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Aevitas to sell sCFH asset rights to 4D Molecular

Pharmaceutical Technology

sCFH is an engineered and improved version of complement factor H (CFH) that can fit into adeno-associated virus (AAV) vectors with solid expression and applications confirmed in cultured human cells in vitro, in addition to various preclinical animal models in vivo. The firm will also receive single-digit royalties on net sales.

In-Vivo 130
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HP&M Welcomes Senior FDA Official, Ana Loloei, to the Firm

FDA Law Blog

Loloei tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions. While at FDA, Ms. During her FDA tenure, Ms. Gibbs , HP&M Director.

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Top 30 New Medical Devices of 2024

XTalks

From non-invasive cancer diagnostics to life-saving cardiovascular implants, the latest medical devices cleared or approved by the FDA in 2024 reflect the remarkable strides in science and engineering. TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR).

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New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry

pharmaphorum

Websites – Companies can use appropriate search engine optimisation (SEO) and marketing tools to ensure that their websites are displayed high on the list of results for relevant key word searches. Why is guidance needed? What is the scope of the Guidance? Companies can sponsor website content if the role of the company is made clear.

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HP&M Files Comments Opposing FDA’s Proposed LDT Rule

FDA Law Blog

filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices. Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation. Javitt — On Monday, Hyman, Phelps & McNamara, P.C.

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April’s Regulatory Focus: Professional and career development

The Pharma Data

Many in the regulatory profession have transitioned from an established previous career such as engineering, law, or bench research. Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . .

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The Challenges and Promise of CAR T-Cell Therapy in Oncology

XTalks

Such challenges highlight a significant unmet need and call for further advancements in the field. Vittoria Biotherapeutics is a clinical-stage cell therapy company that incorporates the latest advancements in cell therapy and gene editing with a unique approach that potentially overcomes some of the issues with this therapeutic modality.