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Obesity care gets personalised: tailoring therapies with Phenomix

Drug Target Review

GLP-1 receptor agonists are a class of medications that mimic glucagon-like peptide-1 (GLP-1), a hormone that helps regulate blood sugar and appetite. Prior to founding Naia, Mark served as CEO of GenturaDx until its successful sale to Luminex Corporation in 2012. GenturaDxs technology is the basis of Luminexs acclaimed Aries platform.

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FDA Inspections: Lesson 1 – Interviewing Employees

FDA Law Blog: Biosimilars

Although FDA has long taken the position that it has broad authority in how it conducts its inspections, it was not until 2012 that Congress put some teeth behind FDAs policy position. Now, guidances are generally not legally binding, unlike statutes or regulations. FDA Guidance , at 8 (emphasis added). If so, please call us.)

FDA
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A Visual Guide to Genome Editors

Codon

One of the great innovations reported in the Doudna and Charpentier labs’ 2012 paper was showing that these two RNA segments could be combined into a single guide RNA, a simplification making the gene-editing tool much easier to work with.) Visit our website to get a copy. Join Asimov Press. It will always be free.

DNA
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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog: Drug Discovery

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

FDA
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Medimaps Launches Next-Gen TBS Osteo Software in Europe

The Pharma Data

With clearance under the EU’s Medical Device Regulation (MDR), the rollout marks a significant step forward in transforming osteoporosis detection and enhancing bone health management throughout Europe. Medimaps Group Launches Next-Generation TBS Osteo Software Across Europe to Revolutionize Osteoporosis Detection Medimaps Group S.A.,

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AZVUDINE

New Drug Approvals

22] In the same month, China’s drug regulator (NMPA) decided to fast-track the approval process, labelling it a first-in-class medication. [14] In July 2022, China’s drug regulator granted conditional approval for it to be used to treat COVID-19, following a local phase III trial. [6] 17 (4): 679–687. doi : 10.3851/IMP2094.

RNA
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Article Periodic: EU’s PIC Regulation adds 35 new entries

Agency IQ

EU’s PIC Regulation adds 35 new entries The European Commission’s latest update to the export and import of hazardous chemicals regulation – which implements the Rotterdam Convention on prior informed consent in the EU – includes 27 pesticides and eight industrial chemicals in the list of substances requiring export notification.