is commonly known, will cover the fiscal years 2023-2027. Many of the advancements included in PDUFA VII are driven in large part by an increase in the development of innovative products such as cell and gene therapies.

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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. When developing biologics, sponsors must manage several scientific considerations specific to large molecule products, including biochemical characterization studies to confirm structural identity, biological activity studies to confirm potency, and mechanism of action maintenance.

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In the News: November 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Voxzogo Approved as a Growth-Improvement Therapy for Children with Dwarfism. Biomarin has obtained FDA accelerated approval for Voxzogo (vosoritide), its first-in-class drug to increase linear growth in pediatric achondroplasia patients over the age of 5 with open epiphyses (growth plates).

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Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. When developing biologics, sponsors must manage several scientific considerations specific to large molecule products, including biochemical characterization studies to confirm structural identity, biological activity studies to confirm potency, and mechanism of action maintenance.

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Equal Parts Caregiver and Advocate: Clinical Trials from the Caregiver’s Point of View

Camargo

“There are only four kinds of people in the world: Those who have been caregivers, those who are currently caregivers, those who will be caregivers, and those who will need caregivers.”. ~ Roslyn Carter. Each November, National Family Caregiver Month recognizes and honors all those who have dedicated themselves to caring for ailing loved ones. It also helps raise awareness of the often-overwhelming issues they face, so that we can work together as a society to alleviate them.